13746769 true A randomised controlled trial evaluating the efficacy and mechanisms of online PeRinatal emOtional skillS groups compared to treatment as usual for women and birthing parents with borderline Personality disordER (PROSPER). PROSPER Principal objective: To determine whether online emotional skills group (ESG) sessions, in addition to standard NHS perinatal mental health care, can help to relieve symptoms of BPD in women and birthing parents who have borderline personality disorder, in comparison to standard NHS perinatal mental health care only. Secondary objectives: To determine whether ESG sessions reduce psychological distress and/or improve wellbeing, social functioning, health-related quality of life, postpartum bonding and caregiving. To determine whether ESG sessions affect the health of participants' babies. To test whether ESG sessions work by improving the regulation of emotions, tolerance of distress, mindfulness and/or the understanding of others. To explore participants' and their therapists' views and experiences of perinatal ESG sessions. Background and study aims People with a diagnosis of borderline personality disorder (BPD) often have difficult relationships, experience distressing changes in mood and are at increased risk of self-harm and suicide. Pregnancy, childbirth and becoming a parent are known as the ‘perinatal period’. During this period, the bond that forms with a baby is very important and can affect the health and later development of the baby. This period can be particularly stressful for women and birthing parents with BPD, but we do not know the best way to help people with BPD during the perinatal period. People with BPD have advised us that they would have valued more help during this very important period of their lives. The aim is to determine the efficacy of perinatal emotional skills groups (ESGs) (in addition to Current NHS care) for women and birthing parents with BPD. Who can participate? Women and birthing parents aged 18 or over who are currently pregnant (from 12 weeks’ gestation onwards) or who have given birth within the past 12 months can take part in the study. Participants will need internet access, at least conversational-level English, and to meet the DSM-5 criteria for borderline personality disorder. What does the study involve? Individuals who decide to take part in the PROSPER study will be randomly put into one of two groups. Group 1 will receive NHS current perinatal mental health care; this currently consists of assessments, care planning, and reviews delivered by staff working in perinatal community mental health teams. Group 2 will attend ESGs for 3 months. This involves attending 12 online sessions (each lasting about 2 hours) covering a range of topics, including feelings about becoming a parent and their relationship with the baby. They will also receive current NHS perinatal mental health care. Babies are welcome to be present during the sessions; there is no expectation that parents need to arrange childcare. A researcher will contact the participants three times during the first 3 months. Participants will also be contacted by the researcher at 4, 8 and 12 months. During each call, the researcher will go through several questionnaires about participants’ mental health and well-being. They will also ask about any complications participants have had since their last call. At 12 months, the researcher will also ask them for some information about their baby’s health. Each video call with the researcher will last for 30-60 minutes. With participants’ consent, the study team would like to video-record a portion of the 12-month video call they have with the researcher, so that we can look at their interactions with their baby. They will ask if participants agree to this during their 8-month follow-up call with the researcher (the call before the 12-month follow-up call); if they agree, they will ask them to sign a consent form. Some participants will also be invited to have a conversation (research ‘interview’) to understand their views on being in the study and their treatment experiences since starting the study. What are the possible benefits and risks of participating? Benefits: There is no guarantee that the study will benefit participants’ health directly; however, it will guide the study team in finding the best way to help people who are perinatal with BPD in future. All appointments for the study can be done remotely, so there is no expectation for participants to travel to see us for this study. Risks: Participants will be asked to spend time completing questionnaires across the year, which will focus on their mental health and wellbeing. If they are put into Group 2, during the Emotional Skills Groups, they will be asked to think about and discuss their feelings about becoming a parent and their relationship with the baby. These discussions will sometimes touch on sensitive matters relating to emotions and relationships. The sessions will be conducted by a clinical psychologist, working with other trained and experienced perinatal health professionals, and the well-being and safety of all those taking part will be closely monitored by an independent group of experts throughout the study. During the optional interview, participants may be asked about their experiences of the support they received for the symptoms of BPD and during pregnancy. For some people, this may cause distress. The research team will try to ensure that participants are comfortable. They can pause or stop the interview at any time with no obligation to continue. Where is the study run from? This study is sponsored by the University of Bristol; the Bristol Trials Centre (at the University of Bristol) is responsible for managing the study. When is the study starting and how long is it expected to run for? The study began in June 2025, with participant recruitment expected to start in June 2026. The study is expected to run until late 2028. Who is funding the study? The National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME), UK. Who is the main contact? Chief Investigator, Prof Paul Moran, paul.moran@bristol.ac.uk The global BPD symptom severity the total score on the Zanarini Rating Scale for Borderline Personality Disorder-Self Report (ZAN-BPD-SR) 4 months post-randomisation (end of intervention delivery) Emotional regulation, distress tolerance, mindfulness and interpersonal sensitivity, the Difficulties in Emotion Regulation Scale, Distress Tolerance Scale, Mindful Attention Awareness Scale and the Brief Symptom Inventory interpersonal sensitivity subscale, respectively, 4 months post-randomisation Psychological distress, wellbeing, social functioning, health-related quality of life and postpartum bonding CORE-10, SWEMWBS, WSAS, EQ-5D-5L & PBQ 4 months post-randomisation Global BPD symptom severity, and psychological distress, wellbeing, social functioning, health-related quality of life and postpartum bonding, ZAN-BPD-SR, and CORE-10, SWEMWBS, WSAS, EQ-5D-5L & PBQ, respectively, at 8- and 12-months post-randomisation Sensitivity the NICHD assessment 12-months post-randomisation Infant weight, height, vaccination status & referrals to safeguarding services self reporting by the participant including use of the Personal Child Health Record (PCHR) 12-months post-randomisation Treatment adherence, therapeutic alliance, and group cohesion attendance of ESG sessions, Working Alliance Inventory – Short Revised and the Group Climate Questionnaire-Short (GQS-S) 4-months post-randomisation Ethics approval required North West - Preston Research Ethics Committee

2 Redman Place, Stratford

London United Kingdom E20 1JQ 26/NW/0022 10.1186/ISRCTN13746769 341566 CPMS: 61444, NIHR: 167051 341566 61444 167051 Interventional Randomized controlled trial Open (masking not used) Active Parallel Treatment Not applicable Treatment 2028-08-31T00:00:00.000Z United Kingdom England Leeds and York Partnership NHS Foundation Trust

St. Marys House St. Marys Road

Leeds England LS7 3JX RGD@2.16.840.1.113883.2.1.3.2.4.18.48 Mersey Care NHS Foundation Trust

V7 Building Kings Business Park Kings Drive

Prescot England L34 1PJ RW4@2.16.840.1.113883.2.1.3.2.4.18.48 Avon and Wiltshire Mental Health Partnership NHS Trust

Bath NHS House Newbridge Hill

Bath England BA1 3QE RVN@2.16.840.1.113883.2.1.3.2.4.18.48 West London NHS Trust

1 Armstrong Way

Southall England UB2 4SD RKL@2.16.840.1.113883.2.1.3.2.4.18.48 Hampshire and Isle of Wight Healthcare NHS Foundation Trust

Tatchbury Mount Hospital Calmore

Southampton England SO40 2RZ RW1@2.16.840.1.113883.2.1.3.2.4.18.48 Hertfordshire Partnership University NHS Foundation Trust

The Colonnades Beaconsfield Close

Hatfield England AL10 8YE RWR@2.16.840.1.113883.2.1.3.2.4.18.48 South London and Maudsley NHS Foundation Trust

Bethlem Royal Hospital Monks Orchard Road

Beckenham England BR3 3BX RV5@2.16.840.1.113883.2.1.3.2.4.18.48 false Participants may enter the study if ALL of the following apply: 1. Women and birthing parents aged 18 years or over who are pregnant (from week 12 gestation onwards) or within 12 months of having a live birth 2. Meet DSM-5 criteria for borderline personality disorder 3. Have internet access 4. Does not require an interpreter to facilitate clinical engagement 5. Provided informed consent for audio-recording of the ESG sessions (if allocated to the ESG group) Adult 18 Years 51 Years Female 216 0 Participants may not enter the study if ANY of the following apply: 1. Those with psychosis, bipolar disorder or substance dependence 2. Those who pose a high risk to their baby or themselves 3. Those requiring admission to a psychiatric hospital 4. Those who are already receiving psychological treatment that is focused on personality or personality disorder symptoms 2026-06-10T00:00:00.000Z 2027-08-31T00:00:00.000Z Specialty: Reproductive Health and Childbirth, Primary sub-specialty: General Obstetrics (antenatal and postnatal care, perinatal mental health); Health Category: Mental health, Reproductive health and childbirth; Disease/Condition: Mood [affective] disorders, Persons encountering health services in circumstances related to reproduction Mental and Behavioural Disorders Women and birthing parents, aged 18 years or over, meeting DSM-5 diagnostic criteria for BPD will be recruited. They will be allocated to receive emotional skills group (ESG) sessions plus standard perinatal mental health care, or standard perinatal mental health care alone, in a 1:1 ratio. Randomisation will be stratified by centre and minimised by perinatal stage and severity of BPD symptoms. The internal pilot, run across 3 sites, will establish whether sufficient numbers of eligible patients can be recruited, engage with their allocated treatment and whether sufficient primary outcome data can be obtained to robustly answer the trial questions. If the progression criteria are met, the main trial recruitment period will start at (at least) 7 sites. If the main trial proceeds, patients from the internal pilot will be included in the final analysis. All participants will be followed up for 1 year following the final randomisation within each cohort. Within each recruitment centre, potentially eligible patients will be identified from the existing caseload by the PI (or delegated member of the clinical team) for screening into the study. The PI (or delegated member of the clinical team) will introduce the study to potentially eligible patients during an in-person or remote consultation and will establish whether the patient agrees to being contacted by a member of the local research team. The PI (or delegated member of the team) will provide the patient with a copy of the participant information using a layered approach, and it will be explained that, if they agree to be contacted by a member of the local research team, then the first step involves participating in a screening interview to assess their eligibility to enter the trial. During the approach at the initial consultation, the PI (or delegated member of the clinical team) will record the relevant clinical eligibility checks on a screening CRF if the patient agrees to be contacted by the local research team, or if the patient does not wish to be contacted. Where possible, reason(s) for non-participation will be stated. A member of the local research team will arrange a time to schedule a call with the participant to explain the study in more detail, answer any questions and complete the rest of the screening assessment if the patient is interested in participating. This will include confirming the presence or absence of DSM-5 symptoms of BPD by administering the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD). The member of the local research team will inform the patient during the screening interview whether they are eligible for the study or not. Following eligibility being confirmed, if the patient would like to take part and has time to proceed, informed consent will be obtained during the initial screening call. If the patient does not have time during this first call, the member of the local research team will schedule a further call with the patient, where informed consent will be obtained. Consent will also be sought for details of the participant to be shared with the qualitative researcher so that they can be approached about taking part in an interview. Patients who are willing to participate in the trial will be asked to provide informed, written consent, either electronically (e-consent) or on paper. The baseline assessment will proceed once informed consent has been obtained. If the participant has time and it is convenient for them, the baseline assessment will take place immediately after informed consent has been obtained. If this is not convenient for the participant, a further call will be arranged in order to complete the baseline assessment with the participant. The assessment will take place online. The assessments include the Zanarini Rating Scale for Borderline Personality Disorder-Self Report (ZAN-BPD-SR), alongside measures of psychological distress (CORE-10), mental well-being (SWEMWBS), infant bonding (PBQ), social function (WSAS) and quality of life (EQ-5D-5L). The participant will complete the questionnaires verbally with the researcher and the researcher will enter the data directly into the REDCap database. Screensharing may be utilised to show the questionnaires, so that participants have time to read and digest the questions. At baseline, participants will be asked to provide socio-demographic details and additional information will be gathered on indicators of socio-economic status. Birth outcomes will be collected from the participant (e.g. birth weight, mode of delivery and whether the baby was transferred to a neonatal unit); these will be collected later if the participant has not yet given birth at the time of joining the study. After informed consent has been provided by the participant and the baseline assessment has been completed, participants will be randomised by the local research team using REDCap. Individuals will be allocated, on a 1:1 ratio, to online perinatal ESGs (in addition to usual care (UC)) or UC alone. There may be a short delay until treatment begins to allow for a sufficient number of participants to be recruited to online ESGs. Participants randomised to perinatal ESGs will attend up to two individual, preparatory sessions (60 minutes per session), followed by 12 online group intervention sessions (2 hours per session). The individual preparatory sessions involve having an opportunity to meet the facilitators and ask any questions, as well as establishing specific, individually tailored goals for the group intervention. The optimum number of participants in each group is 6-8. The ESG sessions will be audio-recorded in order to monitor how well the sessions are being delivered. Participants will be informed in the participant information leaflet that ESG sessions will be audio-recorded and will provide consent to the recording. The comparator treatment will be usual perinatal mental health care, delivered on an individual basis, in accordance with current NICE (National Institute for Health and Care Excellence) guidelines. Usual care (UC) will be delivered by staff working in perinatal community mental health teams and will comprise assessment, care planning, and reviews. UC does not routinely include access to perinatal ESGs. However, as part of UC, during a crisis, patients may be referred to a mental health crisis team, and arrangements may also be made for inpatient treatment if it is not possible to safely manage them in the community. Staff will also be able to refer participants in both groups to psychological treatments during their study participation, except psychological treatments that are focused on personality or personality disorder symptoms, because such treatments are closely related to the intervention (ESG sessions). The rationale for this is that the overarching aim of the study is to test the efficacy of ESGs. The frequency and nature of service contact and treatment associated with UC will be captured in both trial arms directly from participants. Follow-up frequencies will be calculated based on the randomisation date of the last recruited participant within each cohort. All follow-up assessments, at 4,8 and 12 months post-randomisation, will be done remotely by video call (or telephone, if preferred) with a member of the local research team. These calls will each last 30-60 minutes; participants will be asked questions about their mental health and any adverse events they have experienced since the previous assessment. At 12 months, sensitivity will be assessed via a video-recording of a portion of the call; this is so that researchers can assess the participant's interactions with their baby. The assessment is performed using the National Institute of Child Health and Human Development Sensitivity Scale (NICHD). This is optional, and participants will be asked via a consent form at the 8-month follow-up assessment whether they agree to a section of the 12-month follow-up video call being recorded for this purpose. If the participant agrees, at the beginning of the 12-month follow-up call, the local research team will again ask the participant if it is acceptable to record. The following secondary infant outcomes will also be collected at 12 months post-randomisation: weight, height and vaccination status, which will be self-reported by the participant using the Personal Child Health Record (PCHR), i.e. 'Red Book' and referrals to safeguarding services, which will be self-reported by the participant. The embedded mechanistic study will determine how any reductions in BPD severity are mediated; this will be assessed via various questionnaires in all participants during weeks 1, 6 and 12 of treatment (1st, 6th and 12th ESG sessions or the equivalent timepoint in the UC group). Questionnaires administered will be as follows: Difficulties in Emotion Regulation Scale (DERS), Distress Tolerance Scale (DTS), Mindful Attention Awareness Scale (MAAS) and the Brief Symptom Inventory (BSI) interpersonal sensitivity subscale. Additional mechanistic assessments will be carried out in only those randomised to perinatal ESGs during weeks 1, 6 and 12 of treatment measurements. Some participants will also be invited to take part in the embedded qualitative study, participants will be asked to provide verbal consent to being interviewed and these interviews will be audio-recorded. We will examine the views and experiences of both the intervention and the trial with a sample of participants, therapists and their supervisors. Interviews with ESG participants, supervisors and therapists at 4 months will examine group dynamics and the therapeutic alliance with group facilitators, and how the groups may impact the domains of emotional regulation, distress tolerance, mindfulness and interpersonal sensitivity. We will also explore patient and staff perspectives about the emerging relationship with the baby. Usual care participants will be interviewed to examine their experiences and compare them with those of intervention arm participants. We anticipate interviewing up to 30 participants, 14 therapists and 7 supervisors. Each interview will take up to one hour. A Study Within A Trial is also embedded. Given that the PROSPER trial will exclude people with Limited English Proficiency (LEP) due to the current set-up and delivery of the ESG online sessions, the aim of the SWAT is to explore the feasibility of adapting the perinatal ESG group intervention for people with symptoms of BPD who have LEP, and whether it can be tailored for people from different ethnic groups. We will use a mixed-methodology approach to address these objectives. Using detailed screening data, we will collect ethnicity and language data (where available) to explore the need for possible adapted perinatal ESGs. Qualitative methods will then be used to explore the views of perinatal people, therapists and supervisors on barriers and facilitators of setting up adapted perinatal ESG groups for people from ethnic minority groups with LEP. Individual, semi-structured interviews with the therapists and supervisors will be combined within the main qualitative realist evaluation to reduce both participant and researcher burden. Patients excluded from the trial, as deemed 'required an interpreter to facilitate clinical engagement will be approached and provided with the Summary and Main SWAT PIL. With permission via verbal consent, contact details will be passed on to the research team to arrange an interview. Participants who agree to be contacted will be approached by the GCP-trained researcher who will explain more about the interview, answer any questions, and, if they agree, arrange a convenient time via their preferred method to conduct the interview. An interpreter will be provided for interviews taking place with patients approached to take part in PROSPER who were excluded due to LEP. Interviews will be up to 60 minutes. A maximum of 20 therapists and supervisors at sites and up to 15 perinatal people from ethnic minority groups will be interviewed. Behavioural Data sharing statement to be made available at a later date

c219e95e-a4ff-4201-ab6b-26d2e285986f 7cd8ef66-623f-4025-9708-4b50f6fff8e1 4ce2a5bb-753b-4d14-ba3a-b12e206d3967 66d84590-5a1c-4b74-bb3a-751f3f08544f No Nikki Blythe https://orcid.org/0009-0002-9267-4848 Public

Trial Manager, 1-5 Whiteladies Road

Bristol United Kingdom BS8 1NU - Prosper-trial@bristol.ac.uk Public Paul Moran https://orcid.org/0000-0002-9257-8699 Principal investigator Scientific

Chief Investigator, University of Bristol, Canynge Hall, 39 Whatley Road

Bristol United Kingdom BS8 2PS +44 (0)117 455 4673 paul.moran@bristol.ac.uk Public University of Bristol Hospital/treatment centre https://ror.org/0524sp257 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 94157188 true A multicEntre trial to AssesS the validitY of the Kardia six-lead hand-held ECG in psychiatry (Easy ECG V1) Easy ECG V1 1. Compare the diagnostic accuracy of the K6L to the 12L for QT interval in people taking antipsychotic medication. 2. Compare the time to obtain QTc readings between the K6L and 12L – efficiency. 3. Understand the patient acceptability of the K6L compared with the 12L. 4. Using the NICE EVA as reference, determine why and how frequently it is necessary to perform a 12L after a K6L. 5. Describe the prevalence of QT prolongation in patients taking antipsychotics. 6. Understand the clinician acceptability of the K6L. Background and study aims Some medications that are prescribed for patients with mental health problems have side effects that can affect the heart. Doctors use heart tracings called ECGs to understand how the heart is working and ensure it is safe for the person to take these medications. To have a standard ECG, electrode stickers are stuck on the person's chest, wrists and ankles, who then needs to lie still whilst the ECG is recorded. Sometimes, people who need an ECG cannot have it. For example, people who are in distress may not be able to undress or lie still. Sometimes people feel uncomfortable undressing in front of others. Often, NHS clinics do not have the facilities to do ECGs, and the person's GP is asked to do it. Our work has shown that this causes delays in treatment and extra appointments. A new credit-card-sized ECG device (the Kardia 6L [K6L]) has recently been developed. To use it, the person rests two fingers on top of the device and places it so that the back touches the skin of their knee or ankle. The recordings are sent to a phone via Bluetooth. We think the K6L will help more people with mental illness get the ECGs they need. This would help improve safety for people taking medication, reduce the number of appointments and improve the experience for people. We have already shown that the K6L works well in patients seen in a cardiology service. We want to find out how well it works in people seen in mental health services. Who can participate? Patients aged 18 years and over who have been prescribed an antipsychotic medication in any setting What does the study involve? Once consented into the study, participants will first have their demographic information and relevant history recorded. This will be done by reviewing the patient records (notes) and speaking to the participant. Every participant will have their height and weight recorded. Participants will have a 12L ECG followed by a 6L ECG. The 6L should be started as soon as possible after the 12L ECG has been recorded. This time should be no longer than 2 minutes after the 12L has been recorded. The operator will be either a research assistant or a research nurse. At selected sites, a healthcare worker from the participant’s regular clinical team who has been trained to conduct ECGs will carry out the ECGs. The operator of the machines will record the time taken to conduct the 12L from the point that the participant starts to undress or the operator starts to prepare the equipment (whichever comes first). The operator will record the time taken to conduct a 6L starting from the time the operator starts to prepare the equipment. After the ECGs have been take the operator will ask the participant a two-question survey: If you were to have this procedure again with either machine, which test would you choose? What are the reasons you chose [answer from question 1]? What are the possible benefits and risks of participating? We do not anticipate any adverse events in this study. No intervention is being delivered, and data is being collected at one timepoint. Where is the study run from? Leeds Yorkshire Partnership Foundation Trust (UK) When is the study starting and how long is it expected to run for? April 2026 to April 2027 Who is funding the study? Alivecor, Inc. (USA) Who is the main contact? 1. Nazya Azam, nazya.azam@nhs.net 2. Dr George Crowther, georgecrowther@nhs.net QT interval Kardia 6L and standard 12-lead ECG baseline Old ethics approval format Approved 27/10/2025, HRA and Health and Care Research Wales (HCRW) (2 Redman Place, Stratford, London, E20 1JQ, UK; Tel: not available; approvals@hra.nhs.uk), ref: 25/YH/0173 10.1186/ISRCTN94157188 356658 CPMS: 61500 356658 61500 Non-randomized study Interventional Non randomised study Treatment 2027-04-01T00:00:00.000Z United Kingdom England Leeds and York Partnership NHS Foundation Trust

St. Marys House St. Marys Road

Leeds England LS7 3JX RGD@2.16.840.1.113883.2.1.3.2.4.18.48 Tees, Esk and Wear Valleys NHS Foundation Trust

Trust Headquarters West Park Hospital Edward Pease Way

Darlington England DL2 2TS RX3@2.16.840.1.113883.2.1.3.2.4.18.48 Kent and Medway Mental Health NHS Trust

Farm Villa Hermitage Lane

Maidstone England ME16 9PH RXY@2.16.840.1.113883.2.1.3.2.4.18.48 Essex Partnership University NHS Foundation Trust

The Lodge Lodge Approach Runwell

Wickford England SS11 7XX R1L@2.16.840.1.113883.2.1.3.2.4.18.48 Humber Teaching NHS Foundation Trust

Trust Hq Block a Willerby Hill Beverley Road Willerby

Hull England HU10 6ED RV9@2.16.840.1.113883.2.1.3.2.4.18.48 Bradford District Care NHS Foundation Trust

New Mill Victoria Road Saltaire

Shipley England BD18 3LD TAD@2.16.840.1.113883.2.1.3.2.4.18.48 Cambridgeshire and Peterborough NHS Foundation Trust

Elizabeth House Fulbourn Hospital Fulbourn

Cambridge England CB21 5EF RT1@2.16.840.1.113883.2.1.3.2.4.18.48 Surrey and Borders Partnership NHS Foundation Trust

18 Mole Business Park Randalls Road

Leatherhead England KT22 7AD RXX@2.16.840.1.113883.2.1.3.2.4.18.48 Hampshire and Isle of Wight Healthcare NHS Foundation Trust

Tatchbury Mount Hospital Calmore

Southampton England SO40 2RZ RW1@2.16.840.1.113883.2.1.3.2.4.18.48 false Any patient prescribed or due to be prescribed an antipsychotic medication in any setting (ward or outpatient) Mixed 18 Years 100 Years All 800 0 1. Aged under 18 years old 2. Patients who lack capacity and do not have a personal consultee to give advice or where the personal consultee does not think they would want to take part 2025-12-04T00:00:00.000Z 2027-04-01T00:00:00.000Z Cardiovascular and mental health Circulatory System We will conduct a multi-centre study comparing K6L vs 12L ECGs in people receiving antipsychotic therapy. There will be ten NHS sites in total. Our sites span England and Wales and serve a range of rural, urban and semi-rural communities. This will allow us to ensure participants are from a wide range of socioeconomic and ethnic backgrounds. Duration is eighteen months in total (3 months set up, 12 months data collection, 3 months analysis and write up). Recruitment will take place in any clinical area where antipsychotic treatments are prescribed (outpatient or inpatient) in eligible people. Study procedures consist of one 12L ECG and one KardiaMobile 6L ECG per participant, recorded sequentially by the same individual. The 6L should be started as soon as possible after the 12L ECG has been recorded. This time should be no longer than 2 minutes after the 12L has been recorded. Once consented into the study, participants will first have their demographic information and relevant history recorded. This will be done by reviewing the patient records (notes) and speaking to the participant. Demographic information: 1. Age 2. Gender at birth 3. Ethnicity 4. Height 5. Weight History: 1. Primary psychiatric diagnosis for which the antipsychotic is prescribed for 2. Other psychiatric diagnoses 3. Current antipsychotic treatment – type/types of antipsychotic, dose and administration route 4. Other prescribed medications that can impact QT interval 5. Cardiovascular history The 12L will be collected using a MAC 550 (GE Healthcare, WI, USA) or equivalent recorder (calibrated as per machine standards). The 6L will be collected using an Alivecor Kardiamobile 6-lead ECG machine. The operator will be either a research assistant or research nurse. At selected sites (Leeds, Hull, Tees Esk and Wear Valleys (TEWV) and Kent), a healthcare worker from the participant's regular clinical team who has been trained to conduct ECGs will carry out the ECGs. The operator of the machines will record the time taken to conduct the 12L from the point that the participant starts to undress or the operator starts to prepare the equipment (whichever comes first). The operator will also record the time taken to conduct a 6L starting from the time the operator starts to prepare the equipment. After the ECGs have been take the operator will ask the participant a two-question survey: 1. If you were to have this procedure again with either machine, which test would you choose? 2. What are the reasons you chose the [answer from question 1]? Participant survey data will be analysed to understand patient acceptability. A simple count will be used to demonstrate preference between the devices (survey question 1). Content analysis will be used to illustrate the reasons behind this decision and a list of the top 5 reasons for the preference will be created for each type of machine. Healthcare worker time to treatment and ECG quality analysis: At selected sites (Leeds, Kent, Hull and TEWV), 80 ECGs will be collected by a member of the participant's usual treating team who has been trained to use K6L and 12L ECGs. This is to test whether there is a difference in time taken to complete the ECGs and the K6L ECG quality when ECGs are completed by a researcher compared to the usual treating team (real world setting). The data recorded will be identical to the data collection set out above, except that the person conducting the ECG will be asked to indicate which ECG they prefer and why (objective 6). The ECGs will be graded by independent observers who are blinded to the patient and patient details. Noise on ECG will be described according to a noise score (NS) where NS 1 is a completely clear ECG, NS 2 is an ECG with noise but where a good interpretation was possible, NS 3 borderline ECG for noise (analysis based on RR regularity), and NS 4 is not interpretable. K6L validation: The automated QT and QTc analysis will be recorded. This data will be available to the clinical team to aid patient management. Additionally, all other automated intervals will be recorded, e.g. PR interval. Statistical analysis will be performed (Bland Altman and regression analysis) to compare the differences in these results between the 12L versus the K6L for QT, QTc and PR intervals in leads I, II, and AvL. Equivalence of the measurements using the two methods will be carried out using standard equivalence testing methods at a 5% level of significance, with 95% limits of agreement reported. Time to obtain ECG reading: Statistical analysis will be performed to compare the time taken to complete the 6- and 12-lead ECGs. Two separate analyses will be reported: 1. The difference in time when the ECGs are performed by a research assistant. 2. The difference in time when the ECGs are performed by a member of the clinical team (who has been trained to conduct ECGs). Frequency of the need to repeat ECG following K6L: From the 6L data only, using the NICE early valuation assessment criteria for when a repeat QT interval measurement using a 12-lead electrocardiogram (ECG) device is offered following a 6-lead ECG*, we will report the number and proportion of times it would be necessary to complete a 12 Lead ECG following a 6-lead ECG. *When QTc interval is > 440 in men or >470 in women. Prevalence of QT prolongation: The whole cohort will be used to demonstrate the prevalence of QT prolongation in (>440 in men, >470 in women) in people taking antipsychotics. We will also use the data to demonstrate any dose-related effects of antipsychotics on QT (total daily antipsychotic dose as an equivalent to haloperidol vs QTc), and any differences in QTc dependant on antipsychotic type or administration route. All prevalence data will be displayed as a percentage. Recruitment: Potential participants will be identified by their clinical care team, in conjunction with local site research assistants or research nurse (depending on site preference). A research assistant or research nurse (depending on site preference) at each site will recruit 80 participants from both wards and outpatient clinics. The research assistant/nurse will provide the participant information sheet and explain the study. We will work with our PPI group to ensure these materials are understandable and provide easy read versions. Furthermore, we have budgeted for services to translate patient information where necessary. It is hoped that participants will be recruited on the same day, but where necessary they will be given time to consider participation or discuss it with family and friends. Where potential participants lack capacity to consent, personal consultees will be approached on their behalf. Patients who do not wish to participate will receive treatment as usual. ECG registry: Every recruited patient will have the opportunity to opt into a long-term registry. Consent will be obtained to enable the study team to collect adverse cardiac event data and details of the psychotropic prescriptions from hospital or GP records for 10 years. Other Data sharing statement to be made available at a later date 77a68d28-9476-4e3d-9bd5-7e3e6d15a7ec 8b50210b-6e32-4731-9612-ee1882789b29 81826f35-0404-45cc-9d0b-18bac5540999 74e2c6f7-2959-4fd6-86be-20464f387187 No Nazya Azam Scientific

Leeds and York Partnership NHS Foundation Trust, 1st Floor, Main House, St Mary's House

Leeds United Kingdom LS7 3JX +44 (0)7980 958984 nazya.azam@nhs.net Public George Crowther Scientific

Liaison Psychiatry for Older People, Beckett Wing, St James's Hospital

Leeds United Kingdom LS9 7TF +44 (0)7703288239 georgecrowther@nhs.net Public Leeds and York Partnership NHS Foundation Trust Hospital/treatment centre https://ror.org/00n635c12 Non-commercial Alivecor, Inc. 23019026 true Supporting Physical Activity through Co-production in people with Severe Mental Illness (SPACES): a pragmatic randomised controlled trial of a bespoke intervention to increase levels of physical activity in people with SMI compared to usual care SPACES full scale RCT A bespoke physical activity intervention is more effective at increasing levels of physical activity in people with severe mental illness than usual care Background and study aims Life expectancy is reduced by around 15 - 20 years for people with severe mental ill health (SMI) compared to people without SMI, and this gap is increasing. The majority of these early deaths are due to physical health problems, which are partly preventable and which are related to factors including health behaviours such as diet, smoking and physical activity. Increasing physical activity can improve physical health in everyone and The World Health Organization has said that encouraging people to be more active can be as beneficial as quitting smoking. People with SMI are less physically active than the general population. Supporting people with SMI to increase their levels of physical activity could help to reduce the life expectancy gap. Therefore, there is a need to establish whether a physical activity programme (intervention) that is relevant to the needs of people with SMI, is practical, acceptable and useful for people with SMI. In this study, we will explore the clinical effectiveness and cost effectiveness of a physical activity intervention we have co-designed for people living with severe mental ill health. Who can participate? People aged 18 years and over who have a diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder. What does the study involve? People who agree to take part in the study will be randomly allocated to usual care, or to the physical activity intervention plus usual care. We will collect information about participants level of physical activity at the outset of the trial and at 3, 6 and 12 months to establish whether the intervention is effective at increasing the amount of physical activity performed by people with SMI. We will also examine the impact of the intervention on other outcomes relating to mental health and quality of life. What are the possible benefits and risks of participation? This is considered a low-risk research study. Participants may enjoy and value contributing to research. Participants who are randomised into the intervention plus usual care group may experience benefits from the potential increase in physical activity and reduced sedentary behaviour. Where is the study run from? Sheffield Health & Social Care NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? From January 2024 to March 2028 Who is funding the study? National Institute for Health and Care Research (UK) Who is the main contact? Dr Emily Peckham (Chief Investigator), e.peckham@bangor.ac.uk Objective accelerometer-derived minutes per day of Moderate to Vigorous Physical Activity (MVPA) measured at 6-months post randomisation Current secondary outcomes as of 29/05/2026: 1. Data on physical activity (light physical activity and MVPA) and sedentary behaviour will be collected by wrist worn accelerometers at baseline, 3, 6 and 12 months post randomisation 2. The Simple Physical Activity Questionnaire (SIMPAQ) will be used to measure self-reported physical activity and sedentary behaviour at baseline, 3, 6 and 12 months post randomisation Other secondary outcomes measured at 3, 6 and 12 months: 3. Body mass index (kg/m²) 4. Depression (PHQ-9) 5. Anxiety (GAD-7) 6. Loneliness (UCLA-3 item) 7. Health-related quality of life (EQ5D, REQoL) 8. Healthcare resource use and predictive behavioural questionnaire Health risk behaviours (smoking and diet) will be collected at baseline Previous secondary outcomes: 1. Data on physical activity (light physical activity and MVPA) and sedentary behaviour will be collected by wrist worn accelerometers at baseline, 3, 6 and 12 months post randomisation 2. The Simple Physical Activity Questionnaire (SIMPAQ) will be used to measure self-reported physical activity and sedentary behaviour at baseline, 3, 6 and 12 months post randomisation Other secondary outcomes measured at 3, 6 and 12 months: 3. Health behaviours (diet and smoking) 4. Body mass index (kg/m²) 5. Depression (PHQ-9) 6. Anxiety (GAD-7) 7. Loneliness (UCLA-3 item) 8. Health-related quality of life (EQ5D, REQoL) 9. Healthcare resource use and predictive behavioural questionnaire Ethics approval required West of Scotland REC5

West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road

PAISLEY United Kingdom PA2 7DE 24/WS/0040 10.1186/ISRCTN23019026 338802 CPMS: 62060 338802 62060 Multi-center pragmatic randomized controlled trial Interventional Randomised controlled trial Prevention Quality of life 2028-03-31T00:00:00.000Z United Kingdom England Sheffield Health and Social Care NHS Foundation Trust

Centre Court, Atlas Way

Sheffield England S4 7QQ Tees, Esk and Wear Valleys NHS Foundation Trust

Trust Headquarters West Park Hospital Edward Pease Way

Darlington England DL2 2TS Leeds and York Partnership NHS Foundation Trust

2150 Century Way Thorpe Park

Leeds England LS15 8ZB South London and Maudsley NHS Foundation Trust

Bethlem Royal Hospital Monks Orchard Road

Beckenham England BR3 3BX Kent and Medway NHS and Social Care Partnership Trust

Farm Villa Hermitage Lane

Maidstone England ME16 9PH South West Yorkshire Partnership NHS Foundation Trust

Trust Headquarters Fieldhead Hospital Ouchthorpe Lane

Wakefield England WF1 3SP Devon Partnership NHS Trust

Wonford House Dryden Road

Exeter England EX2 5AF Lincolnshire Partnership NHS Foundation Trust Hq

NHS Foundation Trust Carholme Court Long Leys Road

Lincoln England LN1 1FS Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

St Nicholas Hospital Jubilee Road Gosforth

Newcastle upon Tyne England NE3 3XT Surrey and Borders Partnership NHS Trust Hq

18 Mole Business Park Randalls Road

Leatherhead England KT22 7AD RXXHQ@2.16.840.1.113883.2.1.3.2.4.18.48 Betsi Cadwaladr University Lhb Mold Office

Preswylfa Hendy Road

Mold Wales CH7 1PZ 7A1YD@2.16.840.1.113883.2.1.3.2.4.18.48 Coventry and Warwickshire Partnership NHS Trust

Wayside House Wilsons Lane

Coventry England CV6 6NY RYG@2.16.840.1.113883.2.1.3.2.4.18.48 Pennine Care NHS Trust

225 Old Street

Ashton-under-lyne England OL6 7SR RT2HQ@2.16.840.1.113883.2.1.3.2.4.18.48 Patient Service user 1. Aged 18 years or older 2. ICD-10 or DSM-V diagnosis of SMI as documented in GP or psychiatric notes (schizophrenia (F20 and subcodes); schizoaffective disorder (F25 and subcodes); other psychotic and delusional disorders (not of organic origin) (F21-F24 and F26-F29 and subcodes); bipolar and manic episodes (F30 and F31 and subcodes)). 3. Are able to walk unaided 4. Willing to wear an accelerometer Mixed 18 Years 100 Years All 736 0 1. People who lack capacity to participate 2. Primary diagnosis of drug or alcohol abuse 3. Medical contraindication of physical activity as ascertained by GP or mental health team 4. Already physically active, defined as >300 minutes/week of self-reported moderate-to-vigorous physical activity (MVPA) 5. Non-English speakers 6. People who took part in the feasibility study 2024-09-01T00:00:00.000Z 2027-02-28T00:00:00.000Z Increase in physical activity in people with severe mental illness Mental and Behavioural Disorders Control and intervention groups: Both groups will receive usual care. Intervention group only: The intervention comprises of two core components, weekly group-based sessions and one-to-one sessions with the physical activity coordinator. All participants allocated to the intervention, will be offered up to 18 weekly group-based sessions and up to 10 one-to-one sessions delivered by a trained physical activity coordinator. The weekly group-based session will be up to two hours in length and include three components (up to 60 minutes of physical activity, a 30-minute themed discussion and 30 minutes of social time). The physical activity component will be made up of either an outdoor walk, an indoor circuit style activity graded to the needs of the participants (e.g., resistance exercises, balance exercises, cardiovascular exercises) or a community taster session (e.g., walking football, yoga). The themed discussions will involve informal information giving/sharing, which will cover relevant topics (e.g., getting started/keeping going with physical activity, benefits of increasing physical activity and reducing sedentary behaviour, overcoming barriers/hurdles to doing physical activity, being active in everyday life, staying motivated, keeping energised, exploring local indoor and outdoor activities). Time for informal socialising will make up the final portion of the weekly group-based session. The session will be delivered in a suitable NHS or community venue and run weekly for 18 weeks. Randomisation Allocation will be through block randomisation (with random permuted blocks of various integer multiple of two size) with a separate schedule for each combination of centre and diagnosis. There will be no additional stratification factors, beside centre, and diagnosis (Schizophrenia (F20 and subcodes) vs. Schizoaffective disorder (F25 and subcodes) vs. Other psychotic and delusional disorders (not of known organic origin) (F21 – F24 and F26 – F29 and subcodes) vs. Bipolar disorder and manic episodes (F30 and F31, and subcodes)) in the randomisation sequence. The study statistician in Sheffield CTRU will generate the randomisation schedule prior to the start of the study using its own web-based in-house CTRU (SCRAM) randomisation system. Behavioural The datasets generated during and/ or analysed during the current study will be available on request from Emily Peckham email: e.peckham@bangor.ac.uk Available on request

Study website Migrated from study website field

bcc87cb9-c256-4c16-a22b-6916b6f5478c d66ee9c6-10e7-4cf2-b46a-64c98e4f6952 7f951729-213f-48ab-9f30-dd9983e6d2fb Yes Emily Peckham https://orcid.org/0000-0002-9377-1968 Public Scientific Principal investigator

Centre for Mental Health and Society, Wrexham Academic Unit, Technology Park

Wrexham United Kingdom LL13 7YP +44 3000 847 086 e.peckham@bangor.ac.uk Public Sheffield Health and Social Care NHS Foundation Trust Hospital/treatment centre https://ror.org/05cn4v910 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 77855199 true A randomised, controlled feasibility study of the SCEPTRE intervention to support smoking cessation and prevent relapse to tobacco use following a smoke free mental health inpatient stay SCEPTRE Feasibility Trial The aim of this study is to assess the feasibility and acceptability of a new intervention to support smoking cessation and prevent relapse after a smoke-free mental health inpatient stay. Background and study aims The proportion of people with mental illness who smoke tobacco is very high compared to the general population. It can reach figures over 70% among those in certain subgroups, such as hospitalised patients with mental illness compared to 15% in the general population. As people with mental illness are usually heavily addicted to tobacco, smoking causes large amounts of disease and deaths in this group, often from cardiovascular, respiratory illness and cancer. Smoking has been recognised as the single largest cause of health inequalities for people with mental illness. People with mental illness lose up to 20 years of life mainly to the consequences of smoking. Although mental health patients often want to quit and can do so successfully, smoking is rarely addressed in mental health care. Guidance from the National Institute of Health and Care Excellence (NICE) recommends that mental health settings become entirely smokefree, and mental health patients should have access to evidence-based stop smoking treatment. For many patients, receiving treatment in a smokefree inpatient environment will be a rare experience of abstaining from tobacco. Currently, no strategies to help maintain or achieve a smokefree lifestyle and avoid relapse post-discharge exist, meaning most patients will return to old smoking behaviours within days of discharge. We have developed the SCEPTRE intervention to support mental health inpatients after discharge to maintain abstinence or positively change their smoking behaviour, building on existing evidence, behaviour change theory, and working closely with service users and mental healthcare professionals. The intervention was tested in a small-scale pilot study to test the research materials and processes, and preliminary acceptability to people with mental illness. Based on these findings, the SCEPTRE intervention has been revised and will be tested in the current feasibility trial. Who can participate? Adults who are 18 years or older who were smokers before their stay in a hospital's mental health ward and are interested in either maintaining the positive changes to their smoking behaviour or improving their smoking habits once they leave hospital. What does the study involve? A support package has been developed to help people with mental health conditions to maintain the positive changes they have made to their smoking behaviour while in hospital. This package will last for 12 weeks after participants have been discharged and will be delivered by a mental health worker trained to provide personalised support to assist them in meeting their smoking behaviour change goals. All participants in the study will have a random chance of receiving the SCEPTRE support package. This means a computer programme will choose if someone receives the support or their usual care. ‘Usual care’ might mean receiving advice to quit smoking on discharge, offering a short supply of Nicotine Replacement Therapy (NRT) products (smoking cessation medication), or a referral to a local stop-smoking service. Participants will be asked to complete a questionnaire three months and six months after joining the study. The questionnaires can be completed either by email through a secure link, with a member of the research team in person, or via telephone or video call. The questionnaires will take approximately 30 minutes to complete and will ask participants about their smoking habits, mental and physical health, and the health services they use. If someone reports they have not smoked, they will be asked to provide another sample of their breath so that we can measure the Carbon monoxide (CO) in their body. What are the possible benefits and risks of participating? If they are allocated to receive the SCEPTRE support package, participants will benefit through the provision of personalised support to change smoking behaviours following a smokefree stay in a mental health hospital. By positively changing their smoking behaviours, this may have both physical and mental health benefits. Where is the study run from? Sheffield Health and Social Care NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? June 2023 to November 2024 Who is funding the study? National Institute for Health and Care Research (NIHR) (UK). Who is the main contact? victoria.exley@york.ac.uk 1. Recruitment and retention measured using screening data and retention rates captured throughout the duration of the study. 2. Compliance with the protocol measured using self-assessment checklists completed by the MTS's and reported protocol deviations throughout the duration of the study. 3. Level of contamination and suitability of randomisation approach measured using qualitative data collected at 3-months post randomisation and quantitative data collected at 3- and 6-months post randomisation from control participants who quit or reduce smoking. 4. Additional qualitative and quantitative measures of acceptability by undertaking semi-structured interviews with control and intervention group participants at 3 months post-randomisation. Measured using self report (unless otherwise noted): 1. Self-reported 7-day point prevalence abstinence from tobacco validated by exhaled CO <10ppm at 3 and 6 months, 2. Self-reported relapse following discharge from hospital at 3 and 6 months, 3. 1, 2, and 3-month continuous abstinence at 3 months post randomisation, 4. 4, 5, and 6-month continuous abstinence at 6 months post randomisation 5. Tobacco consumption at baseline, 3- and 6-months post-randomisation, 6. Number of quit attempts at baseline, 3 and 6 months, 7. Motivation to quit at baseline 3 and 6 months, 8. Heaviness of Smoking Index at baseline, 3 and 6 months, 9. Use of NRT/e-cigarettes at baseline, 3 and 6 months, 10. Self-efficacy related to smoking cessation at baseline, 3 and 6 months, 11. Change in mental health PHQ-9 at baseline, 3 and 6 months, 12. Change in mental health GAD-7 at baseline, 3 and 6 months, 13. Change in mental health EQ-5D at baseline, 3 and 6 months, 14. Cost of delivering the SCEPTRE intervention and the control condition and feasibility of collecting health economic data measured using a bespoke health resource use questionnaire at 3 and 6 months post-randomisation. Ethics approval required North West- Greater Manchester West Research Ethics Committee

2 Redman Place, Stratford

London United Kingdom E20 1JQ 23/NW/0312 10.1186/ISRCTN77855199 329622 CPMS: 58805, NIHR: 200607 329622 58805 200607 Randomized controlled feasibility trial Interventional Randomised controlled trial Other 2024-11-27T00:00:00.000Z United Kingdom England Leeds and York Partnership NHS Foundation Trust

St. Marys House St. Marys Road

Leeds England LS7 3JX RGD@2.16.840.1.113883.2.1.3.2.4.18.48 East London NHS Foundation Trust

Robert Dolan House 9 Alie Street

London England E1 8DE RWK@2.16.840.1.113883.2.1.3.2.4.18.48 Hertfordshire Partnership University NHS Foundation Trust

The Colonnades Beaconsfield Close

Hatfield England AL10 8YE RWR@2.16.840.1.113883.2.1.3.2.4.18.48 Leicestershire Partnership NHS Trust

Riverside House Bridge Park Plaza Bridge Park Road

Leicester England LE4 8PQ RT5@2.16.840.1.113883.2.1.3.2.4.18.48 Derbyshire Healthcare NHS Foundation Trust

Trust Headquarters Kingsway Hospital Kingsway

Derby England DE22 3LZ RXM@2.16.840.1.113883.2.1.3.2.4.18.48 Oxford Health NHS Foundation Trust

Warneford Hospital Warneford Lane Headington

Oxford England OX3 7JX RNU@2.16.840.1.113883.2.1.3.2.4.18.48 Patient Current participant inclusion criteria as of 10/07/2024: 1. Adults (18 years+) who smoked prior to/during admission on acute NHS mental health wards and express an interest in maintaining abstinence or positively changing their smoking behaviour following discharge 2. Planned discharge within seven to fourteen days to address/accommodation within Trust’s catchment area 3. Able to understand and communicate in English 4. Access to a telephone or alternative digital advice to receive post-discharge support 5. Willing and able to provide informed consent Exclusion criteria: 6. Admitted under the care of older adult, learning disability, psychiatric intensive-care unit or forensic mental health services 7. Patients deemed not clinically appropriate to participate (at clinician discretion) Previous participant inclusion criteria: 1. Adults aged 18 years and older (no maximum age) 2. Current admission to an acute adult mental health inpatient setting 3. Planned discharge within seven to fourteen days to address/accommodation within the Trust’s catchment area 4. Tobacco smokers at time of admission or at any point after (as patients occasionally still commence smoking after admission) who express an interest in maintaining abstinence (if smokefree at time of assessment) or in positively changing their smoking behaviour following discharge (including cigarette reduction and e-cigarette approaches) 5. Able to understand and communicate in English 6. Access to a telephone or computer/alternative digital device to receive post-discharge support 7. Willing and able to provide informed consent Mixed 18 Years 100 Years All 64 38 1. Admitted under the care of older adult, learning disability, psychiatric intensive-care unit (PICU) or forensic mental health services. 2. Patients deemed not clinically appropriate to participate in study (at clinician discretion). 2024-01-23T00:00:00.000Z 2024-07-12T00:00:00.000Z Smoking cessation in persons with mental health disorders Mental and Behavioural Disorders Baseline data collection: Once participant eligibility has been confirmed and consent has been obtained, a baseline visit will be completed to collect all baseline data. The following measures will be collected at baseline: - Demographic measures (gender, age, marital status, ethnicity, primary mental health diagnosis, smoking status, housing/accommodation status) - Mental and physical health measures: The nine-item Patient Health Questionnaire depression scale (PHQ-9), the Generalised Anxiety Disorder 7-item scale (GAD-7), and the quality of life scale (EQ-5D-5L), will be included. The frequency of use of health services during the inpatient stay and in the last six months (before hospital admission and during inpatient stay) will also be collected. Smoking history and behaviour: Smoking history and behaviour prior to admission (including number of cigarettes smoked per day, number of past quit attempts, use of e-cigarettes and NRT); smoking history and behaviour during inpatient stay (including number of cigarettes smoked per day, greatest length of time abstinent during stay, Heaviness of Smoking Index (HSI), Strength of urges to smoke, Motivation to Quit Questionnaire, and use of e-cigarettes and NRT. Participants will also be asked about their smoking status intention post-discharge. Participants will be asked to provide a carbon monoxide (CO) reading. Randomisation: Following a baseline assessment, randomisation will be undertaken by a member of the Trusts research team using REDCap. The outcome of the allocation will be communicated to the participant where possible in person but may also be communicated by text or telephone call. Follow up data collection: Participants will be asked to complete questionnaires at 3 and 6 months post-randomisation. Participants will be asked the same questions as the baseline visit minus the demographic questions. Depending on participant preference, they will be able to complete these via email, in person with a researcher or over the phone/video call. Participants who self-report that they have not smoked will be asked to provide a carbon monoxide (CO) reading. Qualitative interviews: Patient and relative/friend participants will also be invited to take part in short semi-structured interviews at the 3 month follow-up time point to gain a more in-depth understanding of the feasibility of the study procedures and intervention delivery, as well as the impact of the intervention on the patient participant. Semi-structured interviews will also be conducted with the MTSs to explore their experience and perceptions of delivering the intervention. Patient and public involvement: The SCEPTRE PPI group have contributed to the design of both the intervention components, participant study documents, intervention resources, and have provided input to the design of intervention delivery mechanisms and measures. Behavioural The datasets generated during and/or analysed during the current study will be available upon request from the Chief Investigator- Elena Ratschen (elena.ratschen@york.ac.uk). Available on request 2025 Protocol article in https://pubmed.ncbi.nlm.nih.gov/40537238/ (added 20/06/2025) Results Basic results see attached file ISRCTN77855199_BasicResults_02Jan2026.pdf (added 02/01/2026)

Migrated from study website field

5e265482-126a-4a97-a212-520561bba481 1c9123ea-88a6-4620-9fe6-adb9ae8d774a 91178ffe-a15e-454d-be5d-db8bc4e779b4 49f08067-cda8-4a39-acca-cd2145859022 4db67d1d-4d9e-403f-8883-1e55ed407f82 a1f98186-cf81-4d68-9ed8-a910afdd2607 Yes Participant information sheet 44476 SCEPTRE feasibility trial_PIS_Participant_v1.0_19.10.2023.pdf afad263f-94d1-431a-a131-a2bac896594f true application/pdf 267174 51baf1da053b0d9aac3df75ea0ac7bfb Protocol file 44476 SCEPTRE_Feasibility_Protocol_ FINAL v1.0_05.09.2023.pdf aa885170-171a-4d19-a7e7-99190e6da3ef true application/pdf 543784 a72badb8f7508dc34fa1d48d33f0a45f Protocol file ISRCTN77855199_Protocol_v2.0_30April2024.pdf 1f6ddccf-e6b9-4fdb-bb88-55b1b91987c0 true application/pdf 610979 6c0a4c352561e09bf88d2c8a80584a9c Participant information sheet ISRCTN77855199_PIS_v1.2_30April2024.pdf 661e3c8b-8084-41c5-b133-e5aa28c3cce1 true application/pdf 215632 c079faf2b5e72f3856d6427a0c2c16ef Basic results ISRCTN77855199_BasicResults_02Jan2026.pdf 30b6173a-e1bf-498a-8cb0-7652a2958b1b true application/pdf 595375 d87a580406f220713a3952dec94386b1 Victoria Exley https://orcid.org/0000-0002-9326-9046 Scientific

York Trials Unit University of York

York United Kingdom YO10 5DD +44 1904 326856 victoria.exley@york.ac.uk Public Elena Ratschen https://orcid.org/0000-0003-4128-9608 Principal investigator

Mental Health and Addictions Group University of York

York United Kingdom YO10 5DD +44 1904 321678 elena.ratschen@york.ac.uk Public Lisa Huddlestone https://orcid.org/0000-0002-8054-4475 Scientific

Mental Health and Addictions Group University of York

York United Kingdom YO10 5DD +44 1904 321949 lisa.huddlestone@york.ac.uk Public Lesley Sinclair https://orcid.org/0000-0002-2210-8181 Public

York Trials Unit University of York

York United Kingdom YO10 5DD +44 1904 324158 lesley.sinclair@york.ac.uk Public Sheffield Health and Social Care NHS Foundation Trust Hospital/treatment centre https://ror.org/05cn4v910 Non-commercial NIHR Central Commissioning Facility (CCF) 36391109 true MoreRESPECT: A randomised controlled trial of a sexual health promotion intervention for people with severe mental illness delivered in community mental health settings MoreRESPECT A bespoke sexual health intervention designed for people with severe mental illness reduces unprotected sexual acts and is cost-effective Background and study aims People with severe mental illness (SMI) have significant needs in terms of physical health compared to the general population. Initiatives have commenced to address this; however, sexual health has been missed off the agenda. Like everyone else, positive sexual relationships are important for people with SMI, but this is rarely discussed in routine mental health care. Therefore, they can be unaware of important information such as where to get sexual health advice, how to reduce risk of sexually transmitted infections, contraceptive choices and finding relationships that are mutually respectful, not violent or abusive. In a National Institute for Health and Care Research (NIHR)-funded feasibility study, this research team developed a 3-session support package that helped people with SMI to think about their own sexual health and provided useful information about how to improve their sexual health. Following the success of the feasibility study, this full trial will examine the effectiveness and cost-effectiveness of the intervention by recruiting 300 people with SMI from National Health Service (NHS) community mental health teams across England and Scotland. Who can participate? This study will recruit 300 participants with SMI from community mental health teams from NHS mental health services across England and Scotland. What does the study involve? People who agree to take part will be randomly allocated to either usual care (control arm) or usual care plus the moreRESPECT intervention (intervention arm). Data will be collected at baseline and then at 3-, 6-, 9- and 12 months post-randomisation. As part of a nested process evaluation, interviews with a small group of participants will also be conducted at 6 months post randomisation to find out how they found the support package and whether it worked better for some than others and in what circumstances. What are the possible benefits and risks of participating? We cannot promise that taking part in this study will help participants directly. However, some people who took part in a previous study told us that they found taking part interesting, thought-provoking, and informative. The results of this study may help us find out how we can improve sexual health for people with a severe mental illness. Taking part will involve participants setting aside some time to meet with a member of the study team to complete the study’s questionnaires. Participants in the sexual health information sessions group will also need to meet with a trained health professional three times. These may be face-to-face meetings or video call meetings. Participants safety and well-being are very important to us. Our team are trained to ensure participants comfort and minimise distress. We are aware that some participants may find some of the topics and questions about sex embarrassing. Some of the questions may also trigger upsetting memories. We will provide information for local and national support and will have a process to supporting those who may become upset or distressed. Where is the study run from? Glasgow Caledonian University (GCU) (UK) When is the study starting and how long is it expected to run for? September 2022 to December 2027 Who is funding the study? National Institute for Health and Care Research (NIHR) (UK). Who is the main contact? morerespect-trial@york.ac.uk Number of unprotected sex acts (anal, vaginal, oral) are recorded using an adapted version (with permission) of the Sexual Risk Assessment Schedule (SERBAS) at baseline, 3, 6, 9 and 12 months 1. Knowledge about human immunodeficiency virus (HIV) and sexually transmitted infections is recorded using an adapted version (with permission) of the HIV-Knowledge Questionnaire (HIV-KQ) at baseline, 3, 6, 9 and 12 months 2. Perception of the risk of infection with a sexually transmitted infection (STI) is recorded using an adapted version of the Motivation to Engage in Safer Sex measure at baseline, 3, 6, 9 and 12 months 3. Attitudes towards the use of condoms as well as questions on self-efficacy in the use and negotiation of use of condoms are recorded using an adapted version (with permission) of the Condom Use Self-Efficacy Scale at baseline, 3, 6, 9 and 12 months 4. Engagement in risky or protective sexual behaviours is recorded using an adapted version (with permission) of the Behavioural Intentions for Safer Sex measure at baseline, 3, 6, 9 and 12 months 5. General questions about sexual health are recoded using items adapted from the National Survey of Sexual Attitudes and Lifestyle (NATSAL) questionnaire at baseline, 3, 6, 9 and 12 months 6. Health-related quality of life is measured using the EQ-5D-5L standardised instrument at baseline, 3, 6, 9 and 12 months 7. Quality of life for people with different mental health conditions is measured using the Recovering Quality of Life (ReQoL) standardised instrument at baseline, 3, 6, 9 and 12 months 8. Heath care resource use, including medications, is captured using a bespoke resource use questionnaire at baseline, 3, 6, 9 and 12 months Ethics approval required North West – Preston REC

2 Redman Place, Stratford

London United Kingdom E20 1JQ 23/NW/0157 10.1186/ISRCTN36391109 309345 CPMS: 56541, NIHR: 133865 309345 56541 133865 Interventional randomized controlled trial Interventional Randomised controlled trial Prevention 2027-12-31T00:00:00.000Z United Kingdom England Leeds and York Partnership NHS Foundation Trust

St. Marys House St. Marys Road

Leeds England LS7 3JX RGD@2.16.840.1.113883.2.1.3.2.4.18.48 Humber Teaching NHS Foundation Trust

Trust Hq, Willerby Hill Beverley Road Willerby

Hull England HU10 6ED RV9@2.16.840.1.113883.2.1.3.2.4.18.48 Camden and Islington NHS Foundation Trust

St Pancras Hospital 4 St Pancras Way

London England NW1 0PE TAF@2.16.840.1.113883.2.1.3.2.4.18.48 Barnet, Enfield and Haringey Mental Health NHS Trust

Trust Headquarters Block B2 St Ann's Hospital St Ann's Road

London England N15 3TH RRP@2.16.840.1.113883.2.1.3.2.4.18.48 Fieldhead Hospital

Ouchthorpe Lane

Wakefield England WF1 3SP 5N252@2.16.840.1.113883.2.1.3.2.4.18.48 West Park Hospital

Edward Pease Way

Darlington England DL2 2TS Wonford House Hospital

Dryden Road

Exeter England EX2 5AF Sheffield Health & Social Care NHS Foundation Trust

Centre Court Atlas Way

Sheffield England S4 7QQ TAH@2.16.840.1.113883.2.1.3.2.4.18.48 Musgrove Park Hospital

Musgrove Park

Taunton England TA1 5DA Springfield University Hospital

Trinity Building, 15 Springfield Dr

London England SW17 0YF North East London NHS Foundation Trust

West Wing C E M E Centre Marsh Way

Rainham England RM13 8GQ RAT@2.16.840.1.113883.2.1.3.2.4.18.48 Berkshire Healthcare NHS Foundation Trust

London House London Road

Bracknell England RG12 2UT RWX@2.16.840.1.113883.2.1.3.2.4.18.48 Avon and Wiltshire Mental Health Partnership NHS Trust

Bath NHS House Newbridge Hill

Bath England BA1 3QE RVN@2.16.840.1.113883.2.1.3.2.4.18.48 Central and North West London NHS Foundation Trust

Trust Headquarters 350 Euston Road Regents PLACE

London England NW1 3AX RV3@2.16.840.1.113883.2.1.3.2.4.18.48 Gloucestershire Health and Care NHS Foundation Trust

Edward Jenner Court 1010 Pioneer Avenue Gloucester Business Park

Gloucester England GL3 4AW RTQ@2.16.840.1.113883.2.1.3.2.4.18.48 Black Country Healthcare NHS Foundation Trust

Trafalgar House 47-49 King Street

Dudley England DY2 8PS TAJ@2.16.840.1.113883.2.1.3.2.4.18.48 Hertfordshire Partnership University NHS Foundation Trust

The Colonnades Beaconsfield Close

Hatfield England AL10 8YE RWR@2.16.840.1.113883.2.1.3.2.4.18.48 Norfolk and Suffolk NHS Foundation Trust

County Hall Martineau Lane

Norwich England NR1 2DH RMY@2.16.840.1.113883.2.1.3.2.4.18.48 Surrey and Borders Partnership NHS Foundation Trust

18 Mole Business Park Randalls Road

Leatherhead England KT22 7AD RXX@2.16.840.1.113883.2.1.3.2.4.18.48 Oxford Health NHS Foundation Trust

Littlemore Mental Health Centre Sandford Road Littlemore

Oxford England OX4 4XN RNU@2.16.840.1.113883.2.1.3.2.4.18.48 Northamptonshire Healthcare NHS Foundation Trust

St Marys Hospital 77 London Road

Kettering England NN15 7PW RP1@2.16.840.1.113883.2.1.3.2.4.18.48 Lincolnshire Partnership NHS Foundation Trust Hq

NHS Foundation Trust Carholme Court Long Leys Road

Lincoln England LN1 1FS RP7SG@2.16.840.1.113883.2.1.3.2.4.18.48 Greater Manchester Mental Health NHS Foundation Trust

Prestwich Hospital Bury New Road Prestwich

Manchester England M25 3BL RXV@2.16.840.1.113883.2.1.3.2.4.18.48 West London NHS Trust

St Bernards Hospital Ealing

London England UB1 3HW Patient 1. Adults aged > = 16 years 2. Diagnosed with a SMI* 3. In receipt of care from any form of adult community mental health service in each NHS site (outpatient clinics, day care, on caseload of community mental health team including assertive outreach; forensic, early intervention for psychosis, recovery colleges, depot clinics) 4. Willing and able to give informed consent to participate *There is no agreed definition of SMI, so we will adopt a pragmatic and inclusive definition: a Psychiatrist assessed and documented (care record) primary diagnosis of schizophrenia schizoaffective disorder, or delusional/psychotic illness, or bipolar disorder, or major depression (with or without psychotic features), or severe anxiety, or personality disorder. Mixed 16 Years 99 Years All 300 311 1. Pose a current risk to others (e.g. research staff) including risks of sexual and/or physical violence 2. A learning disability or other significant cognitive impairment 3. Those known to be on the sex offenders register 2024-01-03T00:00:00.000Z 2026-06-30T00:00:00.000Z Sexual health promotion intervention for people with severe mental illness Mental and Behavioural Disorders Participants will be randomly allocated to either the sexual health intervention group (in addition to usual care) or the usual care group. Data will be collected at the start of the participant’s involvement (baseline) and then at 3, 6, 9 and 12 months after randomisation. Intervention (Sexual health information sessions plus usual care): In addition to continuing with usual care and support that is usually available, participants will be invited to attend sexual health information sessions delivered by a trained health professional. This will comprise of 3 x 1 hour sessions delivered either face-to-face or via video call. Each time intervention participants meet with a health professional they will discuss things such as: understanding sexually transmitted infections; condoms and contraception; safer relationships, including assertiveness skills and negotiating skills relating to the type of sexual relationships they want to have. Control (Usual Care): Participants will continue with their usual care and support that is usually available to them. Behavioural Data sharing statement to be made available at a later date Protocol

Participant information sheet Migrated from patient info sheet field

e8b5e953-7384-475b-849f-815ccec41bed 6fa43952-3d16-47b7-a616-8f2e710b5282 83af4f3b-e642-41da-9f52-17c138bcfa75 c5ea1378-ee0e-4a1f-b8b6-0837de945ca2 68947cb1-620e-4a23-989a-9993259b6ce8 bb27af06-b636-49a8-ac45-6219673a75d9 778715b1-de74-4691-9904-6602ae6c9c66 No Protocol file ISRCTN36391109_Protocol_v1.8_18Feb2026.pdf b31115f4-7d70-4a66-8d08-283b4d5871c7 true application/pdf 776572 0599423fccc4e516a02f5d64d654455d Liz Hughes https://orcid.org/0000-0002-4480-0806 Scientific

Department of Psychology and Mental Health, School of Health and Well-being, University of Worcester

Worcester United Kingdom WR2 6AJ - elizabeth.hughes2@worc.ac.uk Public Laura Wiley Public

York Trials Unit Department of Health Sciences University of York ARRC Building

York United Kingdom YO10 5DD +44 1904 321947 laura.wiley@york.ac.uk Public Laura Wiley Public

York Trials Unit Department of Health Sciences University of York ARRC Building

York United Kingdom YO10 5DD +44 1904 321947 morerespect-trial@york.ac.uk Public Sam Brady Public

York Trials Unit, Department of Health Sciences, University of York, ARRC Building

York United Kingdom YO10 5DD +44 (0)1904 32(1926) samantha.gascoyne@york.ac.uk Public Mo Hammouda Public

York Trials Unit, Department of Health Sciences, University of York, ARRC Building

York United Kingdom YO10 5DD +44 (0)1904 32(3905) mo.hammouda@york.ac.uk Public Glasgow Caledonian University University/education https://ror.org/03dvm1235 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 17381762 true Assessing the Clinical and cost-Effectiveness of inpatient mental health Rehabilitation services provided by the NHS and independent sector (ACER) ACER V1.0 1. Do sociodemographic and clinical characteristics of patients differ between people receiving inpatient rehabilitation in the NHS and the independent sector? 2. Does service quality differ between inpatient rehabilitation units provided by the NHS and the independent sector? 3. Do the experiences of treatment and care, from the perspectives of patients, informal carers and staff, differ between inpatient rehabilitation services provided by the NHS and the independent sector? 4. Is inpatient rehabilitation clinically more effective at preventing readmission when provided by the independent sector or the NHS, after adjusting for differences between the sectors in terms of patient characteristics and length of stay? 5. Is inpatient rehabilitation more cost-effective when provided by the independent sector or the NHS, after adjusting for differences between the sectors in terms of key predictors of costs such as patient characteristics and length of stay? Background and study aims Mental health rehabilitation services provide specialist treatment to people with particularly severe and complex problems. These services include inpatient units and supported accommodation in the community. Over half of the 4400 mental health inpatient rehabilitation beds in England are provided by the independent sector, but there have been no studies investigating the effectiveness of inpatient rehabilitation services that have included the independent sector. Our study aims to address this gap. Who can participate? Any patient with an adequate understanding of English at one of the mental health inpatient rehabilitation units selected for this study. What does the study involve? A research interview which takes about 30 min where participants will be asked a series of questions about how satisfied they are with different aspects of their life, how they spend their time, the freedom they have to make day-to-day decisions, and how they feel about the care you receive from the inpatient rehabilitation service. The research team will also invite participants to a brief 5 min interview at 6, 12, and 18 months after the first interview. These interviews will be done over the telephone or video call (e.g. Zoom or Microsoft Teams). The research team will also ask participants for their permission to ask a staff member about their abilities, needs, any specific difficulties they may have, their activities in the community, and whether they have been at risk or posed any risk to others. The research team will then contact staff involved in the participant's healthcare at regular intervals over the next 18 months to see if they have been discharged from the inpatient rehabilitation service, and, if they have been discharged, details of where they have been discharged to and whether they have had any readmissions. Participants may ask the researcher to see a copy of these questions. The research team would also ask participants for their permission to collect some information from their healthcare records about the care they have received from mental health services in the past. What are the possible benefits and risks of participating? By participating in this study, participants will help the research team to assess the effectiveness of NHS and independent sector inpatient mental health rehabilitation services. It is hoped that the information collected from this study will help to improve inpatient rehabilitation services in the future. Each participant will be offered £20 in recognition of the time they have given to be involved in the study. Where is the study run from? University College London (UK) When is the study starting and how long is it expected to run for? From December 2019 to October 2025 Who is funding the study? National Institute for Health and Care Research (NIHR) Health Services Delivery Research programme (UK) Who is the main contact? Christian Dalton-Locke (Project Manager) c.dalton-locke@ucl.ac.uk Cohort study: Successful discharge from inpatient rehabilitation, defined as being discharged to the community without readmission, measured using staff reports collected at 6, 12, and 18 months Health economic evaluation: Incremental cost-effectiveness ratio (ICER) comparing rehabilitation in the independent sector and rehabilitation in an NHS service calculated using cost-utility analysis (CUA) where the QALYs are measured using patient responses to the EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire collected at baseline, 6, 12, and 18 months Cohort study: Total inpatient days over the follow-up period measured using staff reports collected at 6, 12, and 18 months Old ethics approval format Approved 08/06/2022, North East - Newcastle & North Tyneside 2 Research Ethics Committee (NHS BT Blood Donor Centre, Holland Drive, Newcastle upon Tyne, Tyne and Wear, NE2 4NQ; +44 (0)2071048086; newcastlenorthtyneside2.rec@hra.nhs.uk), ref: 22/NE/0067 10.1186/ISRCTN17381762 311434 CPMS: 52629, NIHR: 130693, award ID: 311434 52629 130693 award ID: Observational cohort study Observational Cohort study Treatment 2025-10-31T00:00:00.000Z United Kingdom England Camden and Islington NHS Foundation Trust

St Pancras Hospital 4 St Pancras Way

London United Kingdom NW1 0PE TAF@2.16.840.1.113883.2.1.3.2.4.18.48 Avon and Wiltshire Mental Health Partnership NHS Trust

Bath NHS House Newbridge Hill

Bath United Kingdom BA1 3QE RVN@2.16.840.1.113883.2.1.3.2.4.18.48 Birmingham and Solihull Mental Health NHS Foundation Trust

Unit 1 50 Summer Hill Road

Birmingham United Kingdom B1 3RB RXT@2.16.840.1.113883.2.1.3.2.4.18.48 Central and North West London NHS Foundation Trust

Trust Headquarters 350 Euston Road Regents PLACE

London United Kingdom NW1 3AX RV3@2.16.840.1.113883.2.1.3.2.4.18.48 Coventry and Warwickshire Partnership NHS Trust

Wayside House Wilsons Lane

Coventry United Kingdom CV6 6NY RYG@2.16.840.1.113883.2.1.3.2.4.18.48 Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

St Nicholas Hospital Jubilee Road Gosforth

Newcastle upon Tyne United Kingdom NE3 3XT RX4@2.16.840.1.113883.2.1.3.2.4.18.48 Devon Partnership NHS Trust

Wonford House Hospital Dryden Road

Exeter United Kingdom EX2 5AF RWV@2.16.840.1.113883.2.1.3.2.4.18.48 Greater Manchester Mental Health NHS Foundation Trust

Prestwich Hospital Bury New Road Prestwich

Manchester United Kingdom M25 3BL RXV@2.16.840.1.113883.2.1.3.2.4.18.48 Herefordshire and Worcestershire Health and Care NHS Trust

Unit 2 Kings Court Charles Hastings Way

Worcester United Kingdom WR5 1JR R1A@2.16.840.1.113883.2.1.3.2.4.18.48 Leeds and York Partnership NHS Foundation Trust

2150 Century Way Thorpe Park

Leeds United Kingdom LS15 8ZB RGD@2.16.840.1.113883.2.1.3.2.4.18.48 Lincolnshire Partnership NHS Foundation Trust

St George's Long Leys Road

Lincoln United Kingdom LN1 1FS RP7@2.16.840.1.113883.2.1.3.2.4.18.48 Mersey Care NHS Foundation Trust

V7 Building Kings Business Park Kings Drive

Prescot United Kingdom L34 1PJ RW4@2.16.840.1.113883.2.1.3.2.4.18.48 North Staffordshire Combined Healthcare NHS Trust

Lawton House Bellringer Road Trentham

Stoke-on-trent United Kingdom ST4 8HH RLY@2.16.840.1.113883.2.1.3.2.4.18.48 Nottinghamshire Healthcare NHS Foundation Trust

The Resource, Trust Hq Duncan Macmillan House Porchester Road

Nottingham United Kingdom NG3 6AA RHA@2.16.840.1.113883.2.1.3.2.4.18.48 Pennine Care NHS Foundation Trust

225 Old Street

Ashton-under-lyne United Kingdom OL6 7SR RT2@2.16.840.1.113883.2.1.3.2.4.18.48 Rotherham Doncaster and South Humber NHS Foundation Trust

Woodfield House Tickhill Road

Doncaster United Kingdom DN4 8QN RXE@2.16.840.1.113883.2.1.3.2.4.18.48 South London and Maudsley NHS Foundation Trust

Bethlem Royal Hospital Monks Orchard Road

Beckenham United Kingdom BR3 3BX RV5@2.16.840.1.113883.2.1.3.2.4.18.48 South West London and St George's Mental Health NHS Trust

Springfield Hospital 61 Glenburnie Road

London United Kingdom SW17 7DJ RQY@2.16.840.1.113883.2.1.3.2.4.18.48 Sussex Partnership NHS Foundation Trust

Trust Hq Swandean Arundel Road

Worthing United Kingdom BN13 3EP RX2@2.16.840.1.113883.2.1.3.2.4.18.48 Tees, Esk and Wear Valleys NHS Foundation Trust

Trust Headquarters West Park Hospital Edward Pease Way

Darlington United Kingdom DL2 2TS RX3@2.16.840.1.113883.2.1.3.2.4.18.48 St Andrew's Healthcare

Billing Road

Northampton United Kingdom NN1 5DG Priory Group

Priory Head Office Floor 5 Hammersmith Road

London United Kingdom W14 8UD Barnet, Enfield and Haringey Mental Health NHS Trust

Trust Headquarters Block B2 St Ann's Hospital St Ann's Road

London United Kingdom N15 3TH RRP@2.16.840.1.113883.2.1.3.2.4.18.48 Oxleas NHS Foundation Trust

Pinewood House Pinewood PLACE

Dartford United Kingdom DA2 7WG RPG@2.16.840.1.113883.2.1.3.2.4.18.48 Lancashire and South Cumbria NHS Foundation Trust

Sceptre Point Sceptre Way Walton Summit

Preston United Kingdom PR5 6AW Hampshire and Isle of Wight Healthcare NHS Foundation Trust

Tatchbury Mount Hospital Calmore

Southampton United Kingdom SO40 2RZ RW1@2.16.840.1.113883.2.1.3.2.4.18.48 Patient Patients: 1. Inpatients at rehabilitation units that are participating in the study 2. Provide informed consent to participate in the study. All efforts will be made to maximise the capacity of each patient to be able to provide informed consent for the study (for example, by explaining the purpose and process of the study in simple terms and over a number of meetings), and any patient with capacity who declines participation will not be included. However, for eligible patients who lack capacity to give informed consent we will seek advice from a consultee on their participation. Further detail on the procedure for seeking informed consent and assessing capacity is provided in section 8. Research data for participants lacking capacity will be collected via staff interview and healthcare records (as described above), but these participants will not be asked to participate in an interview themselves. The researchers expect only a minority of eligible patients to lack capacity (around 8% based on the REAL study) but it is important they are included in the study in order to prevent sample bias. Services: 1. High dependency, community, or longer-term high dependency rehabilitation units 2. Community rehabilitation units will only be included if they are registered with CQC as an inpatient unit (rather than supported housing or residential care) Adult All 500 755 Patients: 1. Unavailable during the researcher's visit, because they are on leave from the ward during the visit or are otherwise unavailable 2. Do not have an adequate understanding of English to understand the main purpose of the research and what participating would involve for them Services: 1. Highly specialist units that focus on sub-groups (such as people with a diagnosis on the autism spectrum or those with neurodegenerative disease) 2. Specialist forensic mental health units (i.e. low secure rehabilitation units) as they do not form part of the standard mental health rehabilitation care pathway and are subject to specialist commissioning by NHS England 2022-06-08T00:00:00.000Z 2025-09-30T00:00:00.000Z Mental health Mental and Behavioural Disorders As we cannot compare NHS and independent sector services through a randomised trial, our programme will draw together findings from four components to assess the effectiveness of these services: 1. Survey of 60 inpatient mental health rehabilitation services across England (30 NHS and 30 independent sector) 2. In-depth interviews with users, relatives/carers, staff, and commissioners of these services to explore their experiences and perspectives 3. Cohort study to compare outcomes for 600 patients of the NHS and independent sector rehabilitation services surveyed in Component 1, using statistical methods that take account of any differences between them such as the severity of their mental health problems 4. Health economic evaluation to assess the cost-effectiveness of inpatient rehabilitation services provided by the NHS and the independent sector Survey: We aim to recruit 500 patients from 60 inpatient mental health rehabilitation units across England (30 NHS and 30 independent sector) over a 12-month period to participate in a survey (patients at this stage will be asked to consent to take part in Components 1 and 3). Once selected services have agreed to participate, researchers will visit the unit and describe the project to staff. The staff will be asked to introduce the patients to the researchers who will then provide the patient with a Participant Information Sheet. The study will be fully explained to the patient, including the purpose of the study, what their participation would involve, what data will be collected and how it will be collected, and that they are free to withdraw from the study at any point without it affecting their clinical care. The patient will have at least 24 hours to consider whether they would like to participate and have the opportunity to ask the researcher any questions. Patients who provide their informed consent by completing the consent form will then participate in a research interview where data will be collected using standardised measures regarding their quality of life (DIALOG, Recovering Quality of Life, EQ-5D-5L), autonomy (Resident Choice Scale), engagement in activities (Time Use Diary), satisfaction with care (Client Assessment of Treatment), and healthcare costs (Client Receipt Inventory). In addition, staff will be asked to complete standardised measures on the patient's social functioning (Life Skills Profile), challenging behaviours (Special Problems Rating Scale), alcohol and drug use (Clinical Alcohol and Drug Scale), needs (Camberwell Assessment of Needs, and activities (Time Use Diary). Sociodemographic, healthcare service use, current and previous risk, and engagement in community-based activities will be collected from the patient's healthcare records. Also, researchers will complete the QuIRC with the managers of each service. The QuIRC is a quality assessment tool developed specifically for inpatient mental health rehabilitation units. In-depth interview (qualitative) study: We will select and invite 10 inpatient rehabilitation units (5 NHS and 5 independent sector) participating in Component 1 to participate in Component 2. We will invite all staff from these services to participate in a focus group and ask about their experience and perspective of working in these services. We will also conduct additional staff interviews, including interviews with senior service managers, commissioners, and community care coordinators, to expand on any themes not adequately covered in the focus group, including the decision-making process about where an individual receives their inpatient rehabilitation. From these participating services, we will also aim to interview between three and five patients from each service (between 30 and 50 in total) and ask about their experiences and perspectives on the care they are receiving. We will ask these patient participants for permission to contact and invite their relatives/carers to participate in an in-depth interview. We aim to recruit around 20 relatives/carers in total. Interviews with relatives/carers will take place via telephone or videoconferencing. Cohort study: Participants recruited into Component 1 will comprise the cohort for Component 3. The researchers will contact the services managers of the inpatient rehabilitation units participating in Component 1 once a month for 18 months to ask if any of the participants have been discharged from the unit, and if they have been discharged, information about where they have been discharged to including contact details of relevant staff (i.e. their 'key informant') who we may complete future monthly follow-ups with. We expect on most occasions this will be the participant’s community care coordinator. We will invite all participants to a short research interview via telephone or video call (Teams of Zoom) at six, 12, and 18 months to complete two quality of life measures (Recovering Quality of Life and EQ-5D-5L). In addition, at six, 12, and 18 months we will ask key informants of participants who have been discharged from the inpatient rehabilitation service they were recruited from about any subsequent inpatient service use, and social care costs (use of supported accommodation and any individual ‘care packages’). Health economic evaluation: Using data collected in Components 1 and 3 analyses will be conducted to investigate the cost-effectiveness of NHS and independent inpatient rehabilitation services by calculating quality-adjusted life-years. Other The data sharing plans for the current study are unknown and will be made available at a later date Data sharing statement to be made available at a later date 2024 Protocol article in https://doi.org/10.1186/s12888-024-05524-6 (added 07/02/2024) Protocol

Added from spreadsheet

Study website Migrated from study website field

ed7dec09-5495-4856-a130-60c99daf896b 5a450f9e-2514-47c7-867b-f5c2692a8651 da008537-1d15-4859-82c1-8d25ed63e4c3 530832f6-1bf2-4052-999d-2eb2fa6e99eb No Protocol file 42032_Protocol_V1.3_07Jun22.pdf dd5dfdb0-0440-410e-9c55-4b12a696b07a true application/pdf 639856 babd16edce8b0f3131c540fb372b7950 Helen Killaspy https://orcid.org/0000-0003-2481-4802 Principal investigator

University College London UCL Division of Psychiatry Maple House 149 Tottenham Court Road

London United Kingdom W1T 7NF +44 (0)207 679 9710 h.killaspy@ucl.ac.uk Public Christian Dalton-Locke Scientific

University College London UCL Division of Psychiatry Maple House 149 Tottenham Court Road

London United Kingdom W1T 7BN +44 (0)20 7679 9632 c.dalton-locke@ucl.ac.uk Public Camden and Islington NHS Foundation Trust Hospital/treatment centre https://ror.org/03ekq2173 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 22275538 true Evaluating a diabetes self-management intervention for people with severe mental illness: the DIAMONDS programme (Diabetes and Mental Illness, Improving Outcomes and Self-management) DIAMONDS The objectives are: 1. Undertake a 12-month internal pilot to obtain robust estimates of recruitment and retention and to confirm trial viability 2. Determine the effects of the DIAMONDS intervention on HbA1c at 12 months post-randomisation 3. Determine the effects of the DIAMONDS intervention on clinical outcomes taken at baseline, 6 months and 12 months post-randomisation 4. Conduct a detailed economic evaluation to assess the cost-effectiveness of the DIAMONDS intervention 5. Conduct a process evaluation that will harness data from both qualitative and quantitative sources to address questions about whether the intervention was delivered as intended and how outcomes were produced. Additionally, the process evaluation will aim to identify barriers and enablers to post-trial implementation and scale-up, including whether the intervention can support the self-management of other long-term conditions (LTCs) in people with severe mental illness (SMI). Background and study aims People with severe mental illness, such as schizophrenia, bipolar disorder, or severe depression, have poorer physical health and a shorter life expectancy by around 20 years compared with the general population. Higher rates and poorer management of physical long-term conditions such as diabetes and heart disease are partly to blame. There may be several reasons for this, including the individual’s mental illness and treatment, challenges to engaging in healthy behaviours (e.g. exercise, healthy eating), and barriers to accessing healthcare and support. Self-management (which includes taking medications, monitoring symptoms, preventing complications, and leading a healthier lifestyle) is an important part of staying well with a long-term condition. There are many self-management programmes in the NHS to help people with long-term conditions look after themselves, but they often do not address the challenges of people who also have a severe mental illness. The DIAMONDS research programme aims to overcome this problem by developing and testing a self-management intervention that can specifically help people with diabetes and severe mental illness to be healthier. The intervention has been developed in partnership with people with mental illness and diabetes, their family members/friends, and the healthcare staff who support them. It has been designed to address challenges to self-management, which include poor motivation due to mental illness symptoms and medication; limited support from others for self-management; beliefs about their ability to engage in self-management; and limited knowledge and skills for long-term condition management. Who can participate? Patients aged 18 years or older with a severe mental illness (schizophrenia, bipolar disorder, schizoaffective disorder, psychosis, severe depression) and type 2 diabetes What does the study involve? Participants are randomly allocated to either the intervention group or the control group. The intervention group will be offered one-to-one self-management sessions with a DIAMONDS coach over a period of 6 months. The control group will continue with their routine care. All participants will be followed up 6 and 12 months later. What are the possible benefits and risks of participating? Participants in both groups may gain insight into their own lifestyle and behaviours. The participants in the intervention group may develop strategies to manage their diabetes more efficiently. For participants using the digit app, they may develop new skills by engaging with digital technology. Taking part in the study will require participants to attend appointments, have body measurements and blood taken, and complete a study questionnaire which will take time. Where is the study run from? University of York (UK) When is the study starting and how long is it expected to run for? September 2022 to September 2025 Who is funding the study? National Institute for Health and Care Research (NIHR) (UK) Who is the main contact? Dr Lucy Sheehan, lucy.sheehan@york.ac.uk Glycated haemoglobin (HbA1c) measured using blood test at baseline, 6 months and 12 months 1. Cholesterol measured using blood test at baseline, 6 months and 12 months 2. Haemoglobin measured using blood test at baseline, 6 months and 12 months 3. BMI measured using weight and height measurements at baseline, 6 months and 12 months 4. Waist circumference measured using standard trust procedures at baseline, 6 months and 12 months 5. Blood pressure measured using standard trust procedures at baseline, 6 months and 12 months 6. Smoking status assessed through participant self-report at baseline, 6 months and 12 months 7. Urinary albumin to creatinine ratio extracted from patient's medical notes at baseline 8. Physical activity measured using the International Physical Activity Questionnaire (IPAQ) at baseline, 6 months and 12 months 9. Psychiatric symptoms assessed using the Brief Psychiatric Rating Scale (BPRS) at baseline, 6 months and 12 months 10. Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9) at baseline, 6 months and 12 months 11. Diabetes distress assessed using the Problem Areas in Diabetes (PAID) scale at baseline, 6 months and 12 months 12. Summary of diabetes self-care activities assessed using the Summary of Diabetes Self-Care Activities Measure (SDSCA) at baseline, 6 months and 12 months 13. Insulin use assessed through participant self-report at baseline, 6 months and 12 months 14. Diabetes complications extracted from medical records at baseline, 6 months and 12 months 15. Health-related quality of life assessed using the EQ-5D-5L at baseline, 6 months and 12 months 16. Health resource use using a bespoke health resource use questionnaire at baseline, 6 months and 12 months 17. Mechanism of action measured using a set of self-report processes at baseline, 6 months and 12 months Ethics approval required West of Scotland REC 3

Research Ethics, Ward 11, Dykebar Hospital, Grahamston Road

Paisley United Kingdom PA2 7DE 22/WS/0117 10.1186/ISRCTN22275538 316173 CPMS: 53712 316173 53712 Randomized controlled trial Interventional Randomised controlled trial Treatment 2025-09-30T00:00:00.000Z United Kingdom England Bradford District Care NHS Foundation Trust

New Mill Victoria Road Saltaire

Shipley England BD18 3LD TAD@2.16.840.1.113883.2.1.3.2.4.18.48 Leeds and York Partnership NHS Foundation Trust

2150 Century Way Thorpe Park

Leeds England LS15 8ZB RGD@2.16.840.1.113883.2.1.3.2.4.18.48 Sheffield Health & Social Care NHS Foundation Trust

Centre Court Atlas Way

Sheffield England S4 7QQ TAH@2.16.840.1.113883.2.1.3.2.4.18.48 Humber Teaching NHS Foundation Trust

Trust Hq, Willerby Hill Beverley Road Willerby

Hull England HU10 6ED RV9@2.16.840.1.113883.2.1.3.2.4.18.48 Tees, Esk and Wear Valleys NHS Foundation Trust

Trust Headquarters West Park Hospital Edward Pease Way

Darlington England DL2 2TS RX3@2.16.840.1.113883.2.1.3.2.4.18.48 South West Yorkshire Partnership NHS Foundation Trust

Trust Headquarters Fieldhead Hospital Ouchthorpe Lane

Wakefield England WF1 3SP RXG@2.16.840.1.113883.2.1.3.2.4.18.48 Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

St Nicholas Hospital Jubilee Road Gosforth

Newcastle upon Tyne England NE3 3XT RX4@2.16.840.1.113883.2.1.3.2.4.18.48 Southern Health NHS Foundation Trust

Tatchbury Mount Hospital Calmore

Southampton England SO40 2RZ RW1@2.16.840.1.113883.2.1.3.2.4.18.48 Springfield University Hospital

South West London & St Georges Mental Health NHS Trust Shaftesbury Building 9 Springfield Drive

London England SW17 0YF Gloucestershire Health and Social Care NHS Foundation Trust

Trust Headquarters, Edward Jenner Court, 1010 Pioneer Avenue, Gloucester Business Park, United Kingdom

Brockworth, Gloucester NO COUNTRY SPECIFIED, assuming England England GL3 4AW2 Cornwall Partnership NHS Foundation Trust

Carew House, Beacon Technology Park, Dunmere Road

Bodmin England PL31 2QN Musgrove Park Hospital (taunton)

Somerset NHS Foundation Trust

Taunton England TA1 5DA Devon Partnership NHS Trust

Wonford House Hospital Dryden Road

Exeter England EX2 5AF RWV@2.16.840.1.113883.2.1.3.2.4.18.48 Herefordshire and Worcestershire Health and Care NHS Trust

Unit 2 Kings Court Charles Hastings Way

Worcester England WR5 1JR R1A@2.16.840.1.113883.2.1.3.2.4.18.48 Surrey and Borders Partnership NHS Foundation Trust

18 Mole Business Park Randalls Road

Leatherhead England KT22 7AD RXX@2.16.840.1.113883.2.1.3.2.4.18.48 Lincolnshire Partnership NHS Foundation Trust

St George's Long Leys Road

Lincoln England LN1 1FS RP7@2.16.840.1.113883.2.1.3.2.4.18.48 South London and Maudsley NHS Foundation Trust

Bethlem Royal Hospital Monks Orchard Road

Beckenham England BR3 3BX RV5@2.16.840.1.113883.2.1.3.2.4.18.48 Cambridgeshire and Peterborough NHS Foundation Trust

Elizabeth House, Fulbourn Hospital Fulbourn

Cambridge England CB21 5EF RT1@2.16.840.1.113883.2.1.3.2.4.18.48 Livewell Southwest

Local Care Centre 200 Mount Gould Road

Plymouth England PL4 7PY NR501@2.16.840.1.113883.2.1.3.2.4.18.48 Lancashire and South Cumbria NHS Foundation Trust

Sceptre Point, Sceptre Way

Walton Summit, Preston NO COUNTRY SPECIFIED, assuming England England PR5 6AW2 Essex Partnership University NHS Foundation Trust

The Lodge Lodge Approach Runwell

Wickford England SS11 7XX R1L@2.16.840.1.113883.2.1.3.2.4.18.48 Rotherham Doncaster and South Humber NHS Foundation Trust

Woodfield House Tickhill Road

Doncaster England DN4 8QN RXE@2.16.840.1.113883.2.1.3.2.4.18.48 Cheshire and Wirral Partnership NHS Foundation Trust

Trust Headquarters Redesmere The Countess of Chester Health Park Liverpool Road

Chester England CH2 1BQ RXA@2.16.840.1.113883.2.1.3.2.4.18.48 Pennine Care NHS Foundation Trust

225 Old Street

Ashton-under-lyne England OL6 7SR RT2@2.16.840.1.113883.2.1.3.2.4.18.48 Birmingham and Solihull Mental Health NHS Foundation Trust

The Uffculme Centre 52 Queensbridge Road Moseley

Birmingham England B13 8QY RXT@2.16.840.1.113883.2.1.3.2.4.18.48 Midlands Partnership University NHS Foundation Trust

Trust Headquarters St Georges Hospital Corporation Street

Stafford England ST16 3SR RRE@2.16.840.1.113883.2.1.3.2.4.18.48 Camden and Islington NHS Foundation Trust

St Pancras Hospital 4 St Pancras Way

London England NW1 0PE TAF@2.16.840.1.113883.2.1.3.2.4.18.48 Barnet, Enfield and Haringey Mental Health NHS Trust

Trust Headquarters Block B2 St Ann's Hospital St Ann's Road

London England N15 3TH RRP@2.16.840.1.113883.2.1.3.2.4.18.48 Kent and Medway NHS and Social Care Partnership Trust

Farm Villa Hermitage Lane

Maidstone England ME16 9PH RXY@2.16.840.1.113883.2.1.3.2.4.18.48 Patient Current participant inclusion criteria as of 25/10/2024: 1. Adults (aged 18 years or older) 2. Confirmed diagnosis of severe mental illness (SMI; schizophrenia, bipolar disorder, schizoaffective disorder, psychosis, severe depression) and type 2 diabetes Previous participant inclusion criteria: 1. Adults (aged 18 years or older) 2. Confirmed diagnosis of severe mental illness (SMI; schizophrenia, bipolar disorder, schizoaffective disorder, severe depression) and type 2 diabetes Mixed 18 Years 110 Years All 380 431 Current participant exclusion criteria as of 25/10/2024: 1. Cognitive impairments 2. Gestational diabetes, type 1 diabetes, diabetes due to a specific genetic defect or secondary to pancreatitis or endocrine conditions 3. Impaired capacity to participate 4. Current inpatient in an acute or mental health hospital Previous participant exclusion criteria: 1. Cognitive impairments 2. Gestational diabetes, type 1 diabetes, diabetes due to a specific genetic defect or secondary to pancreatitis or endocrine conditions 3. Impaired capacity to participate 2022-12-20T00:00:00.000Z 2024-09-30T00:00:00.000Z Diabetes self-management for people with severe mental illness Nutritional, Metabolic, Endocrine Diabetes mellitus Current interventions as of 05/04/2024: The DIAMONDS RCT is a multi-centre, two-armed, parallel, individually randomised control trial with embedded process and economic evaluations. The trial includes a 12-month internal pilot phase to assess recruitment assumptions and optimise trial processes. The trial has an 18-month recruitment period (including a 12-month pilot period). Once a participant has been enrolled into the study (i.e. after full consent has been given), they will be asked to complete a number of pen-and-paper questionnaires (supported by the R&D team at the participating site), provide a blood sample, have their blood pressure, weight, height, and waist circumference measured. All participants will also be offered to wear a wrist-worn accelerometer (a device to measure physical activity). Participants will then be randomised on a 1:1 basis to either the DIAMONDS intervention (n = 190) or the usual care group (n = 190) using computer-generated permuted blocks of random sizes. The intervention group will be offered individual 1-to-1 sessions over a 6-month period with a trained facilitator (DIAMONDS Coach). The first session will last between 60-90 minutes, the Coach will introduce the intervention and set up the supporting workbook. The following sessions will last 30-60 minutes and the participant will continue to engage with the intervention between these sessions using the workbook. An accompanying app is also available for participants who wish to use it to be used alongside the workbook. Participants who are randomised into the control group will access usual care for people with severe mental illness and diabetes. All participants will be followed-up for 1 year with outcome assessments conducted at 6 and 12 months post-randomisation. These assessments will be the same as those conducted at baseline (with the exception of the wrist-worn accelerometer at the 12-month timepoint). At the end of the intervention period, some participants, as well as carers, and DIAMONDS Coaches will be invited to take part in semi-structured interviews. These interviews will focus on their experience of being part of the DIAMONDS randomised control trial and will inform our process evaluation. Previous interventions: The DIAMONDS RCT is a multi-centre, two-armed, parallel, individually randomised control trial with embedded process and economic evaluations. The trial includes a 12-month internal pilot phase to assess recruitment assumptions and optimise trial processes. The trial has an 18-month recruitment period (including a 12-month pilot period). Once a participant has been enrolled into the study (i.e. after full consent has been given), they will be asked to complete a number of pen-and-paper questionnaires (supported by the R&D team at the participating site), provide a blood sample, have their blood pressure, weight, height, and waist circumference measured. All participants will also be offered to wear a wrist-worn accelerometer (a device to measure physical activity). Participants will then be randomised on a 1:1 basis to either the DIAMONDS intervention (n = 225) or the usual care group (n = 225) using computer-generated permuted blocks of random sizes. The intervention group will be offered individual 1-to-1 sessions over a 6-month period with a trained facilitator (DIAMONDS Coach). The first session will last between 60-90 minutes, the Coach will introduce the intervention and set up the supporting workbook. The following sessions will last 30-60 minutes and the participant will continue to engage with the intervention between these sessions using the workbook. An accompanying app is also available for participants who wish to use it to be used alongside the workbook. Participants who are randomised into the control group will access usual care for people with severe mental illness and diabetes. All participants will be followed-up for 1 year with outcome assessments conducted at 6 and 12 months post-randomisation. These assessments will be the same as those conducted at baseline (with the exception of the wrist-worn accelerometer at the 12-month timepoint). At the end of the intervention period, some participants, as well as carers, and DIAMONDS Coaches will be invited to take part in semi-structured interviews. These interviews will focus on their experience of being part of the DIAMONDS randomised control trial and will inform our process evaluation. Behavioural The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Lucy Sheehan (lucy.sheehan@york.ac.uk) or Jude Watson (jude.watson@york.ac.uk). Available on request Protocol

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7bac2457-5709-4991-913f-ea571a5539e1 a99d2268-1833-4f11-a551-f9b9c7e0d7a9 51f86294-7f9c-48bb-af9e-52b65712dfdc 475da3c0-465e-4072-9c38-f8533099cfbe Yes Participant information sheet 42543_PIS_V2.0_25Aug22.pdf 7e2ca79c-fa85-48a6-981c-8e017aff8b8b true application/pdf 673550 a3b30cc1f632373279842d9d83ab269a Protocol file 42543_PROTOCOL_V1.0_28Jun22.pdf 4d0c0176-cacb-4140-b7e8-e51896683f81 true application/pdf 2000258 a1ab67de8742b646e2c16ee0ea0fd76d Statistical Analysis Plan ISRCTN22275538_SAP_V1.0.pdf 759ef46c-aff3-46fe-a166-f545edf4ff79 true application/pdf 603644 26c2b4370d0e59af265ecc2c523e679b Protocol file ISRCTN22275538_Protocol_v1.7_06Feb2025.pdf 110a0a29-4b31-40a8-a207-b2b0656b60f6 true application/pdf 1067383 774604401eb3a151821687bf52a91069 Lucy Sheehan Scientific

University of York Heslington

York United Kingdom YO10 5DD +44 (0)1904323887 lucy.sheehan@york.ac.uk Public Jude Watson Scientific

University of York Heslington

York United Kingdom YO10 5DD +44 (0)1904321306 jude.watson@york.ac.uk Public University of York University/education https://ror.org/04m01e293 Non-commercial NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-1016-20003 83877229 true Supporting Physical Activity through Co-production in people with Severe Mental Illness (SPACES): a randomised feasibility study of an intervention aimed at increasing the physical activity of people with severe mental ill health SPACES 1. People with conditions like schizophrenia, schizoaffective disorder, and bipolar disorder are less physically active than those without these health conditions, and the World Health Organisation has said that being more physically active can have as big an impact on health as stopping smoking 2. To evaluate the acceptability of a bespoke intervention designed to increase physical activity and the critical parameters for the design of a definitive RCT when compared to treatment as usual Background and study aims Life expectancy is reduced by around 15-20 years for people with severe mental ill health (SMI) compared to people without SMI, and this gap is increasing. The majority of these early deaths are due to physical health problems, which are partly preventable and which are related to factors including health behaviours such as diet, smoking and physical activity. Increasing physical activity can improve physical health in everyone and The World Health Organization has said that encouraging people to be more active can be as beneficial as quitting smoking. People with SMI are less physically active than the general population. Supporting people with SMI to increase their levels of physical activity could help to reduce the life expectancy gap. Therefore, there is a need to establish whether a physical activity programme (intervention) that is relevant to the needs of people with SMI, is practical, acceptable and useful for people with SMI. Practical issues in establishing such a study will also be examined. In this study, we will explore the feasibility of a physical activity intervention we have co-designed for people living with severe mental ill health. Who can participate? People aged 18 and over who have a diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder. What does the study involve? People who agree to take part in the study will be randomly allocated to usual care, or to the physical activity intervention plus usual care. We will collect information on how many people who sign up to the study, the number of people who drop out along the way, and the number of missed sessions for the intervention. We will interview a small group of people about their experience of being part of the study. What are the possible benefits and risks of participation? This is considered a low-risk research study. This is an opportunity for participants to inform the development of future research (larger trial) and participants may enjoy and value contributing to research. Participants who are randomised into the intervention plus usual care group may experience benefits from the potential increase in physical activity and reduced sedentary behaviour. Where is the study run from? Sheffield Health & Social Care NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? From July 2022 to December 2024 Who is funding the study? National Institute for Health and Care Research (UK) Who is the main contact? Dr Emily Peckham (Chief Investigator), e.peckham@bangor.ac.uk 1. Acceptability of the intervention measured using: 1.1. The Acceptability Intervention Measure (AIM) at 6 months post-randomisation (intervention participants only) 1.2. Intervention uptake, attendance, and attrition throughout the study 1.3. Interviews with intervention participants and intervention facilitators at 6 months post-randomisation 2. Feasibility of a full-scale trial measured using: 2.1. Participant recruitment data at the end of recruitment 2.2. Monitoring the quantity and quality of accelerometer-derived physical activity data collected at baseline, 3 months post-randomisation, and 6 months post-randomisation 2.3. Interviews with intervention participants and intervention facilitators at 6 months post-randomisation 1. Physical activity measured using accelerometer data at baseline, 3, and 6 months post-randomisation 2. Sedentary behaviour measured using accelerometer data at baseline, 3, and 6 months post-randomisation 3. Body mass index (BMI) calculated using height and weight measurements at baseline, 3, and 6 months post-randomisation 4. Severity of depression measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline, 3, and 6 months post-randomisation 5. Severty of generalised anxiety disorder measured using the General Anxiety Disorder-7 (GAD-7) questionnaire at baseline, 3, and 6 months post-randomisation 6. Self-reported physical activity and edentary behaviour measured using the Simple Physical Activity Questionnaire (SIMPAQ) at baseline, 3, and 6 months post-randomisation 7. Health-related quality-of-life measured using the EuroQoL 5D-5L (EQ5D-5L) questionnaire at baseline, 3, and 6 months post-randomisation 8. Health-related quality-of-life measured using the Short Form Health Questionnaire - 12 (SF-12) at baseline, 3, and 6 months post-randomisation 9. Mental health-related quality-of-life measured using the Recovering Quality of Life (ReQol) at baseline, 3, and 6 months post-randomisation 10. Healthcare resource use measured using a bespoke healthcare service use questionnaire (collecting participant’s use of primary, secondary, and community healthcare services, with special attention paid to physical activity and mental health related services) at baseline, 3, and 6 months post-randomisation Old ethics approval format Approved 18/08/2022, West of Scotland 5 Research Ethics Committee (via Zoom; +44 (0)141 314 0213; WoSREC5@ggc.scot.nhs.uk), ref: 22/WS/0101 10.1186/ISRCTN83877229 311668 CPMS: 53407 311668 53407 Multicentre feasibility randomized controlled trial Interventional Randomised controlled trial Quality of life 2024-12-31T00:00:00.000Z United Kingdom England Sheffield Health & Social Care NHS Foundation Trust

Fulwood House Old Fulwood Road

Sheffield England S10 3TH TAH@2.16.840.1.113883.2.1.3.2.4.18.48 South West Yorkshire Partnership NHS Foundation Trust

Trust Headquarters Fieldhead Hospital Ouchthorpe Lane

Wakefield England WF1 3SP RXG@2.16.840.1.113883.2.1.3.2.4.18.48 Kent and Medway NHS and Social Care Partnership Trust

Farm Villa Hermitage Lane

Maidstone England ME16 9PH RXY@2.16.840.1.113883.2.1.3.2.4.18.48 North East London NHS Foundation Trust

West Wing C E M E Centre Marsh Way

Rainham England RM13 8GQ RAT@2.16.840.1.113883.2.1.3.2.4.18.48 South London and Maudsley NHS Foundation Trust

Bethlem Royal Hospital Monks Orchard Road

Beckenham England BR3 3BX RV5@2.16.840.1.113883.2.1.3.2.4.18.48 Tees, Esk and Wear Valleys NHS Foundation Trust

Trust Headquarters West Park Hospital Edward Pease Way

Darlington England DL2 2TS RX3@2.16.840.1.113883.2.1.3.2.4.18.48 Leeds and York Partnership NHS Foundation Trust

2150 Century Way Thorpe Park

Leeds England LS15 8ZB RGD@2.16.840.1.113883.2.1.3.2.4.18.48 Patient 1. Aged ≥18 years 2. Schizophrenia and other non-organic psychoses (ICD F20 -F29 and subcodes or DSM equivalent), and Bipolar Disorder and manic episodes (ICD F30 and F31 and subcodes and DSM equivalent) 3. Able to walk unaided Mixed 18 Years 100 Years All 72 71 1. Lack capacity to participate 2. Primary diagnosis of drug or alcohol abuse 3. Have a medical contraindication of physical activity 4. Already physically active, defined as currently doing >300 min/week of self-reported moderate to vigorous physical activity 5. Unwilling to wear accelerometer 6. Non-English speakers 2022-09-26T00:00:00.000Z 2023-04-28T00:00:00.000Z Increasing physical activity levels in adults with severe mental ill health (SMI) Mental and Behavioural Disorders Participants are randomised via block randomisation with a separate schedule for each site/centre to receive either: 1. Usual care alone 2. Usual care plus an 18-week physical activity intervention developed using a synthesis of current evidence and co-produced through public involvement members with SMI and other key stakeholders Behavioural The datasets generated during and/or analysed during the current study will be stored in a publicly available repository. Stored in publicly available repository 2026 Results article in https://doi.org/10.1016/j.mhpa.2026.100765 (added 12/03/2026) 2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38368380/ (added 19/02/2024) Results

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64568dfd-e236-4f9e-a6d6-91ae948bc9de 228974ec-ce97-4abd-b598-9d84c1450c9b e7583cad-21ae-405a-a5d6-6460effd7e97 e7047257-d416-4438-aa27-dfeae25f82f1 536a97a6-bbaa-4a7f-80e2-389a4023dd67 Yes Emily Peckham https://orcid.org/0000-0002-9377-1968 Principal investigator

Centre for Mental Health and Society Bangor University Wrexham Campus

Wrexham United Kingdom LL13 7YP +44 (0)7795315062 e.peckham@bangor.ac.uk Public Emily Peckham https://orcid.org/0000-0002-9377-1968 Scientific

Centre for Mental Health and Society Bangor University Wrexham Campus

Wrexham United Kingdom LL13 7YP +44 (0)7795315062 e.peckham@bangor.ac.uk Public Emily Peckham https://orcid.org/0000-0002-9377-1968 Public

Centre for Mental Health and Society Bangor University Wrexham Campus

Wrexham United Kingdom LL13 7YP +44 (0)7795315062 e.peckham@bangor.ac.uk Public Sheffield Health and Social Care NHS Foundation Trust Hospital/treatment centre https://ror.org/05cn4v910 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 11797465 true Understanding the everyday use of restrictive practices in the care of people living with dementia during a hospital admission: reducing inappropriate use, identifying good practice and alternative approaches to reduce risk and improve care The aim of this in-depth ethnographic study is to examine everyday cultures of restrictive practices in the care of people living with dementia (PLWD) during an acute hospital admission. It will explore what forms these practices take, the rationales for their use, and the experience of these practices from the perspectives of PLWD, their families, and ward staff. It will identify evidence-based (and alternative) strategies in the care of PLWD that are achievable, safe, and transferrable across care settings. The objectives are to: 1. Provide a detailed examination of the social and organisational context in influencing the everyday care of PLWD to understand the (a) nature of restrictive (and alternative) practices within acute wards (b) circumstances and contexts of use (c) care practices when PLWD are perceived as at risk of ‘falls’ or ‘wandering’, or when their behaviour is perceived as ‘challenging’, ‘disruptive’ or ‘aggressive’. 2. Examine the recognition, understandings, and experiences of restrictive (and alternative) practices during an admission from the perspectives of PLWD and their families. 3. Examine staff perspectives (a) their understandings and recognition of restrictive practices (b) the formal frameworks and informal rationales drawn on to inform the care of PLWD. 4. Translate the findings into evidence-based strategies to support best practice and alternative approaches in the care of PLWD at ward level. Background and study aims This study will examine everyday cultures of restrictive practices in the care of people living with dementia (PLWD) during an acute hospital admission in order to understand the nature, rationales, and experiences of PLWD, their families, and ward staff. Data collection will be carried out within nine wards: six acute wards (three general medicine and three older person’s care) and three specialist inpatient mental health wards (dementia specialist mental health in-patient wards across trusts in two regions of the UK (Yorkshire and the South East) and health boards in Wales. 30 days of observation will occur in each acute ward alongside 15 days of observation will occur in each mental health ward. Who can participate? Ward staff, patients and carers and family members of patients with a diagnosis or query of dementia when admitted to hospital What does the study involve? 1. Observing routine ward care practices within and across shifts (am/pm) and different staffing structures (weekends/nights), including handovers 2. Shadowing the work of ward staff and wider hospital staff involved in the care of PLWD 3. Observing clinical assessments, team meetings, and where possible discharge and transfer meetings 4. Observing to identify which patients experience restrictive practices, what forms they take, and if there are any individual patients or groups who appear to be excluded, exempt, or experience increased use of these practices 5. Observing the care of PLWD perceived as at higher risk of adverse incident or ‘challenging’ behaviour 6. Ethnographic interviews (less than 10-minute conversations during ethnographic observation) with ward staff 7. Document analysis of ward records 8. Interviews carried out with PLWD, their care partners and families to explore the recognition, understandings, and experiences of restrictive practices. 9. Follow-up interviews after discharge in the community with PLWD and their family members participating in the ward ethnography and interviews. Analysis will inform the delivery of evidence-based strategies to support best practice in the care of PLWD at the ward level, including open-access training and NHS service organisational interventions. What are the possible benefits and risks of participating? This study is unlikely to directly benefit patient participants (which is explained clearly in the Patient and Family Member Information sheet). This project does, however, give people living with dementia a rare opportunity to contribute to research which may potentially benefit other people living with the condition and their families. This is an observational study and will carry no direct risks to participants' physical health. No changes to lifestyle are expected, nor any freedom of action. It is possible that in some cases observations may cause distress or discomfort, at which point observations will cease. Where is the study run from? University of West London (UK) When is the study starting and how long is it expected to run for? March 2022 to August 2024 Who is funding the study? National Institute for Health and Care Research (NIHR) (UK) Who is the main contact? Andy Northcott, andy.northcott@uwl.ac.uk 1. The visible work of nurses and healthcare assistants involved in delivering everyday care to people living with dementia as staff make decisions relating to the use of restrictive practices during shifts, assessed using ethnographic observation over four hour periods 2. Routine practice and responses when interacting with people living with dementia explored using short ethnographic interviews as care is delivered over four hour periods 3. The potential impacts and consequences of restrictive practice on patient experiences and discharge pathway in the 3 months after discharge, assessed with follow-up interviews with people living with dementia and family carers at monthly intervals There are no secondary outcome measures Old ethics approval format Approved 15/07/2022, London - Bromley Research Ethics Committee (Temple Quay House, 2 The Square, Temple Quay, Bristol, BS1 6PN, UK; +44 (0)207 104 8105; bromley.rec@hra.nhs.uk), ref: 22/LO/0448 10.1186/ISRCTN11797465 313816 CPMS: 53197 313816 53197 Multi-site ethnographic study Observational Case series Quality of life 2024-08-31T00:00:00.000Z United Kingdom England Leeds and York Partnership NHS Foundation Trust

2150 Century Way Thorpe Park

Leeds England LS15 8ZB Carer Health professional Patient Ward staff, patients and carers and family members of patients with a diagnosis or query of dementia when admitted to hospital Mixed All 140 0 Patients without a diagnosis or query of dementia will not be included in observations 2022-09-01T00:00:00.000Z 2024-08-31T00:00:00.000Z Dementia Mental and Behavioural Disorders Unspecified dementia Ethnography and in-situ interviews about the everyday use of formal and informal restrictive practices across a range of hospital settings known to admit people living with dementia. Ethnographic data collection will be carried out within nine wards: six acute wards (three general medicine and three older person’s care) and three specialist inpatient mental health wards (dementia specialist mental health in-patient wards across trusts in two regions of the UK (Yorkshire and the South East) and health boards in Wales. 30 days of observation will occur in each acute ward alongside 15 days of observation will occur in each mental health ward (n = 225 days of observed practice). Other Not expected to be made available 2026 Results article in https://pubmed.ncbi.nlm.nih.gov/41873938/ (added 25/03/2026) Results

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fcb0995d-006b-434c-b4f6-b7fb91aaaab1 d16726ca-f692-4b8a-a588-2b4b3232bed1 862f0ca0-6639-429d-8aaf-d2ceae471803 No Katie Featherstone https://orcid.org/0000-0003-4999-8425 Principal investigator

University of West London

Ealing United Kingdom W5 5RF +44 (0)20 8231 2468 katie.featherstone@uwl.ac.uk Public University of West London University/education https://ror.org/03e5mzp60 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 11763460 true CO-production of a Nature-based Intervention For children with ADHD CONIFAS Current study hypothesis as of 16/12/2022: The study aims to co-produce a nature-based intervention for children and young people with Attention Deficit Hyperactivity Disorder (ADHD) with children, families, and professionals with lived experience of ADHD. It also aims to test the intervention with children and families with lived experience of ADHD and to use their feedback to refine the intervention. _____ Previous study hypothesis: The study aims to co-design a nature-based intervention for children and young people with Attention Deficit Hyperactivity Disorder (ADHD) with children, families, and professionals with lived experience of ADHD. It also aims to test the intervention with children and families with lived experience of ADHD and to use their feedback to refine the intervention. Background and study aims Children with Attention Deficit Hyperactivity Disorder (ADHD) can be creative and energetic and can sometimes struggle with attention and controlling behaviour. Early support with these can be helpful for mental wellbeing, relationships, educational and working opportunities. Engaging with nature has been shown to help with some characteristics of ADHD and to have a positive impact on children’s mental health. Waiting lists to access support for ADHD are often long, leaving children and families unsupported. Government health policy is increasingly focusing on prescribing ‘green treatment’ options like swimming, running, cycling, and using outdoor learning in schools to increase engagement with green spaces. These are not yet specifically tailored to children with ADHD, however. The CONIFAS research study is funded by the National Institute for Health Research’s (NIHR) Research for Patient Benefit (RfPB) funding stream. It is run by the Humber Teaching Hospitals NHS Foundation Trust, the University of York, the COMIC research team, and the Leeds and York Partnership NHS Foundation Trust. It will be run in partnership and with support from the Yorkshire Wildlife Trust, the ADHD Foundation, and patient and public involvement (PPI). The study aims to work with children and their families and professionals from the NHS, charities, and other organisations to create a nature-based intervention for children with ADHD and their families to help with some of the typical characteristics of ADHD. Who can participate? In the co-production phases: children aged between 5-11 years with a diagnosis of ADHD, their parent/guardian, and any professional working in health care or the third sector with experience of working with children with ADHD and/or nature-based activities/interventions. In the user-testing phase: children aged between 5-11 years with a diagnosis of ADHD and their parent/guardian What does the study involve? The study involves the co-production of a nature activity for children with ADHD and user testing of this intervention by children and families with lived experience of ADHD. There are four phases: phase 1 involves three ‘discovery’ sessions (one with 10 children with ADHD and their parent/guardian, one with just these 10 parents/guardians, and one with 10 professionals) where the researchers will discuss nature-based interventions for children with ADHD and any barriers and solutions engaging with nature for these children. Phase 2 involves four coproduction workshops with the same participants as the discovery phase (one with 10 children with ADHD and their parent/guardian, one with just these parents/guardians, one with 10 professionals, and one with everyone together) where the researchers will look at different activities and come up with what the nature-based intervention should be based on discussions from the discovery phase. Phase 3 is the user-testing phase and involves recruiting 10 further children with ADHD and their parent/guardian to test the intervention and complete the pre- and post-measures. The intervention will be tested for 6 weeks. Follow-up will be after this six week period. Phase 4 is the refine phase where the co-production participants meet again and refine the intervention based on information gathered during user testing. What are the possible benefits and risks of participating? Taking part in this study offers the opportunity to contribute to the creation of a nature-based intervention for children and young people with ADHD. Participants will be able to share ideas, thoughts, and experiences about this along with other families and professionals. This study may also inform health and education professionals who may help children and young people in the future. Participants will receive a shopping voucher for their participation. The study team do not foresee any risks to participation, however, as the intervention is nature-based, the discovery and co-design groups will be held at a nature reserve. Typical risks associated with being outdoors apply. Where is the study run from? The study is run from the COMIC research team office and the University of York (UK). All discovery and co-design groups (except the parent/guardian only sessions) will be held in person at Barlow Common, a Yorkshire Wildlife Trust nature reserve near Selby. The parent/guardian only sessions will be virtual. The user-testing phase is done from participant homes and preferred outdoor locations. When is the study starting and how long is it expected to run for? March 2022 to August 2023 Who is funding the study? NIHR Research for Patient Benefit (RfPB) funding stream (UK) Who is the main contact? Ellen Kingsley e.kingsley@nhs.net ADHD symptomatology measured using the Conners’ Global Index (parent version) (CGI-P) completed by the parent/guardian at baseline and 8 weeks Current secondary outcome measures as of 16/12/2022: 1. Revised Children’s Anxiety and Depression Scale (RCADS) (parent) – 47-item parent-report questionnaire measuring anxiety and depression (Chorpita et al 2011). Higher scores indicate increased likelihood of reaching the clinical threshold for anxiety and/or depression. 2. Nature Connectedness Index (NCI) – 6-item child-report questionnaire collecting the degree to which children aged 7-15 feel connected to nature. (Richardson et al., 2019). Higher scores indicate more feelings of connection to nature. 3. A bespoke demographics questionnaire. Completed at baseline only. 4. A bespoke parent-report questionnaire measuring acceptability and accessibility. This will include a measure of adherence to the intervention, sessions completed, and a free response box for any additional feedback. Completed at 6 weeks only. 5. A bespoke child-report questionnaire measuring acceptability. 6. A self-report diary for parents and young people allowing for day-to-day reflections on using the intervention. Completed as often as possible for participants. _____ Previous secondary outcome measures: 1. Anxiety and depression measured using the Revised Children’s Anxiety and Depression Scale (parent version) (RCADS-P) completed by the parent/guardian at baseline and 8 weeks 2. The child's experiences and the acceptability of the intervention measured using a self-report diary completed daily throughout the 6-week intervention 3. Acceptability, accessibility, and fidelity of the intervention measured using a bespoke questionnaire completed by the parent/guardian at 8 weeks 4. Demographic information about the participants collected using a bespoke demographics questionnaire at baseline only Old ethics approval format Co-production phases approved 23/05/2022, University of York Department of Environment and Geography Research Ethics Committee (University of York, Wentworth Way, York, YO10 5NG, UK; +44 (0)1904 322999; environment@york.ac.uk). User-testing phase approved 09/12/2022 by the same committee. 10.1186/ISRCTN11763460 315214 CPMS: 52634, NIHR: 203043 315214 52634 203043 Co-production trial with a non-randomized user-testing phase Interventional Non randomised study Quality of life 2023-08-31T00:00:00.000Z United Kingdom England Leeds and York Partnership NHS Foundation Trust

2150 Century Way Thorpe Park

Leeds United Kingdom LS15 8ZB RGD@2.16.840.1.113883.2.1.3.2.4.18.48 The University of York

Heslington

York United Kingdom YO10 5DD RX37E@2.16.840.1.113883.2.1.3.2.4.18.48 Humber Teaching NHS Foundation Trust

Trust Hq, Willerby Hill Beverley Road Willerby

Hull United Kingdom HU10 6ED RV9@2.16.840.1.113883.2.1.3.2.4.18.48 COMIC research

IT Centre Innovation Way

York United Kingdom YO10 5NP Patient Current inclusion criteria as of 16/12/2022: 1. Child participants must be between 5-11 years of age and have a diagnosis of ADHD. 2. Children and their parents/guardians must have a sufficient understanding of English to participate and must live in Yorkshire, UK. _____ Previous inclusion criteria: 1. Child participants must be between 5-11 years of age and have a diagnosis of ADHD 2. Children, their families, and professionals must have a sufficient understanding of English to participate Child 5 Years 11 Years All 50 51 Children who pose a risk of harm to themselves or others and children who would not be able to participate in the focus groups or user testing due to additional difficulties 2022-05-30T00:00:00.000Z 2023-02-24T00:00:00.000Z Attention Deficit Hyperactivity Disorder (ADHD) Mental and Behavioural Disorders Disturbance of activity and attention Current interventions as of 16/12/2022: The study consists of four phases. In the first phase, three groups with children with ADHD and their family members, professionals from mental health, wildlife charities and researchers will meet for discovery workshops involving creative activities to consider how nature-based interventions may be used and what aspects of support for ADHD are needed. In phase 2 workshops will develop the intervention based on the information gathered in phase 1. In phase 3 a different group of children and families will test the intervention and provide outcomes before and after (including ADHD and mental health symptom measures). Phase 4 will use feedback from the user testing in phase 3 to further improve the intervention. The overall aim of the intervention is to educate families on the benefits of interacting with nature and to support them to do so at their own pace, starting from any level of experience, by building up confidence in nature. The intervention is to be self-led by families with support from the researchers at this stage of development in the form of regular contact with the research team via phone calls to support motivation and problem solving. The intervention materials are offered in a bespoke CONIFAS box which includes: • ‘This box includes…’ instruction sheet • ‘Can you find something…’ cards for introduction activity • Parent/guardian education booklet • Child education booklet • Activity cards set • Daily challenge calendar Support for the use of this intervention will be provided via ‘check-in’ phone calls with the study RA or TC every two weeks. This time will be used to discuss anything participants would like to raise regarding the intervention. A final ‘check-in’ phone call will also be offered at the end of study participation following outcome measure completion. _____ Previous interventions: The intervention will be based on the Five Ways to Wellbeing (Connect, Be Active, Take Notice, Learn and Give), an evidence-based health campaign. It will be developed with participants and staff from the Yorkshire Wildlife Trust who have experience of developing large nature-based campaigns as well working with parents/guardians, young people, and professionals. The study consists of four phases. In the first phase, three groups with children with ADHD and their family members, professionals from mental health, wildlife charities and researchers will meet for discovery workshops involving creative activities to consider how nature-based interventions may be used and what aspects of support for ADHD are needed. In phase 2 workshops will develop the intervention based on the information gathered in phase 1. In phase 3 a different group of children and families will test the intervention and provide outcomes before and after (including ADHD and mental health symptom measures). Phase 4 will use feedback from the user testing in phase 3 to further improve the intervention. Recruitment will be done in two stages. Participants will first be recruited to the co-design element of the study and will participate in the co-design of the intervention. The researchers will recruit 10 children, their parent/guardian, and 10 professionals to participate in the co-design. The second stage of recruitment will recruit 10 children and their parents/guardians that did not participate in the co-design of the intervention to test the intervention and complete outcome measures. Children recruited in both phases must be 5-11 years old and have a diagnosis of ADHD. They must also have a sufficient understanding of English to participate along with their parents/guardians and professionals. The intervention will be tested during the user testing phase for 6 weeks. Follow-up will be 8 weeks after the start of the intervention testing. Behavioural Anonymised participant data will be made available on request. Requests should be made to Hannah Armitt (hannah.armitt@nhs.net) and will be considered by the study management group which includes the co-leads of the study and co-applicants on a case by case basis. The data that will be available is that collected during the user testing phase including data from two timepoints (baseline and 8 weeks) for the CGI-P, the RCADS-P, the self-report diary, and the bespoke acceptability questionnaire. It will be completely anonymised prior to sharing so that no participants are identifiable. The data will only be shared if requested through the named contact and if the study management group approve the request. Criteria for sharing include non-commercial research within the field of child mental health for any type of analysis. Consent for data to be made available to other researchers will have been obtained from participants. Available on request 2024 Results article in https://doi.org/10.1016/j.childyouth.2024.108042 (added 09/01/2025) 2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36126049/ (added 27/09/2022) 2024 Other publications in https://www.nature.com/articles/s41599-024-03278-w (added 17/07/2024) Results

Full protocol

User testing

Study website Migrated from study website field

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COMIC research IT Centre Innovation Way

York United Kingdom YO10 5NP +44 (0)7870992859 e.kingsley@nhs.net Public Hannah Armitt Principal investigator

Humber Teaching NHS Foundation Trust Research Team Willerby Hill Beverley Road

Willerby United Kingdom HU10 6ED +44 (0)1482 301726 hannah.armitt@nhs.net Public Hannah Armitt Scientific

Humber Teaching NHS Foundation Trust Research Team Willerby Hill Beverley Road

Willerby United Kingdom HU10 6ED +44 (0)1482 301726 hannah.armitt@nhs.net Public Leeds and York Partnership NHS Foundation Trust Hospital/treatment centre https://ror.org/00n635c12 Non-commercial National Institute for Health Research http://dx.doi.org/10.13039/501100000272