80009790 true Optimising community C(E)TRs through understanding the experience of people with learning disability and autistic people and investigating their impact on care OptiCaT 1. Do C(E)TRs reduce hospital admissions (primary outcome) and duration of hospital stay in people with learning disability and/or autistic people who are at risk of psychiatric hospital admission? 2. Do C(E)TRs improve other clinical, health and social outcomes? 3. Are C(E)TRs cost-effective? Background and study aims Care (Education) and Treatment Reviews, or C(E)TRs, were introduced in England in 2015 to help people with a learning disability and autistic people get the right support in the community and avoid unnecessary admission to a mental health hospital. However, there is limited evidence about how well C(E)TRs work. This study aims to find out whether community C(E)TRs reduce hospital admissions and improve people’s health, wellbeing and care. Who can participate? The study is for people aged 14 years or older who have a learning disability and/or are autistic, are receiving support from an NHS community mental health services, and are considered at increased risk of admission to a mental health hospital. Family members and paid carers of participants can also take part. What does the study involve? People with a learning disability and autistic people from different parts of England will be recruited to the study and followed-up over time. Researchers will collect information about hospital admissions, mental health, behaviour, quality of life, medication, use of health and social care services, and the care and support people receive. The information will be collected at the point of recruitment, at 6 months, and at 9 months. The information will be collected by questionnaires that a researcher will go through with the participant. The data that are collected will allow researchers to compare people who have a C(E)TR with people who do not. What are the possible benefits and risks of participating? People taking part may not receive a direct personal benefit. However, the information they provide may help improve C(E)TRs and the support provided to people with a learning disability and autistic people in the future. The study is considered to be low risk. Completing questionnaires and assessments will take some time and may be tiring. Interviews may involve discussing difficult experiences, including times when community care has broken down or when hospital admission has been needed, and this could be upsetting. Participants can take a break or stop an interview if they wish, and the research team will help them access appropriate support if needed. Where is the study run from? The study is led by King’s College London (UK), in partnership with Queen Mary University of London and other universities and NHS organisations. Participants are being recruited through NHS services in different parts of England so that the study includes people from a range of geographical areas and communities. When is the study starting and how long is it expected to run for? August 2025 to February 2028 Who is funding the study? The study is funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research Programme (reference NIHR158490) Who is the main contact? Dr Rory Sheehan, opticatstudy@kcl.ac.uk Admission to psychiatric hospital the modified version of the Adult Service Use Schedule (AD-SUS) and also provided by the clinician baseline, 6 months, and 9 months 1. Psychiatric symptoms measured using the Moss Psychiatric Assessment Schedule - Check (Moss-PAS (Check)) at baseline, 6 months, and 9 months 2. Behaviour that challenges measured using the Behaviour Problems Inventory - Short Form (BPI-S) at baseline, 6 months, and 9 months 3. Unmet care needs measured using the Camberwell Assessment of Needs for Adults with Developmental and Intellectual Disabilities - Research version (CANDID-R) at baseline, 6 months, and 9 months 4. Quality of Life measured using the 13-item WHOQOL Disabilities module (WHOQOL-DIS) at baseline, 6 months, and 9 months 5. Health-related quality of life measured using the EuroQoL Five Dimensions - Three Levels questionnaire (EQ-5D-3L) at baseline, 6 months, and 9 months 6. Service use (health and social care contacts) measured using a modified version of the Adult Service Use Schedule (AD-SUS) at baseline, 6 months, and 9 months 7. Family carer distress measured using the Kessler Psychological Distress Scale (K6) at baseline, 6 months, and 9 months 8. Family carer health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire at baseline, 6 months, and 9 months 9. Clinician-rated participant symptom severity measured using the Clinical Global Impression-Severity (CGI-S) Scale at baseline, 6 months, and 9 months 10. Clinician-rated participant health and social functioning measured using the Health of the Nation Outcome Scales (HoNOS) at baseline, 6 months, and 9 months 11. Clinician-rated participant exposure to restrictive practices (physical, mechanical, or chemical restraint) measured using a questionnaire created by the research team at baseline, 6 months, and 9 months 12. Psychotropic medication prescribing measured using a questionnaire created by the research team at baseline, 6 months, and 9 months Ethics approval required Leeds West Research Ethics Committee

NHSBT Newcastle Blood Donor Centre Holland Drive

Newcastle upon Tyne United Kingdom NE2 4NQ 25/YH/0119  10.1186/ISRCTN80009790 335048 NIHR: 158490 335048 158490 Observational Longitudinal study 2028-02-29T00:00:00.000Z United Kingdom England Oxleas NHS Foundation Trust

Pinewood House Pinewood PLACE

Dartford England DA2 7WG RPG@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 North London NHS Foundation Trust

4th Floor, East Wing St. Pancras Hospital 4 St. Pancras Way

London England NW1 0PE G6V2S@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 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 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 Sussex Partnership NHS Foundation Trust

Trust Hq Swandean Arundel Road

Worthing England BN13 3EP RX2@2.16.840.1.113883.2.1.3.2.4.18.48 Cornwall Partnership NHS Foundation Trust

Carew House Beacon Technology Park Dunmere Road

Bodmin England PL31 2QN RJ8@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 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 Hertfordshire Partnership N H S

Harper Lane Shenley

Radlett England WD7 9HQ V09887@2.16.840.1.113883.2.1.3.2.4.18.48 North East London NHS Foundation Trust

Goodmayes Hospital 157 Barley Lane

Ilford England IG3 8XJ RAT@2.16.840.1.113883.2.1.3.2.4.18.48 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 South West London and St George's Mental Health NHS Trust

Springfield Hospital 61 Glenburnie Road

London England SW17 7DJ RQY@2.16.840.1.113883.2.1.3.2.4.18.48 false 1. Children/adolescents (aged between 14 and 17 years, inclusive) or adults (≥18 years) with a clinical diagnosis of learning disability (of any degree) or autism (diagnosis based on service records, expected to conform to ICD-10 chapter F7- criteria for learning disability or ICD-10 F84 criteria for autism) 2. Under the care of a community mental health service (e.g., Child and Adolescent Mental Health Services [CAMHS], Community Learning Disability Team [CLDT], Community Mental Health Team [CMHT]) in a participating Trust 3. Rated as red or amber on the Dynamic Support Register (DSR) 4. Provide informed consent to taking part or, where an adult lacks capacity to consent to participate, a personal or nominated consultee has signed a declaration form or, in the case of children/adolescents (<18 years), a parent/guardian has signed a consent form Mixed 14 Years 99 Years All 300 0 1. No clinically-confirmed diagnosis of learning disability or autism 2. Not on the Dynamic Support Register 3. Currently admitted to a psychiatric hospital 4. Does not provide informed consent or, where an adult lacks capacity, there is no consultee declaration or, in the case of children/adolescents (<18 years) a parent/guardian has not signed a consent form 2025-08-01T00:00:00.000Z 2027-02-28T00:00:00.000Z Intellectual (learning) disability or autism spectrum disorder Other This is an observational prospective cohort study recruiting people aged 14 years and over with a learning disability and/or autism who are considered at increased risk of psychiatric hospital admission (as identified by being rated red or amber on the Dynamic Support Register [DSR]). Participants will be recruited through NHS community mental health services across diverse areas of England. Family or paid carers may also take part. Participants will complete assessments at the start of the study and again at 6 and 9 months. Information will be collected from participants, carers and clinicians about psychiatric hospital admissions, mental health and behaviour, quality of life, unmet needs, use of health and social care services, medication and restrictive practices. Assessments can be completed face-to-face, by telephone or online. We would expect some people to receive a C(E)TR during follow-up and others will not. The main outcome is admission to psychiatric hospital during follow-up. Secondary outcomes include psychiatric symptoms (measured by the Moss-PAS Check), behaviour that challenges (Behaviour Problems Inventory - Short form), unmet need (CANDID-R), quality of life (WHOQOL-DIS), health-related quality of life (EuroQoL Five Dimensions), service use (contacts with health and social care using a modified version of the Adult Service Use Schedule), all of which will be completed by the participant with learning disability or autism. Family carers who are enrolled will complete measures of family carer distress (Kessler Psychological Distress Scale), and carer health-related quality of live (EQ-5D-5L). Clinicians providing care to recruited participants will provide information on participant symptom severity (using the Clinical Global Impression-Severity scale), participant health and social functioning (measured with Health of the Nation Outcome Scale, HoNOS), use of restrictive practices (i.e. Mental Health Act, Deprivation of Liberty Safeguards), psychotropic medication, and whether a C(E)TR was conducted. The main outcome will be psychiatric hospital admission during follow-up. Outcomes will be compared between participants who receive a C(E)TR and those who do not, to investigate whether C(E)TRs are associated with a reduced likelihood of hospital admission and better health and care outcomes. Other Not expected to be made available 7ec7713b-595d-402c-8112-c08062629892 51829bab-ef10-4763-8132-5e6692178f42 1c435748-e516-4e3f-a3f5-a034fa55a259 No Rory Sheehan https://orcid.org/0000-0002-4164-9661 Principal investigator Scientific Public

Institute of Psychiatry, Psychology & Neuroscience King's College London

London United Kingdom SE5 8AF +44 (0)20 7848 0002 rory.sheehan@kcl.ac.uk Public South London and Maudsley NHS Foundation Trust https://ror.org/015803449 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 53835117 true The codesign and evaluation of a novel virtual reality intervention for use in psychiatric inpatient wards Stage One: Gain feedback and reactions of patients and staff on the use of the VR headset to refine the VR content and provide input on the design of the Pilot Stage Two: Explore the feasibility of the use of VR in inpatient wards Background and study aims The current study aims to examine the feasibility and acceptability of a virtual reality (VR) app for use on inpatient psychiatric wards. The study will be completed in two stages. Stage One is a co-design stage, and Stage Two is the Pilot stage. Who can participate? Adult staff who are currently working on an inpatient ward at Springfield University Hospital, and adult inpatients at Springfield University Hospital. What does the study involve? A VR hypnotherapy app that has been developed in collaboration with the company Phase Space will be trialled with psychiatric inpatients. Stage One Sixteen patients and six staff members will be recruited at this stage. The first eight patients will test the headset and provide feedback. Based on this, the app will be modified by Phase Space and then trialled by an additional eight patients. Concurrently with the recruitment of the 16 patients, six staff members from the ward will be recruited to complete an interview about the feasibility and use of VR headsets on the ward. The total feedback will be taken back to Phase Space, which will further modify the app to be implemented in the pilot stage. Stage Two The Pilot stage will be held in the sensory rooms of two inpatient psychiatric wards. The recruitment period will last four weeks. During the four-week period, participants will have the option of attending a drop-in session held on their ward. The drop-in session will be held twice weekly for the four-week period and participants will be able to use the VR headset during this time period. They will be able to attend the drop-in session as frequently as they would like over the four week period, meaning that they have the ability to attend up to eight drop-in sessions. The new app will be piloted on sixteen inpatients to see if it is deemed acceptable and feasible for use on inpatient wards. the first use of the headset, as well as after four sessions (or earlier if the participant decides to end involvement before they reach four sessions). If a participant attends all eight sessions, they will complete the questionnaires again after the eighth session. Additionally, participants will complete the VR Comment Card before and after each use of the VR headset. Participants will also complete a short qualitative interview after their last session. The interview will comprise of asking participants to provide any feedback they have on the VR, as well as understanding more about how they could see the VR implemented into a ward setting. Staff members will be recruited to assist in the running of the VR drop-in sessions. Staff will also be asked to provide any feedback on the sessions and observations of the sessions through a diary. At the end of the recruitment window, staff will also be asked to complete a short interview asking about topics such as any changes in participants’ behaviour after the VR, logistical challenges around patients using the headsets, how the equipment was looked after and maintained, locations used for the VR and demands on staff time for the rollout. What are the possible benefits and risks of participating? There are no guaranteed benefits to taking part in the study. The use of the VR headset may provide participants with feelings of reduced stress. Study involvement also benefits the future of the study, as feedback will be used to develop the software further so it can possibly be implemented in clinical settings. All participants will also receive a gift voucher as a thank you for participation (£20 for Stage One, £30 for Stage Two). It is not anticipated that any significant risks will be involved in the study. It is possible to feel cybersickness when using a VR headset. If this occurs, participants can take off the headset to let the symptoms subside. Participants can also withdraw involvement in the study at any point. It is not anticipated that participants will feel distressed due to study involvement, but if they do, the researchers can alert their care team and participants. If there are any technological problems with the VR headset, the researcher present will be trained to work through the problems. Where is the study run from? Springfield University Hospital, UK. When is the study starting and how long is it expected to run for? February 2025 to January 2026 Who is funding the study? 1. Medical Research Council (MRC), UK 2. Phase Space Ltd, UK Who is the main contact? Megan Cartier, megan.cartier@swlstg.nhs.uk 1. Stage One: Gather feedback and reactions of both staff and patients on the use of the VR headset to refine the content and provide input on the design of the Pilot, measured using qualitative interviews with patients and staff at the end of study involvement 2. Stage Two: Explore the feasibility of the use of VR in inpatient wards, measured using qualitative interviews with patients and staff at the end of study involvement 1. Stage One: Produce an implementation model to be tested in a Pilot, identify any areas requiring further modification, learn how to prepare staff and patients for the VR experience, identify the best location for the VR experience, and understand the practicalities of the headsets, measured using qualitative interviews with staff and patients at the end of study involvement 2. Stage Two: Explore the impact of the VR on patients measured using the Simulator Sickness Questionnaire, Patient Health Questionnaire-8 (PHQ-8), Generalized Anxiety Disorder 7-item Scale (GAD-7), Dissociative Experiences Scale – II (DES-II), Brief Psychiatric Rating Scale (BPRS), Positive and Negative Syndrome Scale (PANSS) at baseline and at the end of study involvement Ethics approval required East of England - Cambridge Central Research Ethics Committee

2 Redman Place, Stratford

London United Kingdom E20 1JQ 25/EE/0097 10.1186/ISRCTN53835117 351569 NCT06917456 CPMS: 63655, APP49548 NCT06917456 351569 63655 APP49548 Interventional N/A: single arm study Open (masking not used) Uncontrolled Single Single-site interventional pilot study Not applicable Other 2026-03-09T00:00:00.000Z United Kingdom England South West London & St. George's Mental Health NHS Trust

Springfield University Hospital Trinity Building 15 Springfield Drive

London England SW17 0YF Health professional Patient Current key inclusion criteria as of 21/01/2026: Staff: 1. Currently working on an inpatient ward at Springfield University Hospital 2. Able to provide informed consent Patients: 1. 18 years of age or older 2. Current inpatient at Springfield University Hospital 3. Able to provide informed consent _____ Previous key inclusion criteria: Staff: 1. Currently working on an inpatient ward at Springfield University Hospital 2. Able to provide informed consent Patients: 1. Aged 18-65 years old 2. Current inpatient at Springfield University Hospital 3. Able to provide informed consent Mixed 18 Years 100 Years All 43 43 Staff: 1. Not currently working on an inpatient ward at Springfield University Hospital 2.Unable to provide informed consent Patients: 1. Unable to provide informed consent 2. Has a history of seizures 3. Has a pacemaker 2025-08-13T00:00:00.000Z 2026-02-23T00:00:00.000Z Mental health conditions Mental and Behavioural Disorders This study examines the use of a virtual reality headset for mental health conditions. There is no randomisation plan for the study as all participants will test out the virtual reality headset. They will use the headset to watch a seven-minute immersive experience, aimed at helping with feelings of stress and aiding in relaxation. Participants receive information on the programme before use and are aided in the use of the headset by two trained researchers. The study of the headset will be done in-person within the wards within the sensory or calm rooms, so participants have a quiet space to try out the headset. Device Not Applicable Virtual reality hypnotherapy app and headset Not expected to be made available f80b1f9f-2028-4673-965d-e387969ea68e 620c188f-0674-494e-8725-90f7f6ecdb15 47377cbf-9e0f-4233-9b82-74d774c55830 d7b3727e-cdb8-46c2-8a6b-d5df16cde3c1 3f88cc39-7ebf-401d-a581-9b148194cd02 No Aileen O'Brien Scientific Principal investigator Public

South West London and St George's Mental Health NHS Trust 15 Springfield Drive

London United Kingdom SW17 0YF +44 (0)2035136491 aileen.o'brien@swlstg.nhs.uk Public Megan Cartier Public

15 Springfield Drive

London United Kingdom SW17 0YF +44 (0)7933172185 megan.cartier@swlstg.nhs.uk Public South West London and St George's Mental Health NHS Trust Hospital/treatment centre https://ror.org/003pb1s55 Non-commercial Medical Research Council http://dx.doi.org/10.13039/501100000265 Phase Space 92005743 true Randomized controlled trial to compare clinical effectiveness and cost-effectiveness of mentalization-based treatment - trauma focused versus treatment as usual for people with probable complex post-traumatic stress disorder in mental health services in England MBT-TF The aim of this study is to conduct a randomised controlled trial (RCT) to investigate whether Mentalization-Based Treatment - Trauma Focused (MT-TF) is an effective treatment for individuals who meet threshold for diagnostic criteria for complex post-traumatic stress disorder (CPTSD) in personality disorder (PD) services compared to Treatment as Usual (TAU). Background and study aims To date, treatments that effectively address both the symptoms of complex trauma and personality difficulties that characterise complex post-traumatic stress disorder (CPTSD) are rare. The burden of CPTSD in the UK includes significant psychiatric comorbidity, chronic illness, and an elevated risk of suicide. Mentalization-Based Treatment - Trauma Focused (MT-TF) aims to directly address the impact of trauma in a complex presentation and alleviate patients' distress in tailored, inclusive, non-stigmatising and non-discriminating treatment pathways that mitigate the risk of drop out by integrating trauma processing. This study aims to compare MBT-TF with TAU for adults meeting the diagnostic criteria for CPTSD in personality disorder services. Who can participate? Males, females, individuals who do not identify as male or female, aged 18 - 65 years old, who meet PTSD criteria with sufficient knowledge of the English language. What does the study involve? Participants are randomised to MT-TF or Treatment as Usual (TAU). Participants randomised to MBT-TF will receive weekly group therapy sessions lasting 90 minutes. Treatment will involve approximately 36 group sessions and up to 5 individual supportive therapy sessions as needed over a 9-month period. Baseline data will be collected pre-randomisation. Participants will be followed up at 3, 9 and 15 months post-randomisation. What are the possible benefits and risks of participating? There is minimal risk from randomisation and treatment to the participants themselves. Both MBT-TF and TAU will be delivered by experienced professionals used to working with this client group. Those who agree to participate in the trial will be involved in a number of time-consuming interviews and assessments, which may be somewhat burdensome but do not carry specific risk. The researchers are experienced in conducting assessments and encourage regular breaks to be taken by the participant if necessary. By agreeing to take part, the participant will receive a treatment intervention that would not normally be offered. The outcomes of the evaluation could also improve the provision of interventions for other patients. Where is the study run from? North London NHS Foundation Trust is sponsoring the study and University College London is the lead. When is the study starting and how long is it expected to run for? March 2025 to June 2028 Who is funding the study? University College London (UK) Who is the main contact? 1. Dr Tobias Nolte, Tobias.NolteMD@annafreud.org 2. Prof. Patrick Luyten, p.luyten@ucl.ac.uk Symptoms of complex post-traumatic stress disorder (CPTSD) assessed by the International Trauma Questionnaire (ITQ) at baseline (T1), 3-month follow-up (T2), 9-month follow-up (T3) and 15-month follow-up (T4). 1. Diagnosis of Borderline personality disorder will be measured by the Borderline Symptom List at baseline (T1), 9-month follow-up (T3) and 15-month follow-up (T4). 2. Childhood trauma will be measured by the Childhood Trauma Questionnaire at baseline (T1) only. 3. Disturbance, impulsivity, severity of personality disorder, global functioning, social functioning, interpersonal functioning, suicide ideation and behaviour, sense of belonging, self-care, emotional distress and health related quality of life will be measured by the International Consortium for Health Outcomes Measurement Personality Disorder List at Collected at baseline (T1), 9 month follow up (T3) and 15 month follow up (T4). 4. Diagnosis of PTSD will be measured by the Clinician Administered PTSD Scale for DSM-5 at baseline (T1), 9 month follow up (T3) and 15 month follow up (T4) and Clinician Administered PTSD Scale for DSM-5 at baseline (T1), 9 month follow up (T3) and 15 month follow up (T4). 5. Levels of personality functioning will be measured by the Level of Personality Functioning Screener-Brief Form at baseline (T1), 9-month follow-up (T3) and 15-month follow-up (T4). 6. Interpersonal difficulties will be measured by the Inventory of Personal Problems at baseline (T1), 9-month follow-up (T3) and 15-month follow-up (T4). 7. Quality of life will be measured by the EQ-5D-5L at baseline (T1), 9-month follow-up (T3) and 15 month follow up (T4). 8. Dissociative experiences will be measured by the Dissociative Experiences Scale-II at baseline (T1), 3-month follow-up (T2), 9-month follow-up (T3) and 15-month follow-up (T4). 9. Psychological distress and psychiatric disorder will be measured by the Brief Symptom Inventory 18 at baseline (T1), 3-month follow-up (T2), 9-month follow-up (T3) and 15-month follow-up (T4). 10. Individual's feeling of loneliness will be measured by the UCLA Loneliness Scale Short Form at baseline (T1), 9-month follow-up (T3) and 15 month follow up (T4). 11. Trust in communicated knowledge will be measured by the Epistemic Trust, Mistrust and Credulity Questionnaire at baseline (T1), 9-month follow-up (T3) and 15-month follow-up (T4). 12. Reflective functioning will be measured by the Reflective Functioning Questionnaire at baseline (T1), 9-month follow-up (T3) and 15-month follow-up (T4) 13. Indicators of failures in mentalizing trauma and adverse relationships will be measured by the Failure to Mentalize Trauma Questionnaire at baseline (T1), 3-month follow-up (T2), 9-month follow-up (T3) and 15-month follow-up (T4). 14. Patient experiences will be measured by the Helping Alliance Questionnaire at baseline (T1) and 9-month follow-up (T3) and Client Satisfaction Questionnaire at 9-month follow-up (T3) only. 15. Feelings of shame related to experiencing traumatic events will be measured by the Trauma-Related Shame Inventory at Baseline (T1), 3-month follow-up (T2), 9-month follow-up (T3) and 15-month follow-up (T4). 16. Service use will be measured by the Adult Service Use Schedule at baseline (T1), 9-month follow-up (T3) and 15-month follow-up (T4). 17. Post-traumatic growth will be measured by the Posttraumatic Growth Inventory - Expanded at baseline (T1), 3-month follow-up (T2), 9-month follow-up (T3) and 15-month follow-up (T4). Ethics approval required London - Hampstead Research Ethics Committee

2 Redman Place

London United Kingdom E20 1JQ 25/LO/0137 10.1186/ISRCTN92005743 340141 340141 Multi-site superiority single-blind randomized controlled trial Interventional Randomised controlled trial Treatment 2028-06-01T00:00:00.000Z United Kingdom England Scotland Wales Oxleas NHS Foundation Trust

Pinewood House Pinewood PLACE

Dartford England DA2 7WG RPG@2.16.840.1.113883.2.1.3.2.4.18.48 Merseycare NHS Trust

V7 Building Kings Business Park

Prescot England L34 1PJ Y03793@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 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 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 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 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 South West London and St. George's Mental Health NHS trust

Springfield Hospital 61 Glenburnie Road

London England SW17 7DJ Barnet, Enfield and Haringey Mental Health NHS Trust

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

London England N15 3TH Patient 1. Aged 18-65 years 2. Meeting PTSD criteria on the ITQ in combination with at least one symptom from each Disturbances in Self-Organization (DSO) cluster, with functional impairment associated with these symptoms as assessed by the ITQ at screening equivalent to CPTSD diagnosis. 3. Scoring ≥31 on the LPFS-BF (36) at screening, which corresponds to 1.5 standard deviations above the latent mean (T score of 65), indicating at least moderate severity in terms of personality disorder features. 4. Sufficient knowledge of the English language. Mixed 18 Years 65 Years All 198 0 1. Current psychotic episode 2. Diagnosis of severe neurological disorder 2025-06-01T00:00:00.000Z 2027-12-31T00:00:00.000Z Complex post-traumatic stress disorder (CPTSD) Mental and Behavioural Disorders Participants are randomised (minimization, 1:1) to Mentalization-Based Treatment - Trauma Focused (MT-TF) or Treatment as Usual (TAU). Participants randomised to MBT-TF will receive weekly group therapy sessions lasting 90 minutes. Treatment will involve approximately 36 group sessions and up to 5 individual supportive therapy sessions as needed over a 9-month period. Participants will be followed up at 3, 9 and 15 months post-randomisation. Behavioural Not expected to be made available 67b128a6-40e4-43aa-9ebb-a13705a88e06 8ebeeebc-1f24-4f19-b164-6f4d43c1fac1 2b4b24ab-10ca-4963-92f4-75919a822f1c 74c7cb7a-e6d2-41d9-923b-bf653f66a229 33e02a5b-fde8-459a-b938-bfd0ed7cd400 No Tobias Nolte Scientific Principal investigator

North London Foundation Trust St Pancras Hospital in Camden

London United Kingdom NW1 0PE +44 (0)20 8702 3000 Tobias.NolteMD@annafreud.org Public Patrick Luyten https://orcid.org/0000-0002-1161-2817 Scientific Principal investigator

University College London 1-19 Torrington Place

London United Kingdom WC1E 7HB +44 (0)2076792000 p.luyten@ucl.ac.uk Public Elizabeth Simes https://orcid.org/0000-0003-1704-6278 Public

University College London 1-19 Torrington Place

London United Kingdom WC1E 7HB +44 (0)2076792000 e.simes@ucl.ac.uk Public Noclor Hospital/treatment centre Non-commercial University College London http://dx.doi.org/10.13039/501100000765 29596999 true A peer-led group programme for people with severe mental illness to reduce risk of cardiovascular disease (PEGASUS): A feasibility evaluation study PEGASUS feasibility study The aim of this research is to feasibility test a trained peer-supported group clinic intervention for people with SMI who have increased risk of CVD. Building on development work, evidence from a systematic review and an experience-based co-design process leading to the development of a co-produced peer-supported group clinic intervention, the objectives of this study are: 1. To establish the feasibility of the intervention for future evaluation in a randomised controlled trial (RCT), specifically: 1.1. Establish the feasibility of recruitment and retention strategies for the main trial 1.2. Assess the acceptability of, and retention to the planned intervention for individuals with SMI and elevated CVD risk 1.3. Determine the feasibility of collecting primary and secondary outcome data for the main trial 2. Estimate the location (proportion) and variability (confidence intervals) of the primary outcome to refine the power calculations for the main trial 3. To refine the content and delivery strategies for the intervention 4. To determine the best method of evaluating intervention implementation and fidelity Background and study aims People living with severe mental illness (SMI), such as schizophrenia or bipolar disorder, often have poorer physical health and can die 15–20 years earlier than the general population. One of the main causes of early death is heart disease. This risk is even higher for people from Black, Asian and minority ethnic communities. The PEGASUS study is testing a new group programme designed to help people with SMI reduce their risk of heart disease. The programme includes support with healthy eating, physical activity, and managing health goals, and is co-led by peer support workers (people with lived experience of mental health difficulties) and healthcare professionals. Who can participate? Adults who have a diagnosis of severe mental illness and also an elevated risk of cardiovascular disease may be able to take part. What does the study involve? Participants will be invited to join a group of 8–12 people for 10 sessions over 6 months. Each session lasts 2 hours and is led by a peer support worker and a healthcare professional. The sessions focus on different aspects of health and wellbeing. Participants will also have an individual ‘onboarding’ session before the group starts, four one-to-one sessions with a peer worker during the programme, and a reunion session after the programme ends. The study will also involve completing questionnaires and health checks at the beginning, middle, and end of the programme. Some participants may be invited to take part in an interview or focus group to share their views on the programme. What are the possible benefits and risks of participating? Taking part may help participants improve their physical health, feel more confident about managing their health, and feel more socially connected. There are no major risks, but some people may find it difficult to talk about their health or take part in group sessions. Support will be available throughout. Where is the study run from? City St George’s, University of London (UK) When is the study starting and how long is it expected to run for? August 2025 to September 2026 Who is funding the study? National Institute for Health and Care Research (NIHR) (UK) Who is the main contact? Dr Bethan Hatherall, bethan.hatherall@citystgeorges.ac.uk Jessica Catchpole, jessica.catchpole@citystgeorges.ac.uk Acceptability of intervention and study delivery as assessed by focus group/interviews at 3 and 6-months. 1. Participant recruitment and retention rate is measured using study records at baseline, 3 months, and 6 months 2. Waist circumference is measured using tape measurement at baseline, 3 months, and 6 months 3. Hip circumference is measured using tape measurement at baseline, 3 months, and 6 months 4. Body mass index (BMI) is measured using height and weight measurements at baseline, 3 months, and 6 months 5. Triglycerides are measured using fasting blood sample at baseline, 3 months, and 6 months 6. HDL-cholesterol is measured using fasting blood sample at baseline, 3 months, and 6 months 7. LDL-cholesterol is measured using fasting blood sample at baseline, 3 months, and 6 months 8. Total cholesterol is measured using fasting blood sample at baseline, 3 months, and 6 months 9. HbA1c is measured using blood sample at baseline, 3 months, and 6 months 10. Blood pressure is measured using automated sphygmomanometer at baseline, 3 months, and 6 months 11. Psychiatric symptoms are measured using the Modified Colorado Symptom Index at baseline, 3 months, and 6 months 12. Dietary behaviour is measured using the Dietary Instrument for Nutrition Education (DINE) adapted by IMPaCT at baseline, 3 months, and 6 months 13. Physical activity is measured using the International Physical Activity Questionnaire - Short Form (IPAQ-SF) at baseline, 3 months, and 6 months 14. Tobacco, cigarette, and betel nut or paan use is measured using self-report questionnaire at baseline, 3 months, and 6 months 15. Alcohol consumption is measured using the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) at baseline, 3 months, and 6 months 16. Health-related quality of life is measured using the EQ-5D-5L at baseline, 3 months, and 6 months 17. Depression is measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline, 3 months, and 6 months 18. Self-efficacy is measured using the Generalised Self-Efficacy Scale at baseline, 3 months, and 6 months 19. Social network is measured using the Lubben Social Network Scale at baseline, 3 months, and 6 months 20. Therapeutic relationship is measured using the Scale to Assess the Therapeutic Relationship (STAR) at baseline, 3 months, and 6 months 21. Progress towards achievement of personalised lifestyle goals is measured using the Goal-Based Outcome Tool at baseline, 3 months, and 6 months 22. Health and social care service use is measured using the DIAMONDS Service Use Survey at baseline, 3 months, and 6 months 23. Physical activity levels are measured using one-week accelerometer wear at baseline, 3 months, and 6 months Ethics approval required Wales Research Ethics Committee 7

2 Redman Place, Stratford

London United Kingdom E20 1JQ 24/WA/0289 10.1186/ISRCTN29596999 326517 CPMS: 59641, NIHR: 204418 326517 59641 204418 Interventional non-randomized Interventional Non randomised study Treatment 2026-09-01T00:00:00.000Z United Kingdom England 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 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 Birmingham and Solihull Mental Health NHS Foundation Trust

Unit 1 50 Summer Hill Road

Birmingham England B1 3RB South West London and St George's Mental Health NHS Trust

Springfield Hospital 61 Glenburnie Road

London England SW17 7DJ Patient Current key inclusion criteria as of 18/12/2025: Service users participants will: 1. Be aged 18 to 75 years 2. Have capacity to consent to participate in research 3. Currently on the caseload of mental health services in community settings or on GP/ ICS severe mental illness (SMI) list 4. Current primary diagnosis of schizophrenia-spectrum disorders (ICD-10 diagnoses F20–29) or bipolar disorder (F31) or in Early Intervention for Psychosis Services (EIPS) with formal diagnosis of psychosis (ICD-10 diagnoses of F29) or an aforementioned diagnosis. 5. If on psychotropic medication, on stable dose for 90 days (N.B. This refers specifically to either adding or changing to a new antipsychotic medication, but not applies to dosage adjustment of a pre-existing antipsychotic medication.) 6. Enhanced CVD risk as indicated by any one of: i) Obesity defined as: waist circumference over 102cm in men (or >90cm in non-white men) or over 88cm in women (or >80cm in non-white women) or BMI≥25 kg/m2 (or ≥23 kg/m2 in non-white people) ii) Hypertension defined as: blood pressure over 130/85 mmHg or documented hypertension on medication iii) Dyslipidaemia defined as: fasting triglyceride level over 1.7mmol/l or total cholesterol ≥5.0 mmol/L or on medication for hyperlipidaemia (e.g. statin) or high-density lipoprotein (HDL) cholesterol level less than 0.9mmol/l (men)/1mmol/l (women) iv) Hyperglycaemia defined as: HbA1c > 37 mmol/mol (5.5%) or fasting plasma glucose level ≥5.6 mmol/l or documented Type-2 diabetes (T2D) 7. If on treatment for T2D, hypertension or hyperlipidaemia, on stable dose medication for at least 90 days Intervention staff: 1. Peer (support) workers and registered mental health nurses (or other healthcare professionals or practitioners with appropriate training) 2. Based at one of the participating sites/Trusts 3. Have been trained and engaged with the PEGASUS programme to deliver (co-facilitate) the PEGASUS intervention for the purposes of this study _____ Previous key inclusion criteria: Service users participants will: 1. Be aged 18 to 75 years 2. Have capacity to consent to participate in research 3. Service Involvement: 3.1 Currently on the caseload of mental health services in community settings 3.2 Or on GP/ICS severe mental illness (SMI) list 4. Diagnosis: 4.1 Current primary diagnosis of schizophrenia-spectrum disorders (ICD-10 diagnoses F20–29) 4.2 Or bipolar disorder (F31) 4.3 Or in Early Intervention for Psychosis Services (EIPS) with formal diagnosis of the above conditions 5. If on psychotropic medication, must be on a stable dose for 90 days 6. Enhanced Cardiovascular Disease (CVD) Risk as indicated by metabolic syndrome (NCEP ATP III definition), confirmed at screening by any three of the following: 6.1 Waist circumference over 102 cm (men) or 88 cm (women) 6.2 Blood pressure over 130/85 mmHg or documented hypertension on medication 6.3 Fasting triglyceride level over 1.7 mmol/l 6.4 HDL cholesterol level less than 0.9 mmol/l (men), 1 mmol/l (women) 6.5 HbA1c > 37 mmol/mol (5.5%) or documented Type-2 diabetes (T2D) and on medication 6.6 If on treatment for T2D, hypertension or hyperlipidaemia, must be on stable dose medication for at least 90 days Intervention staff: 1. Peer (support) workers and registered mental health nurses (or other healthcare professionals or practitioners with appropriate training) 2. Based at one of the five sites/Trusts 3. Have been trained and engaged with the PEGASUS programme to deliver (co-facilitate) the PEGASUS intervention for the purposes of this study Mixed 18 Years 75 Years All 40 18 Current key exclusion criteria as of 18/12/2025: Service users who: 1. Are currently admitted to acute psychiatric care (i.e. inpatient admission or current referral to a Crisis & Home Treatment Team) 2. Have a primary diagnosis of alcohol or substance misuse 3. Are awaiting/going through assessment with EIPS but without formal diagnosis 4. Have a diagnosis of an organic mental health disorder (e.g. dementia) 5. Are currently in receipt of a highly structured and/ or multi-goal healthy lifestyle intervention (e.g. an intervention that combines structured diet and exercise goals, or a highly structured research-based intervention such as DIAMONDS or PRIMROSE-A). Note: referral to single goal lifestyle support, as typically provided in the voluntary-sector or as online NHS advice, is considered as part of care as usual and will be assessed in both trial groups 6. Blood pressure or hyperlipidaemia managed outside of primary care 7. Type 1 diabetes Intervention staff: Peer (Support) Workers, registered mental health nurses or other healthcare professionals or practitioners who are not trained for nor delivering the PEGASUS intervention for the purposes of this study. _____ Previous key exclusion criteria: Service users who: 1. Are currently admitted to acute psychiatric care (i.e. inpatient admission or current referral to a Crisis & Home Treatment Team) 2. Have a primary diagnosis of alcohol or substance misuse 3. Are awaiting/going through assessment with EIPS but without formal diagnosis 4. Have a diagnosis of an organic mental health disorder (e.g. dementia) 5. Are currently in receipt of a highly structured and/ or multi-goal healthy lifestyle intervention (e.g. an intervention that combines structured diet and exercise goals, or a highly structured research-based intervention such as DIAMONDS or PRIMROSE-A). Note: referral to single goal lifestyle support, as typically provided in the voluntary-sector or as online NHS advice, is considered as part of care as usual and will be assessed in both trial groups 6. HbA1c > 86 mmol/mol 7. Blood pressure or hyperlipidaemia managed outside of primary care 8. Type 1 diabetes Intervention staff: Peer (Support) Workers, registered mental health nurses or other healthcare professionals or practitioners who are not trained for nor delivering the PEGASUS intervention for the purposes of this study. 2025-08-01T00:00:00.000Z 2026-03-31T00:00:00.000Z Severe mental illness and metabolic syndrome Mental and Behavioural Disorders The PEGASUS intervention is a therapeutic group programme for people with severe mental illness at risk of cardiovascular disease and has been co-produced by peer workers, clinicians, and most importantly people with lived experience. The programme consists of 10 group sessions over the course of 6 months. The duration of each session is 2 hours. Each session consists of the same group of 8-12 people and the same two facilitators; a mental health peer support worker (someone who has lived experience of mental health difficulties and is using such experience in their work to support others) and a health care professional (this might be a nurse, dietician or occupational therapist). Each session will have a focus on different aspects of health and wellbeing that our previous research has identified as important to people with SMI and cardiovascular disease risk. Participants are also offered an ‘onboarding’ session with one of the facilitators in advance of the first group session, and 4 additional one-to-one sessions with the peer support worker over the course of the programme. A reunion session will be offered within 3 months of the programme finishing. Behavioural The datasets generated during and/or analysed during the current study are/will be available upon request from the Study Team, in accordance with the policies and conditions set out by the ethical or legal restrictions. bethan.hatherall@citystgeorges.ac.uk Jessica.catchpole@citystgeorges.ac.uk Available on request Protocol

Study website Migrated from study website field

0e508769-419b-4e62-b5e9-991a81efdbff ae64e40b-031b-4cfc-9124-f96ef3755d99 799204df-3a73-4022-9e5d-6eb2f8ce94e3 33193943-4046-42ed-b670-18d3e783ab7b Yes Participant information sheet 47785 PIS PEGASUS feasibility study v1.1 15Oct24.pdf 9ac28dec-d594-4119-88d4-c9a0e16b2087 true application/pdf 241085 fdee9d5c0d31e98315ac818ffbc7b4a2 Protocol file ISRCTN29596999 Feasibility study protocol_V2.3_2025Nov20 (1).pdf 922d756d-cd07-4750-bd30-244630aef9a1 true application/pdf 714096 9943e25311a4a518b90678655bd1a259 Bethan Hatherall https://orcid.org/0000-0001-8114-9648 Public Scientific

School of Health and Medical Sciences, City St George's University of London, Northampton Square

London United Kingdom EC1V 0HB - bethan.Hatherall@citystgeorges.ac.uk Public Jessica Catchpole https://orcid.org/0000-0001-7901-1797 Public Scientific

(Lived Experience Researcher), School of Health and Medical Sciences, City St George's University of London, Northampton Square

London United Kingdom EC1V 0HB +44(0)7423 637934 Jessica.catchpole@citystgeorges.ac.uk Public City, University of London University/education https://ror.org/04489at23 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 62821969 true United Kingdom research study into ethnicity and COVID-19 outcomes in healthcare workers: increasing retention of healthcare staff from ethnic minority groups, Work Packages 4 and 5 (qualitative and co-design study) UK-REACH I-CARE WP4&5 This is a qualitative study and does not have a hypothesis. The main research question is: In which contexts, and why, are staff from minoritised groups more likely to leave or stay within the NHS workforce post-pandemic compared to white British groups? Background and study aims The aim of this study is to improve understanding of how and why NHS staff from ethnic minority groups and/or staff who have migrated to the UK (“minoritised groups”) stay or leave the NHS. Ethnic minority staff comprise 24% of all NHS staff, including 42% of doctors and over 90% of nurses in the lowest pay grade. Staff from minoritised groups are at greater risk of harassment, low pay and poor career progression and they have been disproportionately negatively affected by the pandemic. The aim of this study is to explore how these (and other non-work related) experiences and factors influence HCWs, particularly those from minoritised groups, decisions to leave or stay in their jobs. Who can participate? Health care workers aged 18 years and over who have are leaving or thinking of leaving their job, or have recently left their job, and their managers within the health care workforce What does the study involve? We will ask you to: 1. Register your details (including contact details) on our secure web page. 2. Confirm you have read this Information sheet and provide consent to participate in the study using our secure web page, if you are happy to do so. 3. Complete a short demographic questionnaire, which will take approximately 5 minutes. We will ask some basic information about you, including your age, ethnicity, job role and also if you plan to leave or have already left your job. 4. On the basis of the information you provide, we will screen your eligibility against our sampling criteria, and if you meet the criteria, you will be invited to take part in an interview. 5. Your decision to participate will be confidential, and anything you say will also be confidential, and the information you give will be anonymised (so no personal data about you is shared). 6. Interviews will be at a time that is convenient to you and most will likely take place on Microsoft Teams, which is a safe online platform approved by the University of Leicester. If there is a preference for face-to-face/telephone interviews, this will be taken into consideration where feasible. 7. In the interview, you will be asked several open-ended questions regarding your perceptions about different aspects of your job, intention to leave, the impact this has/will have on your personal and professional life and finally your views about improving staff retention. 8. We will record your responses using the Teams feature or use an encrypted voice recorder if doing it face-to-face or telephonically (and will require your consent for this). 9. The interviews will take around 45 minutes – 1 hour to complete. 10. The interviews will primarily be conducted in English; however, if you feel that language will be a significant barrier for you in expressing yourself during the interview, we might be able to arrange for an interpreter. 11. After the interview, we will offer you a £25 shopping voucher as a token of our appreciation, on signing a contributor disclaimer form which reiterates the voluntary nature of your participation 12. If you consent to be re-contacted, we may contact you again to invite you to participate in further aspects of the study such as focus groups or to record your experiences as a ‘story’ What are the possible benefits and risks of participating? This research is part of the UK-REACH I-CARE study and could help to improve our understanding of why healthcare staff leave or stay in the NHS, particularly those from minoritised groups. The findings could inform policy interventions to help NHS organisations retain staff. However, there may be no direct benefit to you personally. There are no known disadvantages or health risks associated with this research. However, there are some questions about sensitive topics that some people may find upsetting – you can choose not to answer any question(s) that you do not feel comfortable answering, and you may stop at any time. The study team has experience of working on/hearing about difficult/sensitive topics and will follow a distress protocol if they identify any signs that you are becoming distressed during the interview and will support you. In addition, on the UK-REACH website (www.uk-reach.org), we provide contact details for organisations that provide support for mental health and wellbeing, including some particularly relevant to healthcare workers. You can also contact the study team by telephone or email. Contact details are provided at the start and end of this document. Where is the study run from? The study is co-led by the University of Leicester and University College London (UK) When is the study starting and how long is it expected to run for? March 2024 to February 2027 Who is funding the study? NIHR Health and Social Care Delivery Research (HSDR) Programme (UK) Who is the main contact? 1. Holly Reilly, hlr21@leicester.ac.uk 2. Manish Pareek, mp426@le.ac.uk 3. Kath Woolf, k.woolf@ucl.ac.uk Work Package 4: Understanding NHS staff perceptions on how, why and in which contexts staff from minoritised groups leave or stay working within the NHS, using qualitative interviews with staff who are thinking of leaving, are in the process of leaving, or have left NHS employment, and with NHS managers. (Single interview per individual). Data will be analysed using the framework approach to thematic analysis to allow for both inductive and deductive contributions. Work Package 5: Synthesis of data from the other work packages, via narrative and a map of the systems involved in the theories that underlie the study overall. Synthesis continues through the study but the final synthesis and workshops will be undertaken once the basic analyses of all other work packages are completed. The final programme/system theory will be co-designed with the Study Stakeholder Group and Patient and Professional Expert Panel in workshops and presented visually as a map to help policy-makers and practitioners understand which interventions to choose and to start to develop evaluation measures. Other resources (training resources/policy interventions) will also be designed in these workshops to support NHS leaders and managers to improve retention, the acceptability of which will be explored via focus groups with NHS staff who took part in Work Package 4. These resources will include audio narratives in the form of 'stories' of individual people from WP4 as well as other formats (e.g. toolkit, report) informed by the STAG. Workshops and focus groups are primarily to co-design resources and the discussions from these will be reported as simple narratives or summaries to aid in co-design work. There are no secondary outcome measures Old ethics approval format Approved 10/04/2025, University of Leicester Health, Biological and Psychology Sciences, Research Ethics Committee (University of Leicester, University Road, Leicester, LE1 7RH, UK; Tel: not available; ethics@le.ac.uk), ref: 25/PR/0361 10.1186/ISRCTN62821969 351368 CPMS: 66339, NIHR: 157268, Grant Code: 351368 66339 157268 Grant Code: Observational; Design type: Qualitative Observational Qualitative study Other 2027-02-28T00:00:00.000Z United Kingdom England University Hospitals of Leicester NHS Trust

Leicester Royal Infirmary Infirmary Square

Leicester England LE1 5WW RWE@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 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 Oxleas NHS Foundation Trust

Pinewood House Pinewood PLACE

Dartford England DA2 7WG RPG@2.16.840.1.113883.2.1.3.2.4.18.48 Stockport NHS Foundation Trust

Stepping Hill Hospital Poplar Grove

Stockport England SK2 7JE RWJ01@2.16.840.1.113883.2.1.3.2.4.18.48 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 Sussex Community NHS Foundation Trust

Brighton General Hospital Elm Grove

Brighton England BN2 3EW RDR@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 England SW17 7DJ Hertfordshire Community NHS Trust

Unit 1a Howard Court 14 Tewin Road

Welwyn Garden City England AL7 1BW RY4@2.16.840.1.113883.2.1.3.2.4.18.48 Bridgewater Community Healthcare NHS Foundation Trust

89 Dewhurst Road Birchwood

Warrington England WA3 7PG RY2@2.16.840.1.113883.2.1.3.2.4.18.48 East and North Hertfordshire NHS Trust

Lister Hospital Coreys Mill Lane

Stevenage England SG1 4AB RWH@2.16.840.1.113883.2.1.3.2.4.18.48 North London NHS Foundation Trust

4th Floor, East Wing St. Pancras Hospital 4 St. Pancras Way

London England NW1 0PE G6V2S@2.16.840.1.113883.2.1.3.2.4.18.48 Homerton Healthcare NHS Foundation Trust

Homerton Row

London England E9 6SR RQX@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 University of Leicester

University Road

Leicester England LE1 7RH 10007796@2.16.840.1.113883.2.1.3.8.2.9.1 University College London

UCL Medical School 74 Huntley Street

London England WC1E 6DE University of Oxford

Ethox Centre Big Data Institute Old Road Campus Headington

Oxford England OX3 7LF Health professional All participants in WP4 will be aged 18 years and over, willing and able to give consent. Participants will be staff working in/who have left/who are intending to leave an NHS Trust identified from our work in other work packages. Purposive sampling will recruit across locations, rurality/urbanity, retention rates and participants will come from a range of ethnic and migration backgrounds and roles (including those in allied health professional roles), and staff responsible for retention (e.g. HR and clinical managers) to capture diverse experiences and any identified gaps from previous WP findings. If necessary, to ensure diversity of experiences, we will additionally invite consenting UK-REACH questionnaire participants from diverse ethnic/migration groups with high or low attrition intentions from across job roles (including allied health professionals) and geographic locations. The WP4 research team will identify participants consenting to recontact and invite up to 14 of these HCWs from groups working within contexts identified in WP2 as putting them at particularly high risk of leaving, and up to 7 managers in organisations with low retention. If needed, the WP4 research team will invite more participants until at least 10 HCWs and 5 managers have agreed. These will take part in focus groups in addition to interviews. 10 interview participants who are identified by the research team as having compelling true-life experiences will be invited to take part in audio recording their stories. They will be reconsented for taking part in this activity. Collaborators in WP5 will come from two groups: 1. We will build on the UK-REACH infrastructure to develop an I-CARE PPEP group from an existing group which draws membership of HCWs (including allied health professionals) and patients to create an equal and diverse group. We will meet this group biannually. 2. Stakeholder Group (STAG): Through the UK-REACH programme, a national stakeholder group (STAG) was created in 2020 and meets periodically. It includes representation from the NHS (including NHS Workforce Education and Training Directorate, NHS Confederation, NHS Race and Health Observatory), major regulators, HCW unions (BMA, RCM), ethnic minority HCW organisations (BAPIO, Filipino Nurses Association). The STAG will meet quarterly during I-CARE. We will specifically reach out to organisations representing allied health professionals through the Allied Health Professions Federation so that these are included, since the current STAG does not include them. Mixed 18 Years 100 Years All 75 0 Anyone not fitting the inclusion criteria or, for WP4, who has not consented 2025-05-01T00:00:00.000Z 2026-02-28T00:00:00.000Z Retention of healthcare staff from ethnic minority groups Other WP4 will adopt a qualitative research design, using interviews with staff and managers at selected NHS trusts. A multi-factorial approach will be applied to purposively sample trusts from all categories (e.g. acute, mental health and community, ambulance etc), locations (e.g NHS regions), across the staff stability spectrum and percentage of ethnic minority staff. Within the sampled Trusts, we will purposively recruit staff (including those who have left/intending to leave) from across ethnic and migration backgrounds and roles (including those in allied health professional roles), and staff responsible for retention (e.g. HR and clinical managers) to capture diverse and intersectional experiences. Various recruitment strategies will be employed to recruit staff from different ethnicities, migration statuses and job roles take part in the study. Interviews will primarily be conducted online, but a face-to-face option would be available if participants prefer this mode and it is logistically feasible. WP5 is a co-design collaborative work package that involves the interaction of the research team with individuals with lived experience of working and experiencing care within the NHS during the current retention crisis, and representatives of organisations with responsibility for representing HCWs and/or protecting patients. Involvement is primarily via the PPEP and STAG through a series of workshops. Workshop materials will be used to create a set of policy interventions. ~20 WP4 participants, with permission to recontact, will be approached to take part in focus groups to seek feedback and refine the suite of policy interventions developed in WP5. Participants will be reconsented to take part in the focus groups WP5 will also involve co-designing of narrative stories together with selected participants from WP4 (based on their interview data) and a team of professional storytellers. We will conduct qualitative interviews with 50 HCWs who have left or are planning to leave their NHS jobs and 25 managers at hospital trusts to understand the reasons for leaving. Interviews will primarily be conducted online and transcripts will be generated, which will be analysed thematically. We will also co-develop a set of policy interventions that can be adopted by the NHS to help staff stay in their jobs. For this, we will conduct workshops with stakeholders (staff, patients, regulators and policy makers) and use the materials gathered in the workshops to develop a set of policy intervention scenarios. A few participants who take part in the interviews and consent to be recontacted will be invited to take part in further focus groups to test and refine these policy intervention scenarios. Alongside this, short narrative audio stories about true-life experiences of HCWs leading to their leaving or staying in their jobs will be co-created with a set of interview participants. These audio narratives will be disseminated through the study website as part of sharing the findings of the study in an impactful way. Other Approved researchers will be able to apply for access to the anonymised transcripts generated during this study via uk-reach@leicester.ac.uk (see data access policy on the UK-REACH website: https://www.uk-reach.org/main/data_sharing. Transcripts will be made available to once analysis and publication have been completed for the main study. Transcripts will be retained by the study for 6 years from the study end date, until 28/02/2032, and will be available for access by other approved researchers until this time. Data sharing mechanisms will be agreed upon within the data sharing agreement for each study requesting access. Participant consent for use in further studies has been obtained but additional ethical approvals may be required for new analyses- this will be addressed on a case-by-case basis within the data sharing agreement. Available on request 2026 Results article in https://doi.org/10.1177/01410768261419581 (added 11/03/2026) 2025 Results article in https://doi.org/10.1016/j.lanepe.2025.101454 (added 11/03/2026) 2024 Results article in https://doi.org/10. 1016/j.lanepe.2024.101133 (added 11/03/2026) 2025 Results article in https://doi.org/10.1186/s12913-025-13348-7 (added 11/03/2026) Results

Migrated from study website field

570a0238-b20b-4275-868e-7254f5a4c5fa 2bc72476-b2f0-4c6c-9808-d62411c546ea 18d6b23f-fe03-448b-9762-a355dd0e93f3 51580a6f-09b5-473c-8fa1-a3394cfd5f0e f23fda92-4aa5-49b2-a92a-69177c7a5092 Yes Holly Reilly https://orcid.org/0000-0001-8984-3802 Scientific

University of Leicester University Road

Leicester United Kingdom LE1 7RH +44 (0)7425611865 hlr21@leicester.ac.uk Public Manish Pareek https://orcid.org/0000-0003-1521-9964 Principal investigator

Development Centre for Population Health Department of Respiratory Sciences University of Leicester University Road

Leicester United Kingdom LE1 7RH +44 (0)116 2585506 mp426@le.ac.uk Public Katherine Woolf https://orcid.org/0000-0003-4915-0715 Principal investigator

UCL Medical School

London United Kingdom WC1E 6DE +44 (0)20 3108 9216 k.woolf@ucl.ac.uk Public University of Leicester University/education https://ror.org/04h699437 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 12939037 true Acceptance and commitment therapy for functional cognitive disorders - feasibility study ACT4FND Feasibility study: The researchers plan to investigate whether the brief group Acceptance and Commitment Therapy (ACT) intervention is feasible to deliver to patients with functional cognitive disorders (FCD) identified within local memory clinics. They also aim to further refine the ACT intervention so it can be manualised and adapted for online delivery. The feasibility study aims to assess: 1. The willingness of clinicians in diagnostic memory clinics (DMCs) to randomise to a brief group intervention vs treatment as usual (TAU) 2. The willingness of FCD patients be randomised to a brief group intervention vs TAU 3. Acceptability of the face-to-face and/or online group intervention and refine in response to feedback 4. Appropriateness and acceptability of clinical outcome measures 5. Follow-up rates, response rates to questionnaires, adherence with the intervention 6. Fidelity of intervention 7. Time needed to collect and analyse data 8. Healthcare utilisation 9. Signal of efficacy in clinical outcomes Background and study aims Functional cognitive disorder (FCD) is a relatively new term in neurology and psychiatry. It is used to describe patients who experience real difficulties with their memory yet show no signs of a neurological condition such as dementia. Brain scans and other investigations do not reveal an abnormality that could account for the symptoms. Diagnostic memory clinics (DMCs) were developed to improve the access of people with dementia to diagnosis and support. Over the past decade, increased numbers of people have been seen in these clinics. A significant proportion of those seen, however, are found to have a functional cognitive disorder. Despite the symptoms being disabling and persistent, memory clinic teams are unsure how to help these patients. Instead, they are discharged back to their GP without any support or treatment. The cause of these memory symptoms is not well understood. Most researchers believe that low mood and anxiety contribute to the symptoms but are not the full explanation. It has been proposed that patients with FCD are unusually alert to memory lapses. These lapses in turn increase fear of memory failure and doubts about the accuracy of recalled memories. This sets up a vicious cycle of increased monitoring for memory lapses and a corresponding decrease in the amount of attention available to be directed towards the world. There is some evidence that brief psychological treatments can be beneficial. These involve education about the condition and stress management advice. A recent study that combined outcomes from multiple independent studies showed that this treatment delivered in small groups improved psychological well-being. However, the majority of studies were of low quality. Also, the proposed interventions were lengthy, involving up to 13 hour-long sessions. The authors concluded that a large-scale research trial is now "urgently needed". At St George's Hospital, a centre of excellence for functional neurological disorders, researchers have developed a five-session group treatment. Initial pilot data suggests it improves quality of life and decreases distress. The aim is to study the feasibility of delivering this group intervention to patients with FCD within local memory clinics. This study design has benefitted from the involvement of patients with FCD, including from the charity FND Hope, from the start. Their involvement has helped refine the study design and particularly the outcome measures to ensure these are appropriate and acceptable. Who can participate? 1. An established diagnosis of FCD made in DMC/CNC and confirmed by the research team 2. Aged 18 years or over What does the study involve? Participants will be randomly allocated to either the ACT group intervention or a treatment as usual (TAU) control group. Self-report clinical outcome measures will be collected after consenting to participate and again 8, 16, and 26 weeks later. What are the possible benefits and risks of participating? The possible benefits of participating include improvement in symptoms and functioning, increased understanding of the condition and its causes, and helping to develop an effective intervention. Risks are that there may be no improvements despite giving up time and effort to participate, distress through increased focus on symptoms, and hopelessness if no improvement occurs. As this is a group treatment there can be the risk of sharing information with others, although discussion of sensitive personal issues is kept to a minimum and principles of confidentiality will be agreed among participants at the start of treatment. The intervention does not delve into distressing or traumatic memories but if these do become a concern or suicidal ideation emerges the trial has a protocol to manage these situations. Where is the study run from? St George's Hospital (UK) When is the study starting and how long is it expected to run for? September 2020 to July 2024 Who is funding the study? National Institute for Health Research (NIHR) (UK) Who is the main contact? Dr Norman Poole Norman.Poole@swlstg.nhs.uk The acceptability of the intervention and the feasibility of conducting a definitive RCT to test efficacy, assessed using the following outcomes: 1. Rates of referral (% of total seen in DMC during study recruitment period; data source: electronic patient records), eligibility (% of those referred meeting inclusion criteria; data source: study database) and enrolment (% of those eligible who agree to participate; data source: study database). Measured over the course of the study and reported at the end using descriptive statistics 2. Clinical and sociodemographic characteristics of ineligible and non-consenting subjects measured using the study database over the course of the study and reported at the end using descriptive statistics 3. Intervention adherence (% of starters who complete ≥4/5 group sessions) measured using the study database over the course of the intervention period and reported at the end using descriptive statistics 4. Intervention acceptability (% satisfied/very satisfied measured with a five-point Likert satisfaction scale and thematic analysis of qualitative responses from one-to-one interviews), measured over the course of the intervention period and reported at the end using descriptive statistics. Acceptability also explored using qualitative methodology during the intervention period 5. Intervention fidelity measured using the Acceptance and Commitment Therapy Fidelity Measure during ACT sessions selected at random over the course of the intervention period and reported at the end using descriptive statistics 6. Intervention safety (% and description of adverse events and serious adverse events in Conditions A and B) measured using the study database over the course of the study and reported at the end using descriptive statistics 7. Appropriateness and acceptability of clinical outcome measures (by thematic analysis of qualitative responses from one-to-one interviews) explored using qualitative methodology during and after the intervention period 8. Response rates to questionnaires (% completed at T0, T1, T2, & T3) collected from the study database at baseline, 8, 16 and 26 weeks 9. Time needed to collect and analyse data time in days, collected during the intervention period and at the 6-month follow up timepoint Current secondary outcome measures as of 07/11/2022: 1. Psychological flexibility is measured using the Acceptance and Action Questionnaire II (AAQ-II) at baseline, 8 weeks, 16 weeks, and 26 weeks 2. Self-appraisal of memory functioning is measured using the Acceptance Multifactorial Memory Questionnaire (MMQ) at baseline, 8 weeks, 16 weeks, and 26 weeks 3. General level of distress and day-to-day functioning is measured using the World Health Organisation Disability Assessment Schedule (WHODAS 2.0) at baseline, 8 weeks, 16 weeks, and 26 weeks 4. Health-related quality of life is measured using the EQ-5F-5L at baseline, 8 weeks, 16 weeks, and 26 weeks 5. Level of depression is measured using the PHQ-9 at baseline, 8 weeks, 16 weeks, and 26 weeks 6. Level of anxiety is measured using the GAD-7 at baseline, 8 weeks, 16 weeks, and 26 weeks 7. Service utilisation is assessed using the Adult Service Use Schedule (AD-SUS) at baseline and again at 26 weeks 8. Assessment of non-health benefits is measured using the ICEpop CAPability measure for Adults (ICECAP-A) at baseline, 8 weeks, 16 weeks, and 26 weeks 9. Self-reported improvement at the end of the study period is assessed using the Clinical Global Impression – Global Improvement (CGI –I) Scale (self-report), at 26 weeks 10. Satisfaction with the interventions offered (Treatment as Usual and ACT) assessed using a Likert 5-point satisfaction with treatment scale at 16 weeks Previous secondary outcome measures: 1. Psychological flexibility measured using the Acceptance and Action Questionnaire II (AAQ-II) at baseline, 8, 16 and 26 weeks 2. Metacognition (perception of own memory functioning) measured using the Self-evaluation of Memory Systems Questionnaire (SMSQ) at baseline, 8, 16 and 26 weeks 3. Mood and anxiety measured using the Patient Health Questionnaire-9 (PHQ9) and Generalised Anxiety Disorder 7-item (GAD7) scales at baseline, 8, 16 and 26 weeks 4. Level of disability measured by the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) at baseline, 8, 16 and 26 weeks 5. Quality of life measured using EuroQol-5D (EQ-5D) at baseline, 8, 16 and 26 weeks 6. Wellbeing measured using the ICEpop CAPability measure for Adults (ICECAP-A) at baseline, 8, 16 and 26 weeks 7. Service utilisation and cost estimate measured using the Client Service Receipt Inventory (CSRI) at baseline, 8, 16 and 26 weeks 8. Medication advice and/or referral to local primary care psychology collected from participants’ notes at 26 weeks Old ethics approval format Approved 30/09/2022, South East Scotland Research Ethics Committee 2 (2ndFloor, Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44 131 536 9000; ruth.fraser4@nhslothian.scot.nhs.uk), ref: 22/SS/0059 10.1186/ISRCTN12939037 313730 CPMS: 53251, NIHR: 202743 313730 53251 202743 Randomized controlled trial Interventional Randomised controlled trial Treatment 2024-07-31T00:00:00.000Z United Kingdom England South West London and St George's Mental Health NHS Trust

Springfield University Hospital 61 Glenburnie Road

London United Kingdom SW17 7DJ St George's Hospital

Blackshaw Rd

London United Kingdom SW17 0QT Patient 1. An established diagnosis of FCD made in DMC/CNC and confirmed by the research team 2. Aged 18 years or over 3. Capacity to provide written informed consent 4. MMSE score ≥25 Adult 18 Years All 48 44 1. Disabling cognitive symptoms in the context of a primary psychiatric disorder (e.g., depression, severe generalised anxiety disorder, schizophrenia) 2. Greater than mild-moderate depressive or anxiety disorders (PHQ9 score ≥15 and/or GAD7 score ≥15) 3. At “medium” or “high” risk of deliberate self-harm and/or suicide (based on RiO electronic medical records structured risk assessment form) 4. Another predominant functional disorder (e.g., functional seizures) 5. Diagnosis of dementia 6. Diagnosis of learning disability 7. Insufficient command of English to engage without an interpreter 2022-11-04T00:00:00.000Z 2023-10-30T00:00:00.000Z Functional cognitive disorder Mental and Behavioural Disorders Simple randomisation is provided by King’s Clinical Trials Unit. Participants will be randomised to either the ACT group intervention (Condition A) or a control group (Condition B). The intervention is weekly for 4 weeks then a final session 4 weeks later, so five sessions in total. Each session is 2 hours. The latter Condition B arm is a treatment as usual (TAU) control. Self-report clinical outcome measures will be collected after consenting to participate and again at 8-, 16-, and 26-weeks post-randomisation. These timepoints can detect immediate and sustained change following the interventions. The measures can be completed face-to-face with the Research Assistant (RA) or online (COVID-19 and/or patient preference dependent). T0: Baseline measures, before intervention (Condition A or Condition B) begins (week 0) T1: At week 8 post-randomisation (4th session will have been completed for Condition A group; TAU will have been provided for subjects in Condition B) T2: At week 16 post-randomisation (group and booster sessions will have been completed in Condition A; at 3-4 months post TAU in Condition B) T3: At week 26 post-randomisation Proposed clinical outcome measures: Acceptance and Action Questionnaire II Self-evaluation of Memory Systems Questionnaire Patient Health Questionnaire-9 WHO Disability Assessment Schedule 2.0 EuroQol-5D (EQ-5D) ICEpop CAPability measure for Adults Client Service Receipt Inventory Other Anonymised participant-level data will be made available at the study end upon reasonable request, which would typically include a protocol and statistical analysis plan, consistent with the data sharing policy (available on request from the Chief Investigator). Where relevant, trial data can be used to contribute to prospective meta-analyses and individual patient data meta-analyses. Requests for data sharing will be considered by the Chief Investigator (Dr Norman Poole, Norman.Poole@swlstg.nhs.uk) and the trial data monitoring committee. Available on request 2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37169496/ protocol (added 15/05/2023) Results Basic results see attached file ISRCTN12939037_BasicResults_31Oct24.pdf (added 31/10/2024)

protocol

b900a1ff-c311-4610-bda2-a5a1a5e8d085 bf8752de-c19d-4dcd-a4aa-d9a80f65235d b9d07d25-07de-401d-931c-7ef97d020d3c Yes Participant information sheet 41249 ACT4FCD PIS_v1.0_11Jul22.pdf 0f74b1ba-bf4b-4477-b6ec-d08e0b469788 true application/pdf 208359 896b9cc4059f5c16e68e0757a0b582b0 Basic results ISRCTN12939037_BasicResults_31Oct24.pdf 2ac1c3d6-da50-4036-a18f-2d764aab2a7a true application/pdf 389963 e58a0a1f785273d31572afe0cd172eb8 Norman Poole https://orcid.org/0000-0002-3187-6430 Principal investigator

Dept of Neuropsychiatry St George's Hospital

London United Kingdom SW170QT +44 (0)7539954380 Norman.Poole@swlstg.nhs.uk Public South West London and St George's Mental Health NHS Trust Hospital/treatment centre https://ror.org/003pb1s55 Non-commercial National Institute for Health Research http://dx.doi.org/10.13039/501100000272 35817096 true Section 17 Leave: supporting unpaid carers This study is exploratory in nature. Phase 1 of the study gathered stakeholder views to inform the development of a Section 17 Leave Standard of Care Protocol. Phase 2 of the study is a feasibility pilot to check whether there are any signals of efficacy for the Section 17 Leave Standard of Care which would indicate a full-scale feasibility trial is warranted. As such, the study would be hypothesis-generating in nature rather than hypothesis testing. Background and study aims Friends and family members often provide substantial support to people experiencing mental health problems. Sometimes an individual’s mental health problems may require them to be detained under the Mental Health Act (1983) (MHA) for assessment and/or treatment, which can mean they need to stay in hospital for a few days, weeks, months or even years at a time. It is important that during such periods the individual maintains contact with their family, friends and communities as these are helpful for their well-being. Maintaining these relationships is also important to carers. Section 17 MHA is a provision for leave from hospital, which could include an hour in the hospital grounds, visits to local shops, or going home for a number of days, for example. This may be supervised so that the individual is accompanied by a friend or family member (‘carer’) or member of hospital staff, to ensure that they comply with the rules, for example around medication. However, unpaid carers are not always involved in meetings and decisions around s.17 leave, even where they are expected to visit or to take care of someone at home during the leave period. A recent small-scale study by the research team found that carers of people on s.17 leave struggled with anxiety, low mood, feelings of guilt, difficulties in paying for activities and taking the time off work to support s.17 leave. Also, some experienced discrimination, and most felt unsupported by practitioners and under-involved in decision-making. Research into the experiences of carers of older and disabled people has similarly found that caring can often have a significant impact on their physical health, emotional and mental wellbeing, and finances. The first part of the study used feedback from unpaid carers and mental health professionals to develop a new s.17 Standard for the Triangle of Care (guidance for NHS Mental Health Trusts on how to fully engage with carers). This second part of the study aims to test if the new s.17 Standard shows promise in practice – how it works, what it costs and if there are signs it makes a difference to carers. Who can participate? 1. Unpaid carers of people who are admitted to hospital under s.2 or s.3 of the Mental Health Act (1983) in participating wards/hospitals, aged 18 years or older 2. Eligible mental health practitioners working within the participating intervention wards on an invitation basis What does the study involve? Carers will be asked to take part in up to three interviews with the research team, each lasting no longer than 1 hour: first, very soon after the patient’s admission to hospital; second, about 2 weeks after the patient’s first episode of s.17 leave (if this happens); third, 6 months later (if the second interview happens). Carers who take part in the first round of interviews will only be contacted to take part in the two further interviews if the person they care for experiences s.17 leave with the carer. Each interview involves asking some basic questions about the carer (for example, age, gender, relationship to the person they care for, services they access or receive), and a series of questions about their experience of caring, their knowledge and experience of s.17 leave and the support they received or would have liked to receive. Eligible mental health practitioners will be invited to take part in either interviews or workshops on two occasions, each lasting no longer than one hour; the first shortly after implementation of the S.17 standard in their ward and the second approximately twelve months after implementation. Practitioners will be asked to share their experiences of the implementation and use of the s.17 standard, barriers and facilitators to using the standard, and suggestions for further refinement of the standard. What are the possible benefits and risks of participating? Carers’ views will help the research team to understand how, if at all, the s.17 Standard affects their experiences when the person they care for is granted s.17 leave from hospital to try to improve support for carers before, during and after s.17 leave. Carers will also be given a £20 shopping voucher after each interview as a thank you for their time.Practitioner views will help the research team to understand the benefits and challenges in implementing the s.17 Standard in practice which will hopefully help to develop the Standard into a more effective tool for practice. It is possible that talking about caring experiences may be distressing. Carers may decline to answer certain questions, take a break, or leave the interview at any time and the research team will provide contact details for support organisations. There are no anticipated risks to practitioners. Where is the study run from? University of York (UK) When is the study starting and how long is it expected to run for? November 2021 to May 2023 Who is funding the study? National Institute for Health Research School for Social Care Research (NIHR SSCR) (UK) Who is the main contact? Prof. Martin Webber martin.webber@york.ac.uk Carers’ experiences of section 17 leave measured using a custom measure designed within this study (s.17 measure) at baseline, 2 weeks after the end of the first period of s.17 leave and 6 months after baseline 1. Carers’ experiences of care measured using the Zarit Burden Interview (ZBI) at baseline, 2 weeks after the end of the first period of s.17 leave and 6 months after baseline. 2. Carers’ mental wellbeing measured using the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) at baseline, 2 weeks after the end of the first period of s.17 leave and 6 months after baseline 3. Carers’ use of services measured using an adapted version of the Client Service Receipt Inventory at baseline and 6 months after baseline Old ethics approval format Approved 08/12/2021, West of Scotland REC 3 (West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, UK; +44 (0)141 314 0212; WosRec3@ggc.scot.nhs.uk), ref: 21/WS/0156 10.1186/ISRCTN35817096 300813 CPMS: 51277, NIHR School for Social Care Research at London School of Economics and Political Sciences Grant Code 102645/CM/UYYB-P154 300813 51277 NIHR School for Social Care Research at London School of Economics and Political Sciences Grant Code 102645/CM/UYYB-P154 Non-randomized; Both; Design type: Process of Care, Complex Intervention, Qualitative Interventional Non randomised study Other 2023-05-18T00:00:00.000Z United Kingdom England 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 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 Leeds and York Partnership NHS Foundation Trust

Main House St Mary’s House St Mary’s Road

Leeds United Kingdom LS7 3JX South West Yorkshire Partnership NHS Foundation Trust

Trust Headquarters Fieldhead Hospital Ouchthorpe Lane

Wakefield United Kingdom WF1 3SP RXG@2.16.840.1.113883.2.1.3.2.4.18.48 North East London NHS Foundation Trust

1st Floor Maggie Lilley Suite Goodmayes Hospital Barley Lane

Goodmayes United Kingdom IG3 8XJ South West London and St George's Mental Health NHS Trust

Newton Building 7 (Entrance 11) Springfield University Hospital 61 Glenburnie Road

London United Kingdom SW17 7DJ Mixed Carers: Unpaid carers (partners, friends or family members) aged 18 years or older who provide regular, ongoing assistance to a person aged 18 years or older who is currently detained under s.2 or s.3 of the Mental Health Act (1983). Practitioners: Practitioners, managers, and Responsible Clinicians who have been involved in the implementation of the s.17 standard in the intervention wards in the study sites and/or who have attempted to use the s.17 standard in practice. This will include staff from different inpatient wards supporting different patient groups and could include carers' leads and potentially care coordinators and crisis team staff in community teams, who have experience of working with service users and/or carers around s.17 leave. Adult 18 Years All 75 134 Exclusion criteria for this study are the inverse of the inclusion criteria. In addition: Carers: Carers will be excluded where it is deeemed by others (e.g. practitioners in mental health services or the local authority) that they pose a risk to others such that meetings with a mental health professional, social worker, support worker or researcher are not recommended; is currently an inpatient themselves or is currently not able to provide care; the person they provide care to has previously had s.17 leave during the current admission; or (for the second and third round of interviews) no period of s.17 leave is granted during the admission. Practitioners: Recruitment will not be open to practitioners, managers and Responsible Clinicians in the control wards across the study sites. 2022-02-18T00:00:00.000Z 2023-04-30T00:00:00.000Z Mental health Mental and Behavioural Disorders Design: In this feasibility study, the researchers will use a non-randomised controlled study design to test the s.17 standard for signals of efficacy. This will enable them to explore the indicative outcomes for carers of patients in intervention wards in comparison to carers of patients in control wards, to help the researchers to determine if it is worthwhile to proceed to a feasibility trial. Additionally, this design will enable them to evaluate how the s.17 standard is implemented in diverse contexts; how it is experienced by practitioners, managers, RCs and carers; and what its indicative costs might be. Setting: The study will be conducted across a number of sites to ensure a diversity of experiences in urban and rural settings in different locations in England. Each site will select wards to implement the new s.17 standard (intervention wards) and wards that will continue with business as usual (control wards); this will be determined through consultation between practitioners and the research team. Sample: The end-point is full data on 30 carers who have experience of leave under s.17 with the person they are caring for during an inpatient admission, in both the test and comparison groups (30 per group), as this is widely viewed as sufficient for an initial test of a new intervention. As the recruitment of carers will be conducted prior to s.17 leave being granted, and it will not be possible to know for certain if leave with a carer will be provided during the admission, the researchers will need to over-recruit carers to ensure a sufficient sample. Data from one trust showed that 90% of s.17 leave was for less than 24 hours. While some of this may be home leave, a high proportion is likely to be in hospital grounds. It is therefore estimated that 50% of carers recruited for the study will experience home leave under s.17 during the admission. Assuming a 25% drop-out or loss-to-follow-up, the researchers will recruit 80 carers of people detained under the MHA in both the test and comparison groups to participate in the study. Recruitment procedures: Carers will be identified at the point at which their loved one is admitted to hospital under s.2 or s.3 MHA or shortly afterwards by staff on inpatient wards. They will be provided with information about the study and asked if they are willing to be contacted by a researcher to explain what the study involves, answer any questions and complete the screening process. The researcher will contact those who consent to being contacted to discuss the study, invite questions and arrange a date/time for the first interview if the carer wishes to take part. Study procedures: Prior to the first interview written consent will be obtained via a consent form or verbal consent will be recorded over the telephone. Carers may take part in up to three interviews. All carer participants will take part in a structured telephone interview at baseline. This will be soon after the admission of the person they provide care for, but before the first period of s.17 leave during that admission. The researchers will ask inpatient staff, care coordinators and/or carers to inform us when the first period of s.17 leave with a carer occurs, so that they can conduct a follow-up structured telephone interview 2 weeks after the end of this to collect outcome data. The length of time from baseline to follow-up will be recorded and controlled for in the analysis. A third structured telephone interview will be held 6 months after baseline to collect final outcome data. Where patients do not receive s.17 leave with a carer during the period of the study, carers will only take part in the first (baseline) interview. Interviews can be conducted by phone or by video conferencing (e.g. MS Teams). Face-to-face interviews will be conducted with carers unable to participate in a telephone or video interview if Covid restrictions allow. Face-to-face interviews would be held in Covid-secure settings e.g. well-ventilated meeting rooms in Trust/hospital buildings. Participants will be offered a £20 shopping voucher to thank them for their time for each interview completed. The same procedures will be followed in the test and comparison groups. Analysis: Recruitment and retention rates, sample socio-demographic characteristics and baseline measures will be described using descriptive statistics. Inferential statistics such as paired t-tests for normally distributed continuous variables will be used to evaluate change in outcomes from baseline to 2 weeks following home leave and at 6 months after baseline. Non-parametric statistics will be used to evaluate change in skewed or categorical variables as required. The analysis will be conducted separately for the test and comparison groups. Finally, a linear regression model will be constructed for the primary outcome to assess the respective contribution of group allocation, sociodemographic and other characteristics to change at 2 weeks after leave and at 6-months follow-up. Process evaluation: The researchers will use multiple methods to also explore how mental health services implement the s.17 standard and the experience of this for practitioners, managers, RCs and carers. Firstly, a qualitative component will be added to all carers’ interviews at 2-week follow-up to explore their experience of the s.17 leave. The researchers will ask them to discuss the support provided; their experience and perception of the impact of the support; challenges with the provision of the support; and their view on any improvements which could be made to improve its effectiveness. Secondly, the researchers will set up implementation groups across the intervention wards to lead the implementation of the s.17 standard in their respective sites. The implementation groups from each site will be introduced and encouraged to share difficulties, solutions and experiences during the study so that they may learn from one another. The researchers will also meet with the groups separately on two occasions to check progress with implementation and identify what it is possible to implement without additional resource. Managers, practitioners and RCs from the intervention wards will be interviewed twice; once 3 months after the site commences using the s.17 standard to discuss any initial teething problems, and again approximately 12 months later to reflect on any implementation issues, barriers and facilitators to using the s.17 standard, and any suggestions for further refinement. This will be a further check on what the s.17 standard should include and what the barriers and facilitators to achieving this are likely to be. Interviews and/or workshops will likely be held remotely, either by telephone (for individual interviews) or using video conference calling such as MS Teams (for interviews and/or workshops). If Covid restrictions allow, face-to-face interviews/workshops could be conducted in Covid-secure settings e.g. well-ventilated meeting rooms in Trust/hospital buildings. Participation in interviews or workshops will be completely voluntary. Thirdly, the researchers will review sites’ self-assessment tool for the s.17 standard (developed by the research team) and practitioners’ use of the tools we develop (carer information leaflet regarding s.17 leave and training slides for practitioners) to assess the extent to which they were able to implement the s.17 standard in routine practice and the timeframe for this. Qualitative data will be analysed using thematic analysis to identify common themes focused on the feasibility and process of implementation, and the experience of the support provided. Data will be analysed iteratively to inform subsequent interviews. Any final revisions to the s.17 standard will be made at the end of the study if required. Costs: The cost analysis will be a simple assessment of the range of costs likely to be incurred through implementing the s.17 standard and providing enhanced support to carers, which would require formal assessment in subsequent research. Indicative costs of the s.17 standard will be calculated by compiling information on resources used (e.g. estimates of time expended in providing the support), in addition to analysis of CSRI information to illustrate additional or reduced use of other services, with unit cost data sourced from PSSRU’s annual publication. Other The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Martin Webber, University of York (martin.webber@york.ac.uk). Only anonymised transcripts and outcomes data will be shared openly, and only where carers and practitioners have provided consent for their anonymised data to be shared with others. Data not consented to be shared will be excluded from any datasets. The University will field any requests for access and review these on a case by case basis, making the data available to the requester when appropriate in line with the consents provided by the study participants. Available on request 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38395842/ (added 10/12/2024) Results

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de08d901-5800-4364-ac15-65ae7d9e1af3 349030cf-b93f-4de5-ad42-f68c4d16d965 cde3835e-d10e-46f3-8789-14d9e60a3e60 Yes Martin Webber https://orcid.org/0000-0003-3604-1376 Scientific

Department of Social Policy and Social Work University of York Heslington

York United Kingdom YO10 5DD +44 (0)1904 321203 martin.webber@york.ac.uk Public University of York University/education https://ror.org/04m01e293 Non-commercial School for Social Care Research http://dx.doi.org/10.13039/100012411 77588384 true Evaluating Mental Health Decision Units in acute care pathways (DECISION): An Interrupted Time Series and Synthetic Control (ITS) Evaluation DECISION To establish the effects of psychiatric decision units (also known as mental health decision units) in England on service use outcomes in order to inform potential national scale up. Background and study aims Many people experiencing a mental health crisis go to A&E and wait a long time for assessment. They may be admitted to a psychiatric ward unnecessarily because of a lack of proper assessment. People not signposted to the most appropriate aftercare might repeatedly attend A&E and be admitted to hospital. New Psychiatric Decision Units (PDUs; also called mental health decision units [MDHUs]) are designed to address this. PDUs are short stay units with a high staff: patient ratio delivering in-depth assessment of individual support, aiming to reduce unnecessary hospital admissions and attendance at A&E, and to improve experiences of crisis care. The researchers will work with PDUs in four different locations in England and examine the effects of the PDU on a wide range of outcomes, including changes to the number, pattern and rate of: inpatient admissions to psychiatric wards, compulsory admissions, number of short (0-5 day) admissions, average length of inpatient stay, attendances at A&E in mental health crisis, number of 4 hour psychiatric ED breaches, average length of ED wait, number of 12 hour trolley waits, number of admissions to an acute bed, arrival at the ED by ambulance and police. These variables are measured for 24 months before and 24 months following the opening of the psychiatric decision unit in each of the four geographical areas involved in the study. The synthetic control method will allow us to compare to what is happening elsewhere in England in order to control for national changes in service use trends over time. The researchers will use routinely collected aggregate data. The DECISION research team includes people who have used mental health services and the research is coproduced. Who can participate? Patient records for 24 months before and 24 months following the opening of the psychiatric decision unit in each of the four geographical areas involved in the study will be used to gather data. A sub study involves qualitative interviews with strategic managers. What does the study involve? Patients records will be analysed to investigate outcomes in the PDU as described above. In a sub study members of PDU staff will be interviewed. What are the possible benefits and risks of participating? It is unlikely that there are any risks in taking part. It is possible that some people may find some of the issues discussed in the interviews sensitive or uncomfortable to talk about. Participants do not have to discuss anything that you find difficult to talk about, and it is OK to not answer any of the questions. If difficult issues come up during the interview participants are free to stop the interview at any point to take a break, rearrange or end the interview, or withdraw from the study. There are no consequences to doing so for participants. Where is the study run from? 1. St George's, University of London (UK) 2. St George's Hospital (UK) 3. Springfield Hospital (UK) 4. Lincolnshire Partnership NHS Foundation Trust (UK) 5. Lincoln County Hospital (UK) 6. Birmingham and Solihull Mental Health NHS Foundation Trust (UK) 7. Queen Elizabeth Medical Centre (UK) 8. Sheffield Health & Social Care NHS Foundation Trust (UK) 9. Royal Hallamshire Hospital (UK) 10. Kingston Hospital NHS Foundation Trust (UK) 11. Sandwell General Hospital (UK) When is the study starting and how long is it expected to run for? March 2019 to February 2021 Who is funding the study? National Institute for Health Research (NIHR) (UK) Who is the main contact? Dr Lucy Goldsmith lgoldsmi@sgul.ac.uk Note: there is a primary outcome for both mental health trusts and acute trusts for each research method. For both the synthetic control (ITS) study and interrupted time series, the variables are measured both 24 months pre- and 24 months post- the implementation period (with the exception of one site, which uses data for 13 months post-implementation). The analyses use aggregate service-level data. 1. Interrupted time series: changes in the number and pattern in the rate of: 1.1. Informal admissions to mental health trust adult inpatient wards (mental health trusts) 1.2. A&E psychiatric presentations (acute trusts) 2. Synthetic control (ITS) study: changes in the number and pattern in the rate of: 2.1. Admissions to mental health trust adult inpatient wards (mental health trust) 2.2. A&E psychiatric presentations (acute trusts) Note: there are a large number of secondary outcomes as MHDUs are purported to make a difference to these outcomes; the study will enable these claims to be examined. For both the synthetic control (ITS) study and interrupted time series, the variables are measured both 24 months pre- and 24 months post- the implementation period (with the exception of one site, which uses data for 13 months post-implementation). The analyses use aggregate service-level data. 1. Interrupted time series and synthetic control study; mental health trust outcomes: 1.1. Total inpatient admissions 1.2. Number of 0-5 day inpatient admissions 1.3. Average length of inpatient stay (bed days) 1.4. Compulsory admissions 1.5. Number of psychiatric liaison episodes at the ED 2. Interrupted time series and synthetic control study; acute trust outcomes: 2.1. Number of 4 hour psychiatric ED breaches 2.2. Average length of psychiatric ED wait 2.3. Number of 12 hour trolley waits 2.4. Number of admissions to acute bed 2.5. Arrival at ED by ambulance and police 3. Additional outcomes for the Interrupted Time Series only: 3.1. Daily mean occupied bed days (mental health trust) 3.2. Out of area admissions (mental health trust) Old ethics approval format Approved 12/08/2019, NRES Committee: East Midlands – Leicester South Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44 (0)207 104 8310; NRESCommittee.Eastmidlands-LeicesterSouth@nhs.net), Ref: 19/EM/0226 10.1186/ISRCTN77588384 256406 NIHR HS&DR 17/49/70 256406 NIHR HS&DR 17/49/70 Multicentre longitudinal observational design using both interrupted time series and synthetic control (ITS) methods Observational Longitudinal study Treatment 2021-02-28T00:00:00.000Z United Kingdom England St George's Hospital

St George's University Hospitals NHS Foundation Trust Blackshaw Road Tooting

London England SW17 0QT Springfield Hospital

South West London and St George's Mental Health NHS Trust 61 Glenburnie Road

London England SW17 7DJ Lincolnshire Partnership NHS Foundation Trust

Unit's 8 & 9 The Point Lions Way

Sleaford England NG34 8GG Lincoln County Hospital

United Lincolnshire Hospitals NHS Trust Greetwell Road

Lincoln England LN2 4AX Birmingham and Solihull Mental Health NHS Foundation Trust

Unit 1 50 Summer Hill Road

Birmingham England B1 3RB Queen Elizabeth Medical Centre

University Hospitals Birmingham NHS Foundation Trust Trust HQ, Po Box 9551 Edgbaston

Birmingham England B15 2TH Sheffield Health & Social Care NHS Foundation Trust

Fulwood House Old Fulwood Rd

Sheffield England S10 3TH Royal Hallamshire Hospital

Sheffield Teaching Hospitals NHS Foundation Trust Glossop Rd

Sheffield England S10 2JF Kingston Hospital NHS Foundation Trust

Galsworthy Road

Kingston Upon Thames England KT2 7QB Sandwell General Hospital

Sandwell and West Birmingham Hospitals NHS Trust Lyndon

West Bromwich England B71 4HJ Patient Aggregate, trust-wide service level data will be used. For example, the number of attendances at A&E for mental health crisis per month; the number of out of area beds used by a Trust per month etc. The 'recruitment start date' and 'recruitment end date' shown below refer to the data collection period across all 4 study sites. Adult All 40 42 None 2012-11-01T00:00:00.000Z 2020-03-31T00:00:00.000Z Mental health crisis / Psychiatric crisis Mental and Behavioural Disorders This is an observational study investigating an intervention which is already part of clinical practice. The intervention is ‘mental health decision units’ (also known as psychiatric decision units). Interrupted time series study: This part of the research looks at outcomes including number of informal psychiatric admissions and number of mental health presentations at A&E in the two years prior to and the two years following an MHDU opening in order to estimate the impact of opening MHDUs on service use and cost. The researchers use aggregate data only for this (e.g. total numbers of informal psychiatric admissions to a mental health NHS Trust each week) and do not access any individual patient data. The researchers will acquire this data from NHS Trusts in aggregate form only. To support interpretation of the interrupted time series data the researchers will conduct qualitative interviews with strategic managers: (n=5 at each site). These will be held with strategic leads for crisis care in Mental Health NHS Trusts, A&E departments and local mental health commissioners to understand the wider policy and service delivery context in which MHDUs have been introduced. Synthetic control study: The researchers will collect similar control data from Trusts without MHDUs for comparative analyses (Trusts with and without MHDUs). The researchers will acquire these data from NHS Digital as this is likely to involve data from a large number of Trusts nationally to generate suitable matched controls. Again these data will be in aggregate form only with no individual data accessed for the research. See also https://www.isrctn.com/ISRCTN53431343 Procedure/Surgery Not expected to be made available 2025 Results article in https://pubmed.ncbi.nlm.nih.gov/41661950/ (added 10/02/2026) 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32326915 protocol (added 27/04/2020) Results

protocol

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Study website Migrated from study website field

47606063-a31a-4796-8f8c-385a23844d2d 6ec4bb66-cb6b-47bd-9203-c09d3ab97678 74f3edd1-23c6-4626-96ae-13ad7820380a a27c1b11-d78e-4cd3-b4e0-39c65a4308c1 No Lucy Goldsmith https://orcid.org/0000-0002-6934-1925 Public

Population Health Research Institute St George's, University of London Cramner Road Tooting

London United Kingdom SW17 0RE +44 (0)208 7250167 lgoldsmi@sgul.ac.uk Public Lucy Goldsmith https://orcid.org/0000-0002-6934-1925 Scientific

Population Health Research Institute St George's, University of London Cramner Road Tooting

London United Kingdom SW17 0RE +44 (0)208 7250167 lgoldsmi@sgul.ac.uk Public St George's, University of London University/education https://ror.org/040f08y74 Non-commercial National Institute for Health Research http://dx.doi.org/10.13039/501100000272 16882519 true An evaluation of factors affecting nurse patient relationships and outcomes in acute mental health inpatient settings The study aims: 1. To understand the content, context and experience of therapeutic relationships between nurses and patients 2. To analyse associations between key structural factors, a measure of therapeutic relationships and outcomes for patients and nurses Background and study aims This study will explore how nurses and patients interact on acute mental health wards. It will examine factors which may influence interactions and how they develop into relationships. It aims to find out whether the presence or absence of a relationship has any impact on the outcome of inpatient admission. It is part of a programme of work initiated in 2006 with a Mental Health Research Network (MHRN) funded group of mental health experts who developed research ideas specifically investigating acute care. Healthcare staff and patients on acute mental health wards in one NHS Trust can participate and they will be asked to complete a questionnaire and may be asked to take part in an interview. Who can participate? Adult healthcare staff who have responsibility for delivering care to patients on the ward, and all adults patients who have been in hospital for seven days or more. What does the study involve? The study will be carried out in three wards in one London mental health trust over a 6 month period and will have two main parts, one in which staff of all professions and patients who have been in hospital for 7 days or more will be asked to complete a questionnaire and another in which they will be interviewed. Based on other studies carried out in these settings the researchers expect that around 40 (75% of total) ward staff will complete the questionnaires. The researchers aim to recruit an equivalent number of patients. The questionnaires will ask about staff levels of burnout and job satisfaction, patient satisfaction with treatment, and both groups’ experience of therapeutic relationships and perceptions of the ward environment. The researchers will ask between 4 and 6 nursing staff and a similar number of patients to participate in in-depth interviews to discuss their experience of developing therapeutic relationships. The researchers will also collect information on the number of staff on each shift and incidents of self-harm and violence on the wards. What are the possible benefits and risks of participating? Benefits: there are no direct benefits to participants other than contributing to knowledge which may help to improve practice in future. Risks: Interviews and questionnaires may bring up distressing feelings. Where is the study run from? The study is run from the University of Essex and will be carried out in South West London and St George's Mental Health NHS Trust (UK) When is the study starting and how long is it expected to run for? April 2020 to January 2022 Who is funding the study? South West London and St George's Mental Health NHS Trust (UK) Who is the main contact? Susan Sookoo (public) ss16845@essex.ac.uk Prof Fiona Nolan (scientific) f.nolan@essex.ac.uk A measure of therapeutic relationships (Scale to Assess Therapeutic Relationships) collected during module 2. The measures below will be collected during module 2 of the study: 1. Satisfaction with treatment measured using the Client Satisfaction Questionnaire (CSQ-8) 2. Ward Atmosphere Scale (WAS) 3. Staff report of burnout and morale measured using the Maslach Burnout Inventory (MBI) 4. Qualitative data from interviews carried out in module 3 and analysed using a narrative inquiry approach Old ethics approval format 1. Approved 16/12/2019, HRA and Health and Care Research Wales (HCRW) (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB; UK; ), ref: 19/LO/1727 2. Approved 18/12/2019, University of Essex REO governance team (), ref: ETH1819-0158 10.1186/ISRCTN16882519 228720 228720 Single centre mixed methods Other Other Stopped 2022-01-01T00:00:00.000Z United Kingdom England Springfield Hospital

South West London ad St George's Mental Health NHS Trust 61 Glenburnie Road

London United Kingdom SW17 7DJ Mixed Healthcare staff: 1. All healthcare staff who have responsibility for delivering care to patients on the ward will be included in the study: nursing staff only will be the focus of module 3 Patients: 1. All patients who have been in hospital for 7 days or more will be eligible to be included in the study, as this will allow an adequate period in which to have experienced life on the ward 2. Only patients thought by staff to have the capacity to give informed consent to the study will be approached, and this will also be checked by the researcher prior to obtaining written consent 3. Only participants who have good command of English will be approached Adult All 92 Does not meet inclusion criteria 2020-04-01T00:00:00.000Z 2020-05-01T00:00:00.000Z Stopped Mental and behavioral disorders Mental and Behavioural Disorders Module 1 (no participant involvement): Information which is routinely collected around: 1. Aggression and self-harm 2. Structural measures; required vs actual staffing hours, use of temporary staff, and hours of structured ward programme Module 2: Questionnaire data will be collected from: 1. All staff from all professional groups working on host wards – measuring ward atmosphere, burnout, teamworking, years of experience, and reported quality of therapeutic relationship. Demographic information on gender, age and ethnicity will also be sought 2. Patients – measuring satisfaction, ward atmosphere, and reported quality of therapeutic relationship. Key demographic data will also be sought, including age, gender, ethnicity and MHA status Module 3: Individual interviews will be carried out with registered nursing staff and also with patients using a narrative inquiry approach. Participants will be asked to ‘tell their story’ of being on the ward describe their experience of forming and maintaining therapeutic relationships with registered nurses. Mixed The current data sharing plans for this study are unknown and will be available at a later date. Available on request Protocol

Added from spreadsheet

Unreferenced after processing basic results

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School of Health and Social care University of Essex

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