86380183 true Understanding the Wellbeing and Support Needs of Carers of Parents with Bipolar PPB Rationale: This study will explore the social care support needs of partners of parents with BD, in a cost-effective manner, by carrying out the study alongside an existing national project evaluating a digital intervention for parents with bipolar disorder (Integrated Bipolar Parenting Intervention, IBPI: https://www.isrctn.com/ISRCTN15962574). It will benefit from the recruitment infrastructure of the IBPI study with additional recruitment through self-referral and our social care and third sector partners. This work will increase understanding of carers’ wellbeing and support needs (including access to Care Act assessments) as well as the relationships between these and carer sociodemographic and clinical factors. This information will raise awareness of what carers need to help them flourish in these roles and improve social care practice in relation to these individuals. Aim: The aim of this study is to understand and address the wellbeing and support needs of partner carers of parents with bipolar. Towards this aim, we will pursue the following objectives: Objectives Work Package 1 (WP1): Online survey • To determine levels of and factors associated with carer wellbeing. • To determine carers’ needs for support including experiences of Care Act assessments. Work Package 2 (WP2): Qualitative interviews • To understand in depth the experiences of carers with respect to their wellbeing and support needs and how they intersect. Work Package 3 (WP3): Co-design • To create an impactful toolkit on identifying and addressing carers’ needs for frontline social care workers. Updated 08/06/2026: • To create two impactful toolkits identifying and addressing carers’ needs for (i) frontline social care workers and (ii) carers Outcomes WP1 will address these objectives using survey methodology and a combination of bespoke questions and standardised questionnaires. WP2 will address this aim through semi-structured qualitative interviews sampled for diversity of carer experience from participants in WP1. WP3 will address this objective through coproduction and implementation of a toolkit informed by WP1 and 2. Background and study aims Bipolar disorder is a common severe mental health issue. Many people living with bipolar disorder are parents. The extreme changes in mood which people with bipolar experience can make both parenting and day-to-day life difficult. Often parents with bipolar are cared for by their partners, who are also co-parenting their children. These partner carers experience many emotional and practical impacts, but there is little research on the specific well-being and support needs and experiences of partner carers. This research aims to understand the needs and experiences of partner carers. Our goal is to find out what needs partner carers have, how they want these needs addressed, and what influences these needs. We will use this information to work with carers and professionals to develop a toolkit to improve social care for these carers. Who can participate? Partners of a parent with bipolar, people living with a partner and child with bipolar and parents with bipolar who have at least one child, up to 18 years old, for whom they have parental responsibility. What does the study involve? The study will include three work packages (WP): WP1: Survey - This will measure well-being, support needs, and experiences with Care Act assessments of 98 partner carers. WP2: Interviews - We will interview 30 partner carers to gain deeper insights into their experiences WP3: Toolkit Development - Based on our survey and interview findings, we will co-produce a toolkit for social care workers about the needs of partner carers, working with 10 carers and 10 professionals. We will also co-produce a toolkit for carers, working with 10 lived experience experts and 10 professionals. Patient and Public Involvement: A member of our team with lived experience as a carer will lead on coordinating input from partner carers throughout the project. He will form a carer reference group which will meet at the beginning of the study and monthly throughout input into how the study is run and how the results are shared. Dissemination: The toolkit is a key output, which will help social care workers better support carers of parents with bipolar. What are the possible benefits and risks of participating? Participation in the survey may cause some emotional distress, as participants are asked to reflect on the challenges of supporting their partner and on their own mental health. To minimise this risk, survey questions were developed in collaboration with the Carer Reference Group (CRG) members who have lived experience. Based on their feedback, we provided clear explanations for why each question is asked and removed a question relating to carers’ hospitalisation history. If participants do experience distress, support resources are provided in the participant information sheet, including organisations such as Mind, Bipolar UK, the Samaritans, and NHS 111 for urgent support. Parenting- and caring-specific resources are also included, informed by CRG feedback. Participants may also experience distress during interviews, as sensitive issues may be discussed. Interviews will be conducted by an experienced researcher who will offer breaks, remind participants that they may choose not to answer any question, and reinforce their right to withdraw at any time. The interview participant information sheet includes the same support resources. Some participants may find taking part inconvenient or time-consuming, particularly for interviews and workshops. To reduce burden, all study activities will be conducted remotely, the survey will be accessible 24/7, allowing participants to complete it at their own pace. Vouchers will be provided for participation in each work package as a token of appreciation. Where is the study run from? Lancaster University, UK. When is the study starting and how long is it expected to run for? The recruitment for the study started in January 2026 and will continue until April 2027. All study activities will end on 30th June 2027 Who is funding the study? National Institute for Health and Care Research (NIHR), UK. Who is the main contact? Prof Stephen Jones, s.jones7@lancaster.ac.uk Carer wellbeing and support needs survey, interview a single timepoint Wellbeing, anxiety, depression, carer wellbeing and support and loneliness standardised measures of wellbeing (Warwick-Edinburgh Mental Wellbeing Scale), anxiety (GAD-7; Generalised Anxiety Disorder 7-item), depression (PHQ-8; Patient Health Questionnaire depression scale), carer wellbeing and support (Carer Wellbeing and Support Measure), and loneliness (using the ONS-recommended UCLA Loneliness Scale and a Direct Loneliness Question from the Community Life Survey) a single timepoint Ethics approval required East Midlands - Leicester South Research Ethics Committee

2 Redman Place, Stratford

London United Kingdom E20 1J 25/EM/0245 10.1186/ISRCTN86380183 337057 CPMS: 59659, NIHR: 207571 337057 59659 207571 Observational A sequential mixed-methods study with a survey, interviews, and co-design workshops 2027-06-30T00:00:00.000Z United Kingdom England Lancashire and South Cumbria NHS Foundation Trust

LSCFT HQ, Sceptre Point, Sceptre Way Walton Summit, Bamber Bridge

Preston England PR5 6AW false 1. Age >= 18 years 2. Partner of a parent with bipolar 3. Living with partner and child 4. Parent with bipolar has at least one child, up to 18 years old, for whom they have parental responsibility. 5. Living in the UK Mixed 18 Years 100 Years All 98 0 1. Live outside of the UK. 2. Live separately from their partner or child. 3. Do not understand written English. 4. Do not have computer literacy skills required to complete the online questionnaire. 2026-01-08T00:00:00.000Z 2027-04-30T00:00:00.000Z • Partner of a parent with bipolar • Living with partner and child • Parent with bipolar has at least one child, up to 18 years old, for whom they have parental responsibility. Mental and Behavioural Disorders We will use both a quantitative survey and qualitative interviews to explore rates of use and experiences of carer’s assessments, as well as support needs and wellbeing. Survey: Our recruitment target for the survey is 98 participants. Participants will complete the survey online. It will be developed and hosted on the online survey software REDCap (Research Electronic Data Capture), which the research team has used previously an ongoing trial (IBPI trial). It will be a cross-sectional survey, so participants will complete the survey once. The survey has been designed with our Carer Reference Group to ensure it is focussed on relevant factors to them, and that it is written in accessible language. The survey includes questions on social demographic information of the carer and their family, including the carer’s age, gender, ethnicity, education, geographical location, and duration of caring. The survey will also ask about their partner’s and their child’s sociodemographic information, including age, gender, ethnicity and diagnoses and recent healthcare usage. These questions will be included to help characterise the sample, which will be used during interview sampling, as well as to explore the relationships between these factors and experiences of wellbeing, depression, and anxiety. The survey also includes questions on knowledge and experiences of Carer’s assessments. These questions will explore whether participants know what a carer’s assessment is and how to access one, and whether they have had one. If so, questions will ask to what extent it met their needs for support and their satisfaction with the process. Overall, this will help us to understand the proportion of this group who are accessing these assessments and what impact they have had. The survey will also include standardised measures of wellbeing, anxiety (GAD-7), depression (PHQ-8) and carer wellbeing and support. Using standardised measures will help us to compare this sample with other groups from other research. There will be questions on what support the participant feels they need, with open-ended response textboxes. Responses to these questions can be explored further during the interview and toolkit development. Finally, there will opportunity for the participant to consent to being invited to an interview and/or to the co-design workshops, or to request not to be contacted. Participants will also be able to opt-in to receiving a summary of the results after the study finishes. Interviews: Our recruitment target for the interviews is 30 participants. Participants will take part in interviews over phone or via video call, depending on their preference. The interviews are expected to last up to an hour, and will be recorded using an encrypted voice recorder. The research assistant (RA), who will be employed by Lancashire and South Cumbria NHS Foundation Trust, will be experienced in interviewing. They will prepare for these interviews by conducting practice interviews with other members of the research team, and with a member of the carer reference group. The RA will conduct the interviews in a semi-structured manner, using a topic guide but allowing participants to explore specific areas of importance to them. The topic guide will be co-developed with the Carer Reference Group, and will be informed by participant responses to the survey. Co-design workshops Our recruitment target for the workshops are 10 partners of parents with bipolar, and 10 social care workers. Each group will meet over five 2-hour sessions to co-design a resource for social care workers, providing guidance for supporting the partners of people with bipolar. Each session will be held online through video conferencing software. Updated 08/06/2026: Our recruitment target for the social care toolkit workshops are 10 partners of parents with bipolar, and 10 social care workers. Each group will meet over five 2-hour sessions to co-design a resource for social care workers, providing guidance for supporting the partners of people with bipolar. Our recruitment target for the carer’s toolkit workshops are 10 lived experience experts and 10 social care workers. Each group will meet for two 2-hour sessions to co-design a resource for carers, providing guidance on the support available for partners of people with bipolar. Each session will be held online through video conferencing software. Other The datasets generated during the current study will be stored in a publicly available repository (Lancaster University Research Directory (Pure Portal: https://portal.lancaster.ac.uk/ask/pure/)). Survey data: The anonymised .csv survey dataset and codebook will be stored on the Lancaster University PURE repository for a minimum of 10 years. This will be available for research purposes under controlled access, after approval from the CI or delegated individual. Interview transcripts: The anonymised survey transcripts in .docx format will be archived on the Lancaster University PURE repository but will be a closed dataset due to the potentially identifying nature of the narratives. A collection of quotes from the interviews will also be stored on PURE and will be available on request with approval from the CI or delegated individual. Co-design workshop filed noted: The anonymised fieldnotes from the codesign sessions will also be stored on PURE and will be available on request with approval from the CI or delegated individual. Stored in publicly available repository Protocol

39bfe005-e33d-4ede-9f95-8d7c56400d42 fa1a4d4c-6ad6-49e9-bd50-55588ac04685 fba68a01-e122-4da2-bd9f-0b449ed4b993 9fe7e92f-7f6d-4874-ba7c-1e65b0035a73 Yes Protocol file 48724_PROTOCOL_V1.1_06Nov2025.docx a2272174-0268-46ce-afdd-be9a2b5223d1 true application/vnd.openxmlformats-officedocument.wordprocessingml.document 410240 7bfb58aad11bae6a0dffad32e5b6cc08 Protocol file ISRCTN86380183_Protocol_V2.1_27Apr26.pdf 9ff698ab-93f2-4f1a-aa32-4a0e51ad8836 true application/pdf 772128 e8270a041e71e547a9462405002b9dfa Steven Jones Principal investigator

Lancaster University Health Innovation One Sir John Fisher Drive

Lancaster United Kingdom LA1 4AT +44 01524593382 s.jones7@lancaster.ac.uk Public Ragin John Public Scientific

Lancashire & South Cumbria NHS Foundation Trust The Lantern Centre, Vicarage Lane, Fulwood  

Preston United Kingdom PR2 8DW +44 1524 522391 Ragin.John@lscft.nhs.uk Public Lancaster University https://ror.org/04f2nsd36 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 15064570 true Empowered Together (coordinated social care in prison): A feasibility and definitive randomised controlled trial, with embedded realist informed process evaluation ET Empowered Together is more effective in reducing the number of unmet social care needs of men in prison than care as usual. Background and study aims Social care helps people who struggle with everyday tasks because of physical or mental health problems. This includes help with cleaning, washing, dressing, using special equipment, and staying connected with others. There hasn’t been much research into how social care works in prisons, but what we do know suggests it’s not as good as it is outside prison. To help improve this, researchers have created a new approach called Empowered Together. The study will test whether this approach works well in prisons. Who can participate? Men in selected prisons can take part if they are aged 18 years or older, have at least 7 months left on their sentence, are thought to have high social care needs, and can give their consent to take part. What does the study involve? The study has three parts. In part one, researchers will work with people who have lived in prison to create training for staff, tools to measure how well Empowered Together works, and a short film, event, and website. In part two, Empowered Together will be tested in two men’s prisons. Seventy-six men with social care needs will take part. Half will receive Empowered Together and half will get usual care. Researchers will test different questionnaires, interview 20 men and 26 staff, and explore the costs of Empowered Together. In part three, a larger group of 426 men will take part. Half will get Empowered Together and half will get usual care. Researchers will compare the two groups using questionnaires, interview 32 men and 56 staff, observe 16 men, and collect information about costs and how well the approach was delivered. What are the possible benefits and risks of participating? The study could help improve social care for future prisoners who need support. Some people might feel upset during interviews when talking about their daily challenges. If this happens, they can speak to the researcher, prison staff, healthcare staff, or a trained listener. Support and advice will be offered if needed. Where is the study run from? Part two will take place in HMP Liverpool and HMP Risley (UK). Part three will be in six to eight prisons, which haven’t been chosen yet. When is the study starting and how long is it expected to run for? February 2025 to January 2030. Who is funding the study? Lancashire and South Cumbria NHS Foundation Trust (UK) Who is the main contact? Dr Katrina Forsyth, katrina.forsyth@manchester.ac.uk Feasibility study: Unmet needs of men in prison will be measured using Camberwell Assessments of Needs-Forensic Research CANFOR-R at baseline, 6 weeks, and 3 months Definitive study: Unmet needs of men in prison will be measured using Camberwell Assessments of Needs-Forensic Research CANFOR-R at baseline, 6 weeks, and 6 months At baseline, 6 weeks, and 3 months in the feasibility trial: 1. Social care related quality of life measured using the Adults Social Care Outcomes Toolkit (ASCOT SCT4) 2. Health related quality of life measured using EQ-5D-5L 3. Wellbeing measured using ICEpop CAPability measure for Adults (ICECAP-A) 4. Recovery outcomes measured using ReQol-10 At baseline, 6 weeks, and 6 months in the definitive trial: 1. Social care related quality of life measured using the Adults Social Care Outcomes Toolkit (ASCOT SCT4) 2. Health related quality of life measured using EQ-5D-5L 3. Wellbeing measured using ICEpop CAPability measure for Adults (ICECAP-A) 4. Recovery outcomes measured using ReQol-10 Ethics approval required Wales REC 3

Castlebridge 4, 15-19 Cowbridge Road East

Cardiff United Kingdom CF11 9AB Reference number not provided 10.1186/ISRCTN15064570 361615 CPMS: 57609, LSCFT-RD24002 361615 57609 LSCFT-RD24002 Two-site parallel individually randomized controlled trial feasibility and definitive study Interventional Randomised controlled trial Screening Treatment Efficacy 2030-01-31T00:00:00.000Z United Kingdom England Hmp Liverpool

68 Hornby Road

Liverpool United Kingdom L9 3DF Y05520@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Risley

Warrington Rd, Risley, Croft, Warrington

Preston United Kingdom WA3 6BP Service user 1. Resident in one of the study prisons 2. Serving a sentence with at least 7 months until release date 3. Over 18 years of age 4. Has mental capacity to consent or appropriate personal or independent consultee who can provide assent (as assessed by researchers in consultation with prison staff) 5. Scores positively on the ET screen Adult 18 Years 100 Years Male 426 426 1. Unsafe for researchers to interview alone 2. In current receipt of a social care package under the Care Act 3. Insufficient knowledge of English to complete assessment and outcome measures 2025-08-01T00:00:00.000Z 2026-04-01T00:00:00.000Z Social care needs of adult men in prison who are at risk of having unmet needs Other ET Screening: All individuals living in the prison(s) are screened using the ET tool. This was adapted for prison use from one used in the community. It is aligned with the Care Act and briefly asks whether individuals: 1. consider themselves to have any physical or mental health condition/impairment or to be neurodiverse 2. experience difficulties in any of the following social care domains in prison: food, hygiene, toileting, clothing, safety, family relationships. A series of probing questions relevant to these social care in prison domains will be used. If individuals report they may have difficulties in two or more social care domains they will go on to receive an ET assessment. ET Assessment: A strengths-based assessment of social care need, conducted by an ET worker. Strengths and assets-based approaches to assessment and care-planning focus on people’s capabilities, explore help available from wider support networks, and take account of issues of importance to the individual. Care needs change over time, therefore follow-up assessments should occur at least twice yearly with clear review dates identified in response to changing needs follow-up assessments should be conducted, with changes to care-plans being jointly agreed. ET Care Coordination: ET worker coordinates care for those meeting criteria for of social care provision under the Care Act 2014. The ET Worker will coproduce a care plan with the individual/family member/peer carer. This will consider placement in the prison (e.g. vulnerable prisoner wing, healthcare wing, adapted cell) and the support required. All domains of the Care Act 2014 will be considered including adaptations to cells and other parts of the prison (e.g. handrails; hygiene equipment, meal trays); support with maintaining personal relationships; coordination of peer support; necessary changes to the regime; and details of any personalised care. ET is delivered by an ET coordinator, qualified to a minimum of Health and Social Care level 4. The ET workers will receive social care management and clinical supervision monthly. Their role as a prison social care specialist will include conducting screening, assessments, and care co-ordination. They will liaise with prison, health and external social care staff, making referrals where appropriate, improving communication and aiming to ensure that individuals’ needs are met. The role of the ET worker will involve acting as an advocate for the person in prison, and this will include referring for, feeding into and attending the Care Act Assessment conducted by the local authority. They will also liaise with prison authorities, whose responsibilities include adaptation of the environment for social care. The control will be care as usual in the prison. As part of a previous programme delivery grant (PDG) we conducted: 1. A realist synthesis to develop the initial programme theory, logic model and intervention delivery platform for Empowered Together 2. A systematic review of suitable outcome measures 3. Development of patient, public involvement and engagement (PPIE) The proposed study builds on the work conducted in the PDG. It contains three work packages: WP1: Development of: 1. Training manual 2. Bespoke outcome measure 3. Fidelity scale 4. Immersive film, audio, blog, event and webpage WP2: Feasibility study/embedded formative process evaluation 1. Feasibility RCT 2. Cost-effectiveness feasibility 3. Realist-informed formative process evaluation (including implementation fidelity) 4. Review of progression criteria WP3: Definitive RCT and embedded summative process evaluation 1. Definitive RCT 2. Cost-effectiveness analysis 3. Realist-informed summative process evaluation (including implementation fidelity) 4. Development of future funding application to adapt Empowered Together for women Timelines for Delivery Months 0 – 12: Set up 0 – 6: WP 1 6 – 20: WP2 20 – 54: WP3 54 – 60: Impact and Dissemination For the feasibility RCT, this will last nine months in total. Recruitment will occur during the first six months to allow the final participants time to complete the three-month intervention. The feasibility RCT will include follow-ups at 42-days (six weeks) and 90-days (three months) (±7 days) post-baseline. For the definitive trial, the duration of the intervention will also be 9 months, and the follow ups will be at six weeks and six months. Randomisation: Following consent and the completion of the brief ET screening tool and baseline assessments, participants will be individually randomised 1:1 to intervention versus social care as usual, stratified by prison (prison 1, prison 2) and age group (<50, ≥50). Randomisation should occur as soon as possible after baseline, but within one week. The randomisation sequence, using variable blocks sizes, will be generated by a statistician independent to the trial team and implemented through a secure web-based system on REDCap, which will ensure concealment of allocation to blinded members of the research team. Only site staff who have been delegated the role of randomisation on the delegation log will be able to access the randomisation system. An automated confirmation email will be generated when a participant is randomised and sent to the CIs and other delegated members of the study team. Prisoners allocated to the intervention arm will then complete the ET assessment. This strengths-based assessment of social care need will be conducted by an ET worker. Strengths and assets-based approaches to assessment and care planning focus on capabilities, explore help available from wider support networks, and take into account issues important to the individual (56). Those with higher-level social care needs based on the ET assessment will receive the ET intervention, whilst those with lower-level social care needs will be given tailored advice and information about appropriate resources or services. We will clarify the definitions of higher and lower level social care needs as part of our preliminary training development workshops. This definition will also be dependent on the individual processes established at the prison. Again, for the definitive trial, following screening for eligibility, participants will be randomised 1:1 to receive ET or CAU. This will be achieved using block randomisation stratified by prison and age group. 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 Protocol

227afbd9-9e7d-4a8e-875b-cc09192df774 c7c95d51-c7a1-47a7-85db-eafcaf8fbb1e 7088a0c0-4fdb-47a7-a113-9d7e769629ad f9a7ae62-39ba-4ddc-83c1-03eabca88b7f No Protocol file 47924 Empowered Together Protocol WP1 and 2 V1 30June25.pdf af9c33f1-4ea2-4941-83e6-a5707506a60f true application/pdf 2005761 bf1c7598afebc6f9a4014800dd66a9d9 Katrina Forsyth https://orcid.org/0000-0001-9980-9464 Scientific Principal investigator

Oxford Rd

Manchester United Kingdom M13 9PL - katrina.forsyth@manchester.ac.uk Public Emily Egan Public

176 Oxford Rd

Manchester United Kingdom M13 9PY +353 834824527 emily.egan@manchester.ac.uk Public Lancashire and South Cumbria NHS Foundation Trust Hospital/treatment centre Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 12201122 true An evaluation of secondary care mental health treatment requirements SC-MHTR To develop a Secondary Care Mental Health Treatment Requirements (SC-MHTR) programme theory that would facilitate understanding of need, barriers to take-up and delivery, and solutions, and form the basis for a full evaluation of SC-MHTRs in anticipation of a national programme rollout across England and Wales. Research questions: 1. How is the SC-MHTR being delivered? 2. What works, for whom at each of the study sites, and what are the mechanisms that underpin this? 3. What can we learn from the sites about improving delivery across different geographic, socio-economic and organisational contexts? 4. How should we evaluate a future national SC-MHTR programme? Background and study aims Many people who attend court have severe and complex mental health problems. They often find it difficult to access treatment. They can face stigma, homelessness, financial and substance problems. A prison sentence can make these problems worse and does not help their mental health. A Mental Health Treatment Requirement (MHTR) can be given instead of a short prison sentence by courts in England and Wales if the person agrees. It means that they must attend for treatment of their mental health problem as part of a community sentence. Secondary MHTRs (SC-MHTR) are for people who need specialist mental health care. Until now, courts have ordered very few SC-MHTRs. The NHS has given money to three courts in England, called ‘proof-of-concept’ sites, to investigate whether more people could benefit from SC-MHTRs. They think that this could improve their mental health and reduce the number of people with severe mental health problems going to prison. The NHS would like to see an increase in SC-MHTRs across the country and needs to learn the best way to go about this. There is no research evidence about how to increase use of SC-MHTRs. We also do not know if they affect health, or if they can work for different people and in different places. This study will examine how people use SC-MHTRs at the proof-of-concept sites and at a Welsh site. The researchers want to know if SC-MHTRs are working, who for, how and why. This will let them tell the NHS the best way to introduce them across the country. They also aim to develop a way to measure their effect on health and on NHS costs across the country in future. Who can participate? Adult patients aged 18 years and over who are under an SC-MHTR, carers of patients under an SC-MHTR, commissioners, policymakers and staff involved in the creation and implementation of SC-MHTRs. What does the study involve? The researchers will get information in three ways: 1. Review documents about people’s expectations about SC-MHTRs 2. Hold interviews with people who designed the SC-MHTR, staff, patients, and their families 3. Examine NHS records that describe patients on SC-MHTRs and SC-MHTR numbers They will use this information to: 1. Find out how SC-MHTRs are being delivered 2. Explain how SC-MHTRs work (or do not work) for which patients and in what circumstances 3. Tell the NHS about the best way to increase SC-MHTRs across the country and overcome problems 4. Design a way to evaluate a future national SC-MHTR programme. What are the possible benefits and risks of participating? There is no direct benefit to research participants, but participants taking part in interviews/workshops may benefit from being part of the research process and contributing to the evaluation of SC-MHTRs. For example, being able to discuss their experiences and 'be heard' may have a positive effect on participants. The study involves the discussion of sensitive topics. There will be a safeguarding protocol in place to minimise the risk of participant distress. Where is the study run from? Lancashire and South Cumbria NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? February 2024 to November 2026 Who is funding the study? National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Programme (UK) Who is the main contact? Dr Kerry Gutridge (Project Manager), kerry.gutridge@manchester.ac.uk Views and experience of staff, patients and carers on secondary care MHTRs collected from 01/10/2024 to 31/01/2026. Data will be analysed using a realist approach to thematic analysis and descriptive statistics, using realist methods to develop an Initial Programme Theory to describe how secondary MHTRs work, in what way and for whom. Quantitative analysis of routine health and justice datasets collected from 01/10/2024 to 31/01/2026. Data will be analysed using a realist approach to thematic analysis and descriptive statistics, using realist methods to develop an Initial Programme Theory to describe how secondary MHTRs work, in what way and for whom. Ethics approval required Wales REC 4

Health and Care Research Wales, Castlebridge 5, 15-19 Cowbridge Road East

Cardiff United Kingdom CF11 9AB 24/WA/0267 10.1186/ISRCTN12201122 339957 CPMS: 64720, LSCFT-RD23010 339957 64720 LSCFT-RD23010 Scientific realist framework Observational Scientific realist framework Other 2026-11-30T00:00:00.000Z United Kingdom England Midlands Partnership University NHS Foundation Trust

Trust Headquarters St Georges Hospital Corporation Street

Stafford England ST16 3SR RRE@2.16.840.1.113883.2.1.3.2.4.18.48 Gloucestershire Health and Care NHS Foundation Trust

Edward Jenner Court 1010 Pioneer Avenue Gloucester Business Park

Gloucester England GL3 4AW RTQ@2.16.840.1.113883.2.1.3.2.4.18.48 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 Carer Health professional Patient Patients: 1. Adults aged 18 years or over 2. Capacity to consent to participate in the study 3. Recommended for, under, or recently (within 3 months) under an SC-MHTR Carers: 1. Adults aged 18 years or over 2. Capacity to consent to participate in the study 3. Family member or informal caregiver of someone recommended for, under, or recently (within 3 months) under an SC-MHTR Professionals: 1. Aged 18 years or over 2. Have working knowledge of how SC-MHTRs operate Mixed 18 Years 120 Years All 84 0 Patients: 1. Aged 17 years and under 2. Lacking the capacity to provide informed consent to participate 3. Not recommended for, under, or recently (within 3 months) under an SC-MHTR 4. Considered by staff not safe to interview due to their current risk assessment Carers: 1. Aged 17 years and under 2. Lacking the capacity to provide informed consent to participate 3. Not a family member or informal caregiver of someone recommended for, under, or recently (within 3 months) under an SC-MHTR Professionals: 1. Aged 17 years and under 2. Do not have a working knowledge of how SC-MHTRs operate 2025-02-01T00:00:00.000Z 2026-11-30T00:00:00.000Z Secondary care mental health treatment requirements Mental and Behavioural Disorders The SC-MHTR is a complex intervention that may be offered after conviction in a magistrates’ or Crown court to tailor a community or suspended sentence. It involves assessment by probation and health personnel and explanation to the offender, assessment, agreement between them and, if agreed, a recommendation to the court, sentencing and then the management of the arrangement and delivery of treatment, with return to court if in breach. Thus, the parties come from very different training and professional backgrounds and co-operation must be achieved between them across separately commissioned services. The NIHR/MRC framework for developing and evaluating complex interventions has informed our research approach. A Scientific Realist Framework will be adopted. A realist approach assumes that the same intervention will not work in the same way everywhere and for everyone, and focuses upon ‘what works, for whom, in what way, and how’. The Government recognises the importance of this approach for evaluating interventions at early stages and to understand how to adapt them to new contexts to understand how and why differences occur. Here, the plan fits with a four-step process within two work packages. In Work Package 1, the researchers will: 1. Formulate an initial programme theory by drawing on extant documents and interviewing central policy staff 2. Conduct preliminary testing of this model with NHS routine data and proof of concept and Wales site staff, patients, and carers 3. Consolidate the programme theory In Work Package 2, the researchers will design the large-scale evaluation Other Not expected to be made available cb17b410-162d-4a90-950b-b65729f171cf d91c1396-a8ca-43fd-b929-036b20a7ba62 acd26bfb-c5f9-4ab5-8e7a-3e893bedf537 dc52518e-7f7e-4de9-9846-d7b940802d98 No Louise Robinson Public Scientific Principal investigator

Division of Psychology and Mental Health School of Health Sciences Faculty of Biology, Medicine and Health University of Manchester Jean McFarlane Building Oxford Road

Manchester United Kingdom M13 9PL +44 (0)1772 676134 louise.robinson@manchester.ac.uk Public Kerry Gutridge https://orcid.org/0000-0001-9705-9102 Public Scientific

2nd Floor, Jean McFarlane Building, University of Manchester, Oxford Road

Manchester United Kingdom M13 9PL +44 (0)7784 016 900 kerry.gutridge@manchester.ac.uk Public Lancashire and South Cumbria NHS Foundation Trust Hospital/treatment centre Non-commercial National Institute for Health and Care Research - Health and Social Care Delivery Research Programme http://dx.doi.org/10.13039/501100000272 21721966 true A pilot cluster randomized controlled trial of psychological treatment selection for depression TherapyMatch-D As a pilot study, no hypothesis testing is undertaken. The aim is to explore the feasibility and effects of an artificial intelligence treatment selection model for depression to improve clinical outcomes in adults accessing two psychological therapies for depression in primary mental health services compared to allocation as usual. Background and study aims: Reviews of clinical trials have concluded that different types of psychological interventions for depression are equally efficacious. Therefore, the largest public provider of psychological services in England, Talking Therapies, routinely offers Cognitive Behavioural Therapy (CBT) and Counselling for Depression (PCE-CfD) as front-line treatments. Despite efforts to improve recovery rates, 1 out of 2 patients accessing any evidence-based psychotherapy usually do not recover from depression. Recent studies have suggested that identifying subgroups of patients that respond differently to diverse treatment modalities or intensity can improve clinical outcomes. One retrospective study used a large routine care dataset of patients who accessed either CBT or PCE-CfD. Researchers found that in about 30% of patients if matched to their optimal treatment using artificial intelligence, patients were twice as likely to recover from depression. The aim of this study is to pilot the effectiveness of using a treatment selection model based on that prior study. The researchers will explore if it is feasible and effective for more patients to recover from depression by being provided with a treatment recommendation compared to allocation as usual. Who can participate? Patients aged 18+ years with depression deemed suitable for high-intensity therapies in participating Talking Therapies sites What does the study involve? Talking Therapies sites will be randomly allocated to the TherapyMatch-D group (experimental) or allocation as usual group (control). During the initial assessment, clinicians in both groups will input suitable patients’ data into a computer programme. In the TherapyMatch-D group, patients who according to prior research would benefit more from either CBT or PCE-CfD will be provided a treatment recommendation and then use shared decision-making with the clinician to reach a final decision. Patients in the control sites will not be given a recommendation and will follow routine care procedures to select treatment, which normally consists of shared decision-making. The researchers will then compare the outcomes of both groups to explore if the treatment selection model is feasible and effective. Furthermore, interviews will be conducted with some patients and clinicians to explore their views and experiences of using artificial intelligence to inform treatment selection. What are the possible benefits and risks of participating? Participants will help researchers to learn if using the TherapyMatch-D artificial intelligence method is feasible and effective in making better treatment selection recommendations for patients accessing talking therapies for depression. The researchers do not expect that taking part in the study will lead to any disadvantages or risks to therapists or to patients. Where is the study run from? Grounded Research Team at Rotherham Doncaster and South Humber NHS Trust (RDaSH) (UK) When is the study starting and how long is it expected to run for? April 2022 to February 2028 Who is funding the study? MindLife UK Who is the main contact? Dr Paulina Gonzalez Salas Duhne, rdash.research-gov@nhs.net Reliable and Clinically Significant Improvement (RCSI) in depression, measured by the Patient Health Questionnaire-9 questionnaire (PHQ-9) at the end of the treatment period (last session of therapy, either CBT or PCE-CfD) 1. Adherence to treatment selection recommendation measured using a question embedded in the TherapyMatch-D computer programme ("does the treatment selected match the recommended treatment by the TherapyMatch-D app?") during initial assessment with client 2. Outcome expectancy (OE) measured using a question embedded in the TherapyMatch-D computer programme (“At this point in time, how confident are you that this kind of treatment will work for you on a scale of 0 (not at all) to 10 (definitely)?”) during initial assessment with client 3. Anxiety measured using the Generalized Anxiety Disorder (GAD-7) at initial assessment, and at each therapy session throughout treatment 4. Functional impairment measured using the Work and Social Adjustment Scale (WSAS) questionnaire at initial assessment, and at each therapy session throughout treatment 5. Clinical, demographic and service utilisation data (such as age, employment status, self-reported disability, index of multiple deprivation, ethnicity, chronicity, antidepressant medication, diagnoses, number of therapy sessions, reason for discharge) measured using the TherapyMatch-D computer programme questionnaire and routine data collected by Talking Therapy sites. Data will be collected at initial assessment, and throughout routine treatment provided 6. Personality profile measured using the Standardized Assessment of Personality–Abbreviated Scale (SAPAS) at initial assessment 7. Adverse events measured using compare rates of reliable deterioration in patients across both arms of the trial at the end of the trial Old ethics approval format Approved 21/07/2023, HRA London - Riverside Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, UK; +44 (0)207 104 8150, +44 (0)207 104 8243, +44 (0)207 104 8255; riverside.rec@hra.nhs.uk), ref: 23/LO/0487 10.1186/ISRCTN21721966 281430 CPMS: 56659 281430 56659 Randomized; Interventional; Design type: Screening, Psychological & Behavioural Interventional Randomised controlled trial Treatment 2028-02-01T00:00:00.000Z United Kingdom England IAPT Services

NHS Greater Manchester Mental Health NHS Foundation Trust Chorlton House 70 Manchester Road

Manchester England M21 9UN Lancashire and South Cumbria Talking Therapies

LSCFT/Mindsmatter Lancashire & South Cumbria NHS Foundation Trust Daisyfield Centre Appleby St

Blackburn England BB1 3BL Leeds Mental Wellbeing Service

Leeds Community Healthcare NHS Trust Burmantofts Health Centre Cromwell Mount

Leeds England LS9 7TA Barnsley IAPT

South West Yorkshire Partnership NHS Foundation Trust Rose Tree Avenue Cudworth

Barnsley England S72 8UA Doncaster IAPT

Talking Shop 63 Hall Gate

Doncaster England DN1 3PB Surrey and Borders Partnership NHS Foundation Trust

Holloway Hill

Chertsey England KT16 0AE 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 Cornwall Partnership NHS Foundation Trust

The Kernow Building

Redruth England TR15 3QE Health professional Patient Therapists/Counsellors: 1. Be employed by a participating IAPT service on a permanent contract, or be employed as temporary staff with a contract that is at least as long as the expected timescale for the project (1 year) 2. Hold a UK-recognized qualification and be approved by IAPT to carry out routine assessments in an IAPT service 3. Attended a group/individual training on how to utilize the computer programme TherapyMatch-D Patients 1. Adults (18 years of age or older). 2. With depression (defined as scoring at least 10 on the PHQ-9), including those with co-morbid anxiety and those taking antidepressant medication (we will monitor and examine potential confounding effects of comorbidity and medication). 3. Seeking mental health care in IAPT services at Step 3 (normally via self-referral, GP referral or stepped up from Step 2 low-intensity IAPT treatment). 4. Deemed eligible for high-intensity treatment in IAPT by assessing therapists (often patients who do not improve at the earlier steps of care), regardless of any prior mental health treatment from IAPT or elsewhere (we will monitor and examine potential confounding effects of prior treatment and baseline severity). 5. Able to take part in the initial assessment in English without the need for interpreters or substantial communication adaptations. Note. The researchers will gather information from all consenting participants (216 per arm). However, only those will a differential treatment response as identified by the algorithm in the TherapyMatch-D computer programme, which we estimate would be approximately 30% of the 216 participants (64 participants per arm), will be included in the primary outcome analysis. In the sub-study, purposive sampling will be used to recruit 4 patients from each arm of the trial (2 per intervention) and 4 clinicians from each arm of the trial. This will result in a planned sample size of 16 participants. Mixed 18 Years 120 Years All 376 0 Therapists/Counsellors: 1. Employment contract with IAPT service is shorter than the expected timescale for the study (1 year) 2. Currently in training (since they are not yet fully qualified to carry out routine assessments) without holding a UK-recognized qualification 3. Failure to attend a group/individual training on how to utilize the digital tool TherapyMatch-D Patients: 1. Individuals below 18 years old 2. Lack of ability to provide informed consent to participate (as determined by the assessing therapist as part of a routine assessment) 3. Patients who do not provide informed consent to participate 4. Patients who are assessed as ineligible for treatment in IAPT (e.g., those who are signposted to other services, or lacking capacity to consent to an assessment). Specific criteria for IAPT exclusion are detailed elsewhere. Common examples include having other severe mental health disorders, highly acute suicide risk, and comorbid substance use disorder that interferes with the person’s ability to engage in therapy 5. Unable to take part in the initial assessment due to language or communication barriers, or requiring substantial adaptations or interpreters 2023-09-25T00:00:00.000Z 2026-05-31T00:00:00.000Z Depression Mental and Behavioural Disorders Talking Therapy sites will be randomised to the TherapyMatch-D group (experimental) or allocation as usual (control). During the initial assessment, clinicians in both groups will input pseudo-anonymized data from consenting patients into a computerized artificial intelligence programme. In the TherapyMatch-D group, patients who according to prior research would benefit more from either Cognitive Behavioural Therapy (CBT) or Person Centred Experiential Therapy (also known as Counselling for Depression; PCE-CfD) will be provided with a treatment recommendation and then use shared decision making to reach a final decision. In the allocation as usual group, patients will not be given a recommendation and will select treatment in the usual way (shared decision-making). Following treatment selection, patients across both groups will undergo treatment as usual (CBT or CFD-PCE). Furthermore, as part of a substudy, interviews will be conducted with patients and clinicians to explore their views and experiences of using artificial intelligence to inform treatment selection. Behavioural In order to comply with the requirements of the research ethics committee, sensitive data must be requested in writing to the data custodian (Chief Investigator). Anonymized data may be made available upon reasonable request. Available on request Protocol

ac67b985-4cd4-465f-a306-67007d64dc44 927fa105-0236-4227-856b-1575cd962965 3c5dd20a-6bac-46ef-939b-e6a3a9411309 Yes Statistical Analysis Plan ISRCTN21721966_SAP_v2_11Aug2023.pdf fa8154d1-2de7-4085-a8c4-de4c9e6a146e true application/pdf 198710 3b26bdef33b360060ae37552f3d021ed Protocol file ISRCTN21721966_PROTOCOL_V2.3_18Jul24.pdf 3aa1d053-bc26-4f66-bb96-e1e1992e1a5f true application/pdf 418709 c6117d7d3be557b6cf4d59e421e25e74 Protocol file ISRCTN21721966 TherapyMatch-D_Protocol_v5.0 - 17June2026.pdf c8ac6584-b077-4f6d-8c05-0afb8d288ec8 true application/pdf 554062 f6c1631e2bb27dbba3e0a2afd1fe01a7 Paulina Gonzalez Salas Duhne https://orcid.org/0000-0003-4010-1503 Scientific Principal investigator

Doncaster and South Humber NHS Foundation Trust 2 St Catherine’s Close Tickhill Road Hospital site Balby

Doncaster United Kingdom DN4 8QN +44 (0)3000 212 456 p.gonzalez1@nhs.net Public Rotherham Doncaster and South Humber NHS Foundation Trust Hospital/treatment centre Non-commercial Mindlife UK 52372836 true Mental health prevention and promotion in general practice settings: a feasibility study MEND Will patients registered at a general practice, presenting with mild-moderate mental health difficulties, be willing to be randomised to a study investigating the efficacy of a brief mental health prevention and promotion intervention? Background and study aims The number of people struggling with their mental health is rising. Soon, the NHS may not be able to meet the demand on mental health services. Offering preventative mental health support may stop people from developing more serious mental health problems. The study aims to understand how preventative mental health support can be delivered in a general practice (GP) setting. The study will recruit individuals from GP settings and randomly allocate them to two groups. One group will be invited to engage in a brief, menu-based psychological intervention alongside their treatment as usual. The main aim of the intervention is to explore if it’s possible to help people when they are first struggling, by teaching them how to look after their emotional wellbeing. The second group will receive treatment as usual and the research team will stay in touch with them too. The feasibility study will test: 1. Whether people are happy to sign-up for, and then stay in the study. 2. Whether people are happy to fill in questionnaires about their wellbeing. 3. What helped, or indeed, stopped the study from running smoothly. 4. Whether the study is safe for everyone involved. We will look at how many people sign up, attend or drop out of the intervention to answer these questions. Questionnaires/interviews will be done with participants, GP staff and the assistant psychologists to understand why the intervention service worked/did not work and how they felt about the study design. As a new area of research, this ‘feasibility study’ is needed to help design, plan and justify a larger study. Who can participate? 60 adult patients at GP surgeries in East Lancashire, with mild-moderate mental health difficulties who agree to participate. What does the study involve? Half of the patients will receive the usual input from their GPs (10-minute appointments). The rest will be offered five weekly 45 minutes of the intervention session. What are the possible benefits and risks of participating? If you choose to participate in the study there is a possibility that you will be allocated to the group which does not receive the brief psychological intervention. On the other hand, if you are allocated to the group that receives the psychological intervention there may be times when you find talking about your mental health upsetting. For some people talking about their mental health can be hard however you will be supported by an appropriately trained professional. The aim of the psychological intervention is to help you feel better and to help you understand how to care for your mental health, just like you do your physical health. Therefore, it is hoped that the benefits of receiving the intervention will be improved emotional wellbeing. Where is the study run from? Lancashire & South Cumbria NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? March 2023 to June 2024 Who is funding the study? National Institute for Health and Care Research (NIHR) (UK). Who is the main contact? Farah Lunat, Farah.lunat@lscft.nhs.uk 1. Depression measured using PHQ-9 2. Anxiety measured using GAD-7 3. Mental wellbeing measured using WEMWBS 4. Resilience measured using BRS Measured at: INTERVENTION ARM - engagement session (consent), first session (if engagement session was longer than 2 weeks ago), fourth session, Post-intervention (4-weeks post-baseline), 4-week follow up (8-weeks post-baseline), 8-week follow up (12-weeks post-baseline), 12-week follow up (16-weeks post-baseline). CONTROL ARM - engagement session (consent) and 16 weeks later. Cost-effectiveness outcome measures at baseline and the final follow-up (16 weeks): 1. Patients' resource use captured using a questionnaire and patient note review. The information to be collected from the participants' electronic health records (EHR) will be: NHS Consultations and referrals; A&E admissions and stays in hospital; Prescribed medication. The EHR that will be accessed is known as EMIS- the EHR used within the GP practices in Pendle West and Burnley East PCN. The questionnaire will collate information about: Private consultations and stays; Over-the-counter medication use; Special items or equipment. 2. Patients’ health-related quality of life (HRQoL) measured using EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L; 34) questionnaire Qualitative and Process Evaluation Qualitative data will be collected to understand factors that facilitate or challenge the successful implementation of interventions and a process evaluation will be conducted to provide insight into the intervention's mechanisms of action. Participants: a patient experience questionnaire will be used to assess intervention acceptability. Semi-structured interviews will be conducted with a sample of participants (10 per arm), to explore their experience of the study and perceived mechanisms for change. General practice staff: A feedback questionnaire will be distributed to GP staff, to understand their experiences and any changes required for a full study. A semi-structured interview with three staff members will also be conducted. Research team: Field notes from the research team will identify factors that supported/impeded the feasibility study. A semi-structured interview will be conducted with the two Assistant Psychologists to understand their perceived mechanisms of change and patient safety processes. Questionnaire responses will be collated, and interviews transcribed. Qualitative analysis will be conducted by the qualitative lead, KG, using NVivo, to provide a comprehensive response to the research questions. Furthermore, the process evaluation will allow for the identification of any mediating variables which should be measured in a full study. Ethics approval required Health Research Authority

Skipton House, 80 London Road

London United Kingdom SE1 6LH 23/NW/0117 10.1186/ISRCTN52372836 323448 CPMS: 56061, NIHR: 204332 323448 56061 204332 Interventional mixed methods Interventional Randomised parallel trial Other 2024-06-30T00:00:00.000Z United Kingdom England Lancashire & South Cumbria NHS Foundation Trust Hq

Sceptre Point Sceptre Way Bamber Bridge

Preston United Kingdom PR5 6AW RW501@2.16.840.1.113883.2.1.3.2.4.18.48 Patient 1. Registered at the research site's General Practice 2. Score <=14 on the GAD-7 and <=15 on the PHQ-9 at screening 3. Aged 16 years and above Adult 16 Years All 60 64 1. Already supported by a mental health service/ engaged in therapy 2. Score >=15 on the GAD-7 and/or >=16 on the PHQ-9 at screening 3. Have a formal diagnosis of a severe mental health difficulty, where it would not be possible to meet their needs with four sessions 4. Require support from crisis services 5. Have a moderate-severe learning disability, where their needs could only be met within a specialist service. 2023-07-01T00:00:00.000Z 2024-02-09T00:00:00.000Z Primary care mental health Mental and Behavioural Disorders Patients who meet the criteria and agree to participate in the study will be randomised to either: - treatment as usual within general practice - treatment as usual within general practice plus a mental health prevention and promotion intervention The mental health prevention and promotion intervention can be delivered either face-to-face in the GP surgery or virtually by an Assistant Psychologist, who has undergone an initial intensive 2-week training in the delivery of brief interventions for prevention and promotion. The virtual delivery method would be via integrated software such as ACCURX or iplato, which are both currently used by the practices in the two PCNs. The training the Assistant Psychologists will receive will be provided by qualified psychological professionals and focus on the principles and applications of different psychological techniques used in brief interventions. The Assistant Psychologists will also be provided with weekly individual clinical supervision by a Clinical Psychologist. Control group: To mimic mental health treatment as usual in general practice, participants in both study arms will be able to access GP appointments as normal. Within these appointments, GP staff will be able to provide any usual form of mental health treatment, such as advice or medication. This feasibility study will collate data about the care each participant receives. Intervention group: The intervention group will receive additional input through a brief psychological intervention aimed at preventing mental ill-health, or deterioration. This is a brief one-to-one psychological menu-based intervention focusing on preventing mental health deterioration and promoting the importance of caring for one’s emotional wellbeing. The intervention consists of four 45-minute appointments delivered weekly, over 5 sessions Follow up for 16 weeks. Qualitative and Process Evaluation Qualitative data will be collected to understand factors that facilitate or challenge the successful implementation of interventions and a process evaluation will be conducted to provide insight into the intervention's mechanisms of action. Behavioural The datasets generated and analysed during the current study will be available upon request from Study sponsor R&D department, research.office@lscft.nhs.uk. Data available will be Individual participant data that underlie the results reported in this article, after deidentification (text, tables,figures, and appendices). The data will be available following study close out ending 5 years following article publication. Data will be available to Researchers who provide a methodologically sound proposal in order to achieve aims identified in the proposal. Data will be accessible on a secure NHS server and access will be facilitated by the research office but without investigator support other than deposited metadata. Available on request

45e10aa0-1c4a-4f21-acd2-77f826397ac3 a17e676d-7954-4e1f-9beb-5f8b34d1a6ee 08a72f4e-ce8a-493d-8537-671e1ba98f3a Yes Miranda Budd Principal investigator

Lancashire & South Cumbria NHS Foundation Trust Trust HQ Sceptre Point Sceptre Way Walton Summit

Preston United Kingdom PR5 6AW - miranda.budd@lscft.nhs.uk Public Lancashire & South Cumbria NHS Foundation Trust Hospital/treatment centre Non-commercial NIHR Central Commissioning Facility (CCF) 14195235 true Solutions Trial: Solution Focused Brief Therapy (SFBT) in 10–17-year-olds presenting at police custody: A randomised controlled trial with internal pilot. To determine whether there is a benefit of support as usual (SAU) plus Solution Focused Brief Therapy (SFBT) over SAU alone in reducing offending behaviours in 10–17-year-olds presenting at a police custody suite. Background and study aims Children and young people who come into contact with the police often need help. This trial aims to test whether offering these children and young people a psychological treatment called Brief Solution Focused Therapy is helpful. Brief Solution Focused Therapy is a short-term therapy that helps people to change by focusing on building solutions rather than getting stuck thinking about problems. We want to find out whether this treatment works by running a clinical trial. We will give some children and young people Brief Solution Focused Therapy plus the routine treatment that they would normally get. Other children and young people will only get the routine treatment that is currently offered when they come into contact with the police. We will decide who gets which treatment at random, which is like flipping a coin. In order to work out whether Brief Solution Focused Therapy is helpful, our trial has two parts. In the first part, we will run what is called a ‘pilot’. This is a test version of the trial which tests whether the trial can be run. If we find that this is the case, we will then move to do the second part, which is continuing with the main trial by inviting more children and young people to take part. All of the children and young people who take part will be asked to complete some measures of things that may change because of taking part in Brief Solution Focused Therapy. We are particularly interested in whether they are involved in any antisocial behaviours over the course of the trial. We will also ask about their background, their general well-being, any criminal activity they have been involved with in the past and any gang connections. We will also interview some of the children and young people receiving SFBT, their parents/guardians, and the professionals that deliver the SFBT therapy. We will ask them about their experiences of taking part in the trial. Who can participate? Young people aged between 10 to 17 years who have been referred to the L&D team by the police in Lancashire and South Cumbria. What does the trial involve? The trial involves completing questionnaires and being randomly allocated to receive SFBT and usual services, or usual services alone. You may also be invited to take part in an interview. What are the benefits and risks of participating? We don’t know if SFBT is helpful to young people in your situation. Taking part will be helpful to us and may help others. We do not think there are any bad things that will happen because of this research. You will be asked to complete some questionnaires and you might receive SFBT. Some of the questions in the questionnaires, and some of the things discussed during the therapy (if you are randomly selected to receive it) will be about stuff that is private and might lead you to feel upset. Where is the trial run from? University of Warwick (UK) Cardiff University (UK) When is the trial starting and how long will it run for? April 2022 to February 2027 Who is funding the trial? Youth Endowment Fund (UK) Who is the main contact? Dr Gwenllian Moody, MoodyG@cardiff.ac.uk Antisocial behaviours are measured using the Self Report Delinquency Measure (CYP completed) at baseline, 6 months and 12 months post randomisation. 1. Criminal offence data are collected from the Police National Computer over the 6-month period prior to the commencement of treatment, and at 12-months post randomisation. 2. Emotional and behavioural difficulties are measured using the Strengths and Difficulties Questionnaire (SDQ) (parent completed and CYP completed) at baseline, 6 months and 12 months post randomisation. 3. Gang Affiliation is measures using The Gang Affiliation Risk Measure (CYP completed) at baseline and 12 months post randomisation. 4. Details of other therapies received will be collected (parent completed for under 16s and CYP completed for 16+) at baseline and 12 months post randomisation. Potential moderators: In addition to the primary and secondary outcomes, we have considered that the following outcomes may moderate the outcomes of this trial. 1. Callous and Unemotional Traits will be measured using the 24-item Inventory of Callous and Unemotional Traits (parent completed and CYP completed) at baseline and 12 months post randomisation. 2. Learning disabilities (LD): Children and young people will be invited to complete two subtests of the Wechsler Abbreviated Scale of Intelligence-II (WASI-II; Wechsler, 2011) to index their Verbal Comprehension Index at baseline only. We are also including a closed question asking if the child has a learning disability (parent completed for under 16s and CYP completed for 16+). Old ethics approval format Approved 16/11/2022, Yorkshire & The Humber - Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 207 1048134; leedswest.rec@hra.nhs.uk), ref: 22/YH/0198 10.1186/ISRCTN14195235 Randomized controlled trial with internal pilot Interventional Randomised controlled trial Treatment 2027-02-28T00:00:00.000Z United Kingdom England Lancashire and South Cumbria NHS Trust

Sceptre Point Sceptre Way Bamber Bridge

Preston England PR5 6AW 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 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 Midlands Partnership University NHS Foundation Trust

Trust Headquarters St Georges Hospital Corporation Street

Stafford England ST16 3SR RRE@2.16.840.1.113883.2.1.3.2.4.18.48 Healthy volunteer 1. Aged between 10 to 17 years 2. Referred to the L&D team by the police Child 10 Years 17 Years All 392 0 1. A clinician has judged that the child or young person is presenting with a mental illness of a nature and degree warranting immediate intervention from specialist services, including assessment for detention under the Mental Health Act. 2. The young person is to be remanded into custody. 3. A child or young person aged 16 years or older judged to lack mental capacity to decide about participating in this trial by staff responsible for gaining informed consent. 4. The child or young person is living outside the area served by Lancashire and South Cumbria NHS Foundation Trust. 5. The child or young person is unable to converse in English. 6. Parents/guardians are unable to converse in English (at least one must be able to converse in English to complete parent/guardian measures) 7. Parents/guardians of under 16s judged to lack mental capacity to decide about participating in this trial by staff responsible for gaining informed consent. 2022-10-01T00:00:00.000Z 2026-08-31T00:00:00.000Z Offending behavior Other Participants in the intervention arm will receive Brief Solution Focused Therapy (SFBT) alongside services as usual. SFBT is a six-session manualised intervention, delivered face-to-face bi-weekly over 12 weeks, on a one-to-one basis, that helps people to change by focus on building solutions rather than getting stuck thinking about problems. Through a programme of SFBT, it is hoped that children and young people can be diverted away from the criminal justice system, reducing their risk of serious youth violence. The six sessions are detailed below. The intervention will be delivered from month six to 19 of the trial. The therapists have been recruited from the existing Liaison and Diversion workforce within LSCFT. Practitioners are from a health and social care skill mix and are in band 5 / 6 clinical roles as per Agenda for Change. All three practitioners recruited to support the trial already have experience in supporting children through custody. For the trial, they have then undertaken 36 hours of SFBT training, facilitated by the same training provider at the same time. Children will be offered a choice of where to participate in the sessions, but choice will be limited to home, school, LSCFT clinical site, community clinic e.g. youth centre. Six sessions will be included and will last no less than 15 minutes and no more than one hour each. The six sessions will be facilitated over a 12-week period. Sessions will be no more frequent than once a week and no less frequent that bi-weekly- this should allow for sickness / absence and inconsistent engagement. Existing fidelity measures are to be adapted. Usual practice arm Participants in the usual practice arm will receive services as usual. Follow-up duration Participants in the intervention and usual practice arms will be followed-up at 6 month and 12 months post randomisation. Randomisation CYP will be randomised on a 1:1 basis to either the intervention (SFBT and SAU) or control arm (SAU only) using stratified permuted block randomisation, ensuring balance on prognostic factors (i.e., Verbal Comprehension Index), and stratifying by custody suite. The randomisation system will be embedded within the trial database, and outcome assessors, trial statisticians responsible for analysing the data, and the research team excluding the trial manager, Data Manager, Senior Trial Manager and those undertaking the process evaluation will remain blind to allocation. The online system also ensures allocation concealment is blinded for researcher recruiting participants. Behavioural The datasets generated during and/or analysed during the current study are/will be available upon request from solutions@warwick.ac.uk Available on request 2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38431608/ (added 05/03/2024) Protocol

Participant information sheet Migrated from patient info sheet field

Study website Migrated from study website field

c7aa100b-b75e-4564-bdc8-905edbe87128 67dab803-59b0-4a9b-b499-896e74b8d5a5 1cffee27-79fd-4ead-9878-3a67218bddbf 8625b1b1-7c3c-4b06-8c5e-8c354745d327 8300c777-9768-4dc9-8dfe-4e7dd8240b04 Yes Samantha Flynn https://orcid.org/0000-0003-3466-9506 Principal investigator

Centre for Educational Development, Appraisal and Research University of Warwick

Coventry United Kingdom CV4 7AL +44 7823362152 s.flynn.1@warwick.ac.uk Public Peter Langdon https://orcid.org/0000-0002-7745-1825 Principal investigator

University of Birmingham, Intellectual Disabilities Research Institute (IDRIS), School of Social Policy and Society

Birmingham United Kingdom B15 2TT +44 751 115 9516 p.langdon@bham.ac.uk Public Gwenllian Moody Scientific

Research Associate Centre for Trials Research (CTR) Cardiff University 7th Floor Neuadd Meirionnydd Heath Park

Cardiff United Kingdom CF14 4YS +44 (0)2920 687257 MoodyG@cardiff.ac.uk Public Lancashire and South Cumbria NHS Foundation Trust Hospital/treatment centre Non-commercial Youth Endowment Fund 14082421 true Care coordinator delivered method of levels therapy to improve engagement and other outcomes in early psychosis (CAMEO): a feasibility cluster randomised controlled trial CAMEO This study investigates the use of a transdiagnostic psychological intervention, called Method of Levels (MOL), delivered by care coordinators working in Early Intervention in Psychosis services. Primary objective: Establish the feasibility of recruiting and retaining participants (care coordinators and service-users) in a cluster randomised controlled trial comparing the effects of MOL-trained care coordinators versus treatment as usual on outcomes (engagement and recovery) for people experiencing first-episode psychosis. Secondary objectives: 1. Establish the acceptability of the MOL training programme amongst care coordinators and of MOL delivered by care coordinators amongst service-users. 2. Identify barriers and facilitators to MOL delivered by care coordinators. 3. Refine the MOL training programme and implementation plan based on participant feedback. 4. Establish the most appropriate primary outcome measure for a definitive trial. 5. Generate further evidence on the promise of the intervention via estimates of effectiveness on key outcome measures. 6. Estimate key parameters to inform a sample size calculation for a definitive trial. Background and study aims The term psychosis describes a range of distressing experiences, including hearing and seeing things others cannot, holding beliefs others find unusual, and feelings of persecution. People experiencing a first episode of psychosis should receive support from early intervention services for up to 3 years and be allocated a care coordinator, often a nurse or social worker, who takes a lead in care planning and promoting recovery. Many service users, however, do not remain in contact with early intervention services for the full 3 years, limiting their access to evidence-based interventions. There is evidence that what people value about early intervention services is the opportunity to talk openly about their difficulties in an atmosphere of trust. Care coordinators are not routinely offered training on how to make these conversations as beneficial as possible. Improving the quality of support offered by care coordinators could make these services more helpful and encourage service-users to remain in contact with them. The aim of this study is to find out if it is feasible to conduct a study where care coordinators are trained to deliver a psychological intervention called Method of Levels, which could support people's recovery and improve relationships between care coordinators and service users. Who can participate? Care coordinators from early intervention teams and service users aged 18 years or older who are working with them What does the study involve? Teams will be randomly allocated to one of two groups. Teams in both groups will continue offering their usual support to service users. Care coordinators working in teams in the second group will also be offered Method of Levels training and supervision. To help them to decide whether a larger trial is justified, the researchers will then examine differences in outcomes and experiences between groups, including psychosis recovery rates and the quality of relationships between service users and care coordinators. What are the possible benefits and risks of participating? Many people report that taking part in research of this kind is a helpful experience. Others say that it is rewarding to take part in research that helps to improve mental health services for other people. Participants might find it helpful to talk about their difficulties or their experiences of working with an Early Intervention in Psychosis service. It is possible that topics will be discussed when completing questionnaires or during interviews that some people find distressing. The researchers think that it is unlikely that participants will experience any long-term distress from taking part in this study. Participants are not under any pressure to take part in this study. The decision about whether to participate will not affect the support received from the Early Intervention in Psychosis service or any other support that participants would usually receive. Participants can choose to skip any questions that cause discomfort or distress and can end participation in the study at any time without giving a reason. The research team will ask for regular feedback about participants' experiences of taking part in the study. Where is the study run from? University of Manchester (UK) When is the study starting and how long is it expected to run for? October 2021 to March 2024 Who is funding the study? National Institute for Health Research (NIHR) (UK) Who is the main contact? Dr Robert Griffiths robert.griffiths-2@manchester.ac.uk Feasibility of recruiting and retaining service user and care coordinator participants, assessed using the number of participants who consent to participate who remain in the study until the end of follow-up at 6 months To help determine the most appropriate primary and secondary outcomes for a definitive trial, participants will be asked to complete a range of standardised outcome measures. Service user participants will be asked to complete the following measures at baseline, 3, and 6 months: 1. Personal recovery from psychosis measured using the Questionnaire about the Process of Recovery (QPR) 2. Quality of life and treatment satisfaction measured using DIALOG 3. Goal conflict reorganisation measured using the Reorganisation of Conflict Scale (ROC) 4. Quality of the therapeutic alliance between clinician and service-user measured using the Working Alliance Inventory-Short Revised (WAI-SR) 5. Health outcome (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) measured using EQ-5D-5L (EuroQol Group) 6. Use of health and social care services (including inpatient, outpatient, A&E, GP) during the study measured using the Resource Use Questionnaire (RUQ) Care coordinator participants will be asked to complete the following measure at baseline and 6 months: Burnout measured using the Maslach Burnout Inventory: Human Services Survey (MBI-HSS) Old ethics approval format Approved 25/04/2022, West Midlands - Black Country Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, HRA1 Meeting Room, NG1 6FS, UK; +44 (0)207 104 8010; blackcountry.rec@hra.nhs.uk), ref: 22/WM/0073 10.1186/ISRCTN14082421 307103 CPMS: 52424, NIHR: 203475 307103 52424 203475 Feasibility cluster randomized controlled trial Interventional Cluster randomised trial Treatment 2024-03-31T00:00:00.000Z United Kingdom England 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 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 Lancashire and South Cumbria NHS Foundation Trust

Sceptre Point Sceptre Way Walton Summit

Preston Andorra PR5 6AW Health professional Patient Early Intervention in Psychosis (EIP) team eligibility criteria: EIP teams operating within three participating NHS Trusts (Greater Manchester Mental Health [GMMH], Lancashire and South Cumbria NHS Foundation Trust [LSCFT], and Merseycare) will be included in the study when organisational support is provided for at least two care coordinators to engage with the MOL training and supervision. Care coordinator participant eligibility criteria: 1. Working within EIP services based within participating NHS Trusts 2. Likely to remain in their current post for the duration of the study 3. Have organisational support from their employer to engage with MOL training and supervision 4. Willing and able to engage with MOL training and supervision 5. Provide informed consent to participate in the study Service user participant eligibility criteria: 1. Current users of an EIP service that is included in the study 2. Have an allocated care coordinator who is participating in the study 3. Due to remain under the care of their EIP service until the end of the study 4. Have the capacity to provide informed consent to participate in the study 5. Have sufficient written and verbal English language skills to complete outcome measures and engage with the MOL intervention 6. Aged 18 years or older Mixed 18 Years 120 Years All 120 114 Does not meet the inclusion criteria 2022-05-06T00:00:00.000Z 2023-04-25T00:00:00.000Z First-episode psychosis Mental and Behavioural Disorders Unspecified nonorganic psychosis The study uses a feasibility cluster randomised controlled trial (C-RCT) design with two parallel conditions: (1) treatment as usual (TAU) or (2) TAU plus support from a care coordinator who has received training in Method of Levels (MOL). Randomisation will take place at the level of EIP teams. Approximately 12 teams will be allocated to groups in random permuted blocks using an online randomisation service (Sealed Envelope Ltd., 2021). Because the researchers are primarily interested in the feasibility of the training programme and the use of the intervention, group allocation will be in a ratio of 1:2, with twice as many teams allocated to the intervention arm than the control arm. Future allocations will be concealed until teams are randomised. Care coordinators working in teams allocated to TAU will not receive MOL training but will continue to have access to any training and supervision normally available. Care coordinators in teams allocated to the treatment arm will receive access to a 3-day MOL training course and monthly MOL supervision sessions for the duration of the study, in addition to any training and supervision they would normally receive. To reduce contamination risk, teams will be located at separate geographical locations and/or be operationally distinct from each other. Care coordinators trained in MOL will be asked to avoid discussing the approach with practitioners based in other teams. Care coordinator participants will receive supervision to support the delivery of the intervention for 6 months. The final follow up will be at 6 months. Other Data sharing statement to be made available at a later date 2026 Results article in https://doi.org/10.1016/j.comppsych.2026.152668 (added 31/03/2026) 2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39217388/ (added 02/09/2024) Results

Added from spreadsheet

Statistical and Health Economic Analysis Plan (SHEAP)

7c594ad7-7c53-4699-8166-3100492d1b2f 4ce111b2-f053-4d73-aa20-a609ca31f023 c13e2316-c0c9-425b-be9d-957574e66325 No Statistical and Health Economic Analysis Plan (SHEAP) ISRCTN14082421_SHEAP_v1.0_16Jan2024.pdf e1dda02f-1d1a-4663-ae99-b9c123ff85c4 true application/pdf 671844 aec216281798f092e31a738a7d1eb870 Robert Griffiths https://orcid.org/0000-0002-5960-914X Principal investigator

University of Manchester Division of Nursing, Midwifery and Social Work Jean McFarlane Building Oxford Road

Manchester United Kingdom M13 9PL +44 (0)7500915979 robert.griffiths-2@manchester.ac.uk Public Greater Manchester Mental Health NHS Foundation Trust Hospital/treatment centre https://ror.org/05sb89p83 Non-commercial National Institute for Health Research http://dx.doi.org/10.13039/501100000272 10697380 true Multi Centre RCT of a group psychOlogical intervention for poStnatal depression in britisH mothers of south asiaN origIn - ROSHNI-2 ROSHNI-2 The aim of this study is to investigate the clinical and cost-effectiveness of a culturally adapted group psychological intervention called the Positive Health Programme (PHP) in British South Asian (BSA) women with post-natal depression. Added 16/09/2022: An add-on study was included in August 2021. The aim of this additional work is to explore and understand the wider consequences of the global pandemic on BSA women during the perinatal period in the context of mental health, isolation, education, interpersonal relationships, child development and views on the vaccination and wider impacts. The pandemic has resulted in the closure of parent support groups including baby play, breastfeeding support and child health clinic drop-in sessions. The researchers will also explore the nature and intensity of breastfeeding problems encountered, help-seeking behaviours and sources of support. Background and study aims Postnatal depression (PND) is a type of depression that some mothers experience after having a baby. It can cause disability and suffering in women, negative consequences for their infants and their family with huge costs to society. Rates of PND in British South Asian (BSA) women are higher than the general population. Due to language and cultural barriers, BSA women often do not access appropriate health care services. This has been highlighted as a major contributor to unequal healthcare across the UK populations. Mothers of South-Asian backgrounds (Bangladesh, Pakistan and India) account for a large number of births in the UK. There is a growing concern about ethnic inequalities in the provision and access to postnatal depression services, which is an identified priority in both England and Scotland. The Positive Health Programme (PHP) is a new culturally adapted treatment program that has been developed to help women with PND. Smaller studies have shown that it may lead to improved mood, and successfully engages and supports women from a South Asian background. The aim of this study is to look at the effectiveness and cost-effectiveness of PHP in the treatment of BSA women with PND. Who can participate? British women of South Asian origin with PND who have had a baby within the last year. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group receive the PHP programme as well as standard treatment. This involves 12 group sessions which last for 60-90 minutes every week for two months and then fortnightly for a further two months. The sessions involve learning life skills and having the opportunity to meet other women in similar circumstances. Those in the second group receive usual care only. At the start of the study and then after four and 12 months, participants in both groups complete a questionnaire to measure their depression levels. At the end of the study, the costs of delivering the programme are also calculated from questionnaires completed by participants at the start of the study and after four and 12 months. What are the possible benefits and risks of participating? Participants who receive the programme may benefit from improvements to their mood. There are no major risks involved with participants, although some women may find taking about experiences and feelings to be difficult. Where is the study run from? Lancashire and South Cumbria NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? July 2016 to August 2022 Who is funding the study? National Institute for Health Research (UK) - HTA programme Who is the main contact? 1. Dr Farah Lunat - project manager farah.lunat@lscft.nhs.uk 2. Professor Nusrat Husain (scientific) nusrat.husain@manchester.ac.uk Recovery from postnatal depression is measured using the Hamilton Depression Rating Scale (HDRS) at 4 months (end of intervention) 1. Treatment response is measured using the Hamilton Depression Rating Scale (HDRS) at baseline, 4 and 12 months 2. Cost data will be collected using an Economic Patient Questionnaire at baseline, 4 and 12 months Old ethics approval format Approved 06/01/2017, North West - Greater Manchester South Research Ethics Committee (3rd Floor, Barlow House 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)207 104 8235; nrescommittee.northwest-gmsouth@nhs.net), ref: 16/NW/0727 10.1186/ISRCTN10697380 CPMS: 32313 32313 Randomized; Interventional; Design type: Treatment, Screening, Diagnosis, Psychological & Behavioural Interventional Randomised controlled trial Treatment 2022-08-26T00:00:00.000Z United Kingdom England Lancashire and South Cumbria NHS Foundation Trust

The Lantern Centre Vicarage Lane

Preston England PR2 8DW Patient Service user 1. Self-ascribed British women of South Asian origin as defined by Office of National Statistics (ONS, 2011) 2. Over the age of 16 years and living with their infants up to the age of 12 months (1-Year) 3. Meet the criteria for DSM-V depression Mixed 16 Years 110 Years Female 720 732 1. Women with diagnosed learning disability that will impact on capacity to consent 2. Postpartum psychosis 3. Any other diagnosed psychosis 4. Actively suicidal (previous history of self-harm or suicide attempt). 2017-02-08T00:00:00.000Z 2022-08-26T00:00:00.000Z Postnatal depression, maternal mental health, interpersonal violence Mental and Behavioural Disorders Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified Consenting, eligible women will be randomized via an independent remote randomisation service based at the King's College Clinical trials unit (CTU). After each block of 18 women have been recruited into the trial in each centre, women will be block randomised to the two treatments to give 9 intervention and 9 control participants. Intervention: Participants receive a CBT-based culturally adapted group psychological intervention called the Positive Health Programme (PHP) added to the Treatment As Usual. The manual assisted intervention PHP has been designed to be delivered by non-specialist mental health professionals. The 12 groups/sessions are educational life skills classes, based on a CBT model. Each PHP session will last for 60-90 minutes and will be delivered weekly for two months, and then fortnightly for further two months. Treatment as usual (TAU): Participants undergo study assessments along with routine assessment and management as usually conducted by the participating general practices. The assessments for both the arms will be at baseline, at 4 months (end of intervention) and then 12 months after baseline. The duration of the assessment will not be more than 45-60 minutes. Added 16/09/2022: An additional work stream was included in November 2021 as an add-on study to the ROSHNI-2 project (14/68/08, HTA). The proposed work is shaped by the suggestions made by participants in the current ROSHNI-2 study for a follow-up and re-engagement to explore other associated risk factors related to maternal mental health and specifically in the context of the pandemic. We aim to increase our understanding of the pandemic-related impact on BSA women including Interpersonal Violence (IPV) in BSA communities. The add-on study is supported by an ongoing MRC-funded international survey study - Psychological impact of COVID-19 pandemic and experience: An International Survey (IRAS Project ID 282858). The project is led by Southern Health NHS Foundation Trust and The University of Portsmouth. It aims to investigate and explore the psychological impact of COVID-19, the resultant restrictions and the impact on behaviours and changes in mental wellbeing across the global population. Other The datasets generated and/or analysed during the current study will be included in the subsequent results publication. Other 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39396350/ (added 15/10/2024) 2022 Protocol article in https://doi.org/10.1192/bjo.2021.1032 (added 16/09/2022) 2025 Other publications in https://pubmed.ncbi.nlm.nih.gov/40112855/ Economic evaluation (added 21/03/2025) 2025 Other publications in https://pubmed.ncbi.nlm.nih.gov/41360447/ Qualitative study exploring perceptions of acceptability and implementation (added 06/01/2026) Poster results see attached file ISRCTN10697380_ROSHNI-2 strategies poster.pdf (added 10/07/2024) Results

Added from spreadsheet

Economic evaluation

Qualitative study exploring perceptions of acceptability and implementation

Unreferenced after processing basic results

36381da8-b829-4d5b-a01b-81d4756c9fd5 0066de9a-21e8-4f19-8fcd-0613225f5c85 e3488097-1da1-4142-ad67-25ab86f1508a 9ef10396-6dc4-4ab3-aea7-70bb73a2a0c3 Yes Uploaded 26/01/2017 ISRCTN10697380_PIS_01Jul16_V1.docx 2a9f9812-7aab-4c6f-ae63-8ebbb7fe987e true application/vnd.openxmlformats-officedocument.wordprocessingml.document 80240 426214eb7d71051d136178d4ae6f1976 Poster results ISRCTN10697380_ROSHNI-2 strategies poster.pdf bab4066f-222d-4665-a373-87612c972192 true application/pdf 6988356 64d6c36fabd592e7f0ad7f7e810b1d6b Farah Lunat https://orcid.org/0000-0003-4091-6139 Public

Lantern Centre Vicarage Lane Fulwood

Preston United Kingdom PR2 8DW +44 (0)1772 773498 farah.lunat@lscft.nhs.uk Public Nusrat Husain Scientific

University of Manchester & Lancashire Care NHS Foundation Trust 3rd Floor, Jean Mcfarlane Building University of Manchester Oxford Road

Manchester United Kingdom M13 9PL +44 (0)161 306 7921 nusrat.husain@manchester.ac.uk Public Lancashire Care NHS Foundation Trust Hospital/treatment centre https://ror.org/03zefc030 Non-commercial National Institute for Health Research http://dx.doi.org/10.13039/501100000272