16689792 true Trauma-focused therapy in early psychosis: A randomised controlled trial assessing the efficacy and mechanisms of action of Eye Movement Desensitization and Reprocessing for psychosis (EMDRp) in comparison to treatment as usual in Early Intervention settings EASE The trial aims to test the clinical efficacy of EMDRp (Eye Movement Desensitisation Reprogramming for psychosis) in reducing overall psychotic symptoms when compared to treatment as usual (TAU) for users of EIP services who have a history of trauma, and to examine the degree to which EMDRp +TAU impacts psychotic symptoms via changes in trauma memory characteristics and reductions in maladaptive beliefs. The specific aims and hypotheses are: Efficacy Objectives 1. Aims: 1.1. Primary: To examine the clinical efficacy of EMDRp in reducing overall psychotic symptoms when compared to TAU for EIP service users with a history of trauma. 1.2. Secondary: To determine whether the treatment gains of EMDRp extend to other valued secondary outcomes (perceived personal recovery, severity of hallucinations, delusions, persecutory ideas and paranoid thinking, post-traumatic sequelae, affective symptoms, personal and social functioning, and health-related quality of life). 2. Hypotheses: 2.1. (Primary efficacy hypothesis) EMDRp+TAU will lead to improved overall psychotic symptoms (PANSS scores) at the end-of-treatment (6-month follow-up) compared to TAU. 2.2. The treatment effect of EMDRp+TAU on overall psychotic symptoms will be maintained at the 12-month follow-up. 2.3. EMDRp+TAU will lead to improved personal recovery, post-traumatic sequelae, affective symptoms (e.g. anxiety and depression) and the severity of participants’ hallucinations, delusions, persecutory ideas / paranoid thinking, functioning and quality of life at the end-of treatment (6-month follow-up) and 12-month follow-up compared to TAU. 2.4. Treatment effects will remain evident after accounting for the effect of concomitant psychological therapies delivered as part of TAU. Mechanistic objectives 1. Aims: 1.1. To examine the degree to which EMDRp+TAU impacts on psychotic symptoms via changes in trauma memory characteristics and reductions in maladaptive beliefs. 2. Hypotheses: 2.1. EMDRp+TAU will improve key mechanistic measures targeted by the intervention: trauma memory characteristics and negative self-beliefs targeted as part of EMDR interventions. 2.3. Treatment effects on PANSS at 6-months and 12-month follow-up assessments will be mediated via changes in key mechanistic measures at the 4-month post-randomisation (mechanistic) assessment. Background and study aims Psychosis can cause distressing experiences such as hearing voices, unusual beliefs and paranoia. Many people with psychosis have experienced traumatic life events, which may contribute to the development and persistence of their symptoms. Eye Movement Desensitisation and Reprocessing for psychosis (EMDRp) is a talking therapy designed to help people process traumatic experiences. Previous research suggests that EMDR may improve trauma-related symptoms, but it is not yet known whether it can also reduce psychotic symptoms in people experiencing psychosis for the first time. This study aims to investigate whether EMDRp, alongside usual care, is more effective than usual care alone in reducing psychotic symptoms in people receiving support from Early Intervention in Psychosis (EIP) services who have experienced trauma. Who can participate? People aged 16 years and over who are receiving support from an NHS Early Intervention in Psychosis service, have active psychotic symptoms, have experienced at least one traumatic life event that continues to affect their mental health, and can provide informed consent. What does the study involve? A total of 314 participants will be randomly allocated to one of two groups: - EMDRp plus treatment as usual - Treatment as usual only Treatment as usual will consist of the standard care provided by participants' EIP teams, which may include medication, psychological support and other treatments. Participants allocated to the EMDRp group will receive up to 16 therapy sessions over six months. Sessions may take place in person or remotely, depending on participant preference. Participants in both groups will complete assessments over 12 months. These assessments will measure psychotic symptoms, recovery, trauma symptoms, mood, quality of life and day-to-day functioning. Some participants will also be invited to take part in an interview about their experiences of the therapy. What are the possible benefits and risks of participating? Participants may benefit from receiving additional psychological therapy that could help reduce the impact of trauma and psychotic symptoms. The findings may help improve treatment options for people experiencing psychosis in the future. Some participants may find discussing traumatic experiences upsetting or emotionally challenging. Appropriate clinical support will be available throughout the study. Where is the study run from? NHS Early Intervention in Psychosis services across England, including sites in Manchester, London, Chorley, Southport and Northumberland. When is the study starting and how long is it expected to run for? September 2026 to May 2029. Who is funding the study? National Institute for Health and Care Research (NIHR), UK. Who is the main contact? Professor Filippo Varese, filippo.varese@manchester.ac.uk. overall psychotic symptoms the total score of the Positive and Negative Syndrome Scale (PANSS) baseline and 6 months recovery the Questionnaire about the Process of Recovery (QPR) baseline, 6 and 12 months severity of delusions and hallucinations the Psychotic Symptoms Rating Scale (PSYRATS) and the Multi-Modal Hallucinations Inventory baseline, 6 and 12 months persecutory ideas and referential thinking (aspects of paranoia) the Revised Green et al. Paranoid Thoughts Scale (R-GPTS) baseline, 6 and 12 months symptoms of post-traumatic stress disorder (PTSD) and and complex PTSD (CPTSD), as per ICD-11, the International Trauma Questionnaire (ITQ) baseline, 6 and 12 months symptoms of PTSD as per DSM-5 the PTSD Checklist for DSM-5 (PCL-5) baseline, 6 and 12 months Symptoms of oppression-based traumatisation the Oppression-Based Traumatic Stress Inventory (OBTSI) baseline, 6 and 12 months Trauma-related dissociation the Dissociative Subtype of PTSD Scale (DSPS) baseline, 6 and 12 months Depression the Patient Health Questionnaire (PHQ-9) baseline, 6 and 12 months Anxiety the General Anxiety Disorder scale (GAD-7) baseline, 6 and 12 months Functioning the Personal and Social Performance Scale (PSP) baseline, 6 and 12 months Health-related quality of life the EQ-5D-5L baseline, 6 and 12 months Mental health-related quality of life the Recovering Quality of Life (ReQoL) baseline, 6 and 12 months Trauma memory characteristics the Adapted Trauma Memory Quality Questionnaire (ATMQQ) baseline, 4, 6, and 12 months Negative beliefs about self and others the Brief Core Schema Scale (BCSS) baseline, 4, 6, and 12 months Experiences of the EMDR intervention semi-structured qualitative interviews post-treatment Ethics approval required North West Liverpool Central Research Ethics Commitee

2 Redman Place, Stratford

London United Kingdom E201JQ 26/NW/0046 10.1186/ISRCTN16689792 339008 CPMS: 60392, NIHR: 168901 339008 60392 168901 Interventional Randomized controlled trial Blinded (masking used) Active Parallel Treatment Not applicable 2029-05-31T00:00:00.000Z United Kingdom England Greater Manchester Mental Health NHS Foundation Trust

Complex Trauma and Resilience Unit (C-TRU) GMMH Research & Innovation Office 1st Floor, Building B One Central Park

Manchester England M40 5BP South London and Maudsley NHS Foundation Trust

Early Intervention Services 190 Kennington Lane

London England SE11 5DL Lancashire and South Cumbria NHS Foundation Trust

Tudor House 18 Euxton Lane

Chorley England PR7 1PS Mersey Care NHS Foundation Trust

Early Intervention Services Hatley Hospital 1B Curzon Road

Southport England PR8 6PL Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

Early Intervention in Psychosis Service Greenacres Centre Green Lane Ashington

Northumberland England NE63 8BL false 1. Meeting Early Intervention for Psychosis (EIP) service entry criteria for First Episode Psychosis (FEP) support, operationally defined using the Positive and Negative Syndrome Scale (PANSS) and/or the psychosis transition criteria of the Comprehensive Assessment of At Risk Mental States (CAARMS) or other locally approved clinical definition of FEP 2. Have an assigned key worker / care coordinator, to enable appropriate risk management at time of trial enrolment 3. Aged ≥ 16 years 4. Willing and able to provide informed consent 5. Judged by their responsible clinician and/or clinically qualified members of the research team as clinically stable (e.g. no medication changes in past month; no current suicidal intent and no suicide attempt in past two months; sufficient substance misuse management and/or stable accommodation to enable reliable engagement in EIP psychological therapies) 6. Active psychotic symptoms indicated by a score of at least 3 (i.e. symptom present) on the P1 (delusions), P3 (hallucinations), P5 (grandiosity) or P6 (suspiciousness/paranoia) items of the PANSS 7. Reporting at least 1 traumatic event on the Trauma and Life Events (TALE) checklist (Carr et al., 2018a), with reported impact on current mental health problems, operationalised as a score ≥5 on item 21c of the TALE Mixed 16 Years 99 Years All 314 0 Current key exclusion criteria as of 02/09/2026: 1. Moderate/severe/profound intellectual disability 2. Requiring an interpreter to partake in research assessment and therapy sessions 3. Previous receipt of EMDR from a qualified psychological therapist in accordance with NICE guidelines within the last 12 months _____ Previous key exclusion criteria: 1. Moderate/severe/profound intellectual disability 2. Non-English speaking 3. Previous receipt of EMDR from a qualified psychological therapist in accordance with NICE guidelines 2026-09-01T00:00:00.000Z 2028-03-31T00:00:00.000Z The target population for this multi-centre RCT is individuals engaging with Early Intervention for Psychosis NHS services, who present with co-occurring psychotic symptoms and a history of trauma affecting their current mental health. Mental and Behavioural Disorders Randomisation processes Participants will be randomised to each trial arm (either EMDRp + TAU or TAU only) on a 1:1 ratio. Randomisation (at the individual level) will be stratified by site and generated using randomly-permuted blocks of varying size, and will be implemented using a centralised, independent and concealed randomisation service at King’s Clinical Trials Unit (KCTU). The randomisation service is web-based, and randomisation will only be known to unblinded staff such as Trial Managers and therapists. Treatment summary Control group: Treatment as Usual (TAU) TAU will be the standard care provided by participants’ Early Intervention for Psychosis (EIP) teams - including social, psychological, medical, or other treatments as decided by the care team. As such, treatment offer and uptake will vary on an individual basis, e.g. due to the person’s most pressing clinical needs, service offer and capacity, and patient choice. Access to TAU in either arm of the trial will be delivered and directed by EIP teams, without any interference or influence from the study team. Treatment: EMDRp (Eye Movement Desensitisation Reprogramming for psychosis) intervention Participants allocated to the EMDRp + TAU arm will receive up to 16 sessions of EMDR (up to 90 minutes per session), over a 6-month treatment window, in addition to TAU. Access to TAU will not be restricted in any way. Therapy delivery will be in person (e.g. participant’s home, NHS premises) or remote, depending on participant preference. EMDR is a protocolised therapy designed to reprocess adverse or traumatic life experiences, and related distress. EMDRp (EMDR for psychosis) is consistent with the standard EMDR protocol, but tailored to the needs of clients with early psychosis. An EMDRp manual has already been evaluated and implemented successfully in our feasibility trial. EMDRp will be delivered by dedicated EMDR therapists, additionally trained in EMDRp, and attend fortnightly supervision sessions with experienced EMDR supervisors. Treatment fidelity will be monitored using procedures already successfully implemented in the EASE feasibility RCT. Behavioural Data sharing statement to be made available at a later date de3323fb-d6cb-4fc0-bd4d-75613f708e82 1b9f06f3-99cc-4452-aedc-ccbde9bd72bd 08420c5c-6df4-4831-bab2-19f4b3629b6c 49a6f4d6-c7f0-419a-9dfd-2bfdc040ee5f No Filippo Varese https://orcid.org/0000-0001-7244-598X Principal investigator

University of Manchester Division of Psychology and Mental Health School of Health Sciences

Manchester United Kingdom M13 9PL +44 7970553732 filippo.varese@manchester.ac.uk Public Kate Allsopp Scientific Public

C-TRU Research and Innovation Greater Manchester Mental Health NHS Foundation Trust Building B, One Central Park Northampton Rd

Manchester United Kingdom M40 5BP +441612710737 kate.allsopp@gmmh.nhs.uk Public Greater Manchester Mental Health NHS Foundation Trust https://ror.org/05sb89p83 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 34358183 true Improving Postpartum Outcomes of Severe mental Illnesses in Ethnically diverse mothers (POSIE) POSIE WP2: To gather and understand the lived experience of mothers who have experienced postpartum SMI through photovoice WP3: To co-design a postpartum SMI care pathway system using insight to improve care experiences Background and study aims People from ethnic minority backgrounds experience poorer outcomes in perinatal mental health care, including higher rates of severe mental illness after childbirth and poorer access to appropriate support. These inequalities can have serious consequences for mothers, babies, and families. This study aims to understand why these inequalities occur and how care can be improved. The study focuses on severe mental illnesses that occur during the first year after birth, such as postpartum psychosis, bipolar disorder, severe depression, and other serious mental health conditions. This stage of the study focuses on Work Package 2 (WP2) and Work Package 3 (WP3): WP2 aims to understand the experiences of people who have received care for postpartum severe mental illness by using a creative research method called Photovoice, where participants share photographs, drawings, and stories about their experiences. WP3 aims to bring together people with lived experience, carers, and professionals to use the findings from WP2 and co-design a culturally safe care pathway that could improve future services and reduce inequalities in care. Who can participate? WP2: 1. Adults aged 18 years or over. 2. People who have experienced postpartum severe mental illness and received care within the last five years from a range of ethnic and social backgrounds. WP3: 1. People who have experienced postpartum severe mental illness. 2. Family members, carers, or supporters of someone who has experienced postpartum severe mental illness. 3. Health and social care professionals, voluntary sector staff, policy makers, and other stakeholders involved in perinatal mental health care. What does the study involve? WP2 involves photovoice workshops where participants will share their experiences of postpartum severe mental illness using photographs. WP3 will review findings from earlier parts of the study and discuss the experiences of care to co-design a novel culturally safe care pathway to be implemented in NHS sites nationally. What are the possible benefits and risks of participating? Participants will have the opportunity to share their experiences and help improve future mental health services. The study may contribute to more equitable, culturally safe, and effective care for people affected by postpartum severe mental illness. Some participants may find it rewarding to contribute to research and service improvement. However, it can be upsetting or emotionally difficult to discuss experiences of mental illness and complete confidentiality in group settings cannot be guaranteed. Where is the study run from? The study is coordinated by the University of Oxford, Department of Psychiatry, and is being conducted in collaboration with NHS organisations, universities, charities, and community partners across England (UK) When is the study starting and how long is it expected to run for? September 2025 to November 2028 Who is funding the study? The study is funded by the National Institute for Health and Care Research (NIHR) through its Health and Social Care Delivery Research (HSDR) Programme (UK) Who is the main contact? Prof. Kamaldeep Bhui, kam.bhui@psych.ox.ac.uk Lived experiences, barriers, facilitators, vulnerabilities, and opportunities for improving care for people with postpartum severe mental illness (PP-SMI), thematic analysis of three photovoice workshops over 3 weeks the four study sites (Oxford, London, Sheffield and Lancashire) WP3: positive and negative experiences of the resources from WP1&2, priority setting meetings of 4–6 people the four study sites Development of a culturally safe co-designed postpartum severe mental illness care pathway and implementation plan, two in-person half-day co-design workshops over 2 months each of the four study sites There are no secondary outcomes Ethics approval required Bromley REC

-

- United Kingdom - 26/LO/0304 10.1186/ISRCTN34358183 342441 CPMS: 61810, NIHR: 167329 342441 61810 167329 Non-randomized study Interventional Non randomised study Other 2028-11-30T00:00:00.000Z United Kingdom England Oxford Health NHS Foundation Trust

Littlemore Mental Health Centre Sandford Road Littlemore

Oxford England OX4 4XN RNU@2.16.840.1.113883.2.1.3.2.4.18.48 South London and Maudsley NHS Foundation Trust

Bethlem Royal Hospital Monks Orchard Road

Beckenham England BR3 3BX RV5@2.16.840.1.113883.2.1.3.2.4.18.48 Sheffield Health Social Care NHS Foundation Trust

Centre Court Atlas Way

Sheffield England S4 7QQ Lancashire and South Cumbria NHS Foundation Trust

Sceptre Point Sceptre Way Walton Summit

Preston England PR5 6AW RW4@2.16.840.1.113883.2.1.3.2.4.18.48 false 1. Aged 18 years or older 2. Able to communicate sufficiently in English or via approved interpretation support to participate meaningfully 3. Willing to take part in the relevant study activities for the work package 4. Have lived experience of receiving care for perinatal severe mental illness (SMI) within the preceding 5 years (from 12 weeks pregnant to up to a year after pregnancy) 5. Willing and able to participate in photovoice workshops (online or in person), including taking or selecting photographs and engaging in group discussion Mixed 18 Years 100 Years All 380 0 1. Individuals who do not have the capacity to provide informed consent 2026-09-01T00:00:00.000Z 2028-11-30T00:00:00.000Z Perinatal severe mental illness Mental and Behavioural Disorders WP2: Exploring patient priorities for postpartum SMI treatment and outcomes Sample size: 60 mothers with experience of postpartum SMI Recruitment: via NHS Trusts and community organisations Procedure: In each site, we will arrange for three consecutive photovoice workshops to be held in a hybrid model of online and carefully chosen creative environments for accessibility and comfort to facilitate discussion. Patients may bring a carer, a family member, friend, or confidante for support. This accompanying person may wish to remain during the workshops, as preferred by the participant, and so we will gather carer views also within the interpretive narratives. The first workshop of between 2 and 3 hours will introduce the research and explain that we are interested in understanding: 1. Experiences and perceptions around postpartum severe mental illness. 2. The causes and complexities of care. 3. Their experiences of care and recommendations. We will provide support and arrange comfort breaks and tailor the process to individual needs. Participants will be given disposable cameras, notebooks and asked to drop them in a central location local to them a week after the workshop. If they choose the online option they may prefer to use their phones and send the images to a project email address, or they can use their own phone even for face to face workshops. In some instances, participants may wish to use existing photographs which they feel reflect their care experiences. As set out, other creative materials will all be considered within the overall process. In the second and third workshops, participants will be presented with their digitised images and guided through reflections to generate narratives and captions for a minimum of 3-5 chosen images (total of 180-300 items). The second workshop will be a session of at least 2 hours, any time within a 6-8 hour time window, and will occur 2 weeks after the first workshop, and a third workshop will be held a week after the second. These times are flexible and can be adjusted around each participant. Prompt questions will be used to elicit their experiences (adapted from Hergenrather, 2009): Describe what you see in this photo and how it makes you feel. Why did you take a photo of this? What does this photo tell us about you? How can it provide opportunities to improve understanding about your illness and life experiences? Do you have suggestions for improving your care? In your care experiences, what helped and what did not work? How can inequalities arise and be reduced? The third workshop will be a group discussion; there will be no topic guide, but the conversation will be generated by which of their images participants wish to share with the rest of the group. The discussion will be facilitated by the research team, and participants will be encouraged to consider two questions: 1. What made a positive difference to your experience? 2. What could have been done differently? All workshops will be co-facilitated with a peer researcher. WP3: Co-design a care pathway to address inequalities in postpartum SMI treatment Sample size: 16 key stakeholders for priority-setting meetings, 80 key stakeholders for co-design days. Recruitment: via NHS Trusts and WP2 contacts and community settings Procedure: The richly contextualised narrative accounts of life-worlds and care experiences of participants from WP2 and WP1 data (CPRD data analysis) will be summarised, using visual and textual materials, to inform co-production of a culturally inclusive care pathway. In a series of priority-setting meetings (3-6 of these) with small groups (3-6 per group), we will review the photovoice outputs to conceptualise ‘touch points’ that characterise positive and negative experiences of patients with a view to generating consensus about the priorities for service improvement (participants). We understand that trust and relationship building are important for a successful co-design process, so we hope to involve the same core participants throughout the events and activities which comprise both of these key co-design phases. For this core group, we will seek to recruit people with lived experience of postpartum severe mental illness, in addition to those involved in priority setting. We aim to ensure there are at least 10 and up to 20 patients, 10 carers, and 25 professional stakeholders. The purpose is to represent multiple intersectional experiences by identity (age, gender, sexuality, neurodivergence) and place characteristics (rural, semi-rural, urban). We will pay these core participants for their time in attending events and participating in co-design activities. Our research staff, including peer researchers, will prioritise relationship building and attending to different needs and preferences of those attending workshops in order to make them a success and a good experience for participants. We will discuss and agree ground rules at the outset of the process, drawn from existing principles of good practice for co-design and user involvement. We will base the process around a series of group meetings. Depending on the composition and preferences of the group, we will consider face-to-face and online as alternatives. WP4: Evaluate the implementation of a postpartum SMI care pathway Sample size: via NHS Trust Recruitment: 5 professionals from each site and 40 mothers who received the intervention at each site. Procedure: The local teams will implement the newly developed care pathways from WP3 with around 40 mothers over 6-9 months at each study site, as well as two additional sites not involved in co-development, to learn about the role of co-design in the adoption of interventions. We will conduct the NoMAD survey before and after implementation and supplement this with interviews at each site to better understand barriers and facilitators to implementation and explore intervention fidelity. WP5: Developing guidance, dissemination and impact Sample size: 40 key stakeholders Recruitment: via NHS Trusts and Community Organisations Procedure: Key stakeholders (people with lived experience, charitable organisations, NHS leaders, healthcare professionals and policymakers) will be convened for a consensus workshop. They will be provided with the culturally inclusive care pathway for postpartum SMI, a proposed implementation strategy and a summary of the implementation evaluation. The workshop will aim to identify the following: 1. Key changes required to existing pathways; 2. the additional resources and expertise used to support the development and revision of existing pathways; 3. the training of staff to support and iterate the pathway over time whilst retaining the ethos and values base; 4. the type and nature of resources required. Behavioural Data sharing statement to be made available at a later date 3057f22a-1a59-4b1b-8ef1-bb3c1f676ec2 69424a9d-cd31-4887-835d-18706dd0f538 0462766f-094d-43e6-83eb-fa6c116d5e15 08989c08-59ba-4c97-b798-1aed64b0505e a6733cbb-51dc-456f-ac8c-8a27c578d602 No Harsimran Sansoy Scientific Public

Department of Psychiatry, University of Oxford, Warneford Hospital

Oxford United Kingdom OX3 7JX - harsimran.sansoy@psych.ox.ac.uk Public Kamaldeep Bhui Principal investigator

Warneford Hospital, Warneford Ln, Headington

Oxford United Kingdom OX3 7JX - kam.bhui@psych.ox.ac.uk Public Roisin Mooney Scientific Public

Warneford Hospital, Warneford Ln, Headington

Oxford United Kingdom OX3 7JX - roisin.mooney@psych.ox.ac.uk Public University of Oxford Hospital/treatment centre https://ror.org/052gg0110 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 94481360 true A link work intervention to support dental visiting in people with severe mental health difficulties: The mouth matters in mental health effectiveness and cost-effectiveness trial To evaluate the effectiveness and cost-effectiveness of a link work intervention for supporting people with severe mental illness to attend a planned dental appointment. There are two main outcomes, namely: i) attendance at a routine dental appointment; and ii) oral health quality of life. It is hypothesised that: 1. The link work intervention plus treatment as usual (TAU) will lead to greater likelihood of attendance at a planned dental appointment, compared with TAU alone. 2. The link work intervention plus TAU will lead to better oral health quality of life, compared with TAU alone. 3. The link work intervention plus TAU will be cost-effective compared with TAU alone. Background and study aims Severe mental illness affects around 1% of people. It includes depression, psychosis, and bipolar disorder. People with severe mental illness often have problems with their teeth and gums. For example, they are more likely to have missing and decayed teeth. This can affect everyday activities like eating, speaking, and smiling. It can place extra stress and burden on people living with severe mental illness. Dentists can treat teeth and gum problems. However, people living with severe mental illness often find attending a dentist difficult. This can be for many reasons. People can feel helpless, anxious, and fearful about attending. They can find it difficult to book, plan, and get to appointments. They may also struggle to pay or arrange access to free dental care. Current dental initiatives do not help people with severe mental illness to attend the dentist. We recently conducted a small trial where link workers helped people with severe mental illness to attend a dentist. This is called a link work intervention. Everyone taking part received their usual care, but half also received the link work intervention. We were able to recruit people to take part. We were able to follow people up over time. People liked and engaged with the intervention. The findings suggested that the link work intervention might help people to see a dentist and improve their quality of life. We want to test the intervention on a larger scale. We want to see if it will lead to better outcomes. We also want to see how much the intervention costs. We want to do this across five NHS sites. We aim to recruit 480 people to take part. Who can participate? People aged 18 years and older with a severe mental health difficulty currently accessing secondary care mental health services at the point of referral (e.g. community mental health team, early intervention for psychosis service), but who have not had a routine dental appointment in the past 3 years. What does the study involve? Participants will be randomly allocated to receive treatment as usual or treatment as usual plus the link work intervention. This will be decided by chance. The researchers will measure how often people in both groups visit the dentist. They will also assess their mental and oral health. They will collect this data when people come into the study and after 9 months. The team will offer interviews to patients receiving the link work intervention to understand how they found it. What are the possible benefits and risks of participating? The intervention aims to support people to access dental services. However, the effectiveness of the intervention is unknown, which is the reason for doing the research. Where is the study run from? Lancashire and South Cumbria NHS Foundation Trust (UK) When is the study starting and how long it is expected to run for? The research started in November 2025 and finishes in July 2029. We hope to open recruitment in May 2026. Who is funding the study? The National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research (HS&DR) Who is the main contact? Dr Jasper Palmier-Claus; j.palmier-claus@lancaster.ac.uk Attendance at a planned dental appointment data from the NHS Business Services Authority (BSA) 9-months Oral health related quality of life Oral Health Impact Profile - 14 item version (OHIP-14) 9-months Self-reported attendance at a planned dental appointment (private or NHS) self-report items 9-months Orofacial pain & disability Manchester Orofacial Pain Disability Scale 9-months Confidence around dental visiting a self-report item 9-months Self-esteem the Rosenberg Self-Esteem Scale 9-months Dental anxiety the Modified Dental Anxiety Scale 9-months Depression the Patient Health Questionnaire 9-months General anxiety the Generalised Anxiety Disorder Questionnaire (GAD-7) 9-months The number of planned dental appointments attended NHS Business Services Authority (BSA) data assessed 9-months Self-reported access to free/subsidised dental care self-report items 9-months Exemption status for dental care the NHS Business Services Authority (BSA) 9-months Completion of a course of dental treatment the NHS Business Services Authority (BSA) 9-months Self-reported utilisation of urgent or emergency dental services self-report items 9-months Quality adjusted life years the European Quality of Life Five-Dimensional Questionnaire (EQ-5D-5L) 9-months Utilisation of healthcare resources a co-designed health economics questionnaire 9-months Ethics approval required East Midlands - Leicester Central Research Ethics Committee

2 Redman Place Stratford

London United Kingdom E20 1JQ 26/EM/0030 10.1186/ISRCTN94481360 350197 CPMS: 65077, NIHR: 171340 350197 65077 171340 Interventional Randomized controlled trial Blinded (masking used) Uncontrolled Parallel Prevention Treatment Not applicable 2029-07-31T00:00:00.000Z United Kingdom England Lancashire and South Cumbria NHS Foundation Trust

The Lantern Centre Vicarage Lane Fulwood

Preston England PR2 8DW 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 Pennine Care NHS Foundation Trust

225 Old Street

Ashton-under-lyne England OL6 7SR Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

St Nicholas Hospital Jubilee Road Gosforth

Newcastle upon Tyne England NE3 3XT RX4@2.16.840.1.113883.2.1.3.2.4.18.48 South London and Maudsley NHS Foundation Trust

Bethlem Royal Hospital Monks Orchard Road

Beckenham England BR3 3BX RV5@2.16.840.1.113883.2.1.3.2.4.18.48 false 1. Aged ≥18 years. 2. Receipt of care from community mental health or early intervention teams at the point of referral. 3. No routine dental appointment (e.g. high street dentist, special care dentist service) in the past three years. This would include any dental examination, diagnosis, advice or treatment (e.g. fillings, root canal, extractions, crowns, dentures, bridges) resulting from a routine (non-emergency) appointment at a dental service. We do not consider emergency dental care (e.g. emergency attendance at Accident & Emergency Department or a dental hospital) within this definition, although any follow-up routine and planned appointments with a dentist would exclude the person from taking part. 4. Able to provide informed consent as determined by trained researchers in consultation with the clinical team. Mixed 18 Years 120 Years All 480 0 Current key exclusion criteria as of 27/07/2026: 1. Current inpatient status on psychiatric ward. This does not include people in rehabilitation homes or supported accommodation in the community. 2. Immediate risk to self or others operationalised as the presence of active intent or planning to harm oneself or others in the near future (e.g. next month), or a suicide attempt in the past month (e.g. life-threatening self-harm, overdose). Where individuals are excluded on this basis, with the person’s consent, the researcher will aim to re-contact them and/or the referrer in approximately one-months’ time to determine if risk has subsided to a point where they are now eligible. 3. Enrolled in another dental randomised controlled trial. Previous key exclusion criteria: 1. Current inpatient status on psychiatric ward. This does not include people in rehabilitation homes or supported accommodation in the community. 2. Immediate risk to self or others operationalised as the presence of active intent or planning to harm oneself or others in the near future (e.g. next month). Where individuals are excluded on this basis, with the person’s consent, the researcher will aim to re-contact them and/or the referrer in approximately one-months’ time to determine if risk has subsided to a point where they are now eligible. 3. Enrolled in another dental randomised controlled trial. 2026-05-01T00:00:00.000Z 2028-04-30T00:00:00.000Z Access to planned dental care in people experiencing severe mental health difficulties. Oral Health Treatment as usual arm: Treatment as usual will include any treatments or services that the participant would normally have access to outside of the trial. For people with severe mental illness this may include support from a care coordinator, support worker, psychologist, occupational therapist, and/or psychiatrist for care around their mental health. Treatment as usual may include medication and case management. We will monitor, rather than withhold, assessment and treatment for oral health in the treatment as usual arm. Treatment as usual plus a link work intervention. Participants in this arm will receive treatment as usual plus the link work intervention. This will consist of six sessions with a link worker over nine-months who will offer practical and emotional support around accessing a routine dental appointment. A mental health link work intervention uses link workers to empower and assist people with severe mental illness currently supported by secondary care mental health services, but not dental services, to access planned dental appointments. Participants will be randomly allocated to one of the two groups with 1:1 ratio, stratified by site. We will follow-up both arms after nine-months. Behavioural Only the direct research team will have access to personal data of participants. Study material and data may be accessed by individuals from the participating Universities and National Health Service (NHS) Trusts, or regulatory authorities for auditing and monitoring purposes. Following publication of the trial results, we will make suitable arrangements for anonymised data to be available from the research team, in line with NIHR data sharing guidance. Available on request 098b0003-76ca-4de4-9c31-84b58d7cfe5d f8480b29-5591-45a0-9934-aa88d1c18500 edc124e0-4d1e-4dbe-bd4c-502b06ad7262 Yes Jasper Palmier-Claus https://orcid.org/0000-0002-4908-2137 Principal investigator Scientific Public

Health Innovation Campus Lancaster University

Lancaster United Kingdom LA14YW +44 (0)1524 65201 J.Palmier-Claus@lancaster.ac.uk Public Lancashire and South Cumbria NHS Foundation Trust Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 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 14068059 true E-cigarettes for Smoking Cessation And reduction in People with mEntal illness (ESCAPE) ESCAPE The main aim is to assess the effectiveness and cost-effectiveness of providing an e-cigarette starter kit to people with mental Illness (PWMI) treated in the community to aid smoking cessation and harm reduction, as an adjunct to ‘usual care’. Background and study aims Tobacco smoking is the single largest contributor to health inequalities for people with mental illness (PWMI). Developing and implementing ways to address this widening health gap has been identified as a priority in the NHS Long Term Plan and the 2019 Tobacco Control Plan for England. E-cigarettes have been suggested as a potentially particularly helpful way to support people with mental illness quit smoking or substantially reduce consumption. However, there have been no fully powered trials to assess this potential. The researchers completed a feasibility study in January 2023 and are now ready to proceed to a full randomised controlled trial (RCT). The aim of this study is to assess the effectiveness and cost-effectiveness of providing an e-cigarette starter kit to PWMI treated in the community to aid smoking cessation and harm reduction. Who can participate? Adults (aged over 18 years) receiving treatment for a mental illness in primary or secondary care, who smoke regularly What will the study involve? Participants are randomly allocated to one of two groups. Group 1 will receive an e-cigarette and e-liquid to use for 4 weeks in addition to the usual care they are receiving. In Group 2, initially participants will continue to receive their care as usual but will receive an e-cigarette and some e-liquid at the end of the study at the 6-month follow-up. Participants who are assigned to the group that receives the e-cigarette will be given an e-cigarette starter kit (an e-cigarette containing e-liquid and an information leaflet). They will also receive a brief face-to-face consultation with a clinician, who will explain how to use the e-cigarette and provide information to enable participants to make positive changes to their smoking behaviour. Participants will be provided with an e-liquid supply for 4 weeks. Participants who are assigned to the group that does not receive an e-cigarette will continue to receive their usual care package and will be provided with an e-cigarette and some e-liquid after the 6-month follow-up. Both groups will be encouraged to consider quitting and to set a target quit date soon. However, if they choose not to set a quit date that is also okay. A member of the research team will ask several questions at the beginning of the study and again after 1 and 6 months. Participants will be given the opportunity to do this at home on an electronic device (by completing the questionnaires online) or in person at a place to suit them; this process may take up to 1 hour. The questions will ask about current smoking status, smoking habits and mental and physical health. Participants may also be asked to breathe into a carbon monoxide monitor which can be done at a place that is convenient for them. What are the possible benefits and risks of participating? Participants may make positive changes to their smoking behaviour and provide data which could help thousands of smokers to quit smoking for good. They will receive a shopping voucher each time they complete the follow-up questionnaires and receive an e-cigarette which they can keep. Where is the study run from? Mental Health Trusts and GP practices mainly in Yorkshire (UK) When is the study starting and how long is it expected to run for? March 2023 to July 2025 Who is funding the study? Yorkshire Cancer Research (UK) Who is the main contact? Dr Anna-Marie Marshall, a.marshall@york.ac.uk 1. Self-reported 7-day point prevalence abstinence measured using a questionnaire (question written in-house) at 6 months 2. Co-verified quit (main outcome) measured using a CO monitor (smokylizer) at 6 months 1. General smoking-related characteristics, abstinence, quit attempts and methods (including e-cigarettes), measured using a questionnaire (questions written in-house) at baseline, 1 month and 6 months 2. Nicotine dependence measured using the Fagerstrom Test for Nicotine Dependence at baseline, 1 month and 6 months 3. Strength of urges to smoke measured using the SUTS questionnaire at baseline, 1 month and 6 months 4. Motivation to quit measured using the Motivation To Stop Scale (MTSS) at baseline, 1 month and 6 months 5. Mental wellbeing measured using PHQ-9 and GAD-7 at baseline and 6 months 6. Alcohol use measured using AUDIT-C at baseline and 6 months 7. Health-related quality of life measured using EQ-5D-5L at baseline and 6 months 8. Attrition measured using a questionnaire (questions written in-house) at 1 month and 6 months 9. Adherence rate measured using a questionnaire (questions written in-house) at 1-month follow-up 10. Cost-effectiveness measured using a questionnaire (questions written in-house) at baseline, 1 month and 6 months 11. Adverse events measured using a questionnaire (questions written in-house) at 1 month and 6 months Old ethics approval format Approved 24/10/2023, Yorkshire & The Humber - South Yorkshire Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207 104 8021; southyorks.rec@hra.nhs.uk), ref: 23/YH/0199 The ethical approval covers a process evaluation and the process evaluation started on 17/02/2025 and will be ended on 31/08/2025. We submitted a substantial amendment to IRAS to enable the main trial's ethical approval to cover the process evaluation. We received a favorable opinion from the REC regarding this amendment on 10 February 2025 and a HRA and HCRW approval on 14 February 2025. 10.1186/ISRCTN14068059 328528 CPMS: 58155 328528 58155 Multi-centre randomized controlled trial Interventional Randomised controlled trial Prevention 2025-07-05T00:00:00.000Z United Kingdom England Tees, Esk and Wear Valleys NHS Foundation Trust

Trust Headquarters West Park Hospital Edward Pease Way

Darlington England DL2 2TS RX3@2.16.840.1.113883.2.1.3.2.4.18.48 Bradford District Care NHS Foundation Trust

New Mill Victoria Road Saltaire

Shipley England BD18 3LD TAD@2.16.840.1.113883.2.1.3.2.4.18.48 Sheffield Clinical Commissioning Group Hq

722 Prince of Wales Road Darnall

Sheffield England S9 4EU 03NPW@2.16.840.1.113883.2.1.3.2.4.18.48 Oxford NHS Foundation Trust

Littlemore Mental Health Centre Sandford Road Littlemore

Oxford England OX4 4XN South West Yorkshire Partnership NHS Foundation Trust

Fieldhead Ouchthorpe Lane

Wakefield England WF1 3SP Nottinghamshire Healthcare NHS Foundation Trust

Duncan Macmillan House Porchester Road

Nottingham England NG3 6AA Lancashire and South Cumbria NHS Foundation Trust

Sceptre Point Sceptre Way Walton Summit

Preston England PR5 6AW Norfolk and Suffolk NHS Foundation Trust

County Hall Trust Headquarters Martineau Lane

Norwich England NR1 2DH CRN North East and North Cumbria

LCRN Level2 Regent Point Regent Farm Road Gosforth

Newcastle Upon Tyne England NE3 3HD Woodstock Bower Surgery

Kimberworth Road

Rotherham England S61 1AH Clifton Medical Centre

239 Doncaster Gate

Rotherham England S65 1DA My Health

Strensall Health Care Centre Southfields Road Strensall

York England YO32 5UA Mosborough Health Centre

Doctors Surgery 34 Queen Street Mosborough

Sheffield England S20 5BQ C88078@2.16.840.1.113883.2.1.3.2.4.18.48 Bartholomew Medical Group

Goole Health Centre Woodland Avenue

Goole England DN14 6RU RWA57@2.16.840.1.113883.2.1.3.2.4.18.48 Bridge View Medical Group

Southwick Health Centre, The Green, Southwick

Sunderland England SR5 2LT Springwell Medical Group

Jack Cohen Health Centre, Springwell Road

Sunderland England SR3 4HG Snaith and Rawcliffe Medical Group

The Marshes Butt Lane Snaith

Goole England DN14 9DY Patient 1. Adults (aged >18 years) 2. Receiving treatment for a mental illness in primary or secondary care 3. Smokes regularly and have smoked combustible cigarettes in the past 7 days) 4. Must be willing to address their smoking behaviour, either by attempting to quit or by reducing their consumption 5. Must have the capacity to provide consent Mixed 18 Years 100 Years All 616 95 1. Patients must not have had an inpatient admission in the last 3 months 2. Smokers who are currently using e-cigarettes regularly (at least weekly) 3. Patients who are participating in other smoking cessation trials 4. Patients who are receiving treatment for drug or alcohol use 5. Patients who have a diagnosis of Alzheimer’s disease or dementia 6. Patients who are pregnant or breastfeeding 2024-03-27T00:00:00.000Z 2024-12-31T00:00:00.000Z Smoking cessation using an e-cigarette in patients living in the community who have a mental illness Mental and Behavioural Disorders The intervention allocation will be determined by block computer randomisation to ensure that each trial site has an equal proportion of intervention and control group participants. Randomisation will occur after consent to take part in the study has been obtained via sealed envelope. The intervention group will be offered an e-cigarette starter kit, compliant with EU regulation, and an information leaflet about e-cigarettes, in addition to usual care. A 20 mg/ml strength DOTPRO e-cigarette starter kit (https://www.liberty-flights.co.uk/DOT-PRO/DOT-PRO-Vape-Kit/) will be offered in a choice of flavours. The starter kit containing a pod-based e-cigarette, a 4-week supply of refill pods and an information leaflet will be provided to participants by their clinician at their scheduled appointment. At the scheduled appointment with a clinician, a brief consultation will also be conducted with participants to provide necessary instructions for the use of the kit lasting between 5-10 minutes. All participants will be encouraged to consider quitting and to set a target quit date within a week, told that smoking cessation is beneficial for their mental and physical health and that e-cigarettes are a safe and effective way to achieve smoking cessation. The control group will receive care as usual, as outlined above and they will be told that smoking cessation is beneficial for their mental and physical health. Device Not Applicable ICON e-cigarette Data will be available upon request from Dr Anna-Marie Marshall (a.marshall@york.ac.uk). Consent from participants was required and obtained. Participants will be allocated a participant number, the names of participants will not appear on the paper-based or online data stored at the University. The NHS code of confidentiality will be adhered to for all patient data and for data. Available on request 2025 Protocol article in https://pubmed.ncbi.nlm.nih.gov/40590411/ (added 09/07/2026) Protocol

563a59cf-0704-4f19-b738-9e9cf122f7f8 f4becf72-eb19-48f3-9ac6-a25cf32c6bb3 d58534ca-26ce-4566-b9da-495eebfde119 54b03076-9eb8-4511-836e-5d1d718a3d92 de54c7d3-d540-478a-ad98-548ad27a54d6 Yes Elena Ratschen Principal investigator

Heslington

York United Kingdom YO10 5DD +44 (0)1904 320000 elena.ratschen@york.ac.uk Public Lion Shahab Principal investigator

University College London 1-19 Torrington Place

London United Kingdom WC1E 6BT +44 (0)20 7679 1805 lion.shahab@ucl.ac.uk Public Yan Ding https://orcid.org/0000-0002-8439-9682 Scientific

Department of Health Sciences Faculty of Sciences Area 4, Alcuin Research Resource Centre University of York

Heslington United Kingdom YO10 5DD +44 (0)1904 32 5600 yan.ding@york.ac.uk Public University of York University/education https://ror.org/04m01e293 Non-commercial Yorkshire Cancer Research http://dx.doi.org/10.13039/501100002653 13567753 true An exploratory study of interventions for self-harm in men's prisons PrisScope To understand what self-harm interventions are currently being delivered to men in England and Wales in a representative sample of prisons, and to learn the treatment experiences and preferences of men who self-harm in prison and staff who work with them. This will inform the development of evidence-based interventions. Background and study aims Self-harm is when someone deliberately hurts themselves. There are many reasons someone might self-harm. It is commoner in prison than in the general public. There were 47,136 self-harm incidents in men’s prisons in the year to March 2019. This was 24% more than the previous year and the highest ever number. Men’s self-harm is different to women’s, but we know less about treating it in men. Self-harm causes physical harm and emotional upset. Men who self-harm are more likely to kill themselves. Self-harm causes anxiety to families, prison staff and other prisoners. It is expensive for the NHS and prison service to provide treatment and keep men safe. The costs of this are not known. There is no treatment that has been tested in a clinical trial. Charities, the NHS and prison service have asked for new treatments. Past research into treatments has not listened to the men themselves. We need to choose the right treatments to test in future clinical trials to see if they reduce self-harm. We want to: • Find out what treatments are being given in prisons. • Understand men’s and staff’s past involvement with self-harm. • Find out what they think of the treatments they have had, treatments that are given now, and possible new treatments. This will let us find treatments that are practical to use in prisons, that men would like, and which might work. After this research we will apply for funding for trials to test these treatments. Future benefits will include reduced self-harm with reduced distress, harm and cost. Who can participate? Adult remand and sentenced prisoners with personal experience of self-harm in prison, and prison staff. What does the study involve? 1. We will interview staff from 22 prisons in England. We will find out which treatments for self-harm they offer men. 2. We will hold discussion groups with staff from up to 11 prisons. We will ask about working with men who self-harm, what might help them and how treatments could be given in prison. 3. We will interview up to 30 men in those prisons. We will ask about their self-harm and treatment they have had. We will ask about possible treatments. These will include education, activities, computer treatments, and talking therapies. Patient and Public Involvement A discussion group with 10 men with direct experience of self-harm in prison helped to design this project. One of our team has self-harmed in prison. He has worked on designing the project and will carry out some of the research. Prison staff support this research. They will give us advice and make sure that prisoners can take part. What are the possible benefits and risks of participating? While there may be no direct benefits for the participants, being able to discuss their experiences and ‘be heard/listened to’ may have a positive effect on those participants who may previously have felt isolated and ignored. Talking about self-harm might be upsetting for some participants. In the event of a participant becoming upset or distressed about any issue, the usual prison support systems will be followed. Staff will be able to access the existing support systems available to them via the HM Prison Service, including private support and counselling support. The men in prison will be able to contact their personal officer, inreach psychology team, mental health staff, or a representative from the chaplaincy department. If a man is distressed and likely to self-harm, the prison will follow their usual procedure implementing the ACCT process. 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? June 2019 to July 2025 Who is funding the study? National Institute for Health and Care Research (NIHR) Research for Patient Benefit Programme (UK). Who is the main contact? Dr Louise Robinson, louise.robinson@manchester.ac.uk Measured at a single time point: 1. Current service provision for self-harm measured using the TIDieR checklist 2. Prisoners' views on self-harm interventions using qualitative interviews, analysed using Framework Analysis 3. Prison staff views on self-harm interventions using qualitative interviews, analysed using Framework Analysis There are no secondary outcome measures Ethics approval required North East - York Research Ethics Committee

NHSBT Newcastle Blood Donor Centre

Newcastle upon Tyne United Kingdom Newcastle upon Tyne 19/NE/0129 10.1186/ISRCTN13567753 262835 CPMS: 56010 262835 56010 Observational qualitative multi-centre Observational Cross sectional study Other 2025-02-20T00:00:00.000Z United Kingdom England Wales Hmp Buckley Hall

H M Prison, Buckley Hall Buckley Farm Lane

Rochdale United Kingdom OL12 9DP Y03148@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp/yoi Deerbolt

H M Young Offenders Institution Bowes Road

Barnard Castle United Kingdom DL12 9BG Y03151@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Durham

H M Prison 19b Old Elvet

Durham United Kingdom DH1 3HU Y03152@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Garth

Ulnes Walton Road

Leyland United Kingdom PR26 8NE Y03318@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Humber

H M Prison The Wolds Everthorpe

Brough United Kingdom HU15 2JZ WW0@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Leeds

H M Prison, Armley Jail Gloucester Terrace Armley

Leeds United Kingdom LS12 2TJ Y02289@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Northumberland

Acklington

Morpeth United Kingdom NE65 9XG WJ8@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Preston

2 Ribbleton Lane

Preston United Kingdom PR1 5AB Y03319@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Wakefield

5 Love Lane

Wakefield United Kingdom WF2 9AG VRD@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Altcourse

Higher Lane Fazakerley

Liverpool United Kingdom L9 7LH YDE03@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Forest Bank

Agecroft Road Pendlebury Swinton

Manchester United Kingdom M27 8UE 5F516@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Frankland

H M Prison Frankland Brasside

Durham United Kingdom DH1 5YD Y03153@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Full Sutton

Full Sutton

York United Kingdom YO41 1PS Y05085@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp & Yoi Hindley (j/yoi)

Gibson Street Bickershaw

Wigan United Kingdom WN2 5TH Y05529@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Lancaster Farms Idts

Lancaster Farms Stone Row Head

Lancaster United Kingdom LA1 3QZ Y03164@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Lindholme

Bawtry Road Hatfield Woodhouse Lindholme

Doncaster United Kingdom DN7 6EE Y05538@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Liverpool

68 Hornby Road

Liverpool United Kingdom L9 3DF Y05520@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Wymott

Ulnes Walton Lane

Leyland United Kingdom PR26 8LW WJ9@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Bedford

St. Loyes Street

Bedford United Kingdom MK40 1HG VE4@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Berwyn

Health and Wellbeing Centre Bridge Road Wrexham Industrial Estate

Wrexham United Kingdom LL13 9QE YDEF4@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Cardiff

Knox Road

Cardiff United Kingdom CF24 0UG VR6@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Dartmoor

Princetown

Yelverton United Kingdom PL20 6RR Y03336@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Elmley

H M Prison, Elmley Church Road Eastchurch

Sheerness United Kingdom ME12 4DZ Y03171@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Erlestoke

Erlestoke House Erlestoke

Devizes United Kingdom SN10 5TU VN7@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Highpoint

H M Prison Highpoint Highpoint Stradishall

Newmarket United Kingdom CB8 9YG Y03144@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Huntercombe

H M Young Offenders Institute Huntercombe PLACE Nuffield

Henley-on-thames United Kingdom RG9 5SB Y03223@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Leeds

H M Prison, Armley Jail Gloucester Terrace Armley

Leeds United Kingdom LS12 2TJ Y02289@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Liverpool

68 Hornby Road

Liverpool United Kingdom L9 3DF Y05520@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Stafford

54 Gaol Road

Stafford United Kingdom ST16 3AW VV6@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Stocken

H M Prison Stocken Hall Road Stretton

Oakham United Kingdom LE15 7RD Y03448@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp the Verne

H M Prison The Verne

Portland United Kingdom DT5 1EQ Y03335@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Usk / Prescoed

Usk and Prescoed Coedypaen

Pontypool United Kingdom NP4 0TB W00118@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Whatton

New Lane Whatton

Nottingham United Kingdom NG13 9FQ Y04875@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Whitemoor

H M Prison Whitemoor Longhill Road

March United Kingdom PE15 0PR RT1HF@2.16.840.1.113883.2.1.3.2.4.18.48 Hmp Wormwood Scrubs Health Inreach Team

H M Prison Wormwood Scrubs Du Cane Road

London United Kingdom W12 0AE RV3KG@2.16.840.1.113883.2.1.3.2.4.18.48 Health professional Other Study Participants – Men in Prison 1. Remand and sentenced prisoners with personal experience of self-harm in prison. 2. 18 years or over. Staff Participants (Mapping) 1. 22 Safer Custody staff (prison staff who manage risk of self-harm), 22 secondary mental health staff Staff Participants (Focus groups/interviews) 1. A least one representative from prison officers, primary care and secondary mental healthcare, Safer Custody Adult 18 Years All 162 127 Study Participants – Men in Prison 1. Unable to provide informed consent. 2. Men where risk to others means that individual interviews could not be conducted. 3. Unable to take part in an interview in English. 4. Men who are too distressed/unwell to participate. Staff Participants (Mapping) 1. Staff without experience of working with men who self-harm. 2. Staff who are unable to take part in an interview in English. Staff Participants (Focus groups/interviews) 1. Staff without experience of working with men who self-harm. 2. Staff unable to take part in an interview in English 2023-09-01T00:00:00.000Z 2025-02-28T00:00:00.000Z Self-Harm Mental and Behavioural Disorders 1. Mapping study: telephone interviews with staff from 22 prisons in England and Wales to identify interventions for self-harm being offered to men 2. Focus groups/interviews with multidisciplinary staff exploring experience and views of prison self-harm and interventions 3. Individual interviews with men with history of self-harm regarding self-harm and interventions Other The datasets generated during and/or analysed during the current study are not expected to be made available due to participants not providing consent for data sharing. Not expected to be made available 56f8da08-bb3f-4daf-9778-5cdac06d204b ee27d95a-e51f-43e9-8583-f21dd3bcf3d3 19831396-2cdb-4968-a19a-2a205b0f88b9 No Louise Robinson https://orcid.org/0000-0001-6455-1360 Principal investigator

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

Manchester United Kingdom M13 9PL +44 1772 676134 louise.robinson@manchester.ac.uk Public Lancashire and South Cumbria NHS Foundation Trust Hospital/treatment centre Non-commercial Research for Patient Benefit Programme http://dx.doi.org/10.13039/501100009128 76699092 true The RESTART Trial: a feasibility clinical trial of psychological therapies for trauma in people with an at-risk mental state RESTART The principal research question is to determine whether it is feasible to conduct a future definitive trial of trauma therapies (eye movement reprocessing and desensitization [EMDR] and trauma-focused cognitive behaviour therapy [TF-CBT]) for people with an at-risk mental state (ARMS) (for psychosis) via examination of four key feasibility outcomes: 1. Trial recruitment 2. Trial retention 3. EMDR/TF-CBT treatment engagement 4. EMDR/TF-CBT treatment fidelity Background and study aims Many young people and adults who have had unusual experiences (such as hearing unusual sounds or murmurs, feeling like something is different or not quite right, periods of confusion, or feeling unsafe) have also experienced distressing life events in their past, which can affect their wellbeing. The psychological and emotional impact of these distressing life events is, however, often not considered in routine psychological therapies that are offered to this clinical group. Previous research has shown that people who have experienced distressing life events can have more severe long-term mental health difficulties, and specific psychological therapies focused on traumatic experiences are safe for and acceptable to people who have already 'transitioned' to a first full-blown episode of psychosis. Eye Movement Desensitization and Reprocessing (EMDR) and Trauma-Focussed Cognitive Behaviour Therapy (TF-CBT) are both used as therapies for people who have experienced stressful life events and mental health difficulties that result from traumatic life experiences. However, we still do not know which of the therapies could be most helpful for people who have had distressing life experiences and unusual experiences, but who have not yet 'transitioned' to a first full-blown episode of psychosis. This study is a feasibility randomised controlled trial (RCT) which aims to find out whether EMDR and TF-CBT can be delivered to and are safe and helpful for and acceptable to people who have experienced distressing life experiences and might be at risk of a future episode of psychosis. The trial will involve comparing patients who receive sessions of EMDR, patients who receive TF-CBT, and patients who only receive their usual care, over a 9-month therapy period. The trial, if successful, will pave the way for a larger-scale research study across multiple NHS Trusts to clarify whether EMDR and/or TF-CBT could be offered routinely to clients who have experienced trauma, and psychological difficulties as a result of difficult life experiences. Who can participate? Patients 16 years of age or older who have been assessed as having an at-risk mental state (ARMS) and have had traumatic experiences in the past What does the study involve? Following consent, participants will be asked to meet with a researcher to complete some questionnaires and an interview about unusual experiences and difficulties they may have had in the past and about the care they have been receiving from NHS mental health services. These questions will help the research team to understand if the trial is right for individuals. If the trial is suitable, participants will be asked to complete some more questionnaires with a member of our research team, before then being allocated at random to one of the three groups: 1. Trauma-focused cognitive behaviour therapy (TF-CBT) for 9 months plus usual NHS treatment (TAU). 2. Eye Movement Desensitization and Reprocessing (EMDR) for 9 months plus usual NHS treatment over 9 months. 3. Usual NHS treatment only. Participants who are assigned to receiving EMDR plus TAU or TF-CBT plus TAU as part of the study will meet with a trained trial therapist in person, over the phone or via video call for up to 24 90-minute therapy sessions over a 9-month period with the number and frequency of sessions decided by participants. In a typical session of EMDR, the therapist will work with participants to teach them strategies to deal with distressing thoughts and feelings. They will be then asked to call to mind a disturbing issue or event while the therapist will encourage them to do some other tasks that can help people to reduce the distress caused by the event (for example, perform side-to-side eye movements). In a typical session of TF-CBT, the therapist will work with participants to improve difficulties brought about by trauma. They will be asked to work on memories or images linked to difficult events from their past. For example, they could be asked to recall a memory and talk through it and explore it. The idea behind this is that the more we revisit a memory the less distressing it may become. During the study, all participants will continue to receive their usual NHS care. This may or may not involve taking medication or receiving other help arranged by other NHS professionals involved in their care. After completing the therapy sessions, roughly 9 months into the study, a member of the research team will meet with all participants for the follow-up assessment, which involves completing most of the questionnaires they helped the team with at the beginning of the trial. They may also be asked to take part, if they wish to, in a more in-depth interview with a member of the research team about their experiences of the therapy. With their permission, the research team will check their NHS medical notes 12 months after they started the trial to better understand how the therapies might impact people's wellbeing. What are the possible benefits and risks of participating? The initial assessment may help to highlight any problems participants are experiencing. If appropriate, the team will signpost participants to other services that they may find helpful. They will also be offered the chance to discuss the initial assessment with a clinically qualified member of the research team. About two-thirds of the people in the study will be allocated at random to receive EMDR or TF-CBT. It is possible that receiving these therapies will improve their mental health. However, this cannot be ensured, but the information we get from this study will help us to better support people who have experienced psychological difficulties because of traumatic life events in the future. It is possible that talking about some of these issues during the assessments may be upsetting. Participants will have the opportunity to discuss any concerns they have with the researchers, and they are free to withdraw from the study at any point without giving a reason. If they decide they would like to withdraw from the research, this decision will not affect any care they may receive now or in the future. The results of the study will be made available to participants, if they wish to, to give them a deeper insight into the therapy and how other people responded to it. The results and findings will not contain any information regarding the identity of any of the participants in the study. Where is the trial run from? The trial is sponsored by The University of Manchester and is being run from Greater Manchester Mental Health NHS Foundation Trust. Participants will be recruited from four additional NHS Trusts including: 1. Pennine Care NHS Foundation Trust 2. Manchester University NHS Foundation Trust 3. Mersey Care NHS Foundation Trust 4. Lancashire and South Cumbria NHS Foundation Trust When is the trial starting and how long is it expected to run for? December 2022 to April 2026 Who is funding the trial? The National Institute for Health Research (NIHR) (UK) Who is the main contact? 1. Aidan Flinn, Aidan.Flinn@gmmh.nhs.uk 2. Filippo Varese (Chief Investigator) Filippo.Varese@manchester.ac.uk The feasibility of a future definitive trial: 1. The feasibility of trial recruitment and retention and EMDR and TF-CBT engagement to inform a future definitive trial, by establishing the number of participants identified, approached, consented and randomised, and the percentage of participants retained at the 9-month follow-up, and the number of sessions attended by participants allocated to the EMDR+TAU and TF-CBT+TAU arms of the trial, respectively. Data pertaining to recruitment, retention and engagement with the interventions considered in the trial will be gathered via the collection of detailed information on the participants' flow in the RCT, aligned with all relevant fields of the CONSORT framework for feasibility studies as well as information on the number of sessions attended by each individual participant allocated to the EMDR+TAU and TF-CBT+TAU arms of the trial. 2. Sample size calculations for a future larger scale trial informed by examining the 'promise of efficacy' of EMDR and TF-CBT on important quantitative clinical outcomes in this client group at baseline and the 9-month follow-up and the variance of these outcomes. 3. The feasibility of extracting, via case note reviews, information on psychological interventions and mental health support received as part of usual NHS care (i.e. treatment as usual [TAU]), and information suggestive of a possible transition to first episode psychosis up to 12 months after participant allocation to treatment. 4. The acceptability of the trauma-focussed therapies (i.e. EMDR and TF-CBT) and trial procedures (including randomisation and intended outcome measures to be considered in a future larger scale trial and measures that will enable the possible mechanisms of actions of trauma therapies in people with an At Risk Mental State (ARMS) in a definitive trial) to trial participants via the analysis of transcripts of qualitative interviews with trial participants collected following the 9-month follow-up assessment. The views of and recommendations made by trial participants will be used to refine/make any adaptations to the therapies and trial procedures in preparation for a future definitive trial. The acceptability of quantitative measures collected will also be examined by considering the completeness (% of missing responses and reasons for missingness) of a range of outcome measures used in previous clinical trials with clients with early psychosis and ARMS (described under secondary outcomes), alongside the completeness of additional mechanistic measures collected at baseline and 9-months follow-up, and during the delivery of EMDR and TF-CBT.  The acceptability of EMDR and TF-CBT will also be examined using the Distress/Endorsement Validation Scale, a brief questionnaire that has previously been used to assess tolerance/acceptability of psychological therapies for trauma, completed at the end of contact with their therapist by trial participants randomly allocated to EMDR+TAU or TF-CBT+TAU. 5. EMDR and TF-CBT fidelity (i.e. the extent to which therapists are able to deliver EMDR and TF-CBT with high levels of treatment, defined as the percentage of therapists and therapy sessions with adequate ratings on measures of EMDR and TF-EMDR treatment adherence/fidelity) assessed using a sample of therapy session video recordings (for a maximum of 10% of the total number of sessions delivered as part of the RCT) which will be rated using relevant treatment fidelity/adherence scales (EFRS and an adapted version of the CTS-R used in other trials of trauma-focussed therapy in people with psychosis). 6. The safety of EMDR and TF-CBT in people with ARMS, assessed via the systematic collection and scrutiny of detailed adverse event (AE) forms (e.g., number of AEs and SAEs related and unrelated to trial procedures and interventions) and signals of symptom exacerbation measured using therapy session measures assessing prodromal and post-traumatic symptoms adapted from previous trials of trauma-focused therapy in psychosis, which will be collected at each therapy session by trial therapists. 7. The views of professional stakeholders on the adaptation and implementation (including the barriers and enablers of successful implementation) of EMDR and TF-CBT in future NHS care for the ARMS group via the analysis of qualitative interviews with trial therapists, supervisors and other professional stakeholders from referring clinical teams and services collected as part of the nested qualitative component of this research. 8. The measurement of health economic outcomes in a future definitive trial using two quality of life and health economic measures (described in the secondary outcome measures). The outcome measures that will be evaluated within this feasibility study have been adapted from previous studies by the research team, including clinical trials of trauma-focused therapy in people with first-episode psychosis and cohort studies examining the impact of trauma in people with an At Risk Mental State (ARMS), and are as follows: Trauma symptom measures, completed at baseline and 9 months post-baseline: 1. Trauma, measured using the International Trauma Questionnaire 2. Post-Traumatic Stress Checklist for DSM-5 3. Dissociative Subtype of PTSD Scale Process of recovery measures, completed at baseline and 9 months post-baseline: 1. Questionnaire about the Process of Recovery Other symptom measures, completed at baseline and 9 months post-baseline: 1. General Anxiety Disorder Scale (7-item version) Health-related quality of life/health economic measures, completed at baseline and 9 months post-baseline: 1. EuroQoL 5-Dimension Level (EQ-5D-5L) 2. Adapted version of the Economic Patient Questionnaire Mechanisms of action of trauma-focussed therapy measures, completed at baseline and 9 months post-baseline: 1. Trauma Memory Questionnaire 2. Brief Post-Traumatic Cognitions Inventory 3. Metacognitions Questionnaire for Post-Traumatic Stress 4. Cognitive Attentional Syndrome Questionnaire 5. Post-Traumatic Growth Inventory Short-Form 6. Expectations of Therapy Questionnaire (developed by lived experience consultants in the research team) to measure/capture common concerns that trauma survivors may have about engaging in trauma focussed interventions and that may have relevance to their individual likelihood of engaging versus discontinuing the interventions offered as part of the trial. With participants' consent, participants will be audio-recorded while completing this measure and asked to elaborate on their answers using techniques/prompts drawn from 'Cognitive Interviewing' methods, to enable an embedded validation of this scale within this trial and to inform strategies to promote client engagement as part of the current feasibility trial and future definitive trial. Quality of the therapeutic relationship (an important predictor of treatment outcome in psychological therapies for psychosis and trauma), completed at three timepoints over the course of therapy (by session 3, at session 12 and at the last therapy session): 1. Working Alliance Inventory - Short Form Revised Ethics approval required West Midlands - South Birmingham Research Ethics Committee

Equinox House, City Link

Nottingham United Kingdom NG2 4LA 23/WM/0113 10.1186/ISRCTN76699092 323676 CPMS: 56377, NIHR: 300850 323676 56377 300850 Single-blind feasibility randomized controlled trial with two nested qualitative studies Interventional Randomised controlled trial Treatment 2026-04-30T00:00:00.000Z 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 Manchester University NHS Foundation Trust

Cobbett House Oxford Road

Manchester England M13 9WL R0A@2.16.840.1.113883.2.1.3.2.4.18.48 Pennine Care NHS Foundation Trust

225 Old Street

Ashton-under-lyne England OL6 7SR RT2@2.16.840.1.113883.2.1.3.2.4.18.48 Mersey Care NHS Foundation Trust

V7 Building Kings Business Park Kings Drive

Prescot England L34 1PJ RW4@2.16.840.1.113883.2.1.3.2.4.18.48 Lancashire and South Cumbria NHS Foundation Trust

Sceptre Point Sceptre Way Walton Summit

Preston England PR5 6AW Health professional Service user Inclusion criteria for the feasibility randomised controlled trial (RCT): 1. 16 years of age or older 2. Meeting at-risk mental state (ARMS) for psychosis criteria as defined by the Comprehensive Assessment of At-Risk Mental States (CAARMS) 3. Capacity and willingness to provide informed consent 4. Reported exposure to at least one potentially traumatic life event, as assessed by the Trauma and Life Events checklist (TALE) Inclusion criteria for the nested qualitative study with RCT participants: 1. Participated in the feasibility RCT 2. Capacity and willingness to provide informed consent Inclusion criteria for nested qualitative study with NHS professional stakeholders: 1. Being a RESTART trial therapist and/or an NHS professional who worked in services involved in the RESTART feasibility RCT 2. Capacity and willingness to provide informed consent Mixed 16 Years 65 Years All 100 76 Exclusion criteria for a feasibility randomised controlled trial (RCT): 1. Under 16 years of age 2. Non-English speaking or requiring an interpreter for the intervention (the assessment battery at present can only be delivered in English) 3. Evidence of recent or past transition from at-risk mental state (ARMS) for psychosis status to first episode psychosis (FEP), operationally defined as meeting Comprehensive Assessment of At-Risk Mental States (CAARMS) transition criteria (i.e., history of a treated or untreated psychotic episode of one week’s duration or longer) and/or previous or current treatment with antipsychotics at a dose of over 5 mg of haloperidol or equivalent for over 3 weeks 4. Judged by the assigned care coordinator/responsible clinician and the research team as not being sufficiently clinically stable to engage safely in a clinical trial of trauma-focused therapy (e.g., acutely suicidal and suicide attempt in the previous two months; in a current mental health crisis; not in stable housing) Exclusion criteria for nested qualitative study RCT participants: 1. Unwilling or unable to provide consent 2023-07-17T00:00:00.000Z 2025-09-30T00:00:00.000Z NHS service users who meet at-risk mental state (ARMS) criteria, operationally defined using the Comprehensive Assessment of At-Risk Mental States (CAARMS) interview Mental and Behavioural Disorders Participants will be randomised using a ratio of 1:1:1 to one of three different groups including: 1. Eye Movement and Desensitization Reprocessing (EMDR) plus treatment as usual (TAU) - EMDR involves memory representations of traumatic life experiences being reprocessed in order to decrease the distress caused by them and change the dysfunctional beliefs and perceptual associations related to the traumatic event. This is achieved through an eight-phase treatment protocol that aims to address past memories, present triggers and future templates. The intervention offered as part of this trial has been modified and expanded relative to the usual approach taken in the treatment for post-traumatic stress disorder (PTSD) in order to account for specific issues related to the experience of psychotic symptoms and their impact on the client’s well-being. 2. Trauma-Focused Cognitive Behaviour Therapy (TF-CBT) plus TAU - TF-CBT is a formulation-based intervention tailored to the specific needs of the clients, depending on their individual presenting problems (e.g., different trauma-related symptoms, prodromal symptoms or other difficulties that may exacerbate their risk of transition to psychosis). The TF-CBT intervention delivered as part of this trial will be adapted for delivery in individuals with an ARMS from a similar, manualised intervention already developed for a definitive trial of trauma-focused therapy for individuals with schizophrenia-spectrum disorders by integrating intervention strategies and models for the treatment of PTSD and psychotic symptoms (Peters et al., 2022). 3. TAU only - TAU will be in line with all standard and individually prescribed clinical interventions as directed by national clinical guidelines for psychosis/ARMS (National Institute for Health and Care Excellence, 2014) and the participants’ clinical teams. Participants randomised to either EMDR plus TAU or TF-CBT plus TAU will receive 24 sessions of EMDR or TF-CBT over a 9-month treatment window, in addition to TAU. Each session will last up to 90 minutes and will be audio/video-recorded for fidelity monitoring purposes when participants consent to this. Therapy sessions will take place at a mutually convenient location for therapists and participants (e.g., the participant’s home, on NHS premises) or remotely. Randomisation will be independent and concealed, via an online pseudo-random list hosted by sealedenvelope.com with random permuted blocks of varying sizes. The allocation sequence will be held at an external centralised randomised service and will be revealed via a secure web-based service (sealedenvelope.com). The allocation will use random permutated blocks of varying size, which will not be known to the study team, so allocation concealment is assured. Following the completion of the baseline assessment, RAs will notify the trial manager and study CI that a given participant can be randomised by providing them with the relevant participant ID. The trial manager or the project CI will be responsible for entering the participant ID on the secure web-based randomisation service provided by sealedenvelope.com. The system will generate an immediate allocation to the trial arm and confirmation emails will be sent to specific members of the team (the trial manager and/or the project CI). In addition to being recorded centrally on the sealedenvelope.com system, allocations will be recorded by the trial manager on a randomisation log accessible only to unblinded members of the research team. The RAs who will conduct the 9-month post-randomisation assessments will be blind to treatment allocation. Behavioural The datasets generated and/or analysed during the current study will be available on request from Prof. Filippo Varese (Filippo.Varese@manchester.ac.uk) Available on request Protocol

Study website Migrated from study website field

de9c2888-9c0c-4567-a348-cfebdc8e200e 8ef3ae94-4339-4547-8f79-1780f6361f52 391918e3-0640-4f10-a8a2-f002909c5383 6339e44c-f1fd-48dc-8c3a-6a020e29983b Yes Filippo Varese https://orcid.org/0000-0001-7244-598X Principal investigator

The University of Manchester Division of Psychology and Mental Health Room 2.40 2nd Floor Zochonis Building Brunswick Park

Manchester United Kingdom M13 9PL +44 (0)161 306 0434 filippo.varese@manchester.ac.uk Public Aidan Flinn Public Scientific

Greater Manchester Mental Health NHS Foundation Trust Building B, One Central Park Northampton Road

Manchester United Kingdom M40 5BP +44 (0)7795 318075 Aidan.Flinn@gmmh.nhs.uk Public University of Manchester University/education https://ror.org/027m9bs27 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 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