A peer support programme to help adults with psychosis talk about mental health and reduce stigma
| ISRCTN | ISRCTN67429289 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67429289 |
| IRAS number | 343302 |
| Secondary identifying numbers | CPMS 62177, NIHR163493 |
- Submission date
- 30/09/2025
- Registration date
- 20/10/2025
- Last edited
- 20/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aim
People who experience psychosis often face stigma and discrimination, which can negatively affect how they consider themselves and their identities. This is referred to as ‘internalising’ stigma. This can cause serious problems with self-esteem, cause depression and anxiety, and lead to withdrawal from others, study or work.
To help people with psychosis feel less troubled by ‘internalised stigma’, mental health researchers in Manchester adapted an American intervention into a new intervention called ‘Let’s Talk’. A small trial was conducted to test this intervention. Let’s Talk involved Peer Support Workers (PSWs), who also have experience of psychosis, meeting with people taking part in the trial (Peers). PSWs and Peers discussed mental health stigma, and how to talk about mental health difficulties with others. Many sessions focused on helping Peers understand how to decide whether they want to discuss their mental health difficulties with others, or not. The trial found that people were interested in taking part, that most participants offered the intervention attended the sessions, and most participants attended the research assessments.
A larger trial of Let’s Talk is planned to understand more clearly how it can help improve the personal wellbeing of people who experience psychosis. In a larger trial, more participants can be included and more advanced research tests can be run to see what parts of the Let’s Talk approach are most helpful. This would help make Let’s Talk as effective as possible, and it could then be offered in NHS mental health services.
Who can participate?
People in four UK areas aged 16+ who meet an ICD-11 Schizophrenia or other primary psychotic disorders diagnosis (as determined by the participant’s clinical team) or are receiving care for psychosis from Early Intervention Services (EIS), or under the care of a secondary or tertiary mental health service at the point of referral to ensure provision of care. They will also report moderate to severe self-reported disclosure-related distress (scoring >3 on the disclosure distress screening item), and moderate to severe internalised stigma (scoring of ≥3 on at least one of the Internalised Stigma domains of the Semi-structured Interview Measure of Stigma (SIMS)).
What does the study involve?
Participants will meet with a research assistant (RA), and they will complete a range of questionnaires, including the Questionnaire about the Process of Recovery (QPR). Participants will be randomly allocated (50:50 chance) to either receive the peer-delivered Let’s Talk intervention (plus their usual mental health treatment) or receive their usual mental health care alone (TAU). Participants who are allocated to receive the Let’s Talk intervention will be offered sessions with a peer support worker over 16 weeks, which will involve completing an 8-module workbook together. Participants will meet with research assistants again at 4 and 12 months to complete the same set of questionnaires.
What are the possible benefits and risks of participating?
If the Let’s Talk intervention is found to improve personal recovery outcomes, this could add to the current evidence base for helpful psychological interventions and potentially benefit future mental health services for people experiencing psychosis. A potential risk is that participants may find the research assessment process distressing. Participants will be offered choices around their assessments, including the option of breaks and assessments spread across multiple occasions.
Where is the study run from?
The lead site is Greater Manchester Mental Health NHS Foundation Trust (GMMH). Avon and Wiltshire Mental Health Partnership NHS Trust (AWP), South London and Maudsley NHS Foundation Trust (SLaM) and North East London NHS Foundation Trust (NELFT) are also sites from which the Let’s Talk 2 study is run.
When is the study starting and how long is it expected to run for?
May 2025 to August 2028. The study will begin enrolling participants in November 2025 to May 2027. Overall, the study is expected to run for 40 months.
Who is funding the study?
National Institute for Health and Care Research (NIHR), UK.
Who is the main contact?
Dr Melissa Pyle, based at Greater Manchester Mental Health NHS Foundation Trust (GMMH), melissa.pyle@gmmh.nhs.uk
Contact information
Public, Scientific, Principal investigator
Greater Manchester Mental Health NHS Foundation Trust
The Psychosis Research Unit, R&I
Central Park Hub, Building B
Northampton Road
Manchester
M40 5BP
United Kingdom
 ORCID ID |
0009-0004-5337-9031 |
|---|---|
| Phone | +44 (0)161 271 0084 |
| melissa.pyle@gmmh.nhs.uk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Internet/virtual, Other therapist office, Telephone |
| Study type | Treatment |
| Participant information sheet | 48087_PIS_V3_08Sept2025.pdf |
| Scientific title | A peer-delivered programme for mental health disclosure distress and internalised stigma (Let’s Talk) in comparison to treatment as usual in adults with psychosis: A randomised controlled trial to investigate the efficacy of a peer intervention targeted at stigma-related mechanisms |
| Study acronym | Let's Talk 2 |
| Study objectives | The study objective is to establish Let’s Talk’s clinical efficacy in a multisite Randomised Controlled Trial (RCT) for adults with psychosis who report moderate to severe Internalised Stigma (IS) and disclosure-related distress; and to assess whether improved measures of personal recovery are mediated via key stigma variables. The objective is to recruit 352 participants to detect a target difference of 4.5 points on the QPR. Eligible participants will be randomised to either the intervention arm (Let’s Talk + Treatment as Usual (TAU)) or the control arm (TAU alone). Participants allocated to the intervention will be offered up to 16 sessions over a four-month intervention window with up to one booster session. Outcome data will be collected at baseline, at 4-month assessment (end of treatment) and at 12-month assessment (12 months post-randomisation). The study will determine whether the treatment effect on recovery is mediated by key mechanisms targeted in the intervention: (1) reduced IS (primary mechanism), (2) reduced stigma stress (degree to which perceived stigma is exceeded by personal coping resources for stigma) and (3) reduced disclosure distress. |
| Ethics approval(s) |
Approved 16/09/2025, Cambridge South Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, United Kingdom; +44 (0)207 104 8115; cambridgesouth.rec@hra.nhs.uk), ref: 25/EE/0718 |
| Health condition(s) or problem(s) studied | Schizophrenia, schizotypal and delusional disorders |
| Intervention | Design A clinical efficacy randomised controlled trial (RCT) will be conducted across 4 NHS secondary or tertiary care mental health services in the UK: Avon and Wiltshire, Greater Manchester, North East London, and South London. Participants who meet all inclusion criteria and no exclusion criteria will be randomly allocated to either Let’s Talk plus treatment as usual (TAU), or TAU alone. Participants will be randomised at the individual level via a Clinical Trials Unit (CTU)-hosted, web-based system using random permuted blocks. Randomisation will be at a 1:1 ratio, stratified by site. Outcome and mediational variables will be collected in research assessments at baseline, 4 months (end of treatment) and 12 months post-randomisation. The assessments will be conducted by raters who are blind to participant allocation. Clinical efficacy aims 1. To establish the efficacy of Let’s Talk + TAU in improving personal recovery (primary outcome) when delivered to adults with psychosis who report moderate to severe internalised stigma and disclosure-related distress compared to TAU alone. 2. To establish the efficacy of Let’s Talk + TAU on secondary outcomes of improving quality of life, reducing depression, and reducing social interaction anxiety compared to TAU alone. Clinical efficacy hypotheses 1. Let’s Talk plus TAU will result in improved measures of personal recovery at the end of treatment (4-month follow-up; primary outcome) and 12-month follow-up compared to TAU alone. 2. Let’s Talk plus TAU will result in improved quality of life at the end of treatment (4-month follow-up) and 12-month follow-up compared to TAU alone. 3. Let’s Talk plus TAU will result in a reduction in the level of depression and social interaction anxiety at the end of treatment (4-month follow-up) and 12-month follow-up. Mechanistic aims 1. To examine the extent to which Let’s Talk plus TAU impacts on measures of personal recovery via a decrease in stigma-specific processes (Internalised stigma [IS], stigma stress, and disclosure distress). Mechanistic hypotheses 1. Let’s Talk + TAU will lead to reductions in IS and stigma stress 2. The mechanisms by which Let’s Talk + TAU lead to improvements in personal recovery are due to reductions in IS, stigma stress and disclosure distress. Primary outcome The primary outcome will be the total score on the 15-item Questionnaire about the Process of Recovery (QPR) at 4-month follow-up. The QPR was developed in collaboration with patients to assess personal recovery from psychosis, containing items that were initially derived from qualitative interviews about this topic. It has excellent reliability, validity, and sensitivity to change and is nationally adopted as a PROM for evaluation of early intervention for psychosis services, forming part of the Mental Health Services Data Set. Patients consistently prioritise personal recovery over specific symptom change, and the QPR has been cited as the only measure of recovery that directly maps onto all 5 processes of the influential CHIME framework of personal recovery. Secondary outcomes Secondary outcomes will assess relevant dimensions of psychiatric distress and quality of life. 1. The Social Interaction Anxiety Scale (SIAS), a 20-item self-administered scale questionnaire, which reflects anxieties people may encounter in social situations. Items are rated on a 5-point scale from 0 (not at all) to 4 (extremely). The SIAS is a reliable and valid measure, with initial testing demonstrating high levels of internal consistency and test-retest reliability. 2. Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9), a validated, nine-item, patient-reported outcome measure (PROM). The PHQ-9 is a brief self-administered scale which reflects the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, fifth edition) criteria. It classifies current symptoms on a scale of 0 (not at all) to 3 (nearly every day). 3. The DIALOG scale is a validated, 11-item, patient-reported outcome and experience measure (PROM/PREM). The DIALOG scale assesses eight life domains (mental health, physical health, job situation, accommodation, leisure, partner/family, friendship, personal safety) and three treatment aspects (medication, practical help, meetings with healthcare professionals). The items are rated on a 7-point scale from “totally dissatisfied” to “totally satisfied” with the value 4 representing a neutral “in the middle.” 4. The Psychotic Symptoms Rating Scale: Multimodal Hallucinations, an unpublished scale adapted from the PSYRATS: Auditory Hallucinations subscale for assessing the presence and impact of nonauditory hallucinations. 5. The Revised Green et al Paranoid Thoughts Scale (R-GPTS), a reliable measure of paranoia comprising two subscales to assess ideas of reference (Part A; 8 items) and ideas of persecution (Part B; 10 items), over the past month. The two subscales are designed to be treated as distinct measures and should be scored separately. A total score for each subscale is obtained by adding together the items. Items are scored on a 4-point scale from 0 (Not at all) to 4 (Totally). Mechanistic outcomes The proposed mechanisms of action for Let’s Talk will also be measured with the following instruments: 1. The Semi-structured Interview Measure for Stigma in Psychosis (SIMS), which assesses experienced, perceived, and internalised stigma. 2. Stigma stress will be assessed by the 8-item Stigma Stress Scale. 3. Disclosure-related distress will be assessed using a single item from the Disclosure Distress Scale. Assessment schedule Research assessments comprising the above measures will be completed at baseline, 4 months (end of treatment) and 12 months post-randomisation. Participants will receive £25 on completion of each research assessment as a token of appreciation for their time (£75 total). Treatment condition (Let's Talk + TAU) Let’s Talk will be delivered, in addition to TAU, on a one-to-one basis by Peer Support Workers (PSWs). A 4-month treatment window permits ≤16 sessions, with an option for 1 booster session to consolidate gains. The expectation for delivery is in-person, but the intervention can be delivered remotely via video call or telephone as a contingency. The aims of Let’s Talk are to: help participants weigh pros and cons of disclosing which vary by setting (e.g., disclosure at one’s employment has different costs and benefits than disclosure to one’s friendship network); teach relatively safe ways to disclose should the person decide to do so; help people craft stories that reflect their disclosure goals; support participants with internalised stigma and developing affirming self-beliefs. Sessions with the PSW will be structured around the Let's Talk manual and workbook, which have been refined based on qualitative feedback from participants and PSWs in the Let's Talk feasibility RCT. All participants allocated to Let’s Talk will receive a copy of the workbook. All routine or additional treatments in the comparator arm will be monitored. Comparator condition (TAU) The control condition is treatment as usual (TAU). All participants in the intervention and comparator arms are required to be under the care of a secondary or tertiary care mental health service as a condition of inclusion. In the UK, TAU for psychosis is based on the Care Programme Approach and typically includes psychiatric medication, assignment of community-based health and social care staff, care coordination, access to rehabilitative services, and outpatient care. Referrers for participants in the TAU arm will not be requested to withhold any treatment throughout the duration of the trial, and all routine or additional treatments will be monitored. Except for emergent risk issues, TAU alone will also not involve liaison between researchers and the participants’ healthcare teams. Research Assistants will identify any risks to self or others that require immediate action. All routine or additional treatments in the TAU arm will be monitored. |
| Intervention type | Behavioural |
| Primary outcome measure | Personal recovery will be measured using the total score on the 15-item Questionnaire about the Process of Recovery (QPR) at 4 months |
| Secondary outcome measures | The following secondary outcome measures will assess relevant dimensions of psychiatric distress and quality of life at baseline, 4 and 12 months: 1. Social anxiety will be measured using the Social Interaction Anxiety Scale (SIAS) 2. Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9) 3. Satisfaction in multiple life domains and in treatment aspects will be measured using the DIALOG 4. Paranoia will be measured using the revised Green et al. Paranoid Thoughts Scale (R-GPTS) 5. The presence and impact of non-auditory hallucinations will be assessed using The Psychotic Symptoms Rating Scale: Multimodal Hallucinations. This is an unpublished scale adapted from PSYRATS-AH. The proposed mechanisms of action for Let’s Talk will also be measured with the following instruments at baseline, 4 months and 12 months: 1. Experienced, perceived, and internalised stigma will be measured using the Semi-structured Interview Measure for Stigma in Psychosis (SIMS) 2. Stigma stress will be assessed by the 8-item Stigma Stress Scale (SSCI-8) 3. Disclosure distress will be measured using the single-item Distress Disclosure Index (DDI) |
| Overall study start date | 01/05/2025 |
| Completion date | 31/08/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | All |
| Target number of participants | Planned Sample Size: 352; UK Sample Size: 352 |
| Key inclusion criteria | 1. Age 16+ 2. Meet ICD-11 Schizophrenia or other primary psychotic disorders diagnosis (as determined by the participant’s clinical team) or be receiving care for psychosis from Early Intervention Services (EIS) to account for diagnostic uncertainty in the early stages of psychosis. 3. Under the care of a secondary or tertiary mental health service at point of referral to ensure provision of care. 4. Able to provide written, informed consent (for ethical considerations). 5. Willing to engage in a peer support intervention. 6. Moderate to severe self-reported disclosure-related distress as determined by scoring > 3 on the disclosure distress screening item. 7. Moderate to severe internalised stigma as determined by a score of > = 3 on at least one of the Internalised Stigma domains of the Semi-structured Interview Measure of Stigma. |
| Key exclusion criteria | 1. A primary diagnosis of alcohol or substance dependency, where this is clearly the cause of their psychotic symptoms. This does not exclude people who use substances or alcohol, only those with a primary diagnosis. This will be confirmed by participants' care teams. 2. A diagnosis of moderate to severe learning disability. This will be confirmed by participants' care teams. 3. An ICD-11 diagnosis of organic psychosis. This will be confirmed by participants' care teams. 4. Language barriers that are an obstacle to participation, since we are unable to provide translation of the intervention workbook or interpreters during intervention sessions. 5. Immediate risk to self or others. This will be confirmed by participants' care teams. 6. Currently receiving structured, individual psychological therapy. |
| Date of first enrolment | 01/11/2025 |
| Date of final enrolment | 31/05/2027 |
Locations
Countries of recruitment
- United Kingdom
Study participating centres
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
Beckenham
BR3 3BX
United Kingdom
C E M E Centre
Marsh Way
Rainham
RM13 8GQ
United Kingdom
Newbridge Hill
Bath
BA1 3QE
United Kingdom
Sponsor information
Hospital/treatment centre
Prestwich Hospital, Bury New Road, Prestwich
Manchester
M25 3BL
England
United Kingdom
| Phone | +44 (0)1612710084 |
|---|---|
| researchoffice@gmmh.nhs.uk | |
| Website | https://www.gmmh.nhs.uk// |
"ROR" |
https://ror.org/05sb89p83 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3 | 08/09/2025 | 16/10/2025 | No | Yes |
| Protocol file | version 2.0 | 22/09/2025 | 16/10/2025 | No | No |
Additional files
Editorial Notes
30/09/2025: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
