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
Schizophrenia, schizotypal and delusional disorders, psychosis
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 (Internali
Current inclusion criteria as of 03/07/2026: 1. Age 16+ years 2. Meet the 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 or be attending NHS mental health services for the treatment 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. Previous inclusion criteria: 1. Age 16+ years 2. Meet the 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.
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.