Schizophrenia, schizotypal and delusional disorders, psychosis Mental and Behavioural Disorders
Conditions
Interventions
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 E
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 compa
Sponsors
Greater Manchester Mental Health NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Personal recovery will be measured using the total score on the 15-item Questionnaire about the Process of Recovery (QPR) at 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United Kingdom
Contacts
Public ContactMelissa Pyle
Outcome results
None listed