Psychosis Mental and Behavioural Disorders Unspecified nonorganic psychosis
Conditions
Interventions
The researchers will conduct a feasibility randomised controlled trial (RCT) across two UK sites, Greater Manchester, and Northeast London. Participants who meet the inclusion criteria will be randoml
Sponsors
Greater Manchester Mental Health NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 16+ years 2. Meet ICD-10 F20-F29 Schizophrenia spectrum diagnosis, or be receiving services from Early Intervention Services (EIS) 3. Under the care of a mental health service with a care coordinator 4. Competent to provide written, informed consent (for ethical considerations) 5. At least a moderate level of self-reported disclosure-related distress screening scale (Rüsch et al., 2014), as determined by scoring >3 on the screening item 6. At least moderate levels of internalised stigma as determined by a a score of =3 on at least one of the Internalised Stigma domains the Semi-structured Interview Measure of Stigma (Wood et al., 2016)
Exclusion criteria
Exclusion criteria: 1. A primary diagnosis of alcohol or substance dependency (ICD-10 F10 – F19 diagnosis), 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 the participant's care coordinator or psychiatrist 2. A diagnosis of moderate to severe learning disability, as confirmed by the participant's care coordinator or psychiatrist 3. An ICD-10 diagnosis of organic psychosis, as confirmed by the participant's care coordinator or psychiatrist 4. Non-English speaking, where this prevents engagement in informed written consent and interviews 5. Immediate risk to self or others as confirmed by the participant's care coordinator or psychiatrist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As a feasibility RCT, a single primary outcome is not meaningful. The key outcomes to inform a definitive trial are: 1. Referral rates: the number of referrals received relative to the number randomised into the trial over the recruitment window 2. Recruitment as assessed by the proportion of eligible participants recruited into the study over the recruitment window 3. Attendance at the Let’s Talk programme sessions measured by the session record for each participant allocated to the intervention arm of the trial at end of treatment (2.5 months) 4. Fidelity to the Let’s Talk programme manual and principles of peer support as measured by the Let’s Talk Fidelity Scale and using the Peer Support Principle-Based Fidelity Index at end of treatment (2.5 months) 5. Most used Let’s Talk strategies as assessed by the proportion of strategies recorded in individual Let’s Talk session records completed after each session 6. Follow-up/questionnaire response rate as assessed by the proportion of questionnaires completed at 2.5 months (end of treatment) and 6-month follow-up Updated 19/01/2022: The end of treatment timepoint was changed from 2 months to 2.5 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Experienced, perceived, and internalised stigma assessed using the Semi-structured Interview Measure for Stigma in Psychosis (SIMS) at baseline, 2.5 months follow-up and 6 months follow-up 2. Disclosure related distress assessed using a single item question rated on a 1-7 Likert Scale at baseline, 2.5 months follow-up and 6 months follow-up 3. Stigma stress assessed by the 8-item Stigma Stress Scale at baseline, 2.5 months follow-up and 6 months follow-up 4. Recovery assessed using the Process of Recovery Questionnaire at baseline, 2.5 months follow-up and 6 months follow-up 5. Depression assessed using the Calgary Depression Rating Scale for Schizophrenia (CDSS50) at baseline, 2.5 months follow-up and 6 months follow-up 6. Anxiety assessed using the Social Interaction Anxiety Scale (SIAS) at baseline, 2.5 months follow-up and 6 months follow-up 7. Quality of life assessed by the Manchester Short Assessment of Quality of Life Scale at baseline, 2.5 months follow-up and 6 months follow-up 8. Empowerment measured using the Rogers Empowerment Scale (RES) at baseline, 2.5 months follow-up and 6 months follow-up 9. Help-seeking and service utilisation/engagement assessed by an economic patient questionnaire at baseline, 2.5 months follow-up and 6 months follow-up 10. Health status evaluated using the EQ5D at baseline, 2.5 months follow-up (end of treatment) and 6 months follow-up 11. Internalised shame measured using the Internalised Shame Scale at baseline, 2.5 months follow-up and 6 months follow-up 12. Self-esteem measured using the Self-Esteem Rating Scale - Short form at baseline, 2.5 months follow-up and 6 months follow-up Updated 19/01/2022: The 2 months follow-up timepoint was changed to 2.5 months follow-up. | — |
Countries
England, United Kingdom
Outcome results
None listed