Effect of a Peer-led Self-management Program for Recent-onset Psychosis — PLSMI  

Psychotic Disorders Clinical Trial

Official title: Effectiveness of a Peer-led Self-Management Program for People With Recent-onset Psychosis: A Randomized Controlled Trial

Status Active, not recruiting

Clinical Trial Summary

This randomized controlled trial is to test the effectiveness of a peer-led self-management program (PLSMI) for people with recent-onset psychosis in the community over 18-month follow-up, compared with a conventional psychoeducation group and routine community mental healthcare.

Clinical Trial Description

Objectives: to investigate the effectiveness of a peer-led self-management intervention (PLSMI) for recent-onset psychosis on patient outcomes over 18-months follow-up, compared with a conventional psycho-education group and routine care only group.

Hypotheses: When compared with those in a psycho-education group and routine care, the PLSMI participants will indicate significantly greater:

1. Improvement in patients' level of recovery at 1-2 weeks post-intervention (Primary hypothesis and outcome);

2. Reduction of their re-hospitalization rates and symptom severity, and/or improvement in functioning, satisfaction with service, problem-solving, and insight into illness at 1-2 weeks post-intervention; and/or

3. Improvements in the above outcomes (hypotheses 1) at 6-, 12- and/or 18-month follow-ups.

Primary outcome is patients' level of recovery. Qualitative interviews with purposely selected PLSMI participants and all peer support workers (agreed for interview) will enhance understanding about their perceived benefits, service satisfaction, strengths, and limitations of the intervention undertaken from peer-workers' and participants' perspectives.

Study Design: A multi-center randomized controlled trial with repeated-measures, three-group design on a community-based PLSMI will be conducted with both outcome and process evaluation.

Subjects: 180 people with recent-onset psychosis (not more than 3 years onset) randomly selected from 6 Integrated Community Centers for Mental Wellness and randomly assigned into 3 arms.

Instruments/Measures: Level of self-reported recovery (QPS, primary outcome); occurrence and frequency of and time to psychiatric hospitalization over past 6 or 18 months; symptom severity (PANSS); problem solving ability (C-SPSI-R:S); illness insight (ITAQ); functioning (SLOF), and service satisfaction (CSQ-8).

Focus group interviews will be conducted to collect views on benefits and weaknesses of PLSMI.

Data analyses: Comparing the mean value changes of outcomes between-groups across time on intention-to-treat basis, using MANOVA/Mixed Modeling/Generalized Estimation Equations test and comparing the occurrence of and time to hospitalization between groups using survival analysis and Cox regression test; content analysis of qualitative data from focus-group interviews and intervention sessions.

Expected results: The findings provide evidence of the effectiveness of peer-support self-management program for early-stage psychosis in community mental health healthcare on improving patients' recovery and other important patient outcomes, as well as service satisfaction. ;

Related Conditions & MeSH terms

• Early Psychosis
• Mental Disorders
• Psychotic Disorders

• NCT number: NCT04166019
• Study type: Interventional
• Source: Chinese University of Hong Kong
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2020
• Completion date: June 30, 2024