NCT07129369

Effects of a Peer-facilitated, Acceptance-based Self-learning for Illness Management (PASIM) Program

Evaluating the Effects of a Peer-facilitated, Acceptance-based Self-learning for Illness Management (PASIM) Program for Adults With Recent-onset Psychosis: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Psychosis is a very disabling mental illness with a wide range of dysregulations and disruptions in cognition, emotions, and behaviors, resulting in poor functioning and frequent relapses, especially in the first five years of the illness. There is a knowledge gap about whether Peer-facilitated, Acceptance-based Self-learning for Illness Management (PASIM) can have longer-term and more significant benefits than current professional-led psychoeducation in diverse health outcomes of these psychotic patients such as functioning, problem-solving, and recovery. This multi-center randomized controlled trial with repeated measures, 3-arm design is proposed to test and compare the effects between two alternative interventions (PASIM and Psychoeducation Group program) and a usual-care-only group over an 18-month follow-up.

Detailed description

Objectives: To test the primary hypothesis that the PASIM program can produce significantly greater improvements than psychoeducation and/or usual-care only groups at 1-week, 9-month, and/or 18-month follow-ups on patients' functioning; To test the hypothesis that the PASIM program will produce significantly greater improvements than psychoeducation and usual-care-only over the 18-month follow-ups in patients' psychotic symptoms, problem-solving, illness insight, rehospitalization rates, and/or service satisfaction (secondary outcomes); To explore the strengths, weaknesses and areas for improvements of and satisfaction with the PASIM program, from participants' and peer facilitators' perspectives, using individual semi-structured interviews. Design: A multi-center randomized controlled trial with repeated measures, 3-arm design will be conducted with both outcome and process evaluation. Subjects: 186 adults with recent-onset psychosis and randomly assigned into three study groups. Data collection procedure: After explaining the study and ethical issues to participants, written consent and then baseline measurement will be obtained. During interventions, participants' attendance, workbook completion and attritions will be monitored. At 1-week (Posttest-1), and 9- (Posttest-2) and 18-month (Posttest-3) post-intervention, outcome measurements will be evaluated. In addition, individual semi-structured interviews will be conducted after Posttest-1. Data analysis: Generalized Estimating Equation test will be used to compare mean-value changes in individual outcomes, and Kaplan-Meier survival-analysis used to analyze the relative risks of re-hospitalizations, between groups over follow-ups. Content analysis will be conducted for qualitative interview data. Expected results: The PASIM is the first peer-supported self-help for illness management intervention for early-stage psychosis, particularly in Chinese population. It can be a useful and potential cost-saving intervention in community mental healthcare service, providing accessible, self-learned illness self-management training facilitated by peer-support workers (persons recovered from psychosis) in views of limited healthcare resources and mental health professionals in locally and internationally.

Conditions

• Psychotic Disorders
• Recent-Onset Psychosis

Interventions

Type	Name	Description
BEHAVIORAL	PASIM program	The program consists of 5 modules for ROP patients (translated, refined and validated by research team) and 4 group sessions (1.5 hours per session; 8-10 members/group; in-between completion of the 5 modules) facilitated by a peer-support worker over 5 months. The 5 modules include: Module 1-Patient's well-being; Module 2-Getting the best out of support services; Module 3-Acceptance and insight toward psychosis and long-term self-care; Module 4-Dealing with psychosocial effects of the illness- I; and Module 5-Dealing with physical/mental health effects of the illness- II. The 4 group sessions will be conducted at the orientation and after reading the 1st, 3rd and 5th module to introduce the program, encourage to complete the module per month, performing value clarifying and acceptance (psychological flexibility) exercises, and clarify and discuss self-care learning and and challenges.
BEHAVIORAL	Psychoeducation	The psychoeducation group (5 subgroups with 12-14 patients per group) will be led by one trained psychiatric nurse experienced in psychiatric rehabilitation and psychoeducation group. The program consists of 12 two-hour sessions held weekly or biweekly (similar to the PASIM) over 5 months with four key components, including introduction and goal setting; an education workshop on psychosis care and community service; learning effective coping and self-care skills with rehearsals/reviews; and skills practices and preparing for future life.
BEHAVIORAL	Usual-Care-only	Participants receive usual community mental healthcare services provided by POPCs and ICCMWs.

Timeline

• Start date: 2026-01-02
• Primary completion: 2028-08-31
• Completion: 2028-10-31
• First posted: 2025-08-19
• Last updated: 2025-08-19

Locations

2 sites across 1 country: China