An interventional study of Peer-led self-management program and Psycho-education group in Early Psychosis and Psychotic Disorders, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Health services research
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.
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:
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.
1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.
This study's enrollment of 180 is above the median of 70 across 1,333 interventional studies indexed under Psychotic Disorders.
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Exclusion Criteria:
Peer-led self-management program (PLSMI) consists of 10 weekly/biweekly, 1.5-hour sessions (4 months), based on the modified Crisis-resolution-team Optimization and Relapse Prevention (CORE) program workbook/manual and psycho-education programs developed by the research team. The program based on completion of a self-management workbook, consisting of the main components: personal recovery goals, plans to re-establish community functioning and support networks following a crisis, identifying early warning signs and creating a relapse prevention plan, and strategies and coping resources to problem-solving and maintain well-being. Participants work through the workbook at their own pace, with the support from the peer support worker, to facilitate/support their recovery. They will meet in group with a trained peer support worker on 10 sessions, usually at 7-12 days intervals over 4 months.
Behavioral: Peer-led self-management program · Behavioral: Usual care
Psycho-education groups (12-18 members/group; 10 two-hour sessions, weekly/biweekly), 4-month duration similar to the PLSMI, will be led by one trained advanced practice psychiatric nurse in each center experienced in psychiatric rehabilitation, and are guided by a validated group-intervention protocol based on the research team's and McFarlane et al.'s psycho-education programs for psychosis.
Behavioral: Psycho-education group · Behavioral: Usual care
Usual care (control) participants (and treatment groups) will receive routine psychiatric outpatient and community mental healthcare services.
Behavioral: Usual care
The program based on completion of a self-management workbook, consisting of the main components: personal recovery goals, plans to re-establish community functioning and support networks following a crisis, identifying early warning signs and creating a relapse prevention plan, and strategies and coping resources to problem-solving and maintain well-being.
Also known as: PLSMI
The psycho-education group program is comprised of six components: introduction and goal-setting; basic understanding of psychosis and symptom and emotion self-care; education workshop of psychosis care, treatment and community support services; learning about self-care skills; establishing social support and effective coping skills; and skills practices, review and future plan.
Routine care services consist of monthly psychiatric consultation and treatments prescribed by psychiatrist, nursing advice on community care, brief education (1-2 hourly sessions) about mental illness/treatments by psychiatric nurses, home visits by case managers, and/or referrals to community/welfare services.
Questionnaire about the Process of Recovery (QPR)
Level of recovery from illness is measured with the Questionnaire about the Process of Recovery (QPR) developed by Neil et al. (2009). Items are rated on a 5-point Likert scale (0=disagree strongly to 4=agree strongly; score range= 0-88); the higher total score indicates a higher of recovery progress.
Time frame: At recruitment
Questionnaire about the Process of Recovery (QPR)
Level of recovery from illness is measured with the Questionnaire about the Process of Recovery (QPR) developed by Neil et al. (2009). Items are rated on a 5-point Likert scale (0=disagree strongly to 4=agree strongly); the higher total score indicates a higher of recovery progress.
Time frame: At 1-2 weeks post-intervention
Questionnaire about the Process of Recovery (QPR)
Level of recovery from illness is measured with the Questionnaire about the Process of Recovery (QPR) developed by Neil et al. (2009). Items are rated on a 5-point Likert scale (0=disagree strongly to 4=agree strongly); the higher total score indicates a higher of recovery progress.
Time frame: At 6 months post-intervention
Questionnaire about the Process of Recovery (QPR)
Level of recovery from illness is measured with the Questionnaire about the Process of Recovery (QPR) developed by Neil et al. (2009). Items are rated on a 5-point Likert scale (0=disagree strongly to 4=agree strongly); the higher total score indicates a higher of recovery progress.
Time frame: At 12 months post-intervention
Questionnaire about the Process of Recovery (QPR)
Level of recovery from illness is measured with the Questionnaire about the Process of Recovery (QPR) developed by Neil et al. (2009). Items are rated on a 5-point Likert scale (0=disagree strongly to 4=agree strongly); the higher total score indicates a higher of recovery progress.
Time frame: At 18 months post-intervention
Re-hospitalization rate
Occurrence of and time to hospitalization, and frequency of re-hospitalizations over past 5-6 months
Time frame: Change from recruitment to 18 months follow-up
Positive and Negative Syndrome Scale (PANSS)
Symptom severity is assessed with the 30-item Positive and Negative Syndrome Scale (PANSS) developed by Kay (1987) across three sub-scales: positive symptoms, negative symptoms and general psychopathology. Items are rated on a 7-point Likert scale (1= absent to 7= extreme; total score range= 7-210); a higher total score indicates more severe psychotic symptoms.
Time frame: Change from recruitment to 18 months follow-up
Specific Level of Functioning Scale (SLOF)
Patient functioning is measured by the 43-item Specific Level of Functioning Scale (SLOF) developed by Schneider and Struening (1983) in terms of three domains: physical functioning/personal care, social functioning and community living skills. Items are rated on a 5-point Likert scale (1=very poor to 5=very well; total score range= 43-215); a higher total score indicates a higher level of functioning.
Time frame: Change from recruitment to 18 months follow-up
Revised Social-Problem-Solving Inventory (C-SPSI-R:S)
Problem-solving ability will be assessed with a 25-item Chinese version of Revised Social-Problem-Solving Inventory (C-SPSI-R:S), comprising 2 domains: problem-solving style (rational/impulsive; careless/avoidance) and orientation (positive/negative). Items are rated on a 5-point Likert scale (1=not at all true to 4=extremely true; total score range= 0-100); a higher total score indicates better problem solving ability.
Time frame: Change from recruitment to 18 months follow-up
Insight and Treatment Attitude Questionnaire (ITAQ)
Insight into illness and treatment is measured by the 11-item Treatment Attitude Questionnaire (ITAQ) developed by McEvoy et al. (1989) measuring patients' insights and recognition of their illness and attitudes towards the need for treatments. Items are rated on a 3-point Likert scale (0=not necessary to receive treatment to 2=treatment should be required/continued regularly; total score range= 0-22; a higher total score indicates better insight into the illness/treatment.
Time frame: Change from recruitment to 18 months follow-up
Client Satisfaction Questionnaire (CSQ-8)
Patient satisfaction with service is measured by the 8-item Client Satisfaction Questionnaire (CSQ-8) developed by Attkisson and Zwick (1982). Items are rated on a 4-point Likert scale (1= very dissatisfied to 4= very satisfied; total score range= 8-32); a higher total score indicates a better satisfaction with the services received/receiving.
Time frame: Change from recruitment to 18 months follow-up
Plan to share: No — The name and email of the researchers can be shared openly for communication and collaboration.
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Chinese University of Hong Kong