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

The Chinese University of Hong Kong

Status: Completed

Conditions: Psychotic Disorders; Early Psychosis

Treatments: Behavioral: Usual care; Behavioral: Peer-led self-management program; Behavioral: Psycho-education group

Study type: Interventional

Funder types: Other

Identifiers

NCT04166019

19101314

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hong Kong Chinese residents, aged 18-60 years;
• Having Global Assessment of Functioning scores ≥ 51, indicating mild to moderate symptoms and difficulty in psychosocial/occupational functioning and thus mentally stable to comprehend the self-care training and education provided; and
• Able to understand Cantonese/Mandarin

Exclusion criteria

• Participated in or having been receiving other psycho-education/psychotherapies;
• Having co-morbidity of another mental illness (learning disability and cognitive and personality disorders) or any clinically significant medical diseases; and
• Having visual/language/communication difficulty

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups

Peer-led self-management program

Experimental group

Description:

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.

Treatment:

Behavioral: Peer-led self-management program

Behavioral: Usual care

Psycho-education group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Psycho-education group

Behavioral: Usual care

Usual care only

Other group

Description:

Usual care (control) participants (and treatment groups) will receive routine psychiatric outpatient and community mental healthcare services.

Treatment:

Behavioral: Usual care