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

NCT04166019 | Completed DMC

• 1 other identifier: 19101314
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early Psychosis; Psychotic Disorders

Keywords

first-onset psychosis; randomized controlled trial; peer support; self management; recovery; re-hospitalization

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  At 18 months post-intervention

Secondary Outcomes (6)

• Re-hospitalization rate

  Change from recruitment to 18 months follow-up

• Positive and Negative Syndrome Scale (PANSS)

  Change from recruitment to 18 months follow-up

• Specific Level of Functioning Scale (SLOF)

  Change from recruitment to 18 months follow-up

• Revised Social-Problem-Solving Inventory (C-SPSI-R:S)

  Change from recruitment to 18 months follow-up

• Insight and Treatment Attitude Questionnaire (ITAQ)

  Change from recruitment to 18 months follow-up

Study Arms (3)

Peer-led self-management program

EXPERIMENTAL

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 group

ACTIVE COMPARATOR

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 only

OTHER

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

Behavioral: Usual care

Interventions

Peer-led self-management program BEHAVIORAL

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

Peer-led self-management program

Psycho-education group BEHAVIORAL

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.

Psycho-education group

Usual care BEHAVIORAL

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.

Peer-led self-management program; Psycho-education group; Usual care only

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Integrated Community Centers for Mental Wellness: collaborator

Study Sites (1)

Integrated Community Centers for Mental Wellness

Hong Kong, Hong Kong

Location

Related Publications (2)

• Johnson S, Lamb D, Marston L, Osborn D, Mason O, Henderson C, Ambler G, Milton A, Davidson M, Christoforou M, Sullivan S, Hunter R, Hindle D, Paterson B, Leverton M, Piotrowski J, Forsyth R, Mosse L, Goater N, Kelly K, Lean M, Pilling S, Morant N, Lloyd-Evans B. Peer-supported self-management for people discharged from a mental health crisis team: a randomised controlled trial. Lancet. 2018 Aug 4;392(10145):409-418. doi: 10.1016/S0140-6736(18)31470-3.

  PMID: 30102174 BACKGROUND

• Chien WT, Bressington D, Chan S, Lubman DI. Effects of peer-support illness-management program for people with recent-onset psychosis (Oral presentation, Proceeding p. 14). THE IRES - 627TH INTERNATIONAL CONFERENCES ON ECONOMICS AND SOCIAL SCIENCES (ICESS; June 2019). Thailand: Bangkok.

  BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Wai Tong Chien, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and researchers (and center staff) are blind to the group assignment and intervention undertaken and concealed to the participant list.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment; repeated-measures 3-arm randomized controlled trial

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 18, 2019
• Study Start: December 1, 2020
• Primary Completion: May 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)