Effects of a Peer-facilitated, Recovery-focused Self-illness Management Program for First-episode Psychosis

NCT06487195 | Active Not Recruiting DMC

• 1 other identifier: 16404722
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

Psychosis is a major disabling and disruptive mental illness characterized by a wide variety of disturbances in cognition and emotions, resulting in poor psychosocial functioning and frequent relapses. Despite convincing evidence of short-term symptom control and functional recovery, there has been a limited amount of data generated over the past two decades on the long-term outcomes of early interventions for psychotic patients (especially, first-episode psychosis, FEP). We propose a controlled trial with an adequate study power to examine the longer-term effects (18 months) of a Peer-facilitated, Recovery-focused Self-Illness-Management program (Peer-RESIM) for adults with FEP. Specifically, the proposed study will assess the effects of better-prepared PSWs, and a culturally adapted intervention protocol designed by our multidisciplinary research team, on improving patients' self-care and recovery.

Conditions

Psychotic Disorders

Keywords

First-episode psychosis; randomized controlled trial; peer facilitator; recovery; illness self-management; functioning

Outcome Measures

Primary Outcomes (8)

• Questionnaire about the Process of Recovery (QPR)

  Level of recovery from illness will be measured with the Questionnaire about the Process of Recovery (QPR) developed by Neil et al. (2009). It consists of 22 items and three subscales (self-empowerment, 10 items; effective interpersonal relationships, 6 items; and rebuilding life, 6 items). Items will be rated on a 5-point Likert scale (0, "disagree strongly" to 4, "agree strongly"; total score range, 0-88).

  Total score self-reported at recruitment

• Questionnaire about the Process of Recovery (QPR)

  Level of recovery from illness will be measured with the Questionnaire about the Process of Recovery (QPR) developed by Neil et al. (2009). It consists of 22 items and three subscales (self-empowerment, 10 items; effective interpersonal relationships, 6 items; and rebuilding life, 6 items). Items will be rated on a 5-point Likert scale (0, "disagree strongly" to 4, "agree strongly"; total score range, 0-88).

  Total score self-reported at 1 week post-intervention

• Questionnaire about the Process of Recovery (QPR)

  Level of recovery from illness will be measured with the Questionnaire about the Process of Recovery (QPR) developed by Neil et al. (2009). It consists of 22 items and three subscales (self-empowerment, 10 items; effective interpersonal relationships, 6 items; and rebuilding life, 6 items). Items will be rated on a 5-point Likert scale (0, "disagree strongly" to 4, "agree strongly"; total score range, 0-88).

  Total score self-reported at 9 months post-intervention

• Questionnaire about the Process of Recovery (QPR)

  Level of recovery from illness will be measured with the Questionnaire about the Process of Recovery (QPR) developed by Neil et al. (2009). It consists of 22 items and three subscales (self-empowerment, 10 items; effective interpersonal relationships, 6 items; and rebuilding life, 6 items). Items will be rated on a 5-point Likert scale (0, "disagree strongly" to 4, "agree strongly"; total score range, 0-88).

  Total score self-reported at 18 months post-intervention

• Specific Level of Functioning Scale (SLOF)

  Patient functioning will be measured with the 43-item Specific Level of Functioning Scale by Schneider and Struening (1983), consisting of 4 domains:- self-maintenance (12 items), social functioning (14 items), activities (11 items), and community-living skills (6 items), assessed using a 5-point Likert scale (1-"highly dependent/typical/always' to 5-"fully self-sufficient/ typical/never").

  Total score self-reported at recruitment

• Specific Level of Functioning Scale (SLOF)

  Patient functioning will be measured with the 43-item Specific Level of Functioning Scale by Schneider and Struening (1983), consisting of 4 domains:- self-maintenance (12 items), social functioning (14 items), activities (11 items), and community-living skills (6 items), assessed using a 5-point Likert scale (1-"highly dependent/typical/always' to 5-"fully self-sufficient/ typical/never").

  Total score self-reported at 1 week post-intervention

• Specific Level of Functioning Scale (SLOF)

  Patient functioning will be measured with the 43-item Specific Level of Functioning Scale by Schneider and Struening (1983), consisting of 4 domains:- self-maintenance (12 items), social functioning (14 items), activities (11 items), and community-living skills (6 items), assessed using a 5-point Likert scale (1-"highly dependent/typical/always' to 5-"fully self-sufficient/ typical/never").

  Total score self-reported at 9 months post-intervention

• Specific Level of Functioning Scale (SLOF)

  Patient functioning will be measured with the 43-item Specific Level of Functioning Scale by Schneider and Struening (1983), consisting of 4 domains:- self-maintenance (12 items), social functioning (14 items), activities (11 items), and community-living skills (6 items), assessed using a 5-point Likert scale (1-"highly dependent/typical/always' to 5-"fully self-sufficient/ typical/never").

  Total score self-reported at 18 months post-intervention

Secondary Outcomes (4)

• Positive and Negative Syndrome Scale (PANSS)

  Changes in mean scores from recruitment to 18 months follow-up

• Chinese version of the Revised Social-Problem-Solving Inventory (C-SPSI-R:S)

  Changes in mean scores from recruitment to 18 months follow-up

• RE-hospitalisation rates

  Changes in average rates from recruitment to 18 months follow-up

• 8-item Client Satisfaction Questionnaire (CSQ-8)

  Changes in mean scores from recruitment to 18 months follow-up

Other Outcomes (1)

• Perception and insight/attitude towards illness/treatment

  Changes in mean scores from recruitment to 18 months follow-up

Study Arms (3)

Peer-facilitated, Recovery-based Self-illness-management programme (Peer-RESIM)

EXPERIMENTAL

The Peer-RESIM consists of 10 1.5-hour sessions (7-12 day intervals; 4 months), based on the modified CORE program manual and psychoeducation programs developed by the research team. The printed/online program is based on a self-care, personal plan for recovery workbook with 4 key 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 for problem-solving and maintaining wellbeing. After completing the recovery plan, participants will be empowered and supported by a peer-support worker and group members during scheduled sharing sessions.

Behavioral: Peer-facilitated, Recovery-based Self-illness-management programme; Behavioral: Treatment-as-usual only

Psycho-education group

ACTIVE COMPARATOR

The psychoeducation group (6 subgroups; 10-12 participants per group) will be led by one experienced psychiatric nurse trained in psychiatric rehabilitation and psychoeducation group programs. The program will be guided by a validated treatment protocol based on psychoeducation programs for psychotic disorders developed by the research team and McFarlane et al. The psychoeducation program consists of ten 2-hour sessions held weekly/biweekly (similar to the Peer-RESIM, completed within 4 months), with 4 key components, including introduction and goal setting; an education workshop on psychosis, treatments, and community services; group exercises and rehearsals and discussions on illness management, coping and self-care; and a summary, evaluation and future plan.

Behavioral: Psycho-education group; Behavioral: Treatment-as-usual only

Treatment-as-usual only (TAU)

OTHER

Participants in the usual care only group (and the two intervention groups) will receive routine community mental healthcare services.

Behavioral: Treatment-as-usual only

Interventions

Peer-facilitated, Recovery-based Self-illness-management programme BEHAVIORAL

The Peer-RESIM program will consist of 10 1.5-hour sessions (7-12 day intervals; 4 months), based on the modified CORE program workbook/manual and psychoeducation programmes developed by the research team.

Also known as: Peer-RESIM

Peer-facilitated, Recovery-based Self-illness-management programme (Peer-RESIM)

Psycho-education group BEHAVIORAL

The psychoeducation group (6 subgroups; 10-12 participants per subgroup) will be led by one experienced psychiatric nurse trained in psychiatric rehabilitation and psychoeducation group programmes.

Psycho-education group

Treatment-as-usual only BEHAVIORAL

Participants in the TAU group will receive routine community mental healthcare services.

Also known as: TAU

Peer-facilitated, Recovery-based Self-illness-management programme (Peer-RESIM); Psycho-education group; Treatment-as-usual only (TAU)

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;
• clinically and primarily diagnosed with a first-episode psychosis according to the DSM-V criteria (American Psychiatric Association 2013), and within 3 years onset of illness;
• able to understand Cantonese/Mandarin; and
• having Global Assessment of Functioning scores ≥51, indicating mild-to-moderate symptoms and challenges in maintaining work/school/family roles, but mentally stable and comprehendible to the training and education offered

You may not qualify if:

• recently received/are currently receiving another psychosocial or psychoeducation intervention;
• having a comorbidity of learning/cognitive/personality disorder, and/or clinically significant medical disease; or
• having a visual/language/communication difficulty/disorder.

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 (4)

• Chien WT, Bressington D. A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Res. 2015 Sep 30;229(1-2):277-86. doi: 10.1016/j.psychres.2015.07.012. Epub 2015 Jul 10.

  PMID: 26193827 BACKGROUND

• 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

• Craig TK, Garety P, Power P, Rahaman N, Colbert S, Fornells-Ambrojo M, Dunn G. The Lambeth Early Onset (LEO) Team: randomised controlled trial of the effectiveness of specialised care for early psychosis. BMJ. 2004 Nov 6;329(7474):1067. doi: 10.1136/bmj.38246.594873.7C. Epub 2004 Oct 14.

  PMID: 15485934 BACKGROUND

• D'Zurilla TJ, Nezu A,M. Problem-solving therapy : a positive approach to clinical intervention,3rd ed. New York, NY: Springer; 2007.

  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: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors, researchers and clinical staff are blind to the group and intervention assignment; they are also concealed to the participant lists.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel assignment; repeated-measures, multi-centre 3-arm RCT

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 5, 2024
• Study Start: February 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)