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

NCT ID: NCT06487195

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-10-31

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.

Detailed Description

People with first-episode psychosis (FEP) are often anxious/stressed and unprepared to manage the illness and associated disturbances of daily living and functioning. Due to this unpreparedness for illness management and diverse adverse health effects in FEP, different approaches to psychosocial interventions provide significant benefits in improving patients' symptom management and preventing relapses. However, similar to early interventions, inconsistent/inconclusive results have been reported for most psychosocial health outcomes, particularly over a long-term follow-up.

There is increasing evidence showing that recovery-focused care is an effective approach to community-based psychiatric rehabilitation and mental health practice. Using this approach, empowered self-help and hope cultivation can help patients develop a sense of purpose and meaning in life and optimism for the future. Peer support can be provided by ex-/co-patients with similar illness experience who have been trained to provide voluntary/in-job mental health services. Consequently, they are well-placed to model and encourage active and autonomous recovery in their peers (fellow-patients). This innovative method of supporting recovery-focused mental healthcare is increasingly popular among those developing mental healthcare services and policies.[9] However, there few high-quality trials have assessed this strategy, and there is little evidence of its positive effects on functional and clinical recovery, symptoms and hospitalizations and service satisfaction, especially in Asian countries. Structured self-help (and/or peer-supported) training and practices may have the advantage of empowering and facilitating FEP patients to meet their (co-patients') real-life personal and illness care goals; they also minimize professional input, which may enhance the feasibility, accessibility, and/or user-friendliness of an intervention and keep its cost of delivery low.

Milton and our (1st-)Co-I conducted a multi-center randomized controlled trial of peer-facilitated recovery from severe mental illness intervention in England, using the Crisis- Resolution-Team Optimisation and RElapse Prevention(CORE) program. In their trial, significantly fewer participants in the treatment group (n=120) were admitted to inpatient care (29%vs.38%), time-to-readmission was longer (112vs.86 days), and service satisfaction was higher (78%vs.41%) than the usual care only group, over a 1-year follow-up period. A similar service is required in Hong Kong, and this peer-facilitated, self-management model/approach can be adopted/tested.

Mental healthcare should maximize the self-management of individual first-episode psychosis patients' mental wellbeing, peer support, and experience-sharing for patients to improve their illness self-care and recovery. Based on the findings of Milton's and our Co-I's randomized trial of CORE program, a similar peer-facilitated, recovery-based self-illness-management program can be adopted/tested in Hong Kong, with cultural adaptations to match local service development strategies/needs.

This proposed randomized controlled trial tests two main hypotheses that:

(1) the Peer-facilitated, Recovery-focused Self-Illness-Management program (Peer-RESIM) will yield significantly greater improvements than psychoeducation and/or routine-care only at 1-week, 9-month and/or 18-month follow-ups in patients' recovery and functioning (primary outcomes).

2. It also tests the hypothesis that the Peer-RESIM will yield significantly greater improvements than the other two groups at 1-week, 9-month and/or 18-month follow-ups in psychotic symptoms, problem-solving, re-hospitalization rates, and/or service satisfaction (secondary outcomes).

The trial examines whether the Peer-RESIM participants will indicate clinically significant changes/benefits in two primary outcomes at 1-week, 9-month and/or 18-month follow-ups.

In addition, focus-group interviews will be conducted to explore the perceived benefits, service satisfaction and strengths/limitations of the Peer-RESIM from peer-facilitators' and participants' perspectives.

Methods: A assessor-blinded, three-arm multi-centre RCT was conducted. A list of 198 Chinese adult patients with FEP randomly selected from four Community Centers for Mental Wellness in Hong Kong (in 2023) (i.e., 16-17 subjects/group from each center; a total of 66 participants per group) and randomly assigned into one of the three study groups (Peer-RESIM, psycho-education, or usual care only group) by matching with computerized random numbers.

After four-month interventions, the patient outcomes will be measured at immediately, 9 months, and 18 months post-intervention, and analysed on intention-to-treat basis. Clinical significant changes in the primary outcomes will be assessed within and between groups according to Jacobson and Traux's criteria to examine the clinical benefits to patients. Focus-group interviews will also be conducted to explore the perceived benefits, service satisfaction and strengths/limitations of the Peer-RESIM from peer-facilitators' and participants' perspectives.

Study outcomes and variables:

Socio-demographic and clinical data (e.g., gender, age, clinical diagnosis, illness duration, and medications) will be collected at baseline, and changes in medications will be recorded during the study.

Primary outcomes include: the Questionnaire about the Process of Recovery (QPR) and the 43-item Specific Level of Functioning Scale.

Secondary outcomes include: the 30-item Positive and Negative Syndrome Scale (PANSS); the Revised Social-Problem-Solving Inventory (C-SPSI-R:S); Frequency and length of time to rehospitalization(s); and the 8-item Client Satisfaction Questionnaire (CSQ-8). (Note: illness/treatment insight and drug attitude as appropriate).

Conditions

Psychotic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Treatment-as-usual only

Intervention Type: BEHAVIORAL

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

Psycho-education group

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.

Group Type: ACTIVE_COMPARATOR

Psycho-education group

Intervention Type: 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.

Treatment-as-usual only

Intervention Type: BEHAVIORAL

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

Treatment-as-usual only (TAU)

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

Group Type: OTHER

Treatment-as-usual only

Intervention Type: BEHAVIORAL

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

Interventions

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

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.

Intervention Type: BEHAVIORAL

Psycho-education group

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.

Intervention Type: BEHAVIORAL

Treatment-as-usual only

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Peer-RESIM; TAU

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Integrated Community Centers for Mental Wellness

UNKNOWN

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Wai Tong CHIEN

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wai Tong Chien, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Integrated Community Centers for Mental Wellness

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: BACKGROUND

PMID: 26193827 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30102174 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15485934 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

16404722

Identifier Type: -

Identifier Source: org_study_id