Peer-led Psycho-education for Schizophrenia

NCT ID: NCT03246932

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 342 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2025-09-30

Brief Summary

Profession-led psycho-education programs for people with schizophrenia are evidenced to improve patients' knowledge about the illness, mental state and relapse rate. Nevertheless, other benefits to patients, for example, their functioning and insight into illness or to be substantive in a longer term (>12 months) are inconsistent and uncertain, especially in Asian populations. This single-blind multi-site randomized clinical trial was to test the effects of a peer-expert-led psycho-education group intervention (in addition to usual care) for adult patients with schizophrenia spectrum disorders over a 24-month follow-up, in comparison to a profession-led psycho-education group or treatment-as-usual only.

Detailed Description

Objectives: This study is to test the effectiveness of a peer-expert-led psycho-education group programme for Chinese outpatients with schizophrenia spectrum disorders over an 24-month follow-up. The program is an integrated,psycho-education program that addresses patients' knowledge and self-management of schizophrenia and problem-solving skills. Methods: A single-blind, multi-site randomized controlled trial will be conducted with 342 Chinese patients with schizophrenia in Hong Kong, China and Taiwan. In each of three study sites, the participants will be randomly selected from the eligible patient list (i.e., 114 subjects from each study site) and after baseline measurement, be assigned to either the peer-led psycho-education program, profession-led psycho-education group, or usual psychiatric care. The patients' mental and psychosocial functioning, insights into illness, and their re-hospitalization rates will be measured at recruitment and at one week, and 6, 12 and 24 months after completing the interventions. Hypothesis: The patients in the peer-led psycho-education program will report significantly greater improvements in their symptoms and re-hospitalisation rates (primary outcomes) and other secondary outcomes (e.g., insight into illness and functioning) over the 24-month follow-up, when compared with those in profession-led psycho-education group and/or usual care. Conclusions: The findings will provide evidence whether the peer-led psycho-education group program can better improve Chinese schizophrenia sufferers' psychosocial functioning and reduce their illness relapse.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Peer-led psycho-education group

A structured, researcher-designed peer expert-led psycho-education program (6 months), comprised of 12 bi-weekly, 2-hour group sessions (10-12 patients per group). The program was based on the psycho-education and self-help, problem-solving programs by Chien et al. (2010) and Lehman et al. (2004).

Group Type: EXPERIMENTAL

Peer-led psycho-education group

Intervention Type: BEHAVIORAL

A structured, researcher-designed peer-led psycho-education program (6 months), comprising of 12 bi-weekly, 2-hour group sessions.

Routine psychiatric care

Intervention Type: OTHER

Routine psychiatric outpatient care, or Treatment-as-usual (TAU).

Routine psychiatric care

Routine psychiatric outpatient care, including medication, psychiatric consultation in outpatient clinic, brief education by psychiatric nurses, financial and social welfare advices by social workers, and individual counseling by clinical psychologist.

Group Type: OTHER

Routine psychiatric care

Intervention Type: OTHER

Routine psychiatric outpatient care, or Treatment-as-usual (TAU).

Profession-led psycho-education group

A psycho-education group program (12 sessions, bi-weekly) based on Dr. Macpherson's Family Psychoeducation Program in 1996 and Chien and Bressington's one in 2014/15 will be used.

Group Type: ACTIVE_COMPARATOR

Profession-led psycho-education group

Intervention Type: BEHAVIORAL

A psychoeducation group program (12 sessions, bi-weekly).

Routine psychiatric care

Intervention Type: OTHER

Routine psychiatric outpatient care, or Treatment-as-usual (TAU).

Interventions

Peer-led psycho-education group

A structured, researcher-designed peer-led psycho-education program (6 months), comprising of 12 bi-weekly, 2-hour group sessions.

Intervention Type: BEHAVIORAL

Profession-led psycho-education group

A psychoeducation group program (12 sessions, bi-weekly).

Intervention Type: BEHAVIORAL

Routine psychiatric care

Routine psychiatric outpatient care, or Treatment-as-usual (TAU).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients, aged 18+, attending one psychiatric outpatient clinic under study;
• diagnosed as schizophrenia and its subtypes according to the Diagnostic and Statistical Manual, 4th Text-Revised Edition, as ascertained by the Structured Clinical Interview (SCID-I);
• having onset of the illness for not >5 years; and
• able to communicate in Cantonese language.

Exclusion Criteria

• mentally unstable and unfit for study participation at recruitment;
• with co-morbidity of other severe mental health problems such as depression and substance misuse; and
• have recently received or are receiving any structured psychosocial intervention.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role: collaborator

Jilin University Medical Science Division

UNKNOWN

Sponsor Role: collaborator

Taipei Medical University

OTHER

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

WT Chien, PhD

Role: PRINCIPAL_INVESTIGATOR

CUHK

Locations

Jilin Medical College

Jilin, Jilin, China

TM Psy Centre

Tuenmen, NT, Hong Kong

Countries

China; Hong Kong

References

Chien WT, Norman I. The effectiveness and active ingredients of mutual support groups for family caregivers of people with psychotic disorders: a literature review. Int J Nurs Stud. 2009 Dec;46(12):1604-23. doi: 10.1016/j.ijnurstu.2009.04.003. Epub 2009 May 28.

Reference Type: BACKGROUND

PMID: 19481205 (View on PubMed)

Chien WT, Leung SF, Yeung FK, Wong WK. Current approaches to treatments for schizophrenia spectrum disorders, part II: psychosocial interventions and patient-focused perspectives in psychiatric care. Neuropsychiatr Dis Treat. 2013;9:1463-81. doi: 10.2147/NDT.S49263. Epub 2013 Sep 25.

Reference Type: BACKGROUND

PMID: 24109184 (View on PubMed)

Chien WT, Clifton AV, Zhao S, Lui S. Peer support for people with schizophrenia or other serious mental illness. Cochrane Database Syst Rev. 2019 Apr 4;4(4):CD010880. doi: 10.1002/14651858.CD010880.pub2.

Reference Type: BACKGROUND

PMID: 30946482 (View on PubMed)

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)

Other Identifiers

CWai-Tong

Identifier Type: -

Identifier Source: org_study_id