NCT03246932

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable schizophrenia

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
3.3 years until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

March 19, 2026

Status Verified

August 1, 2025

Enrollment Period

4.5 years

First QC Date

August 8, 2017

Last Update Submit

March 17, 2026

Conditions

Schizophrenia

Keywords

peer expert or specialistpsycho-educationschizophreniaoutpatients

Outcome Measures

Primary Outcomes (2)

  • Positive and Negative Syndrome Scale

    The Positive and Negative Syndrome Scale assesses the severity of psychotic symptoms on three subscales: positive symptoms (7 items), negative symptoms (7 items) and general psychopathology (16 items). will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.

    from recruitment to 24-month follow-up

  • Specific Level of Functioning Scale

    Patients' levels of psychosocial functioning will be assessed with the Specific Level of Functioning Scale at baseline and one week, 6 months, 12 months and 24 months follow-up.

    from recruitment to 24-month follow-up

Secondary Outcomes (2)

  • Re-hospitalization rate

    from recruitment to 24-month follow-up

  • Six-item Social Support Questionnaire

    from recruitment to 24-month follow-up

Other Outcomes (1)

  • Insights to illness and treatment

    from recruitment to 24-month follow-up

Study Arms (3)

Peer-led psycho-education group

EXPERIMENTAL

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).

Behavioral: Peer-led psycho-education groupOther: Routine psychiatric care

Routine psychiatric care

OTHER

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.

Other: Routine psychiatric care

Profession-led psycho-education group

ACTIVE COMPARATOR

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.

Behavioral: Profession-led psycho-education groupOther: Routine psychiatric care

Interventions

Peer-led psycho-education groupBEHAVIORAL

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

Peer-led psycho-education group
Profession-led psycho-education groupBEHAVIORAL

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

Profession-led psycho-education group
Routine psychiatric careOTHER

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

Peer-led psycho-education groupProfession-led psycho-education groupRoutine psychiatric care

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jilin Medical College

Jilin, Jilin, 0432, China

Location

TM Psy Centre

Tuenmen, NT, Hong Kong

Location

Related Publications (4)

  • 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.

    PMID: 19481205BACKGROUND

  • 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.

    PMID: 24109184BACKGROUND

  • 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.

    PMID: 30946482BACKGROUND

  • 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: 26193827BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • WT Chien, PhD

    CUHK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be blinded to the group assignments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 11, 2017

Study Start

December 1, 2020

Primary Completion

May 31, 2025

Study Completion

September 30, 2025

Last Updated

March 19, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)CN(1)