Peer-led Psycho-education for Schizophrenia

The Effectiveness of a Peer-led Psycho-education Group in Schizophrenia: A Multi-site Randomised Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Peer-led psycho-education group; Other: Routine psychiatric care; Behavioral: Profession-led psycho-education group

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.

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Jilin, Jilin, China, 0432
      • Jilin Medical College
• Hong Kong
  • NT
    • Tuen Mun, NT, Hong Kong
      • TM Psy Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: 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.; Other: Routine psychiatric care; Routine psychiatric outpatient care, or Treatment-as-usual (TAU).
Other: 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.	Other: Routine psychiatric care; Routine psychiatric outpatient care, or Treatment-as-usual (TAU).
Active Comparator: 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.	Other: Routine psychiatric care; Routine psychiatric outpatient care, or Treatment-as-usual (TAU).; Behavioral: Profession-led psycho-education group; A psychoeducation group program (12 sessions, bi-weekly).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-item Social Support Questionnaire	Patients' perceived social support will be assessed with the Six-item Social Support Questionnaire at baseline and one week, 6 months, 12 months and 24 months follow-up.	from recruitment to 24-month follow-up
Re-hospitalization rate	Average amount (number) and length of hospital stay of the patients over previous six months 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insights to illness and treatment	Patients' insight and attitudes to illness and treatment will be measured with the Insight and Treatment Attitudes Questionnaire at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.	from recruitment to 24-month follow-up

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Taipei Medical University; Hospital Authority, Hong Kong; Jilin University Medical Science Division
• Investigators: Principal Investigator: WT Chien, PhD, CUHK

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: schizophrenia; psycho-education; outpatients; peer expert or specialist
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: CWai-Tong

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No