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Peer-led Psycho-education for Schizophrenia

Primary Purpose

Schizophrenia

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Peer-led psycho-education group
Profession-led psycho-education group
Routine psychiatric care
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring peer expert or specialist, psycho-education, schizophrenia, outpatients

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jilin Medical College
  • TM Psy Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Active Comparator

Arm Label

Peer-led psycho-education group

Routine psychiatric care

Profession-led psycho-education group

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 8, 2017
Last Updated
August 28, 2023
Sponsor
Chinese University of Hong Kong
Collaborators
Hospital Authority, Hong Kong, Jilin University Medical Science Division, Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03246932
Brief Title
Peer-led Psycho-education for Schizophrenia
Official Title
The Effectiveness of a Peer-led Psycho-education Group in Schizophrenia: A Multi-site Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Hospital Authority, Hong Kong, Jilin University Medical Science Division, Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
peer expert or specialist, psycho-education, schizophrenia, outpatients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be blinded to the group assignments.
Allocation
Randomized
Enrollment
342 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer-led psycho-education group
Arm Type
Experimental
Arm Description
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).
Arm Title
Routine psychiatric care
Arm Type
Other
Arm Description
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.
Arm Title
Profession-led psycho-education group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer-led psycho-education group
Intervention Description
A structured, researcher-designed peer-led psycho-education program (6 months), comprising of 12 bi-weekly, 2-hour group sessions.
Intervention Type
Behavioral
Intervention Name(s)
Profession-led psycho-education group
Intervention Description
A psychoeducation group program (12 sessions, bi-weekly).
Intervention Type
Other
Intervention Name(s)
Routine psychiatric care
Intervention Description
Routine psychiatric outpatient care, or Treatment-as-usual (TAU).
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale
Description
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.
Time Frame
from recruitment to 24-month follow-up
Title
Specific Level of Functioning Scale
Description
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.
Time Frame
from recruitment to 24-month follow-up
Secondary Outcome Measure Information:
Title
Re-hospitalization rate
Description
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.
Time Frame
from recruitment to 24-month follow-up
Title
Six-item Social Support Questionnaire
Description
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.
Time Frame
from recruitment to 24-month follow-up
Other Pre-specified Outcome Measures:
Title
Insights to illness and treatment
Description
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.
Time Frame
from recruitment to 24-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WT Chien, PhD
Organizational Affiliation
CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jilin Medical College
City
Jilin
State/Province
Jilin
ZIP/Postal Code
0432
Country
China
Facility Name
TM Psy Centre
City
Tuen Mun
State/Province
NT
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19481205
Citation
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.
Results Reference
background
PubMed Identifier
24109184
Citation
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.
Results Reference
background
PubMed Identifier
30946482
Citation
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.
Results Reference
background
PubMed Identifier
26193827
Citation
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.
Results Reference
background

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Peer-led Psycho-education for Schizophrenia

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