Peer-led Psycho-education for Schizophrenia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Peer-led psycho-education group
* Behavioral: Profession-led psycho-education group
* Other: Routine psychiatric care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer-led psycho-education group<br>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<br>* A structured, researcher-designed peer-led psycho-education program (6 months), comprising of 12 bi-weekly, 2-hour group sessions.<br>Other: Routine psychiatric care<br>* Routine psychiatric outpatient care, or Treatment-as-usual (TAU).<br>|
| Other: Routine psychiatric care<br>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<br>* Routine psychiatric outpatient care, or Treatment-as-usual (TAU).<br>|
| Active Comparator: Profession-led psycho-education group<br>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 group<br>* A psychoeducation group program (12 sessions, bi-weekly).<br>Other: Routine psychiatric care<br>* Routine psychiatric outpatient care, or Treatment-as-usual (TAU).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peer expert or specialist, psycho-education, schizophrenia, outpatients