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NCT Number: NCT03246932

Peer-led Psycho-education for Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jilin Medical College, Jilin City, Jilin, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peer-led psycho-education group

Behavioral

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

Profession-led psycho-education group

Behavioral

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

Routine psychiatric care

Other

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

Primary outcomes

  1. Positive and Negative Syndrome Scale

    Time frame: from recruitment to 24-month follow-up

    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.

  2. Specific Level of Functioning Scale

    Time frame: from recruitment to 24-month follow-up

    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 outcomes

  1. Re-hospitalization rate

    Time frame: from recruitment to 24-month follow-up

    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.

  2. Six-item Social Support Questionnaire

    Time frame: from recruitment to 24-month follow-up

    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.

Other outcomes

  1. Insights to illness and treatment

    Time frame: from recruitment to 24-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Hospital Authority, Hong Kong
  • Jilin University Medical Science Division
  • Taipei Medical University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 11, 2017
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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