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Peer-led Psycho-education for Schizophrenia

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ClinicalTrials.gov Identifier: NCT03246932
Recruitment Status : Active, not recruiting
First Posted : August 11, 2017
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
Hospital Authority, Hong Kong
Jilin University Medical Science Division
Taipei Medical University
Information provided by (Responsible Party):
Prof. Wai Tong CHIEN, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Peer-led psycho-education group Behavioral: Profession-led psycho-education group Other: Routine psychiatric care Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor will be blinded to the group assignments.
Primary Purpose: Treatment
Official Title: The Effectiveness of a Peer-led Psycho-education Group in Schizophrenia: A Multi-site Randomised Controlled Trial
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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).

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.
Behavioral: Profession-led psycho-education group
A psychoeducation group program (12 sessions, bi-weekly).

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246932


Locations
China, Jilin
Jilin Medical College
Jilin, Jilin, China, 0432
Hong Kong
TM Psy Centre
Tuen Mun, NT, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Hospital Authority, Hong Kong
Jilin University Medical Science Division
Taipei Medical University
Investigators
Principal Investigator: WT Chien, PhD The HK Polytechnic University

Publications:
Responsible Party: Prof. Wai Tong CHIEN, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03246932     History of Changes
Other Study ID Numbers: CWai-Tong
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Prof. Wai Tong CHIEN, Chinese University of Hong Kong:
peer expert or specialist
psycho-education
schizophrenia
outpatients

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders