Clinical trial NCT03246932: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Schizophrenia
Keywords: peer expert or specialist
psycho-education
schizophrenia
outpatients
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hospital Authority, Hong Kong
name: Jilin University Medical Science Division
name: Taipei Medical University
First posted: 2017-08-11
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Positive and Negative Syndrome Scale
timeFrame: from recruitment to 24-month follow-up
measure: Specific Level of Functioning Scale
timeFrame: from recruitment to 24-month follow-up
Secondary outcomes:
measure: Re-hospitalization rate
timeFrame: from recruitment to 24-month follow-up
measure: Six-item Social Support Questionnaire
timeFrame: from recruitment to 24-month follow-up
Other outcomes:
measure: Insights to illness and treatment
timeFrame: from recruitment to 24-month follow-up
Locations:
city: Jilin
country: China
facility: Jilin Medical College
state: Jilin
city: Tuen Mun
country: Hong Kong
facility: TM Psy Centre
state: NT
Study officials:
affiliation: CUHK
name: WT Chien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.