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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00940394
Other study ID # 216020
Secondary ID
Status Completed
Phase Phase 2
First received July 15, 2009
Last updated August 19, 2014
Start date January 2007
Est. completion date December 2011

Study information

Verified date August 2014
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority Hong Kong: The Chinese University of Hong Kong / The Hong Kong Polytechnic University
Study type Interventional

Clinical Trial Summary

The mutual support group intervention would significantly improve the families' burden of care, functioning and social support, reduce the patients' severity of symptoms and re-hospitalizations, and reduce the demands for utilization of family services, when compared with the standard care group.


Description:

Family interventions in schizophrenia have shown positive effects on patients but little attention has been paid to their effects on family members, particularly those in non-Western countries. This multi-site randomized controlled trial evaluated the effectiveness of a bi-weekly, 12-session, family-led mutual support group for Chinese caregivers of schizophrenia sufferers over 36 months, compared with a family psychoeducation group program and standard psychiatric care. It was conducted with 114 families of outpatients with schizophrenia in Hong Kong of whom 38 were assigned randomly to a mutual support group, a psychoeducation group, or standard care. Families' psychosocial health status and patients' symptom severity and length of re-hospitalizations at recruitment, one-month, 18-month, and 36-month post-intervention were compared between groups.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date December 2011
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- family caregivers lived with and cared for one family member diagnosed with schizophrenia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV; American Psychiatric Association, 1994)

- family caregivers were at least 18 years of age and could understand and read the Chinese (Mandarin) language; and

- family caregivers were free from any mental illness themselves.

Exclusion Criteria:

- the patients with schizophrenia suffered no co-morbidity due to other mental illness during recruitment to the study

- family caregivers cared for more than one family member with mental or chronic physical illness; and/or

- family caregivers had been the primary carers for less than three months

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
mutual support group
bi-weekly, 12-session, family-led mutual support group
psychoeducation group
bi-weekly, 12-session, family psychoeducation group
Other:
Standard care
Routine mental health care services provided by the outpatient clinic and related agencies for families of people with schizophrenia

Locations

Country Name City State
Hong Kong Li Ka Shing Specialty OPD Sha Tin NT
Hong Kong AHNH Psychiatric OPD Taipo NT

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (3)

Chien WT, Chan SW. The effectiveness of mutual support group intervention for Chinese families of people with schizophrenia: a randomised controlled trial with 24-month follow-up. Int J Nurs Stud. 2013 Oct;50(10):1326-40. doi: 10.1016/j.ijnurstu.2013.01.0 — View Citation

Chien WT, Thompson DR, Norman I. Evaluation of a peer-led mutual support group for Chinese families of people with schizophrenia. Am J Community Psychol. 2008 Sep;42(1-2):122-34. doi: 10.1007/s10464-008-9178-8. — View Citation

Chien WT, Thompson DR. An RCT with three-year follow-up of peer support groups for Chinese families of persons with schizophrenia. Psychiatr Serv. 2013 Oct;64(10):997-1005. doi: 10.1176/appi.ps.201200243. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary length of re-hospitalizations at recruitment, six-month, 18-month and 36-month post-intervention No
Secondary families' perceived social support at recruitment, six-month, 18-month and 36-month post-intervention No
Secondary patients' symptom severity at recruitment, six-month, 18-month and 36-month post-intervention No
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