Effectiveness of Family Group Interventions for People With Schizophrenia (MSG)

August 19, 2014 updated by: Chien Wai-Tong, The Hong Kong Polytechnic University

Evaluation of the Effects of Mutual Support and Psycho-educational Group Interventions for Family Caregivers of People With Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • NT
      • Sha Tin, NT, Hong Kong
        • Li Ka Shing Specialty OPD
      • Taipo, NT, Hong Kong
        • AHNH Psychiatric OPD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: standard care
Families receive routine community and family mental health care services
Other: Standard care
Routine mental health care services provided by the outpatient clinic and related agencies for families of people with schizophrenia
Other Names:
  • Usual psychiatric care
Experimental: mutual support group
bi-weekly, 12-session, family-led mutual support group
Behavioral: mutual support group
bi-weekly, 12-session, family-led mutual support group
Other Names:
  • FMSG
Active Comparator: psychoeducation group
bi-weekly, 12-session, family psychoeducation group program
Behavioral: psychoeducation group
bi-weekly, 12-session, family psychoeducation group
Other Names:
  • FPGP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
length of re-hospitalizations
Time Frame: at recruitment, six-month, 18-month and 36-month post-intervention
at recruitment, six-month, 18-month and 36-month post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
families' perceived social support
Time Frame: at recruitment, six-month, 18-month and 36-month post-intervention
at recruitment, six-month, 18-month and 36-month post-intervention
patients' symptom severity
Time Frame: at recruitment, six-month, 18-month and 36-month post-intervention
at recruitment, six-month, 18-month and 36-month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Chien Wai-Tong, PhD, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 15, 2009

First Submitted That Met QC Criteria

July 15, 2009

First Posted (Estimate)

July 16, 2009

Study Record Updates

Last Update Posted (Estimate)

August 21, 2014

Last Update Submitted That Met QC Criteria

August 19, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 216020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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