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

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ClinicalTrials.gov Identifier: NCT00940394
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : August 21, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: mutual support group Behavioral: psychoeducation group Other: Standard care Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Evaluation of the Effects of Mutual Support and Psycho-educational Group Interventions for Family Caregivers of People With Schizophrenia
Study Start Date : January 2007
Primary Completion Date : September 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 Name: 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 Name: FMSG
Active Comparator: psychoeducation group
bi-weekly, 12-session, family psychoeducation group program
Behavioral: psychoeducation group
bi-weekly, 12-session, family psychoeducation group
Other Name: FPGP


Outcome Measures

Primary Outcome Measures :
  1. length of re-hospitalizations [ Time Frame: at recruitment, six-month, 18-month and 36-month post-intervention ]

Secondary Outcome Measures :
  1. families' perceived social support [ Time Frame: at recruitment, six-month, 18-month and 36-month post-intervention ]
  2. patients' symptom severity [ Time Frame: at recruitment, six-month, 18-month and 36-month post-intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

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): NCT00940394


Locations
Hong Kong
Li Ka Shing Specialty OPD
Sha Tin, NT, Hong Kong
AHNH Psychiatric OPD
Taipo, NT, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Principal Investigator: Chien Wai-Tong, PhD The Hong Kong Polytechnic University
More Information