Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 4:41 AM
Study NCT ID:
NCT00940394
Status:
COMPLETED
Last Update Posted:
2014-08-21
First Post:
2009-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Family Group Interventions for People With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-19', 'studyFirstSubmitDate': '2009-07-15', 'studyFirstSubmitQcDate': '2009-07-15', 'lastUpdatePostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of re-hospitalizations', 'timeFrame': 'at recruitment, six-month, 18-month and 36-month post-intervention'}], 'secondaryOutcomes': [{'measure': "families' perceived social support", 'timeFrame': 'at recruitment, six-month, 18-month and 36-month post-intervention'}, {'measure': "patients' symptom severity", 'timeFrame': 'at recruitment, six-month, 18-month and 36-month post-intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mutual support group', 'psychoeducation group', 'family caregivers', 'schizophrenia'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '18584319', 'type': 'RESULT', '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.'}, {'pmid': '23820670', 'type': 'RESULT', '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.'}, {'pmid': '23433723', 'type': 'RESULT', 'citation': '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.2013.01.004. Epub 2013 Feb 19.'}, {'pmid': '30618880', 'type': 'DERIVED', 'citation': 'Chien WT, Bressington D, Chan SWC. A Randomized Controlled Trial on Mutual Support Group Intervention for Families of People With Recent-Onset Psychosis: A Four-Year Follow-Up. Front Psychiatry. 2018 Dec 18;9:710. doi: 10.3389/fpsyt.2018.00710. eCollection 2018.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2582821/pdf/TONURSJ-2-28.pdf', 'label': 'Effectiveness of Psychoeducation and Mutual Support Group Program for Family Caregivers of Chinese People with Schizophrenia'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* family caregivers were at least 18 years of age and could understand and read the Chinese (Mandarin) language; and\n* family caregivers were free from any mental illness themselves.\n\nExclusion Criteria:\n\n* the patients with schizophrenia suffered no co-morbidity due to other mental illness during recruitment to the study\n* family caregivers cared for more than one family member with mental or chronic physical illness; and/or\n* family caregivers had been the primary carers for less than three months'}, 'identificationModule': {'nctId': 'NCT00940394', 'acronym': 'MSG', 'briefTitle': 'Effectiveness of Family Group Interventions for People With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Evaluation of the Effects of Mutual Support and Psycho-educational Group Interventions for Family Caregivers of People With Schizophrenia', 'orgStudyIdInfo': {'id': '216020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'standard care', 'description': 'Families receive routine community and family mental health care services', 'interventionNames': ['Other: Standard care']}, {'type': 'EXPERIMENTAL', 'label': 'mutual support group', 'description': 'bi-weekly, 12-session, family-led mutual support group', 'interventionNames': ['Behavioral: mutual support group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'psychoeducation group', 'description': 'bi-weekly, 12-session, family psychoeducation group program', 'interventionNames': ['Behavioral: psychoeducation group']}], 'interventions': [{'name': 'mutual support group', 'type': 'BEHAVIORAL', 'otherNames': ['FMSG'], 'description': 'bi-weekly, 12-session, family-led mutual support group', 'armGroupLabels': ['mutual support group']}, {'name': 'psychoeducation group', 'type': 'BEHAVIORAL', 'otherNames': ['FPGP'], 'description': 'bi-weekly, 12-session, family psychoeducation group', 'armGroupLabels': ['psychoeducation group']}, {'name': 'Standard care', 'type': 'OTHER', 'otherNames': ['Usual psychiatric care'], 'description': 'Routine mental health care services provided by the outpatient clinic and related agencies for families of people with schizophrenia', 'armGroupLabels': ['standard care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'state': 'NT', 'country': 'Hong Kong', 'facility': 'Li Ka Shing Specialty OPD', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}, {'city': 'Taipo', 'state': 'NT', 'country': 'Hong Kong', 'facility': 'AHNH Psychiatric OPD'}], 'overallOfficials': [{'name': 'Chien Wai-Tong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chien Wai-Tong', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}