Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-04 @ 8:44 PM
Study NCT ID:
NCT04430868
Status:
UNKNOWN
Last Update Posted:
2020-06-12
First Post:
2020-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Redesign For 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-11', 'studyFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2020-06-11', 'lastUpdatePostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change scores of Brief Psychiatric Symptom Rating Scale (BSRS)', 'timeFrame': '3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention', 'description': 'The Chinese version of BSRS with 50 items is administered to measure psychiatric symptoms. BSRS items were evaluated on a five-point Likert scale from 0 (not present) to 4 (extremely severe). The total score ranged from 0 to 200, with higher scores reflecting more severe of psychiatric symptoms.'}, {'measure': 'Change scores of Occupational Self Assessment (OSA)', 'timeFrame': '3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention', 'description': 'The OSA with 29 items is administered to measure occupational engagement.'}, {'measure': 'Change scores of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)', 'timeFrame': '3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention', 'description': 'The Chinese version of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) was administered to measure subjective quality of life. The total scores ranged from 33-165, with higher scores indicating comparatively lower quality of life.'}, {'measure': 'Change scores of Montreal Cognitive Assessment (MoCA)', 'timeFrame': '3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention', 'description': 'The Chinese version of MoCA was administered to measure cognition, with higher scores indicating better cognition.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Rehabilitation']}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the effects of lifestyle redesign program plus treatment as usual versus treatment as usual on cognition, psychiatric symptoms, quality of life, and occupational engagement for schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of schizophrenia, based on the ICD-10 diagnostic criteria for research (World Health Organization, 1992)\n* age from 20 to 65\n* attending day care center regularly for at least 1 month and taking stable dose of medication\n\nExclusion Criteria:\n\n* comorbid other mental disorder (e.g. depression, anxiety, ADHD...etc.)\n* comorbid mental retardation\n* lacking the reading and writing skills'}, 'identificationModule': {'nctId': 'NCT04430868', 'briefTitle': 'Lifestyle Redesign For Schizophrenia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan'}, 'officialTitle': 'The Impact of Lifestyle Redesign Program in Schizophrenia', 'orgStudyIdInfo': {'id': 'B20190705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LRP group', 'description': 'The participants in LRP group receive lifestyle redesign program plus treatment as usual. The LRP intervention consisted of one 90-minute session each week for 10 weeks', 'interventionNames': ['Behavioral: lifestyle redesign program']}, {'type': 'NO_INTERVENTION', 'label': 'TAU group', 'description': 'The participants in TAU group received usual treatment at the same time as LRP group.'}], 'interventions': [{'name': 'lifestyle redesign program', 'type': 'BEHAVIORAL', 'description': 'In this group, it starts with health education, the participants then change their opinions and experience health activities, and it ends with discussion and sharing their experience.', 'armGroupLabels': ['LRP group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Occupational Therapist', 'investigatorFullName': 'YU SHIUAN LIAW', 'investigatorAffiliation': 'Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan'}}}}