Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 11:47 AM
Study NCT ID:
NCT01006694
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2009-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paraprofessional Treatment of Depression in Vietnam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D017367', 'term': 'Selective Serotonin Reuptake Inhibitors'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D014179', 'term': 'Neurotransmitter Uptake Inhibitors'}, {'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D018490', 'term': 'Serotonin Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 473}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2009-11-02', 'studyFirstSubmitQcDate': '2009-11-02', 'lastUpdatePostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change across time (random effects slope) in depressive symptoms, as assessed by the PHQ-9 questionnaire', 'timeFrame': '0, 6, 12, 24 weeks', 'description': 'The PHQ-9 (Patient Health Questionnaire-9) assesses depressive symptoms, over the last two weeks. It is assessed at 0, 6, 12, 24 weeks. The outcome target is the linear and quadratic change slopes across these 4 time points.'}], 'secondaryOutcomes': [{'measure': 'Change across time (random effects slope) in anxiety symptoms, as assessed by the GAD-7 questionnaire', 'timeFrame': '0, 6, 12, 24 weeks', 'description': 'The GAD-7 (General Anxiety Disorder-7) assesses anxiety symptoms, over the last two weeks. It is assessed at 0, 6, 12, 24 weeks. The outcome target is the linear and quadratic change slopes across these 4 time points.'}, {'measure': 'Change across time (random effects slope) in physical health, as assessed by the SF-12 questionnaire, Physical Health subscale', 'timeFrame': '0, 6, 12, 24 weeks', 'description': 'The SF-12 questionnaire, Physical Health subscale, assesses physical health functioning. It is assessed at 0, 6, 12, 24 weeks. The outcome target is the linear and quadratic change slopes across these 4 time points.'}, {'measure': 'Change across time (random effects slope) in mental health, as assessed by the SF-12 questionnaire, Mental Health subscale', 'timeFrame': '0, 6, 12, 24 weeks', 'description': 'The SF-12 questionnaire, Mental Health subscale, assesses mental health functioning. It is assessed at 0, 6, 12, 24 weeks. The outcome target is the linear and quadratic change slopes across these 4 time points.'}, {'measure': 'Change across time (random effects slope) in behavioral activation skills and behaviors, as assessed by the BADS questionnaire.', 'timeFrame': '0, 6, 12, 24 weeks', 'description': 'The BADS (Behavioral Activation for Depression Scale) questionnaire assesses behavioral activation-related skills and behaviors. It is assessed at 0, 6, 12, 24 weeks. The outcome target is the linear and quadratic change slopes across these 4 time points.'}, {'measure': '"Substantial improvement" in depressive symptoms, as assessed by the PHQ-9', 'timeFrame': '6, 12, 24 weeks', 'description': 'Rates of substantial symptomatic improvement (50% or greater reduction in PHQ-9 scores from baseline), to (a) 6 weeks, (b) 12 weeks, (c) 24 weeks.'}, {'measure': '"Depression remission", as assessed by the PHQ-9', 'timeFrame': '6, 12, 24 weeks', 'description': 'Depression remission (PHQ-9\\<5), at (a) 6 weeks, (b) 12 weeks, (c) 24 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression', 'collaborative care', 'Vietnam', 'behavioral activation'], 'conditions': ['Depressive Symptoms']}, 'descriptionModule': {'briefSummary': 'Trained para-professional health care workers will implement a stepped-care model of depression care in commune health stations in Vietnam.', 'detailedDescription': 'This project focuses on evaluation of a collaborative care system for treatment of depression in Vietnam. This system involves training para-professional health care workers in a stepped-care model system of depression care to be implemented in commune health stations in Vietnam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>=18\n2. Depression Diagnosis\n\nExclusion Criteria: active psychosis, mania, substance abuse, suicidal behaviors, cognitive impairment.'}, 'identificationModule': {'nctId': 'NCT01006694', 'briefTitle': 'Paraprofessional Treatment of Depression in Vietnam', 'organization': {'class': 'OTHER', 'fullName': 'Vietnam Veterans of America Foundation'}, 'officialTitle': 'Paraprofessional Treatment of Depression in Vietnam', 'orgStudyIdInfo': {'id': '20090928.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Guideline Antidepressant Medication', 'description': 'Guideline Antidepressant Medication, following the VN National Mental Health plan.', 'interventionNames': ['Drug: Guideline Antidepressant Medication']}, {'type': 'EXPERIMENTAL', 'label': 'Behavioral Activation + Medication', 'description': 'Psychoeducation, behavioral activation therapy, and medication delivered within a collaborative care model.', 'interventionNames': ['Other: Behavioral Activation + Medication']}], 'interventions': [{'name': 'Behavioral Activation + Medication', 'type': 'OTHER', 'otherNames': ['BA + SSRI'], 'description': 'Psychoeducation, behavioral activation therapy, and medication delivered within a collaborative care model.', 'armGroupLabels': ['Behavioral Activation + Medication']}, {'name': 'Guideline Antidepressant Medication', 'type': 'DRUG', 'description': 'Guideline Antidepressant Medication, following the VN National Mental Health plan.', 'armGroupLabels': ['Guideline Antidepressant Medication']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nha Trang', 'state': 'Khanh Hoa', 'country': 'Vietnam', 'facility': 'Khanh Hoa Provincial Hospital', 'geoPoint': {'lat': 12.24507, 'lon': 109.19432}}, {'city': 'Da Nang', 'country': 'Vietnam', 'facility': 'Danang Psychiatric Hospital', 'geoPoint': {'lat': 16.06778, 'lon': 108.22083}}], 'overallOfficials': [{'name': 'victoria ngo, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RAND'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vietnam Veterans of America Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'RAND', 'class': 'OTHER'}, {'name': 'Vanderbilt University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Bahr Weiss', 'investigatorAffiliation': 'Vanderbilt University'}}}}