Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-04-13 @ 8:42 PM
Study NCT ID:
NCT00618566
Status:
COMPLETED
Last Update Posted:
2012-10-17
First Post:
2008-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Group Therapy Program for Women With Physical Disabilities
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-15', 'studyFirstSubmitDate': '2008-02-08', 'studyFirstSubmitQcDate': '2008-02-08', 'lastUpdatePostDateStruct': {'date': '2012-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The following hypothesis is specific to the primary outcome: Hypotheses: 1. WPD receiving the intervention will demonstrate a greater improvement in depressive symptom scores compared to participants in the wait-list control groups.', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcomes: Hypothesis 2: the intervention group will demonstrate a greater improvement in coping and problem-solving skills, health behavior, body image and sexual self-esteem and loneliness compared to wait-listed controls.', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Women with physical Disabilities', 'Secondary Conditions', 'Depression', 'Cognitive Behavioral Therapy', 'Consumer Control'], 'conditions': ['Depressive Symptoms']}, 'descriptionModule': {'briefSummary': 'More women with disabilities (30%) report "feelings such as sadness, unhappiness, or depression that prevent them from being active" compared to women without disabilities (8%). The contexts of the lives of WPD, which often include high rates of poverty, architectural and attitudinal barriers, and higher vulnerability to violence and abuse, contribute to this mental health disparity. To help address this disparity, the overall goals of this pilot study are to: 1)1. Develop a cognitive behavioral group therapy intervention to address the specific needs of WPD who experience depressive symptoms; and 2. Pilot-test the intervention to preliminarily evaluate its efficacy using a mixed-methods approach. The proposed and revised study outcomes were derived from our previous work with WPD as well as from feedback obtained from community meetings conducted since our last submission of this proposal. A pilot of the modified intervention with a total of 90 participants will be conducted using a using a wait list control design. The decision to use a wait list control design was made jointly with our community partners to ensure that all WPD participating in the study have access to the intervention.', 'detailedDescription': 'The project will use a longitudinal mixed method research design. Phase I will utilize focus groups conducted with WPD to support development of the group therapy program. Phase II will evaluate the efficacy of the intervention using a randomized design. Measures to protect human subjects include development of detailed safety and referral protocols including 24 hour access to emergency mental health assessment and intervention as needed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with physical disabilities age 18 and older who require some form of accommodation and experience significant depressive symptoms as defined by a cut off score of 16 or greater on the CES-D.\n\nExclusion Criteria:\n\n* Women currently receiving other psychotherapy treatment\n* Women who are psychotic or have significant cognitive impairment\n* Women who are actively suicidal with intent and plan\n* Women who have discontinued or initiated antidepressant medications within an 4 week time period.'}, 'identificationModule': {'nctId': 'NCT00618566', 'acronym': 'CBT-WPD', 'briefTitle': 'Group Therapy Program for Women With Physical Disabilities', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'A Peer Implemented Cognitive Behavioral Group Therapy Intervention for Use With Women With Physical Disabilities With Secondary Depression', 'orgStudyIdInfo': {'id': 'NIDRR'}, 'secondaryIdInfos': [{'id': 'H133G060135'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oregon', 'interventionNames': ['Behavioral: WPD and Depression Treatment Group']}], 'interventions': [{'name': 'WPD and Depression Treatment Group', 'type': 'BEHAVIORAL', 'description': 'Intervention selected will depend on Phase I data analysis.', 'armGroupLabels': ['Oregon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Dena Hassouneh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Department of Education', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dena Hassouneh', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}