Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT01203293
Status:
COMPLETED
Last Update Posted:
2014-08-28
First Post:
2010-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-26', 'studyFirstSubmitDate': '2010-06-11', 'studyFirstSubmitQcDate': '2010-09-15', 'lastUpdatePostDateStruct': {'date': '2014-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Penn State Worry Questionnaire', 'timeFrame': 'Baseline'}, {'measure': 'Penn State Worry Questionnaire', 'timeFrame': 'Week 20'}, {'measure': 'Penn State Worry Questionnaire', 'timeFrame': 'Week 28.'}], 'secondaryOutcomes': [{'measure': 'SF-36 Social Functioning Scale', 'timeFrame': 'Baseline'}, {'measure': 'SF-36 Social Functioning Scale', 'timeFrame': 'Week 20'}, {'measure': 'SF-36 Social Functioning Scale', 'timeFrame': 'Week 28'}, {'measure': 'Quality of Life Inventory', 'timeFrame': 'Baseline'}, {'measure': 'Quality of Life Inventory', 'timeFrame': 'Week 20'}, {'measure': 'Quality of Life Inventory', 'timeFrame': 'Week 28'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Generalized Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to implement culturally adapted Cognitive Behavioral Therapy (CBT) based interventions in general health settings that are delivered to reduce Generalized Anxiety Disorder (GAD) symptoms, increase levels of functioning, and improve health-related quality of life.', 'detailedDescription': 'This project seeks to lay the foundation for an effectiveness trial that will lead to the advancement of CBT based treatments for GAD among Spanish-speaking Latinos, particularly Puerto Ricans. This area of research is important in light of the limited treatment options currently available for Spanish-speakers with GAD and the long-term negative consequences of this condition. Participants in this study are recruited in general health settings. Patients meeting criteria for enrollment will be randomly assigned to receive either cognitive behavior based therapy or treatment as usual. Assessments for all participants will be collected at baseline, post-treatment, and at two months follow-up visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of GAD\n* 18 to 65 years\n* Spanish speaker\n* able to read and write\n* plan to continue receiving services in the health care setting during the next six months\n\nExclusion Criteria:\n\n* severe cognitive impairment, psychoses, history of bipolar disease, alcohol or drug abuse or dependence\n* clinically judged to have a high acute suicide risk\n* life-threatening medical condition\n* currently receiving psychotherapy'}, 'identificationModule': {'nctId': 'NCT01203293', 'briefTitle': 'Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector', 'organization': {'class': 'OTHER', 'fullName': 'University of Puerto Rico'}, 'officialTitle': 'CBT for Latinos With Generalized Anxiety Disorder in the General Medical Sector', 'orgStudyIdInfo': {'id': '5SC1MH90599-2'}, 'secondaryIdInfos': [{'id': '5SC1MH090599', 'link': 'https://reporter.nih.gov/quickSearch/5SC1MH090599', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavior Therapy', 'interventionNames': ['Behavioral: Cognitive behavior based therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'interventionNames': ['Behavioral: Treatment as usual']}], 'interventions': [{'name': 'Cognitive behavior based therapy', 'type': 'BEHAVIORAL', 'description': '15-20 individual psychotherapy sessions', 'armGroupLabels': ['Cognitive Behavior Therapy']}, {'name': 'Treatment as usual', 'type': 'BEHAVIORAL', 'description': 'Treatment as usual is an active comparator group in which patients are provided referrals to specialty mental health care services or can use any primary or specialty care services available to them in usual care.', 'armGroupLabels': ['Treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00936', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'University of Puerto Rico, Medical Sciences Campus', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Puerto Rico', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mildred Vera', 'investigatorAffiliation': 'University of Puerto Rico'}}}}