Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT00073632
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2003-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acceptance-Based Treatment for Generalized Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '2003-12-02', 'studyFirstSubmitQcDate': '2003-12-02', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician Severity Rating from ADIS for GAD', 'timeFrame': 'pre, post, 3 mo. f/u, 9 mo. f/u'}, {'measure': 'Penn State Worry Questionnaire', 'timeFrame': 'pre-, post-, 3 mo. f/u, 9 mo. f/u'}, {'measure': 'Depression Anxiety and Stress Scales, anxiety and stress subscales', 'timeFrame': 'pre-, post-, 3 mo. f/u, 9 mo. f/u'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anxiety Disorders', 'Generalized Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '17292696', 'type': 'BACKGROUND', 'citation': 'Roemer L, Orsillo SM. An open trial of an acceptance-based behavior therapy for generalized anxiety disorder. Behav Ther. 2007 Mar;38(1):72-85. doi: 10.1016/j.beth.2006.04.004. Epub 2006 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'This study will develop and implement an awareness- and acceptance-based for treatment of individuals with generalized anxiety disorder.', 'detailedDescription': 'Participants in this study are recruited from intakes at the Center for Anxiety and Related Disorders at Boston University. Participants will be randomly assigned to receive either acceptance and mindfulness-based strategies plus cognitive behavioral therapy or no treatment for 16 weeks. The treatment will involve daily practice of mindfulness techniques to help draw attention to and accept various emotional states. Interviews, questionnaires, and depression and anxiety scales will be used to assess participants. Assessments will be conducted post-treatment and at 3- and 9-month follow-up visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generalized Anxiety Disorder (GAD)\n* Willing to maintain medication levels and refrain from any additional psychosocial treatment during the course of the study\n\nExclusion Criteria:\n\n* Bipolar disorder, psychotic disorder, or substance dependence'}, 'identificationModule': {'nctId': 'NCT00073632', 'briefTitle': 'Acceptance-Based Treatment for Generalized Anxiety Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Boston'}, 'officialTitle': 'Developing a New Therapy for GAD: Acceptance-Based CBT', 'orgStudyIdInfo': {'id': 'R21MH063208', 'link': 'https://reporter.nih.gov/quickSearch/R21MH063208', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R21MH063208', 'link': 'https://reporter.nih.gov/quickSearch/R21MH063208', 'type': 'NIH'}, {'id': 'DSIR AT-AS'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Acceptance Based Behavioral Therapy', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Center for Anxiety and Related Disorders', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Lizabeth Roemer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Boston'}, {'name': 'Susan M Orsillo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Boston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Lizabeth Roemer, Ph. D.', 'oldOrganization': 'University of Massachusetts Boston'}}}}