Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 11:43 PM
Study NCT ID:
NCT00961493
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2009-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RCT of an Acceptance-based Behavior Therapy for GAD
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2009-08-18', 'studyFirstSubmitQcDate': '2009-08-18', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety Disorders Interview Schedule for DSM-IV, Clinician Severity Rating of GAD', 'timeFrame': 'pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up'}, {'measure': 'Hamilton Anxiety Rating Scale', 'timeFrame': 'pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up'}, {'measure': 'Penn State Worry Questionnaire', 'timeFrame': 'pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory - II', 'timeFrame': 'pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up'}, {'measure': 'Quality of Life Inventory', 'timeFrame': 'pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Generalized Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether acceptance-based behavior therapy for GAD results in greater symptom reduction and increased quality of life than applied relaxation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* principal diagnosis of GAD\n* at least moderate (4 on a scale from 0 to 8) on the ADIS Severity Scale for GAD symptoms\n* willing to maintain current psychotropic medication levels (and have been stabilized on any current medications for at least three months) and refrain from other psychosocial treatments for anxiety or mood problems during the course of therapy\n* fluent in English\n* 18 years or older\n\nExclusion Criteria:\n\n* bipolar disorder\n* psychotic disorders\n* substance dependence\n* active suicidal intent\n* if anxious symptomatology is due to a medical/physical condition'}, 'identificationModule': {'nctId': 'NCT00961493', 'briefTitle': 'RCT of an Acceptance-based Behavior Therapy for GAD', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Boston'}, 'officialTitle': 'Randomized Controlled Trial of an Acceptance-based Behavior Therapy for Generalized Anxiety Disorder', 'orgStudyIdInfo': {'id': 'R01MH074589', 'link': 'https://reporter.nih.gov/quickSearch/R01MH074589', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH074589', 'link': 'https://reporter.nih.gov/quickSearch/R01MH074589', 'type': 'NIH'}, {'id': 'NIH MH074589'}, {'id': 'DSIR 83-ATAS2'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Behavioral: Acceptance based behavioral therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Behavioral: Applied relaxation']}], 'interventions': [{'name': 'Acceptance based behavioral therapy', 'type': 'BEHAVIORAL', 'description': "16 individual psychotherapy sessions focused on psychoeducation about anxiety, anxious responding, the function of emotions, mindfulness, and problems with efforts to constrict one's emotional experience; training in mindfulness skills; practice applying mindfulness skills in daily life, including acceptance of, rather than efforts to control, internal experience; and identification of values in areas of life and practice engaging in chosen actions.", 'armGroupLabels': ['1']}, {'name': 'Applied relaxation', 'type': 'BEHAVIORAL', 'description': '16 sessions of individual psychotherapy focused on psychoeducation about anxiety and anxious responding; training in multiple forms of relaxation; early cue detection; and practice applying relaxation in daily life.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Center for Anxiety and Related Disorders at Boston University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Lizabeth Roemer, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Boston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Boston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychology', 'investigatorFullName': 'Lizabeth Roemer', 'investigatorAffiliation': 'University of Massachusetts, Boston'}}}}