Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-27 @ 2:47 AM
Study NCT ID:
NCT00938093
Status:
COMPLETED
Last Update Posted:
2018-08-13
First Post:
2009-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Late-life Anxiety in Primary Care Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D016584', 'term': 'Panic Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2009-07-10', 'studyFirstSubmitQcDate': '2009-07-10', 'lastUpdatePostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PSWQ-A', 'timeFrame': '4 months'}, {'measure': 'HAM-A', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Generalized Anxiety Disorder', 'Panic Disorder', 'Anxiety Disorder Not Otherwise Specified']}, 'descriptionModule': {'briefSummary': 'The research study proposed is designed to examine the outcomes of a cognitive behavioral guided self-care intervention with older adults diagnosed with generalized anxiety disorder and recruited from a primary care setting. It is hypothesized that the cognitive behavioral guided self-care intervention will produce greater declines in worry and anxiety than enhanced usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 60 years\n* a DSM-IV diagnosis of GAD\n* able to read English.\n\nExclusion Criteria:\n\n* current psychotherapy\n* a DSM-IV diagnosis of alcohol or substance abuse\n* a diagnosis of dementia or global cognitive impairment operationalized as a score of \\< 24 of the Mini-Mental Status Examination\n* psychotic symptoms\n* active suicidal ideation'}, 'identificationModule': {'nctId': 'NCT00938093', 'briefTitle': 'Treatment of Late-life Anxiety in Primary Care Settings', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Treatment of Late-life Anxiety in Primary Care Settings', 'orgStudyIdInfo': {'id': 'MH65281'}, 'secondaryIdInfos': [{'id': 'MH65281'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive-behavioral therapy', 'description': 'cognitive-behavioral therapy', 'interventionNames': ['Behavioral: Cognitive behavioral therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Enhanced usual care', 'description': 'enhanced usual care', 'interventionNames': ['Behavioral: Enhanced usual care']}], 'interventions': [{'name': 'Cognitive behavioral therapy', 'type': 'BEHAVIORAL', 'description': 'Participants receive 10 telephone therapy sessions and an accompanying workbook focused on cognitive-behavioral techniques for managing anxiety.', 'armGroupLabels': ['Cognitive-behavioral therapy']}, {'name': 'Enhanced usual care', 'type': 'BEHAVIORAL', 'description': 'Participants receive written information about anxiety, referrals for treatment, and an optional letter to their primary care physician.', 'armGroupLabels': ['Enhanced usual care']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gretchen Brenes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}