Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-02-03 @ 12:53 AM
Study NCT ID:
NCT00050050
Status:
COMPLETED
Last Update Posted:
2014-05-26
First Post:
2002-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-23', 'studyFirstSubmitDate': '2002-11-20', 'studyFirstSubmitQcDate': '2002-11-20', 'lastUpdatePostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADHD symptoms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adult', 'ADHD', 'ADD'], 'conditions': ['Attention Deficit Disorder With Hyperactivity']}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in adults who have not responded to drug treatment.\n\nStudy hypothesis: CBT is an effective treatment for adult ADHD.', 'detailedDescription': "ADHD, previously believed to be a disorder of childhood, affects as many as 5 percent of adults. Adults with ADHD are at high risk for academic and occupational underachievement, relationship difficulties, and reduced quality of life. This study will determine whether CBT is more effective than drug therapy in treating ADHD symptoms in adults who have been resistant to previous drug therapies.\n\nParticipants will be randomly assigned to receive 12 to 15 weekly sessions of either CBT or drug therapy which may include new or previously taken drugs. Questionnaires will be used to assess participants' ADHD symptoms at study start and at study completion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ADHD of at least moderate severity\n* On current drug therapy for ADHD\n\nExclusion Criteria:\n\n* Depression, panic disorder, bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders\n* Current substance abuse or dependence\n* IQ less than 90\n* Suicide risk\n* History of cognitive behavioral therapy'}, 'identificationModule': {'nctId': 'NCT00050050', 'briefTitle': 'Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'CBT for Residual ADHD Symptoms in Adults', 'orgStudyIdInfo': {'id': 'R03MH060940', 'link': 'https://reporter.nih.gov/quickSearch/R03MH060940', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R03MH060940', 'link': 'https://reporter.nih.gov/quickSearch/R03MH060940', 'type': 'NIH'}, {'id': 'DSIR AT-AS'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Cognitive behavioral therapy', 'type': 'BEHAVIORAL'}, {'name': 'Drug therapy', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Steven A. Safren, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Behavioral Medicine', 'investigatorFullName': 'Steven A. Safren', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}