Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-22 @ 7:25 AM
Study NCT ID:
NCT00541957
Status:
COMPLETED
Last Update Posted:
2011-07-08
First Post:
2007-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-06', 'studyFirstSubmitDate': '2007-10-08', 'studyFirstSubmitQcDate': '2007-10-08', 'lastUpdatePostDateStruct': {'date': '2011-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression symptoms', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'Psychosocial functioning', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Major depression', 'Primary care'], 'conditions': ['Major Depression']}, 'referencesModule': {'references': [{'pmid': '21731830', 'type': 'DERIVED', 'citation': 'Uebelacker LA, German NM, Gaudiano BA, Miller IW. Patient health questionnaire depression scale as a suicide screening instrument in depressed primary care patients: a cross-sectional study. Prim Care Companion CNS Disord. 2011;13(1):PCC.10m01027. doi: 10.4088/PCC.10m01027.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot study. The purpose of this study is to determine whether adding 4 months of behavioral therapy to primary care physician medication treatment(relative to medication treatment alone) improves outcomes for persistently depressed primary care patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current MDD or MDD within the past year or current dysthymia\n* PHQ-9 \\> 10\n* have been prescribed an antidepressant medication (by their PCP) at least 8 weeks before pre-treatment timepoint\n* are able to speak, read, and understand English sufficiently well to complete study procedures\n* are between the ages of 18 and 70\n\nExclusion Criteria:\n\n* presence of significant suicidal ideation or risk\n* history of bipolar disorder, schizophrenia, psychotic symptoms, or severe alcohol or drug problems within the past year;\n* history of antisocial personality disorder or borderline personality disorder;\n* currently in psychotherapy or have received counseling more frequently than once per month in the past year.'}, 'identificationModule': {'nctId': 'NCT00541957', 'briefTitle': 'Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients', 'organization': {'class': 'OTHER', 'fullName': 'Butler Hospital'}, 'officialTitle': 'Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients', 'orgStudyIdInfo': {'id': 'K23MH067779', 'link': 'https://reporter.nih.gov/quickSearch/K23MH067779', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '2', 'description': 'Medication prescribed by PCP', 'interventionNames': ['Drug: Medication prescribed by PCP']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Medication prescribed by PCP + behavior therapy', 'interventionNames': ['Behavioral: behavior therapy', 'Drug: Medication prescribed by PCP']}], 'interventions': [{'name': 'behavior therapy', 'type': 'BEHAVIORAL', 'description': '10 sessions over 4 months', 'armGroupLabels': ['1']}, {'name': 'Medication prescribed by PCP', 'type': 'DRUG', 'description': 'Can include any antidepressant medication', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02860', 'city': 'Pawtucket', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Memorial Hospital of RI', 'geoPoint': {'lat': 41.87871, 'lon': -71.38256}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Lisa Uebelacker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Butler Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butler Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Memorial Hospital of Rhode Island', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Lisa Uebelacker, Ph.D., PI', 'oldOrganization': 'Butler Hospital'}}}}