Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00043602
Status:
COMPLETED
Last Update Posted:
2013-09-26
First Post:
2002-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinician Managed Interpersonal Psychotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-25', 'studyFirstSubmitDate': '2002-08-09', 'studyFirstSubmitQcDate': '2002-08-12', 'lastUpdatePostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Rating Scale for Depression', 'timeFrame': 'Measured at Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression', 'Depression, Postpartum']}, 'descriptionModule': {'briefSummary': 'This 12-week study will evaluate the effectiveness of Clinician-Managed Interpersonal Psychotherapy (CM-IPT) in treating postpartum depression and will compare CM-IPT to standard IPT.', 'detailedDescription': 'CM-IPT is delivered in 12 sessions over the course of a year. Standard IPT is delivered in 12 sessions in the first 12 weeks after treatment assignment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Women between 8 and 24 weeks postpartum\n* Meet DSM-IV criteria for Major Depression\n* Hamilton Rating Scale for Depression score of 12 or more\n\nExclusion criteria:\n\n* Active substance abuse\n* Psychotic disorders'}, 'identificationModule': {'nctId': 'NCT00043602', 'briefTitle': 'Clinician Managed Interpersonal Psychotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Clinician Managed Interpersonal Psychotherapy', 'orgStudyIdInfo': {'id': 'R01MH059668', 'link': 'https://reporter.nih.gov/quickSearch/R01MH059668', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH059668', 'link': 'https://reporter.nih.gov/quickSearch/R01MH059668', 'type': 'NIH'}, {'id': 'DSIR 83-ATAS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants will receive clinician-managed interpersonal psychotherapy', 'interventionNames': ['Behavioral: Clinician managed interpersonal psychotherapy (CM-IPT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Participants will receive standard interpersonal psychotherapy', 'interventionNames': ['Behavioral: Standard interpersonal psychotherapy (IPT)']}], 'interventions': [{'name': 'Standard interpersonal psychotherapy (IPT)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive 12 sessions of IPT over 12 weeks.', 'armGroupLabels': ['2']}, {'name': 'Clinician managed interpersonal psychotherapy (CM-IPT)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive 12 sessions of CM-IPT over 1 year.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Scott P. Stuart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Scott Stuart', 'oldOrganization': 'University of Iowa'}}}}