Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT00330005
Status:
COMPLETED
Last Update Posted:
2006-05-25
First Post:
2006-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study of Psychodynamic Psychotherapy for Bipolar Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011615', 'term': 'Psychotherapy, Group'}], 'ancestors': [{'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-05', 'completionDateStruct': {'date': '2005-01'}, 'lastUpdateSubmitDate': '2006-05-24', 'studyFirstSubmitDate': '2006-05-24', 'studyFirstSubmitQcDate': '2006-05-24', 'lastUpdatePostDateStruct': {'date': '2006-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'depression symptoms'}, {'measure': 'manic symptoms'}, {'measure': 'number of days without a bipolar mood episode'}, {'measure': 'global assessment of functioning'}, {'measure': 'clinical global impression for bipolar disorder'}]}, 'conditionsModule': {'keywords': ['psychotherapy', 'bipolar disorder', 'psychodynamic', 'psychoeducation', 'illness management', 'controlled trial', 'pilot study'], 'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare a group psychotherapy intervention, the Integrative Outpatient Model, to a convenience control, in adults with bipolar disorder.', 'detailedDescription': 'The psychotherapy literature suggests that psychological treatments can have a significant impact on the clinical course and outcome for bipolar disorder (Swartz \\& Frank, 2001). Very few outcome studies have been conducted in group psychotherapy for bipolar disorder, and there are no preliminary studies conducted using the Integrative Outpatient Model, developed specifically for bipolar disorder. Given the lack of preliminary data, a pilot study with a matched-control design is indicated to obtain preliminary data regarding this treatment modality and approach. The IOM is a weekly, long term psychotherapy.\n\nComparison: Individuals who participate in group psychotherapy will be compared to a control group on mood and symptom ratings, up to 1 year post intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:bipolar disorder; functioning level appropriate for outpatient group psychotherapy; willingness to engage in a psychotherapeutic intervention -\n\nExclusion Criteria: cognitive impairment; prominent psychosis; under 18 years old\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00330005', 'briefTitle': 'A Pilot Study of Psychodynamic Psychotherapy for Bipolar Disorder', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'A Pilot Study of Psychodynamic Psychotherapy for Bipolar Disorder', 'orgStudyIdInfo': {'id': 'FFPR-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Group Psychotherapy', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78212', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center - Department of Psychiatry', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Jodi M Gonzalez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}}}}