Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-28 @ 5:31 AM
Study NCT ID:
NCT01685294
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2012-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-03', 'releaseDate': '2025-03-18'}, {'resetDate': '2025-06-25', 'releaseDate': '2025-06-24'}, {'resetDate': '2025-07-31', 'releaseDate': '2025-07-15'}], 'estimatedResultsFirstSubmitDate': '2025-03-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-12', 'studyFirstSubmitDate': '2012-08-29', 'studyFirstSubmitQcDate': '2012-09-11', 'lastUpdatePostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months', 'timeFrame': '3 Months from Baseline'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Suicidality at 3 Months', 'timeFrame': '3 Months from Baseline', 'description': 'Suicidality as measured by the Beck Scale for Suicide Ideation.'}, {'measure': 'Change from Baseline in In-Prison Functioning at 3 Months', 'timeFrame': '3 Months from Baseline', 'description': 'In-prison functioning will be assessed by the number of correctional programs enrolled/completed and disciplinary/incident reports (measured by the Timeline Followback); aggression/victimization (measured by the Conflict Tactics Scale 2); social support (measured by the Multidimensional Scale of Perceived Social Support and the UCLA Loneliness Scale)'}, {'measure': 'Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months', 'timeFrame': '6 Months from Baseline'}, {'measure': 'Change from Baseline in Suicidality at 6 Months', 'timeFrame': '6 Months from Baseline', 'description': 'Suicidality as measured by the Beck Scale for Suicide Ideation.'}, {'measure': 'Change from Baseline in In-Prison Functioning at 6 Months', 'timeFrame': '6 Months from Baseline', 'description': 'In-prison functioning will be assessed by the number of correctional programs enrolled/completed and disciplinary/incident reports (measured by the Timeline Followback); aggression/victimization (measured by the Conflict Tactics Scale 2); social support (measured by the Multidimensional Scale of Perceived Social Support and the UCLA Loneliness Scale)'}, {'measure': 'Cost-effectiveness', 'timeFrame': '6 months post-baseline', 'description': 'Cost-effectiveness based on costs of IPT and TAU, improvements in HRSD scores, LIFE scores, and cost-offsets, including medical costs, programs completed, fewer fights, fewer suicide attempts, and reduced length of incarceration due to more "good time."'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Major Depressive Disorder (MDD)', 'Suicidality', 'Incarcerated Populations', 'Prisons', 'Interpersonal Psychotherapy (IPT)'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '38743716', 'type': 'DERIVED', 'citation': 'Johnson JE, Hailemariam M, Zlotnick C, Richie F, Wiltsey-Stirman S. Analysis of implementation processes in a hybrid effectiveness-implementation trial of interpersonal psychotherapy (IPT) for major depressive disorder in prisons: Training, supervision, and recommendations. PLoS One. 2024 May 14;19(5):e0288182. doi: 10.1371/journal.pone.0288182. eCollection 2024.'}, {'pmid': '30857489', 'type': 'DERIVED', 'citation': 'Felton JW, Hailemariam M, Richie F, Reddy MK, Edukere S, Zlotnick C, Johnson JE. Preliminary efficacy and mediators of interpersonal psychotherapy for reducing posttraumatic stress symptoms in an incarcerated population. Psychother Res. 2020 Feb;30(2):239-250. doi: 10.1080/10503307.2019.1587192. Epub 2019 Mar 11.'}, {'pmid': '30714749', 'type': 'DERIVED', 'citation': 'Johnson JE, Stout RL, Miller TR, Zlotnick C, Cerbo LA, Andrade JT, Nargiso J, Bonner J, Wiltsey-Stirman S. Randomized cost-effectiveness trial of group interpersonal psychotherapy (IPT) for prisoners with major depression. J Consult Clin Psychol. 2019 Apr;87(4):392-406. doi: 10.1037/ccp0000379. Epub 2019 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine the effects of a first-line treatment for major depressive disorder (MDD), interpersonal psychotherapy (IPT), among men and women prisoners.', 'detailedDescription': 'The purpose of this 3-year randomized trial is to promote uptake of evidence-based treatment in criminal justice settings by conducting a fully-powered randomized effectiveness study that collects pilot implementation data, including cost-effectiveness data. Group IPT will be compared to treatment as usual (TAU) in a sample of 90 male and 90 female prisoners with MDD from 4 institutions, allowing us to explore gender effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet all DSM-IV criteria for primary (non-substance induced) major depressive disorder\n* Expectation of at least 6 months of incarceration at baseline interview\n* Incarcerated for at least 4 weeks\n\nExclusion Criteria:\n\n* Lifetime:\n\n * Bipolar disorder\n * Psychotic disorder\n* Are imminently suicidal\n* Cannot understand English well enough to understand the consent form or assessment instruments when read aloud'}, 'identificationModule': {'nctId': 'NCT01685294', 'briefTitle': 'Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression', 'orgStudyIdInfo': {'id': '1R01MH095230-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH095230-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH095230', 'link': 'https://reporter.nih.gov/quickSearch/R01MH095230', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual (TAU)', 'description': 'Standard prison mental health treatment instead of the research groups, including individual therapy, medication, etc.'}, {'type': 'EXPERIMENTAL', 'label': 'Group Interpersonal Psychotherapy (IPT) for Depression + TAU', 'description': 'Participants will receive Group IPT for Depression + TAU.', 'interventionNames': ['Behavioral: Group IPT for Depression + TAU']}], 'interventions': [{'name': 'Group IPT for Depression + TAU', 'type': 'BEHAVIORAL', 'description': 'Interpersonal psychotherapy (IPT) will be administered in 20 group 90-minute sessions over 10 weeks and 4 individual sessions (before group starts, in the middle of the group, at the end of the group, and one month after the group ends). These sessions will focus on improving your relationships with others, building healthy relationships, setting goals, and increasing coping skills. Additionally, participants will receive standard prison mental health treatment, individual therapy, medication, etc.', 'armGroupLabels': ['Group Interpersonal Psychotherapy (IPT) for Depression + TAU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02324', 'city': 'Bridgewater', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Correctional Institute - Old Colony Correctional Center', 'geoPoint': {'lat': 41.99038, 'lon': -70.97504}}, {'zip': '01702', 'city': 'Framingham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Correctional Institution - Framingham', 'geoPoint': {'lat': 42.27926, 'lon': -71.41617}}, {'zip': '01702', 'city': 'Framingham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'South Middlesex Correctional Center', 'geoPoint': {'lat': 42.27926, 'lon': -71.41617}}, {'zip': '02056', 'city': 'Norfolk', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Correctional Institution - Norfolk', 'geoPoint': {'lat': 42.11954, 'lon': -71.32506}}, {'zip': '02920', 'city': 'Cranston', 'state': 'Rhode Island', 'country': 'United States', 'facility': "Adult Correctional Institution - Men's & Women's Medium & Minimum Security Facilities", 'geoPoint': {'lat': 41.77982, 'lon': -71.43728}}], 'overallOfficials': [{'name': 'Jennifer E. Johnson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor (Research), Department of Psychiatry and Human Behavior', 'investigatorFullName': 'Dr. Jennifer Johnson', 'investigatorAffiliation': 'Brown University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-03-18', 'type': 'RELEASE'}, {'date': '2025-04-03', 'type': 'RESET'}, {'date': '2025-06-24', 'type': 'RELEASE'}, {'date': '2025-06-25', 'type': 'RESET'}, {'date': '2025-07-15', 'type': 'RELEASE'}, {'date': '2025-07-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dr. Jennifer Johnson, Associate Professor (Research), Department of Psychiatry and Human Behavior, Brown University'}}}}