Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-07 @ 7:56 PM
Study NCT ID:
NCT02214667
Status:
TERMINATED
Last Update Posted:
2020-03-17
First Post:
2014-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081702', 'term': 'Jails'}], 'ancestors': [{'id': 'D000081682', 'term': 'Correctional Facilities'}, {'id': 'D000072182', 'term': 'Non-Medical Public and Private Facilities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Inability to recruit enough participants', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-13', 'studyFirstSubmitDate': '2014-08-10', 'studyFirstSubmitQcDate': '2014-08-10', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability', 'timeFrame': 'Study months 21 through 34', 'description': 'Client Satisfaction Questionnaire-8, Narrative Evaluation of Intervention Interview'}], 'secondaryOutcomes': [{'measure': 'Feasibility of Adapted Interventions', 'timeFrame': 'Study months 21 through 34', 'description': 'How successfully can the adapted interventions be implemented (Focus Group interviews)'}, {'measure': 'Fidelity', 'timeFrame': 'Study months 21 through 34', 'description': 'DDMI and IGT Adherence Forms'}, {'measure': 'Substance use', 'timeFrame': 'Study months 20 through 30', 'description': 'Addiction Severity Index'}, {'measure': 'Psychiatric symptoms', 'timeFrame': 'Study months 20 through 30', 'description': 'Brief Psychiatric Rating Scale'}, {'measure': 'Health status', 'timeFrame': 'Study months 20 through 30', 'description': 'SF-12'}, {'measure': 'Service use', 'timeFrame': 'Study months 20 through 30', 'description': 'Epidemiological Catchment Area Interview'}, {'measure': 'Externalizing behaviors', 'timeFrame': 'Study months 20 through 30', 'description': 'Triarchic Psychopathy Measure'}, {'measure': 'Quality of life measure', 'timeFrame': 'Study months 20 through 30', 'description': 'Heinrichs-Carpenter Quality of Life Scale, Plus'}, {'measure': 'Arrest', 'timeFrame': 'Study months 20 through 30', 'description': 'Self-report and official jail records'}, {'measure': 'Treatment preferences', 'timeFrame': 'Study months 20 through 30', 'description': 'Visual analog ranking of 8 different aspects of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Jail', 'co-occurring disorders', 'implementation', 'acceptability', 'feasibility', 'fidelity'], 'conditions': ['Co-occurring Mental and Substance Use Disorders', 'Crime', 'Criminogenic Thinking', 'Implementation', 'Adaptation']}, 'referencesModule': {'references': [{'pmid': '28778175', 'type': 'DERIVED', 'citation': 'Van Dorn RA, Desmarais SL, Rade CB, Burris EN, Cuddeback GS, Johnson KL, Tueller SJ, Comfort ML, Mueser KT. Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial. Trials. 2017 Aug 4;18(1):365. doi: 10.1186/s13063-017-2088-z.'}]}, 'descriptionModule': {'briefSummary': 'Treatment adaptation and implementation study for adult jail inmates with co-occurring substance use disorders.', 'detailedDescription': 'We will adapt dual-diagnosis motivational interviewing and integrated group therapy for jail inmates with co-occurring substance use and mental health disorders and to evaluate the feasibility of implementing the adapted interventions and associated research and communication protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) drug or alcohol abuse or dependence and SMI (major depressive disorder; depressive disorder not otherwise specified \\[NOS\\]; bipolar disorder I, II, or NOS; schizophrenia spectrum disorder; schizoaffective disorder; schizophreniform disorder; brief psychotic disorder; delusional disorder; or psychotic disorder NOS);\n* (2) resident of Wake County and detained in The Jail;\n* (3) \\>18 years of age; (4) able to speak/read English; and (5) able to provide informed consent.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02214667', 'briefTitle': 'Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates', 'organization': {'class': 'OTHER', 'fullName': 'RTI International'}, 'officialTitle': 'Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates', 'orgStudyIdInfo': {'id': 'R34DA036791', 'link': 'https://reporter.nih.gov/quickSearch/R34DA036791', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DDMI-IGT', 'description': 'Subjects randomized to the experimental condition will receive adapted versions of dual-diagnosis motivational interviewing (\\[DDMI\\] one session before release from jail) and integrated group therapy (\\[IGT\\] 12 community-based sessions over a 2-month period).', 'interventionNames': ['Behavioral: Dual-diagnosis motivational interviewing (DDMI)', 'Behavioral: Integrated group therapy (IGT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Subjects randomized to the usual care condition will receive jail and community-based behavioral health services.', 'interventionNames': ['Behavioral: Jail and community-based behavioral health services']}], 'interventions': [{'name': 'Dual-diagnosis motivational interviewing (DDMI)', 'type': 'BEHAVIORAL', 'description': 'DDMI is an evidence-based adaptation to motivational interviewing. DDMI incorporates an integrated framework and accommodates cognitive impairments and disordered thinking associated with co-occurring substance use and mental disorders.', 'armGroupLabels': ['DDMI-IGT']}, {'name': 'Integrated group therapy (IGT)', 'type': 'BEHAVIORAL', 'description': 'IGT is an evidence-based practice for treating co-occurring disorders. IGT focuses on relapse prevention by reducing substance use and stabilizing psychiatric symptoms.', 'armGroupLabels': ['DDMI-IGT']}, {'name': 'Jail and community-based behavioral health services', 'type': 'BEHAVIORAL', 'description': 'Existing behavioral health service programs', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27709', 'city': 'Research Triangle Park', 'state': 'North Carolina', 'country': 'United States', 'facility': 'RTI International', 'geoPoint': {'lat': 35.89709, 'lon': -78.86029}}], 'overallOfficials': [{'name': 'Richard A Van Dorn, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RTI International'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RTI International', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'Boston University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}