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| Tracking Information | |||||
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| First Received Date ICMJE | July 3, 2001 | ||||
| Last Updated Date | January 16, 2009 | ||||
| Start Date ICMJE | April 2000 | ||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Hamilton Depression Scale, Timeline Follow-back (substance measure) [ Time Frame: 18 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00018655 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Integrated Intervention for Substance Abusers With Depressive Disorders | ||||
| Official Title ICMJE | Integrated Intervention for Substance Abusers With Depressive Disorders | ||||
| Brief Summary | This study is a randomized clinical trial comparing outcomes of Integrated Cognitive Behavioral Treatment plus standard medications for veterans with both substance use disorders, depressive disorders versus the most commonly administered form of therapy for substance use disorders and depression, Twelve Step Facilitation (AA/NA model) group treatment plus medications. |
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| Detailed Description | This study is a randomized clinical trial comparing outcomes of Integrated Cognitive Behavioral Treatment plus standard medications for veterans with both substance use disorders, depressive disorders versus the most commonly administered form of therapy for substance use disorders and depression, Twelve Step Facilitation (AA/NA model) group treatment plus medications. Follow-up assessments were conducted at quarterly intervals for one year following treatment. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Factorial Assignment, Safety Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 276 | ||||
| Estimated Completion Date | September 2012 | ||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Veterans age 18 and older with alcohol, cannabinol, and/or stimulant dependence and independent mood disorders will be included. Exclusion Criteria: Psychotic disorders |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00018655 | ||||
| Responsible Party | Brown, Sandra - Principal Investigator, Department of Veterans Affairs | ||||
| Study ID Numbers ICMJE | MHBS-041-99S | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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