SUPER Study (Substance Use and PTSD Treatment Effectiveness Research Study)
| Tracking Information | |||||
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| First Received Date ICMJE | December 13, 2005 | ||||
| Last Updated Date | April 18, 2013 | ||||
| Start Date ICMJE | July 2006 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Severity of drug & alcohol use (ASI drug and alcohol composite scores), [ Time Frame: The ASI is administered at baseline and 3 months, 6 months and 12 months post baseline. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
severity of drug & alcohol use (ASI drug and alcohol composite scores), | ||||
| Change History | Complete list of historical versions of study NCT00265564 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
PTSD symptoms (IES total score), drug craving (Brief Substance Craving Questionnaire), mental health status (SF-36V), social functioning (SF-36V), legal problems (ASI legal composite), treatment satisfaction (CSQ-8) [ Time Frame: All secondary outcome measures, with the exception of the CSQ-8, are administered at baseline and 3 months, 6 months and 12 months post enrollment. The CSQ-8 is administered at 3 months, 6 months and 12 months post enrollment. ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
PTSD symptoms (IES total score), drug craving (Brief Substance Craving Questionnaire), mental health status (SF-36V), social functioning (SF-36V), legal problems (ASI legal composite), treatment satisfaction (CSQ-8) | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | SUPER Study (Substance Use and PTSD Treatment Effectiveness Research Study) | ||||
| Official Title ICMJE | Effectiveness of Screening and Treatment for PTSD in SUD Patients | ||||
| Brief Summary | This study proposes a prospective program of research that will identify feasible and inexpensive methods to detect and treat comorbid PTSD among VA SUD patients, thereby improving substance abuse treatment outcomes. |
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| Detailed Description | Background: This study proposes a prospective program of research that will identify feasible and inexpensive methods to detect and treat comorbid PTSD among VA SUD patients, thereby improving substance abuse treatment outcomes. Objective(s): Our objectives are to test the effectiveness of substituting 2 hours/week of Seeking Safety-based groups for standard substance use focused groups for male patients attending outpatient substance use disorder treatment who meet clinical criteria for PTSD. Primary outcomes measures will assess substance use disorder severity and secondary outcome measures will assess mental health and substance use related problems plus treatment satisfaction. We hypothesize that enhanced SUD treatment that incorporates "Seeking Safety" will improve SUD treatment outcomes for PTSD-SUD patients as compared to outcomes for PTSD-SUD patients receiving treatment as usual. Additionally, we examine two hypothesized models via which "Seeking Safety" may effect substance use outcomes. We examine whether 1) reductions in PTSD symptomatology and 2) improvements in coping strategies used in response to PTSD symptoms (reductions in using to cope and other avoidance coping strategies) partially mediate the effect of treatment on substance use outcomes. Methods: This is a randomized clinical trial of 210 male veterans with PTSD and substance use disorders attending outpatient substance use disorder treatment at the VA Oakland mental health center. Patients will be randomized to 3 months of outpatient substance abuse treatment including either 2 hours/week of "Seeking Safety" or standard addiction focused group therapy. Data will be collected in patient interviews at treatment entry and at 3, 6 and 12 months after treatment initiation and by medical record review. Substance use, PTSD symptomatology, mental health, social functioning, legal problems, use of coping techniques, and treatment satisfaction outcomes will be assessed at treatment entry and 3, 6 and 12 months later using well-validated survey instruments. Primary and secondary treatment outcomes of patients in "Seeking Safety" versus treatment as usual will be compared by repeated measures ANCOVA. We will test the mediational hypotheses according to the 4-step method described by Baron and Kenny (1986). Status: Project began in January, 2006; Recruitment is complete. Treatment and assessment is ongoing. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Intervention ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 125 | ||||
| Completion Date | July 2011 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00265564 | ||||
| Other Study ID Numbers ICMJE | IIR 04-175 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | September 2011 | ||||
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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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