SUPER Study (Substance Use and PTSD Treatment Effectiveness Research Study)
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|ClinicalTrials.gov Identifier: NCT00265564|
Recruitment Status : Completed
First Posted : December 14, 2005
Last Update Posted : November 7, 2014
|Condition or disease||Intervention/treatment|
|Substance Use Disorders Posttraumatic Stress Disorder||Behavioral: Modified Seeking Safety integrated into std outpatient SUD care Behavioral: Standard outpatient SUD care|
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, treatment and assessment is complete and primary trial finds are published. Secondary analysis is ongoing.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effectiveness of Screening and Treatment for PTSD in SUD Patients|
|Study Start Date :||July 2006|
|Primary Completion Date :||April 2011|
|Study Completion Date :||July 2011|
Active Comparator: Arm 1
Seeking Safety is a manualized, empirically supported, cognitive behavioral therapy that treats substance use disorders and comorbid PTSD. Participants assigned to the Seeking Safety arm attend two one hour sessions of group therapy for 12 weeks.
Behavioral: Modified Seeking Safety integrated into std outpatient SUD care
The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks.
Other Name: Seeking Safety
Active Comparator: Arm 2
Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.
Behavioral: Standard outpatient SUD care
Patients assigned to standard care meet twice weekly in "Recovery 1" groups, which focuses on building abstinence.
- 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. ]
- 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. ]Composite measures of PTSD symptoms, drug craving and mental health status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265564
|United States, California|
|VA Palo Alto Health Care System|
|Palo Alto, California, United States, 94304-1290|
|Principal Investigator:||Jodie A. Trafton, PhD||VA Palo Alto Health Care System|