SUPER Study (Substance Use and PTSD Treatment Effectiveness Research Study)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Screening and Treatment for PTSD in SUD Patients

Conditions
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Substance Use Disorders, Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Modified Seeking Safety integrated into std outpatient SUD care
* Behavioral: Standard outpatient SUD care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: veteran status and VA healthcare eligibility, a diagnosis of any alcohol or drug use disorder, having completed an intake for outpatient SUD treatment at the VA Oakland outpatient mental health clinic, and meeting criteria for a PTSD diagnosis based on a preliminary screen with the PC-PTSD and subsequent full clinical evaluation using the CAPS Exclusion Criteria: current participation in any day or inpatient mental health treatment, any contraindications communicated by that patient's primary clinician, acute psychosis, mania, dementia, or suicidal intent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Seeking Safety<br>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<br>* The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks.<br>* Other names: Seeking Safety;|
| Active Comparator: Usual Care<br>Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment. | Behavioral: Standard outpatient SUD care<br>* Patients assigned to standard care meet twice weekly in Recovery 1 groups, which focuses on building abstinence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Alcohol Use (ASI Alcohol Composite Scores) | Alcohol and drug use composite scores were separately analyzed. The ASI alcohol composite score measures the severity of substance use and amount of use in the past 30 days and consequences of use. Scored as values between 0 and 1 with higher values indicating more severe substance use (i.e. lower values indicate a better outcome). | Administered at baseline and 3 months, 6 months and 12 months post baseline. | 
| ASI Drug Composite Score | Addiction Severity Index (ASI) drug composite scores measure past 30 days substance use (McLellan et al., 1992). The ASI assesses lifetime and current use of all major classes of drugs of abuse, history of substance-related problems, and history of SUD treatment. Scored as values between 0 and 1 with higher values indicating more severe substance use (i.e. lower values indicate a better outcome). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Symptoms (IES Total Score) | Composite measures of PTSD symptoms. Items are rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Total score ranging from 0 (not at all) to 88 (extremely) | Administered at 3 months, 6 months and 12 months post enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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outcomes assessment, substance use disorders, stress disorders, post-traumatic, screening