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

VA Office of Research and Development

Status: Completed

Conditions: Posttraumatic Stress Disorder; Substance Use Disorders

Treatments: Behavioral: Standard outpatient SUD care; Behavioral: Modified Seeking Safety integrated into std outpatient SUD care

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00265564

IIR 04-175

Details and patient eligibility

About

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.

Full 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, treatment and assessment is complete and primary trial finds are published. Secondary analysis is ongoing.

Enrollment: 117 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. veteran status and VA healthcare eligibility,
2. a diagnosis of any alcohol or drug use disorder,
3. having completed an intake for outpatient SUD treatment at the VA Oakland outpatient mental health clinic, and
4. 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

1. current participation in any day or inpatient mental health treatment,
2. any contraindications communicated by that patient's primary clinician,
3. acute psychosis, mania, dementia, or suicidal intent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

Seeking Safety

Active Comparator group

Description:

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.

Treatment:

Behavioral: Modified Seeking Safety integrated into std outpatient SUD care

Usual Care

Active Comparator group

Description:

Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.

Treatment:

Behavioral: Standard outpatient SUD care