Integrated Cognitive Behavioral Therapy for Co-Occurring PTSD and Substance Use Disorders
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 56
- Locations
- 2
- Primary Endpoint
- Decrease from baseline in Clinician Administered PTSD Scale (CAPS) score (PTSD symptom severity) at 3-months and at 6-months
Study Overview
Brief Summary
The purpose of this study is to assess the safety and practicality, feasibility and efficacy of ICBT for co-occurring PTSD and substance use disorders within the OEF/OIF/OND Veterans population, as delivered by routine clinicians at the Veterans Affairs.
Detailed Description
The proposed research will evaluate the safety and practicality, feasibility, and efficacy of a relatively simple, manual guided integrated cognitive behavioral therapy (ICBT). ICBT (a revised edition of what was formerly called cognitive behavioral therapy for posttraumatic stress disorder [CBT for PTSD]) has been designed and developed for delivery by counselors employed in community addiction treatment programs and offered in conjunction with standard community addiction treatment. The investigators have completed a Stage I Safety & Practicality Study, Feasibility Study and Pilot Randomized Controlled Study (comparing ICBT versus a control condition) in community addiction treatment and for all studies found that ICBT was safe and effective in reducing PTSD symptoms, improving retention, and in reducing substance use. The present study proposes to conduct a Stage I study of ICBT among Operation Enduring Freedom (OEF) Operation Iraqi Freedom (OIF) and Operation New Dawn (OND) Veterans within the Veterans Affairs treatment setting. The investigators will modify the existing ICBT for testing in a VA setting, and use a combined individual and group modality.
There are 3 specific aims for this study, and hypotheses for each aim:
Aim 1: To test the feasibility of ICBT with OEF/OIF/OND Veterans diagnosed with PTSD and substance use disorders, and assess substance use and PTSD outcomes at 3- and 6-month follow-up (Stage I Phase I: Safety and practicality testing; Feasibility Study).
- This aim is to test the effect of ICBT on symptoms of PTSD and substance use disorders among returning OEF/OIF/OND Veterans seen in a VA clinic. ICBT will be tested with 16 Veterans who meet criteria for both PTSD and substance use disorder at the PTSD or SATP clinics. The investigators propose that ICBT will result in significant reductions in PTSD and substance use severity from baseline to follow-up assessment.
- Hypothesis 1: Participants receiving ICBT will have significant reductions in PTSD symptom severity as assessed by their Clinician Administered PTSD Scale (CAPS) score from baseline to a 6-month follow-up assessment.
- Hypothesis 2: Participants receiving ICBT will have significant reductions in substance use as assessed by their Addiction Severity Index (ASI) drug and alcohol severity composite scores from baseline to a 6-month follow-up assessment.
Aim 2: To revise the ICBT materials and protocol based on Stage I Phase I findings (Stage I Phase II).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •OEF/OIF/OND Veteran status;
- •Diagnosis of PTSD confirmed by the Clinician Administered PTSD Scale (CAPS) with a total symptom score of 44 or more;
- •Diagnosis of a substance use disorder (abuse or dependence) and confirmed by the Structured Clinical Interview of DSM-IV Section E (SCID-E);
- •Willing and able to provide informed consent;
Exclusion Criteria
- •Acute psychotic symptoms (however, persons with a psychotic disorder are eligible if their symptoms are stable and they are well connected with appropriate mental health services);
- •Psychiatric hospitalization or suicide attempt in the past month (however, if the hospitalization or attempt was directly related substance intoxication or detoxification and ther person is currently stable, they are eligible);
- •Medical or legal situations are unstable such that ability to participate in the full duration of the study seems unlikely.
Outcomes
Primary Outcomes
Decrease from baseline in Clinician Administered PTSD Scale (CAPS) score (PTSD symptom severity) at 3-months and at 6-months
Time Frame: Baseline, post-treatment, 3 months post treatment
Secondary Outcomes
- Reduction from baseline in substance use severity (Addiction Severity Index [ASI]) at 3-months and at 6-months(Baseline, post treatment, 3 months post treatment)
Investigators
Mark McGovern
Associate Professor of Psychiatry and of Community and Family Medicine
Dartmouth-Hitchcock Medical Center