A Stage II Efficacy Study of Cognitive Behavioral Therapy for PTSD in Community Addiction Treatment

The main hypothesis being tested is that a cognitive behavioral therapy (CBT) for posttraumatic stress disorder (PTSD) can improve treatment retention and outcomes for both posttraumatic stress and substance use disorders. The investigators have completed the Stage I Safety & Practicality Study, Feasibility Study and Pilot Randomized Controlled Study (comparing CBT for PTSD to versus a control condition) and for all studies found that CBT for PTSD was safe and effective in reducing PTSD symptoms, improving retention, and in reducing substance use. The present study proposes to continue testing the hypotheses by evaluating and comparing the PTSD, retention and substance use outcomes resulting from CBT versus a control condition and to treatment as usual. This is termed a "Stage II Efficacy Study" of behavioral therapy development and requires comparing the investigational treatment (CBT) with a control treatment, within the context of addiction treatment-as-usual (intensive outpatient programs). This is a larger randomized controlled trial in response to the outcomes of the pilot trial. The proposed research will evaluate the efficacy of a relatively simple, manual-guided cognitive behavioral therapy (CBT) for PTSD. 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. Outpatients at each of 7 community addiction treatment programs, diagnosed with current PTSD will be randomly assigned to receive either: 1) CBT for PTSD in conjunction with standard treatment-as-usual (TAU) (n=76); 2) A manual-guided individual addiction counseling (IAC) adapted from the Individual Drug Counseling Manual in conjunction with TAU (n=76); or 3) TAU (n=76) without additional individual treatment for either PTSD or substance use disorders. Treatment will be delivered by frontline counselors from and onsite in the addiction treatment programs.

Our objective is to test the following specific hypotheses:

1. Patients exposed to CBT for PTSD plus treatment-as-usual (TAU) will show significantly greater improvements in PTSD symptom severity relative to patients in the other two interventions (IAC+TAU and TAU alone) at both the three-month and six-month follow-ups. The IAC+TAU condition will show no greater reduction in PTSD symptom severity than the TAU condition at both the three-month and six-month follow-ups.
2. Patients receiving the CBT for PTSD plus TAU will manifest equivalent reductions in substance use severity (drug and/or alcohol) to patients in the IAC+TAU intervention conditions at both the three-month and six-month follow-ups. CBT and IAC are both active treatments targeting substance use symptoms. The CBT+TAU and IAC+TAU condition patients will exhibit greater reductions in substance use than patients in the TAU condition at both the three-month and six-month follow-ups.
3. Patients in the CBT condition will have better retention in the addiction treatment program relative to the IAC+TAU and TAU alone intervention conditions. IAC+TAU will have better retention in the addiction treatment program than TAU alone.

This study involves a three-group repeated measure design. Within the NIDA stage model, it is a randomized controlled trial with a matched-attention control condition. The investigators plan to examine the outcomes associated with the intervention versus control condition versus treatment-as-usual among patients receiving outpatient addiction treatment services (intensive outpatient programs). The investigators will employ assessments at baseline, three-month follow-up, and six-month follow-up. Eligible subjects will be randomly assigned to the study CBT therapy (plus addiction treatment-as-usual), the matched attention control condition (individual addiction counseling [IAC] plus addiction treatment-as-usual) or the addiction treatment-as-usual, and all will be followed for the research assessments regardless of whether they drop out of treatment early (whenever possible).

Patients admitted to the participating addiction treatment programs are routinely screened for PTSD using a brief self-report survey, the PTSD checklist (PCL). These forms are collected by clinical staff of teh treatment program and scored for PTSD diagnostic criteria. Patients scoring 44 or greater on the PCL are approached by a clinic staff about potential interest in the study. If they wish to learn more about the study, research coordinator (or on-site employee) is contacted, a suitable time arranged, and the patient engaged in the process of informed consent.