Study of Treatment for Posttraumatic Stress Disorder and Substance Use

• Change in substance use from baseline to 3-months post-treatment [ Time Frame: 3 months post-treatment ] [ Designated as safety issue: No ]
  Substance use measured via urine drug screens and the Addiction Severity Index Drug Use Composite score. These outcome variables will be measured multiple times between baseline and follow-up (weekly urinalysis, monthly administration of the ASI).
• Change in PTSD symptoms from baseline to 3 months post-treatment [ Time Frame: 3 months post-treatment ] [ Designated as safety issue: No ]
  PTSD symptoms assessed using the PTSD Checklist,a self-report measure, and the Clinician-Administered PTSD Scale. These measures are administered at baseline, end of treatment, and 3-month follow-up.

The purpose of this study is to determine if an integrated, cognitive-behavioral model of psychotherapy is effective in the treatment of individuals with posttraumatic stress disorder (PTSD) and substance use disorder (SUD).

This project is designed to evaluate a new model of psychotherapy that was developed for individuals with PTSD and SUD. The new model helps them to explore the past as a step in their recovery process. It has major public health relevance in that it is a low-cost, flexible model designed for all trauma and substance abuse types, both genders, and all clinical settings. It has particular relevance for VA in that many veterans suffer from PTSD and SUD. The new model has demonstrated positive results in a small study on civilian men. If the results of the current study are positive, a larger study could be done for the next stage of scientific testing.

• Posttraumatic Stress Disorder
• Substance Use Disorder

• No Intervention: Modified Treatment as Usual
  Participants randomly assigned to this condition may attend treatments they naturalistically seek out, with the exception of exposure-based PTSD therapies (e.g., prolonged exposure, cognitive processing therapy, eye move desensitization and reprocessing) and other integrated PTSD/SUD treatments (e.g., Seeking Safety).
• Experimental: Integrated psychotherapy for PTSD/SUD
  Participants randomly assigned to this arm will receive 17 sessions of Creating Change (described further under Assigned Interventions).
  Intervention: Behavioral: Creating Change (therapy model)

Inclusion Criteria:

• Meet DSM-IV criteria for current PTSD and current substance use disorder
• Have used a substance in the 60 days prior to intake
• Outpatient
• Plan to stay in Boston for the next 6 months
• If on psychiatric medication, are on a stable regimen for at least 4 weeks prior to participation in the study
• Have a stable mailing address and live nearby enough to come to VA Boston for treatment
• Able to sign informed consent
• Willing to participate in all assessments and urine testing
• Willing to provide a release of information for study staff to contact treaters as needed for clinical concerns

Exclusion Criteria:

• Any current acute medical condition that would either interfere with the patient's ability to attend treatment, or would be of such severity as to affect the patient's psychological functioning
• Current bipolar I disorder, schizophrenia or other psychotic disorders, mental retardation, or organic mental disorder
• Any obvious clinical sign that the patient is not sufficiently stable to participate in the treatment, or notification by the patient's primary providers that participation would be contraindicated
• Dangerousness that would present a threat to staff or patients (e.g., history of assault within the past 6 months)
• The patient is mandated to treatment