Integrated Alcohol Disorder and PTSD Treatment
Phase: PHASE2
Conditions: PTSD, Alcoholism
Sponsor: VA Office of Research and Development

NCT01601067
Integrated Alcohol Disorder and PTSD Treatment
04/14/2016

Objectives 
The primary aim will be to evaluate the effects on alcohol use and PTSD symptoms of an exposure-
based integrated AD and PTSD intervention (i.e., COPE) when compared to a present-focused 
coping skills intervention (i.e., Seeking Safety [SS]) in male and female Veterans with comorbid AD 
and PTSD. Hypotheses for the primary aim are:  
1. At post-treatment, both groups will show reductions in alcohol use, but COPE will demonstrate
greater reduction in PTSD symptoms than SS.
2. At the 2nd and 3rd post treatment follow up assessment ,COPE will have significantly fewer
percent drinking days than SS.
3. At the 2nd and 3rd post treatment follow up assessment ,COPE will continue to have lower PTSD
symptom scores.
Design. 
The proposed study will be a randomized controlled trial comparing  Concurrent Treatment of PTSD 
and Substance Use Disorders using PTSD (COPE) to Seeking Safety (SS) for the treatment of male 
and female Veterans with AD/PTSD.  178 participants will be enrolled through the San Diego VA and 
randomized at the individual level. Measures will occur at baseline, post-treatment, and two post 
treatment follow up assessments.  Participants will complete the 2nd post treatment  assessment 
interview and set of questionnaires 3 months after the 1st post treatment  appointment.  Participants 
will be scheduled for their 3rd and last post treatment interview 3  months after completing their  2nd 
post treatment assessment.  All procedures will be done for research purposes. 
Methods 
All work will be carried out at the SAMI outpatient program and PTSD clinics of the Veteran Affairs 
San Diego Healthcare Systems (VASDHS). Random permuted blocks will be used which ensure 
exactly equal treatment numbers at certain equally spaced points in the sequence of patient 
assignment. Randomization will be stratified by gender to ensure a balanced number of males and 
females are in each treatment group. 
The Timeline Follow-back Procedure (TLFB50) will be employed at baseline, post-treatment, 5-
month, and 8-month follow up to evaluate drinking and all drug use during the 30 days preceding 
each interview. 
The Clinician-Administered PTSD Scale for DSM-V(CAPS54,55) is a standard semi-structured 
interview used to assess PTSD diagnosis and severity. As part of the CAPS, a list of potentially 
traumatic events is given to respondents. 
Eligible participants will contact our study in response to flyers/ brochures posted in San Diego VA 
hospital, including the Mission Valley, Chula Vista, and Oceanside CBOCS; and by referral from VA 
primary care, substance use mental illness (SAMI), PTSD (OEF/OIF/OND, PCT, MST), and other 
clinics (ADTP, SARRTP); and also from VASDHS and VMRF websites under "Research 
opportunities"