A Randomized Controlled Trial for Veterans with PTSD and Substance Use Disorder: Creating Change versus Seeking Safety

ABSTRACT

Background: Posttraumatic stress disorder (PTSD) and substance use disorder (SUD) co-occur in military veterans and other populations. Objective: To conduct a randomized controlled trial to compare a new past-focused treatment (Creating Change; CC), to a well-established, evidence-based present-focused treatment for PTSD/SUD (Seeking Safety; SS), on symptoms of both disorders. CC guides patients to process the past through exploration of PTSD/SUD life themes and memories whereas SS focuses on coping skills in the present. Methods: Fifty-two male and female veterans with current PTSD/SUD were randomized (n = 26 per treatment) and assessed at baseline, end-of-treatment and 3-month follow-up. They received 17 individual one-hour sessions. Results: Intent-to-treat analyses indicated that both conditions improved over time, with no difference between conditions, on PTSD, alcohol use, and drug use (our primary outcomes) as well as mental health symptoms, quality of life, self-efficacy, and SUD cognitions. Effect sizes were medium except for alcohol use, which was large. Change over time reflected improvement from baseline to end-of-treatment, with gains sustained at follow-up, although alcohol use showed continued improvement from end-of-treatment to follow-up. Both treatments evidenced a strong safety profile; and attendance, alliance, and treatment satisfaction were also very strong. Conclusions/importance: CC has promise as a PTSD/SUD therapy with strong public health relevance and the potential to fill important gaps in the field. We used minimal exclusionary criteria to obtain a real-world sample, which was severe—predominantly substance-dependent with chronic PTSD and additional psychiatric diagnoses. Future research is warranted, especially on nonveteran samples and treatment mechanisms of action.

KEYWORDS:

• PTSD
• substance abuse
• therapy
• veterans
• trauma

Disclosures

Lisa M. Najavits was an employee of VA Boston Healthcare System throughout this project. She developed Creating Change and Seeking Safety prior to and outside of her VA employment. Her potential conflict of interest was reviewed by the General Counsel of the Veterans Affairs Central Office and she was cleared to conduct this study prior to starting it. She receives royalties from Guilford Press for Seeking Safety and is Director of Treatment Innovations, which provides training and consultation related to various therapy models. Karen Krinsley, Matthew W. Gallagher, Molly E. Waring, and Christopher Skidmore report no competing interests.

Acknowledgments

This trial was registered at www.clinicaltrials.gov (#NCT0127-4741). We extend sincere appreciation to Joni Utley, PsyD, Kay Johnson, LICSW, and Helen Tretiak-Carmichael, MA for their work on this project and to Danny Kaloupek, PhD for his instrumental support of it.

Notes

1 We do not report SUD remission as DSM criteria for sustained full remission is based on the past year, which was beyond the timeframe for this study; moreover the standard SUD treatment outcome is reduction in substance use and SUD-related problems.

Additional information

Funding

This project was supported by the Department of Veterans Affairs, Clinical Sciences Research and Development grant #SPLA-06-S09.