In a study among United States combat veterans, researchers found no significant difference between two of the most common treatments for post-traumatic stress disorder (PTSD) and no benefit for combination treatment. The study results are published in the Dec. 5 online issue of the Journal of the American Association (JAMA) Psychiatry.
The head-to-head randomized clinical trial was conducted between 2012 and 2016 by researchers at four sites: Ralph H. Johnson Veterans Affairs (VA) Medical Center, VA Ann Arbor Healthcare System, Massachusetts General Hospital and VA San Diego Healthcare System. It was led by principal investigator Sheila Rauch, PhD, associate professor in the Department of Psychiatry and Behavioral Sciences at the Emory University School of Medicine.
The study included 223 service members or veterans of the Iraq and/or Afghanistan wars with combat-related PTSD and significant impairment (Clinician-Administered PTSD Scale score ≥50) of at least three months duration.
Current clinical practice guidelines recommend both trauma-focused psychotherapies, such as exposure therapy, and antidepressants, known as selective serotonin reuptake inhibitors (SSRIs), as effective treatments for PTSD.
Investigators looked at how sertraline hydrochloride (commonly prescribed SSRI) plus enhanced medication management compared to prolonged exposure therapy plus placebo and the combination of prolonged exposure therapy plus sertraline and to help reduce the severity of PTSD symptoms over 24 weeks of treatment.
“Our study is the first to compare psychotherapy and medications in veterans with PTSD. The findings provide guidance for clinicians that both prolonged exposure therapy and sertraline are effective treatments for PTSD in veterans, both resulting in large reductions in symptoms,” says Rauch, who also serves as clinical director of the Emory Healthcare Veterans Program and director of Mental Health Research and Program Evaluation at the Atlanta VA Medical Center.
Rauch noted the efficacy of sertraline in this study is larger than previous studies and may suggest that standardization of psychoeducation and support may enhance response to this medication. Combination sertraline and prolonged exposure did not show additional benefit.
During the double-blinded study, participants completed assessments at the start and routinely throughout the 24 weeks, as well as a one-year follow-up assessment.
Participants completed up to 13 90-minute sessions of prolonged exposure therapy throughout the 24-week study period. Sertraline dosage was adjusted as needed during a 10-week period and continued until the end of the study. Medication management was manualized.
Rauch says the study also examined mechanisms and predictors of change. Additional publications will be forthcoming to address questions of who responds better to medication versus prolonged exposure therapy as well as what mechanisms may be involved.
According to the American Psychological Association, prolonged exposure therapy is a psychological treatment that helps people confront their fears - approach fear instead of avoiding it. Clinicians create a safe environment in which to “expose” individuals to the things they fear and avoid.
This study is supported by the following DOD and NIH grants: U.S. Department of Defense through the U.S. Army Medical Research and Materiel Command (MRMC), Randomized Controlled Trial of Sertraline, Prolonged Exposure Therapy, and Their Combination in OEF/OIF Combat Veterans with PTSD, Award #W81XWH-11-1-0073; the National Center for Advancing Translational Sciences of the National Institutes of Health (Award #UL1TR000433).