Efficacy of Prolonged Exposure Therapy, Sertraline Hydrochloride, and Their Combination Among Combat Veterans With Posttraumatic Stress Disorder A Randomized Clinical Trial

• Type of Material: Article
• Authors: Sheila Rauch, Emory University; H. Myra Kim, Veterans Affairs Atlanta Healthcare System; Cindy Powell, Emory University; Peter W. Tuerk, Veterans Affairs Medical Center, Charleston; Naomi M. Simon, Massachusetts General Hospital; Ron Acierno, Veterans Affairs Medical Center, Charleston; Carolyn B. Allard, Veterans Affairs San Diego Healthcare System; Sonya B. Norman, Veterans Affairs San Diego Healthcare System; Margaret R. Venners, Veterans Affairs Atlanta Healthcare System; Barbara Rothbaum, Emory University; Murray B. Stein, Veterans Affairs San Diego Healthcare System; Katherine Porter, Veterans Affairs Atlanta Healthcare System; Brian Martis, Veterans Affairs San Diego Healthcare System; Anthony P. King, Veterans Affairs Atlanta Healthcare System; Israel Liberzon, Veterans Affairs Atlanta Healthcare System; K. Luan Phan, University of Illinois; Charles W. Hoge, Walter Reed Army Institute of Research
• Language: English
• Date: 2019-02-01
• Publisher: American Medical Association (AMA)
• Publication Version: Final Published Version
• Copyright Statement: © 2018 American Medical Association. All rights reserved.
• Final Published Version (URL): http://dx.doi.org/10.1001/jamapsychiatry.2018.3412
• Title of Journal or Parent Work: JAMA Psychiatry
• ISSN: 2168-622X
• Volume: 76
• Issue: 2
• Start Page: 117
• End Page: 126
• Grant/Funding Information: This work was supported by the US Department of Defense through the US Army Medical Research and Materiel Command (Randomized Controlled Trial of Sertraline, Prolonged Exposure Therapy, and Their Combination in OEF/OIF Combat Veterans with PTSD; [award W81XWH-11-1-0073; principal investigator, Dr Rauch]); and the National Center for Advancing Translational Sciences of the National Institutes of Health (award UL1TR000433).
• Keywords: Psychiatry; PHARMACOTHERAPY; PLACEBO; Science & Technology; AUGMENTATION; METAANALYSIS; GUIDELINES; PSYCHOTHERAPY; REFUGEES; PAROXETINE; Life Sciences & Biomedicine; PTSD
• Research Categories: Health Sciences, Pharmacology; Health Sciences, Epidemiology

Abstract

Importance: Meta-analyses of treatments for posttraumatic stress disorder (PTSD) suggest that trauma-focused psychotherapies produce greater benefits than antidepressant medications alone. Objective: To determine the relative efficacy of prolonged exposure therapy plus placebo, prolonged exposure therapy plus sertraline hydrochloride, and sertraline plus enhanced medication management in the treatment of PTSD. Design, Setting, and Participants: The Prolonged Exposure and Sertraline Trial was a randomized, multisite, 24-week clinical trial conducted at the Veterans Affairs Ann Arbor Healthcare System, Veterans Affairs San Diego Healthcare System, Ralph H. Johnson Veterans Affairs Medical Center, and Massachusetts General Hospital Home Base Veterans Program between January 26, 2012, and May 9, 2016. Participants and clinicians were blinded to pill condition, and outcome evaluators were blinded to assignment. Participants completed assessments at weeks 0 (intake), 6, 12, 24, and 52 (follow-up). Participants (N = 223) were 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 3 months' duration. Analyses were on an intent-to-treat basis. Intervention: Participants completed up to thirteen 90-minute sessions of prolonged exposure therapy by week 24. Sertraline dosage was titrated during a 10-week period and continued until week 24; medication management was manualized. Main Outcomes and Measures: The primary outcome was symptom severity of PTSD in the past month as assessed by the Clinician-Administered PTSD Scale score at week 24. Results: Of 223 randomized participants, 149 completed the study at 24 weeks, and 207 (180 men and 27 women; mean [SD] age, 34.5 [8.3 years]) were included in the intent-to-treat analysis. Modified intent-to-treat analysis using a mixed model of repeated measures showed that PTSD symptoms decreased significantly during the 24 weeks (sertraline plus enhanced medication management, 33.8 points; prolonged exposure therapy plus sertraline, 32.7 points; and prolonged exposure therapy plus placebo, 29.4 points; β,-9.39; 95% CI, -11.62 to -7.16; P <.001); however, slopes did not differ by treatment group (prolonged exposure therapy plus placebo group, -9.39; sertraline plus enhanced medication management group, -10.37; and prolonged exposure therapy plus sertraline group, -9.99; P =.81). Conclusions and Relevance: No difference in change in PTSD symptoms or symptom severity at 24 weeks was found between sertraline plus enhanced medication management, prolonged exposure therapy plus placebo, and prolonged exposure therapy plus sertraline. Trial Registration: ClinicalTrials.gov Identifier: NCT01524133.