Comparing written exposure therapy to Prolonged Exposure for the treatment of PTSD in a veteran sample: A non-inferiority randomized design

Contemp Clin Trials Commun. 2021 Apr 7:22:100764. doi: 10.1016/j.conctc.2021.100764. eCollection 2021 Jun.

Abstract

Posttraumatic stress disorder (PTSD) is highly prevalent among veterans. Although there are effective treatment approaches for PTSD, such as Prolonged Exposure (PE) and Cognitive Processing Therapy, many providers trained in these approaches do not use them, or use them without sufficient fidelity, and veterans drop out of these treatments at very high rates. The time intensive nature of these treatments is frequently cited as a barrier to receiving the treatment among veterans and delivering the treatment among providers. According, there is an urgent need to establish more efficient and effective PTSD treatment approaches in order to meet the needs of veterans seeking care. Written exposure therapy (WET) is an efficient, exposure-based treatment, and may represent a plausible alternative treatment option to address PTSD in veterans. Although WET has been found to be effective and non-inferior to more time intensive trauma-focused treatment, it has not yet been investigated with a veteran sample. In an ongoing randomized controlled trial (RCT) we are investigating whether WET is non-inferior in treating PTSD compared with the more time intensive PE. The study sample will include 150 men and women veterans diagnosed with PTSD who are randomly assigned to either WET (n = 75) or PE (n = 75). Participants are assessed prior to treatment and 10-, 20-, and 30-weeks after the first treatment session. The primary outcome is PTSD symptom severity assessed with the Clinician Administered PTSD Scale for DSM-5. Establishing that PTSD can be treated effectively with fewer treatment sessions would represent a significant advance in improving access to evidence-based care for veterans with PTSD.

Keywords: CAPS-5, Clinician Administered PTSD Scale for DSM-5; CEQ, Credibility/Expectancy Questionnaire; CPT, Cognitive Processing Therapy; Clinical trial; DSM-5, Diagnostic and Statistical Manual of Mental Disorders, 5th Edition; DoD, Department of Defense; EBTs, evidence-based treatments; Exposure-based treatment; IRB, Institutional Review Board; ITT, intent-to-treat; LEC, Life Events Checklist; Military veterans; PCL-5, PTSD Checklist for DSM-5; PE, Prolonged Exposure; PI, principal investigator; PTSD, posttraumatic stress disorder; Posttraumatic stress disorder; RCT, randomized clinical trial; SCID-5, Structured Clinical Interview for DSM-5; SITBI, Self-Injurious Thoughts and Behaviors Interview; Trauma-focused treatment; VA, Department of Veterans Affairs; WAI-SR, Working Alliance Inventory-Short Revised; WET, Written Exposure Therapy.