93 - RECONsolidation of Traumatic memories to ResOLve Posttraumatic Stress Disorder (RECONTROL): Preliminary Results

Abstract Text: Background and

Purpose: PTSD is highly prevalent (138,000 incident cases in military personnel, 2000-2015) and vexingly difficult to treat. PTSD has been associated with high rates of suicide, depression, and impairment in multiple domains. Even in well-designed controlled trials with “proven” treatments, such as prolonged exposure (PE), a response is achieved in less than half of military personnel with PTSD. While there are approved pharmacologic and non-pharmacologic therapies for PTSD, they are often poorly tolerated or ineffective, with poor compliance and high dropout rates, and even when a response is achieved, long-term therapy is necessary to prevent relapse. Despite these limitations, PE, cognitive processing therapy, or pharmacotherapy, such as selective serotonin reuptake inhibitors, are currently considered the standard of care. It is apparent that novel approaches need to be assessed to attempt to identify better tolerated and more efficacious therapies.
Reconsolidation of Traumatic Memories (RTM) is a particularly promising new imaginal approach, which, in five open or waitlist-controlled trials of combat PTSD to date, has been characterized by low dropout rates, marked reduction in symptom severity, and rapid responses. RTM is an imaginal approach that incorporates some aspects of exposure therapy, but replaces the difficult-to-tolerate prolonged nature of typical exposure approaches with a novel, brief technique that deliberately and rapidly provokes dissociation between the traumatic memory and associated emotions or feelings. Most notably, RTM eliminates the difficult process at the heart of PE that requires recounting one’s traumatic experience over and over again in excruciating detail.
Population: Active duty, Reservist, National Guard, or retired military service members who are eligible for care in the DoD healthcare system and who meet criteria for PTSD, as confirmed by administration of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) by an independent study administrator.

Design: This is a randomized, single-blind, two-arm, controlled clinical trial that aims to enroll 108 individuals with PTSD, comparing up to ten 90-minute sessions of either RTM or PE. Due to the COVID pandemic, the great majority of participants have completed assessments and intervention sessions by video teleconference (VTC) rather than in person.
Outcome Measures: The primary outcome measure is symptom severity on the CAPS-5 after completion of intervention, compared to baseline. In addition to the response achieved at the end of the intervention, rapidity of response is assessed with the PTSD Checklist for DSM-5 (PCL-5) after every other session, comparing Kaplan-Meier curves for the two study arms. Finally, durability of response is compared for the two arms by repeat administration of the CAPS-5 at 2, 6 and 12 months.
Preliminary

Results: As of December 2022, 60 participants have been enrolled (65% male, Mean age=49), 38 of whom have completed post-intervention assessments. To keep assessors blinded, results are provided for all participants combined. Of the completers, PCL-5 scores declined by a mean of 20.3 points (p <.001; 95% CI, 14.4 to 26.2) from pre- to post-treatment, and CAPS-5 scores were reduced by a mean of 13.4 points (p <.001; 95% CI, 9.6 to 17.2), with 22/38 (58%) no longer meeting criteria for PTSD. The dropout rate to date is 23%.
Preliminary

Conclusions: The novel intervention for PTSD, Reconsolidation of Traumatic Memories, has been well-received by military study participants to date, and is considerably easier to complete than Prolonged Exposure. Although we remain blinded to treatment allocation at this juncture, the preliminary results with all participants combined together are promising. In addition, conduct of both PE and RTM via VTC has been well-received and practical.

Disclaimer: The authors have no conflicts of interest to disclose. The views expressed in this presentation are solely those of the presenter and do not necessarily represent those of the Uniformed Services University, Department of Defense, any other U.S. government agency or the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and should not be construed as such.

Keywords: PTSD, Post-traumatic Stress Disorder, Prolonged Exposure, military, intervention, clinical trial, Post-traumatic Stress, RTM