American Medical University conducts a clinical trial of PTSD Treatment and Emotion Regulation Skills Training for Women With Military Sexual Trauma
Photo by Diego Gonzalez
The Medical University of South Carolina is enrolling patients into the clinical trial investigating PTSD Treatment and Emotion Regulation Skills Training for Women With Military Sexual Trauma.
Prior research has found that Veterans with military sexual trauma (MST) who have more difficulties with emotion regulation were more likely to drop out of PTSD treatment prematurely. The purpose of this study is to determine whether integrating evidence-based emotion regulation skills training with a scientifically validated treatment for PTSD called Prolonged Exposure (PE), will enhance PTSD treatment retention and 'dose received' and subsequently improve treatment outcomes for MST-related PTSD and difficulties with emotion regulation. Results from this project that examine the feasibility of integrating these two treatments will provide methodological evidence and justification for a randomized control trial, if warranted.
The purpose of this study is to learn ways to improve treatments for women with military sexual trauma (MST). The researchers want to learn whether combining evidence-based emotion regulation skills training with a trauma-focused therapy improves treatment outcomes. An evidence-based trauma treatment known as Prolonged Exposure will be used. Emotion regulation skills will also be included in treatment. Veterans with a positive or sub threshold diagnosis of PTSD who experienced a military sexual trauma (MST) will be included. Participants will complete up to twelve 90 minute sessions of PE with Dialectical Behavior Therapy (DBT) Emotion Regulation Skills Training followed by a post-treatment assessment. All aspects of the project including consent, baseline, treatment and follow-up will be completed either in person or via videoconferencing.
The trial is designed to enroll Female 18 years and older and is being conducted in the Ralph H. Johnson VAMC, Charleston, South Carolina, United States.
The study start date is August 10, 2020.
The patients that can be enrolled into this study include:
- MST-related index event
- Diagnosis of PTSD related to MST assigned on the basis of the Clinician Administered PTSD Scale (CAPS; Weathers et al., 2013)
- Difficulties with emotion regulation as identified by the Difficulties with Emotion Regulation Scale (DERS; Gratz & Roemer, 2004; although there is no clinical cutoff for the DERS, a total score of 99 is indicative of one standard deviation above average difficulties with emotion regulation for women)
This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04792775
