PTSD Treatment and Emotion Regulation Skills Training for Veterans With Military Sexual Trauma (PE+ER)

NCT04792775 | Completed

• 1 other identifier: Pro00107912
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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 pilot 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.

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Mental Disorder; Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Clinical Administrated PTSD Scale (CAPS)

  The Clinician Administered PTSD (Posttraumatic stress disorder) Scale (CAPS) is a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-V) criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. Scores range from 0 to 80.

  13 weeks

Secondary Outcomes (1)

• PTSD Checklist, 5th Version (PCL-5)

  13 weeks

Study Arms (1)

Prolonged Exposure + Emotion Regulation Skills Training

EXPERIMENTAL

Twelve, 90-minute sessions of Prolonged Exposure (PE) with Dialectical Behavior Therapy (DBT) Emotion Regulation Skills Training.

Behavioral: PE+ER

Interventions

PE+ER BEHAVIORAL

PE includes the following components: a) psychoeducation about the common reactions to traumatic events and presentation of the treatment rationale b) repeated in vivo exposure to traumatic stimuli, c) repeated, prolonged, imaginal exposure to traumatic memories, and d) relapse prevention strategies and further treatment planning (session 12). DBT Emotion Regulation Skills is integrated as part of this intervention. DBT training provides skills to understand, name, experience and tolerate emotions, as well as skills to change negative emotional responses and to reduce vulnerability to emotion dysregulation (Linehan et al., 2015). The current project includes an adapted 3- session individual emotion regulation skills training intervention to be implemented concurrently with PE which consists of initial teaching/instruction and brief skills review for the remainder of PE treatment.

Prolonged Exposure + Emotion Regulation Skills Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Having a household member who is already enrolled in the study
• Active psychosis or dementia at screening
• Suicidal ideation with clear intent
• Current moderate to severe Substance Use Disorder
• Concurrent enrollment in a clinical trial for PTSD or depression.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Georgia State University: collaborator

Study Sites (1)

Ralph H. Johnson VAMC

Charleston, South Carolina, 29401, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Mental Disorders; Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders

Study Officials

• Wendy Muzzy, MRA, MLIS

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Amanda Gilmore, PhD

  Georgia State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 11, 2021
• Study Start: August 16, 2021
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)