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

NCT ID: NCT04792775

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2024-01-19

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.

Detailed Description

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. Fifteen participants will be enrolled.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prolonged Exposure + Emotion Regulation Skills Training

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

Group Type: EXPERIMENTAL

PE+ER

Intervention Type: 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.

Interventions

PE+ER

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgia State University

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy Muzzy, MRA, MLIS

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Amanda Gilmore, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgia State University

Locations

Ralph H. Johnson VAMC

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro00107912

Identifier Type: -

Identifier Source: org_study_id