Clinical trial NCT04792775: PTSD Treatment and Emotion Regulation Skills Training for Veterans With Military Sexual Trauma (PE+ER)
Official title: PTSD Treatment and Emotion Regulation Skills Training for Veterans With Military Sexual Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorder
Traumatic Stress Disorder
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Georgia State University
First posted: 2021-03-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical Administrated PTSD Scale (CAPS)
timeFrame: 13 weeks
Secondary outcomes:
measure: PTSD Checklist, 5th Version (PCL-5)
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VAMC
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Wendy Muzzy, MRA, MLIS
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgia State University
name: Amanda Gilmore, PhD
role: PRINCIPAL_INVESTIGATOR
References: