Efficacy of Virtual Warrior Renew Therapy for Veterans Who Experienced Military Sexual Trauma

Not Applicable

Recruiting

• Conditions: Military Sexual Trauma (MST); Post Traumatic Stress Disorder
• Interventions: Behavioral: Warrior Renew; Behavioral: Health & Wellness

• Registration Number: NCT05776719
• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research

Brief Summary

Group treatments may be helpful for Veterans who have experienced military sexual trauma (MST). By doing this study, the investigators hope to learn if two different groups: Warrior Renew and Health \& Wellness are effective in reducing mental health symptoms in Veterans who have experienced MST and if either is more effective than the other. Participation in this research will last about 16 weeks.

Detailed Description

This project will examine mental health treatment in a group setting for Veterans who have experienced military sexual trauma. Military sexual trauma or MST is defined as any experience of sexual assault or sexual harassment experienced during military service. Survivors of MST may develop mental health symptoms. Group treatment for survivors of MST may be helpful. This study will compare two different group treatments: 1) Warrior Renew; and 2) Health \& Wellness.

By doing this study, the investigators hope to learn: 1) if one or both of the group treatments are safe and effective in reducing mental health symptoms in Veterans who have experienced MST; and 2) if there are differences based on gender that should be addressed differently in developing treatments for survivors of MST.

Study Timeline

• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-20
• Study Start: 2023-05-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16
• Primary Completion: 2026-11-30
• Study Completion: 2030-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

1. Has established care with VA medical or mental health provider.
2. Reports having experienced military sexual trauma.
3. Between the ages of 18 and 75.
4. Is an outpatient and is able to comply with all study procedures, including the eight weeks of group treatment and the assessment measures.
5. Positive screen on the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).
6. Able to participate in virtual group therapy via telehealth.

Exclusion Criteria

1. Impaired decision-making capacity that in the clinical judgment of their provider would affect their ability to provide informed consent.
2. Current/active suicidal ideation as evidenced by a positive screen on the Columbia Suicide Severity Rating Scale (C-SSRS), or a suicide attempt or psychiatric hospitalization within the past year
3. Current or past diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, psychotic or dissociative disorders.
4. Current/active diagnosis of a substance use disorder or an alcohol use disorder as measured by the Alcohol Use Disorders Identification Test-Concise (AUDIT-C).66
5. Unable to read English.
6. Currently receiving trauma-focused group or individual psychotherapy treatment. (Previous psychotherapy or current pharmacotherapy is acceptable).
7. Concurrently enrolled in another research protocol involving a mental health intervention during this study
8. Has had previous Warrior Renew treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warrior Renew	Warrior Renew	8 weeks, once weekly 90 minute sessions, groups of 8-10 subjects, gender stratified
Health & Wellness	Health & Wellness	8 weeks, once weekly 90 minute sessions, groups of 8-10 subjects, gender stratified

Primary Outcome Measures

Name	Time	Method
PTSD Checklist for DSM-5 (PCL-5)	Changes from baseline at week 8	The 20-item PCL-550 will be used to assess symptoms of PTSD using items consistent with the Diagnostic and Statistical Manual 5 (DSM-5, 2013) criteria for PTSD. The wording of PCL-5 items reflects both changes to existing symptoms and the addition of new symptoms in DSM-5. The PCL-5 uses a self-report Likert rating scale of 0-4 for each symptom, including the anchors of: "Not at all," "A little bit," "Moderately," "Quite a bit," and "Extremely." A score of 31-33 has been identified as the optimally efficient cutoff for a probable diagnosis of PTSD (VA National Center for PTSD, 2015).
PTSD Checklist for DSM-5	Changes from baseline at week 16	The 20-item PCL-550 will be used to assess symptoms of PTSD using items consistent with the Diagnostic and Statistical Manual 5 (DSM-5, 2013) criteria for PTSD. The wording of PCL-5 items reflects both changes to existing symptoms and the addition of new symptoms in DSM-5. The PCL-5 uses a self-report Likert rating scale of 0-4 for each symptom, including the anchors of: "Not at all," "A little bit," "Moderately," "Quite a bit," and "Extremely." A score of 31-33 has been identified as the optimally efficient cutoff for a probable diagnosis of PTSD (VA National Center for PTSD, 2015).

Trial Locations

Locations (3)

VA Portland Health Care System; 🇺🇸 Portland, Oregon, United States

VA Puget Sound Health Care System American Lake Division; 🇺🇸 Tacoma, Washington, United States

VA Puget Sound Health Care System; 🇺🇸 Seattle, Washington, United States