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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Post Traumatic Stress Disorder; Military Sexual Trauma (MST)
• Intervention / Treatment: Behavioral: Warrior Renew; Behavioral: Health & Wellness

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 Type: Interventional
• Enrollment (Actual): 191
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • VA Portland Health Care System
  • Washington
    • Seattle, Washington, United States, 98105
      • VA Puget Sound Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. Dissociative, delusional or psychotic symptoms due to medical conditions or mental health disorders that in the clinical judgement of the PI or LSI would impede the participant's ability to participate actively in the study.
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).
5. Unable to read English.
6. Currently receiving trauma-focused group or individual psychotherapy treatment. (Previous psychotherapy, current pharmacotherapy, peer support groups, or maintenance therapy groups or individual therapy, defined as therapeutic services that have been ongoing for at least three months and are not trauma-focused, 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Warrior Renew; 8 weeks, once weekly 90 minute sessions, groups of 8-10 subjects, gender stratified	Behavioral: Warrior Renew; The group format includes warm-up community building exercises, psychoeducational presentation of material standardized by the use of PowerPoint slides, followed by discussion of the information and interactive exercises, and closes with exercises to improve affect management skills, such as mindfulness or guided imagery.
Active Comparator: Health & Wellness; 8 weeks, once weekly 90 minute sessions, groups of 8-10 subjects, gender stratified	Behavioral: Health & Wellness; PowerPoint slide decks will be shown via shared screen. The wellness group will be largely educational in nature and will encourage discussion, setting goals, and making healthy choices. Similar topics covered in this group have been used previously in health promotion classes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Checklist for DSM-5 (PCL-5)	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).	Changes from baseline to end of 8-week treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire - 9 (PHQ-9)	The PHQ-9 is self-report, nine-item screening tool for depression. The tool rates the frequency of depressive symptoms based on DSM-5 criteria for major depression, asking respondents rate each item according to the following instructions, "Over the last 2 weeks how often have you been bothered by any of the following:" Items are rated via four choices: 0= not at all, 1= several days, 2 = more than half the days, and 3= nearly every day. Scores are summed with higher scores indicating higher level of psychological distress. The PHQ-9 has been shown to have a sensitivity of 88% and specificity of 88% for Major Depression, with a Cronbach alpha of .89 (Kroenke et al., 2001). It has suggested interpretations of 5-9 = mild, 10-14 = moderate, 15-19 = moderate severe, and 20-27 = severe depression.	Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Generalized Anxiety Disorder Assessment (GAD-7)	The GAD-7 is a 7-item self-report measure of general anxiety. Respondents rate each item according to the following instructions, "Over the last 2 weeks how often have you been bothered by any of the following:" Items are rated via four choices: 0= not at all, 1= several days, 2 = more than half the days, and 3= nearly every day. Scores are summed with higher scores indicating higher level of psychological distress. The GAD-7 has been shown to have an 89% sensitivity and a 82% specificity for identifying general anxiety disorder, based on DSM-5.	Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Dimensions of Anger Reactions-5 (DAR-5)	The DAR-5 is a 7-item measure of anger that contains four questions about anger response (frequency, intensity, duration, and physical antagonism), and three items related to anger functional impairment (adverse impact on social relationships, work, and health). The revised version of this measure will be used, which reduced the Likert scale responses from nine to five items with no loss of validity. The measure has shown good internal consistency, with a Cronbach's alpha of .77 for anger response and .85 for anger impairment. Test-retest reliability was .66 for anger response and .56 for anger impairment. The scale has also shown good construct validity, showing significant correlations with all seven subscales of the longer State-Trait Anger Expression Inventory (STAXI).	Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Internalized Shame Scale (ISS)	The ISS is a 30-item self-report measure of trait shame, comprised of a 24-item internalized shame subscale and a 6-item self-esteem sub-scale. The measure asks about different experiences of shame without actually using the word "shame", which can be triggering and difficult to admit. A score of 50 or higher is purported to represent problematic levels of shame. The measure has shown strong internal consistency and reliability on both the internalized shame and self-esteem subscales with alpha coefficients of .88 and .96, and test-retest relatability of .81 and .75 respectively.	Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Posttraumatic Cognitions Inventory (PTCI)	The 33-item PTCI was used to assess trauma-related thoughts and beliefs. The PTCI has three subscales: negative cognitions about the self, negative cognitions about the world, and self-blame as well as a global scale, total negative cognitions, which is the sum of the three subscales. Items are rated using a seven-point Likert-type response scale that ranges from 1 = totally disagree, to 7 = totally agree. Negative thinking scores are computed by summing the items in each subscale with higher scores indicating higher ratings of negative thinking. The PTCI has demonstrated good internal consistency, test-retest reliability, and validity.	Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Attitudes towards Emotional Expression Scale (AEE)	The AEE is a 20-item scale that measures the belief that the expression of emotions is a sign of weakness (weakness); the belief that emotions should be kept under control (control); the belief that other people will reject expressed emotions (social); and the tendency to keep emotions to oneself (non-expression). Respondents are asked to respond to each item on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5) so that scores on the total scale have a possible range of 20 to 100, with higher scores indicating more negative attitudes toward emotional expression. It is reliable, single total score with alpha reliability of .93, and valid with high correlation with the Emotional Expression Questionnaire (r = .62, p<.001).	Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Veteran RAND 12-Item Health Survey (VR-12)	The VR-12 is a 12-item instrument primarily used to measure health related quality of life and disease burden. The instrument summarizes both physical health and mental health influences on overall quality of life. The VR-12 was derived from the Veterans RAND 36 Item Health Survey and has been used extensively with a Veteran population.	Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Pain, Enjoyment of Life and General Activity Scale (PEG)	The PEG is a three-item scale of pain, derived from the Brief Pain Inventory, and includes items of pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G). Overall, reliability of the PEG was good (0.73 and 0.89 in two samples). Construct validity for the PEG was also good for pain-specific measures (Krebs et al., 2009).	Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Pain Self-Efficacy Questionnaire (PSEQ)	The PSEQ is a 2-item questionnaire of pain, derived from the 10-item PSEQ. The 2-item scale has shown good validity and internal consistency, and had good convergent validity (Nicholas et al., 2015).	Changes from baseline to after 8-week treatment and at end of 16-week follow up.

Collaborators and Investigators

• Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Amanda E Wood, PhD, VA Puget Sound Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Actual): July 30, 2025
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: PTSD; randomized clinical trial; MST; group therapy; military sexual trauma
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Sexual Trauma; Wounds and Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: W81XWH-22-1-1114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As per our current IRB restrictions, no individual participant data will be available to outside researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No