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Military Sexual Trauma (MST)NCT05776719

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

A study testing Health & Wellness and Warrior Renew in people with Military Sexual Trauma (MST) and Post Traumatic Stress Disorder, run by Seattle Institute for Biomedical and Clinical Research at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Health & Wellness and Warrior Renew
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
2 sitesUnited States
Study dates
17 Jul 2023to 30 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Impaired decision-making capacity that in the clinical judgment of their provider would affect their ability to provide informed consent.
  • 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.
  • 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.
  • 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).
  • Unable to read English.
  • 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).
  • Concurrently enrolled in another research protocol involving a mental health intervention during this study.
  • Has had previous Warrior Renew treatment.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • VA Portland Health Care System

    Portland, Oregon, 97239

  • VA Puget Sound Health Care System

    Seattle, Washington, 98105

Other trials in United States

About this study

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.

Read the 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.

Being tested
Health & Wellness, Warrior Renew
Keywords
group therapy, military sexual trauma, randomized clinical trial, PTSD, MST
Medical subject headings
Military Sexual Trauma, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health & WellnessBehavioural

    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.

  • Warrior RenewBehavioural

    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.

Study groups in NCT05776719
Study groupRoleWhat they receive
Health & WellnessActive comparator8 weeks, once weekly 90 minute sessions, groups of 8-10 subjects, gender stratified
Receives: Behavioral: Health & Wellness
Warrior RenewExperimental8 weeks, once weekly 90 minute sessions, groups of 8-10 subjects, gender stratified
Receives: Behavioral: Warrior Renew

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Changes from baseline to end of 8-week treatment.

Secondary outcomes (9)
  1. 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.

    Measured: Changes from baseline to after 8-week treatment and at end of 16-week follow up.

  2. 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.

    Measured: Changes from baseline to after 8-week treatment and at end of 16-week follow up.

  3. 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).

    Measured: Changes from baseline to after 8-week treatment and at end of 16-week follow up.

  4. 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.

    Measured: Changes from baseline to after 8-week treatment and at end of 16-week follow up.

  5. 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.

    Measured: Changes from baseline to after 8-week treatment and at end of 16-week follow up.

  6. 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).

    Measured: Changes from baseline to after 8-week treatment and at end of 16-week follow up.

  7. 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.

    Measured: Changes from baseline to after 8-week treatment and at end of 16-week follow up.

  8. 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).

    Measured: Changes from baseline to after 8-week treatment and at end of 16-week follow up.

  9. 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).

    Measured: Changes from baseline to after 8-week treatment and at end of 16-week follow up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2023
  2. Study start17 Jul 2023
  3. Primary completion30 Jul 2025
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 randomization to either targeted group intervention or control group intervention; groups separated by gender
Masking
None (open label)
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05776719
Sponsor's protocol ID
W81XWH-22-1-1114
Status last verified
Aug 2025
First submitted
23 Feb 2023
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: As per our current IRB restrictions, no individual participant data will be available to outside researchers.

Publications

  • Wood AE, Zaccari BA, Hee Wai TY, Crooker MN, Evanisko MS, Clark JB, Sewell JB, Silverman SC, Dolph SJ, Katz LS. Group Therapy for Posttraumatic Stress Disorder Symptoms Among Veterans With Military Sexual Trauma: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jun 1;9(6):e2618896. doi: 10.1001/jamanetworkopen.2026.18896.

    PubMed 42313385

Questions about this trial

What is this clinical trial studying?

A study testing Health & Wellness and Warrior Renew in people with Military Sexual Trauma (MST) and Post Traumatic Stress Disorder, run by Seattle Institute for Biomedical and Clinical Research at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PTSD Checklist for DSM-5 (PCL-5) (time frame: Changes from baseline to end of 8-week treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05776719, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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