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.
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
- Conditions the study is for
- Military Sexual Trauma (MST), Post Traumatic Stress Disorder
- What is being tested?
- Health & Wellness and Warrior Renew
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Health & Wellness | Active comparator | 8 weeks, once weekly 90 minute sessions, groups of 8-10 subjects, gender stratified Receives: Behavioral: Health & Wellness |
| Warrior Renew | Experimental | 8 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.
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
- First posted20 Mar 2023
- Study start17 Jul 2023
- Primary completion30 Jul 2025
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Military Sexual Trauma (MST)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Amanda Wood, VA Puget Sound Health Care System
- Investigators
- Amanda E Wood, PhD, Principal investigator, VA Puget Sound Health Care System
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Warrior Renew Therapy for Veterans Who Experienced Military Sexual Trauma
- ClinicalTrials.gov ID
- NCT05776719
- Acronym / sponsor ID
- W81XWH-22-1-1114
- Keywords
- group therapy, military sexual trauma, randomized clinical trial, PTSD, MST
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization to either targeted group intervention or control group intervention; groups separated by gender
| Arm | Type | Receives |
|---|---|---|
| Health & Wellness | Active comparator | Behavioral: Health & Wellness8 weeks, once weekly 90 minute sessions, groups of 8-10 subjects, gender stratified |
| Warrior Renew | Experimental | Behavioral: Warrior Renew8 weeks, once weekly 90 minute sessions, groups of 8-10 subjects, gender stratified |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health & WellnessPowerPoint 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. | Behavioural | Health & Wellness |
| Warrior RenewThe 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. | Behavioural | Warrior Renew |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Changes from baseline to end of 8-week treatment.
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).
9 secondary outcomes
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Dimensions of Anger Reactions-5 (DAR-5)
Time frame: Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Internalized Shame Scale (ISS)
Time frame: Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Posttraumatic Cognitions Inventory (PTCI)
Time frame: Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Attitudes towards Emotional Expression Scale (AEE)
Time frame: Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Veteran RAND 12-Item Health Survey (VR-12)
Time frame: 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)
Time frame: Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Changes from baseline to after 8-week treatment and at end of 16-week follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Derived from this study: PubMed 42313385Wood 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.
- Individual participant dataSharing planned: No. As per our current IRB restrictions, no individual participant data will be available to outside researchers.
Related trials for Military Sexual Trauma (MST)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda E Wood, PhD principal investigator
VA Puget Sound Health Care System
2 sites in 1 country: see every site and its status.
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.