Virtual Warrior Renew Therapy for Military Sexual Trauma

Recruiting at 2 trial locations

Overseen By Myduyen N Nguyen, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Institute for Biomedical and Clinical Research

Disqualifiers: Schizophrenia, Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

134 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that current pharmacotherapy (medication treatment) is acceptable, so you likely can continue your medications.

Is Virtual Warrior Renew Therapy safe for humans?

The available research on Warrior Renew Therapy, including its brief and virtual versions, suggests it is generally well-tolerated by participants, with no significant safety concerns reported in the studies conducted with female veterans who experienced military sexual trauma. ^{1 2 3 4 5}

What makes the Virtual Warrior Renew Therapy unique for treating military sexual trauma?

Virtual Warrior Renew Therapy is unique because it is delivered over video teleconferencing, making it accessible to veterans who might not otherwise have access to care. It focuses on reducing self-blame and improving mental health symptoms like anxiety and depression, and most participants found the virtual format effective and convenient. ^{1 3 4 6 7}

What data supports the effectiveness of the treatment Warrior Renew Therapy for Military Sexual Trauma?

Research shows that Warrior Renew Therapy significantly reduces symptoms of anxiety, depression, and PTSD (posttraumatic stress disorder) in female veterans who have experienced military sexual trauma. Participants in both in-person and virtual formats reported improvements, with many preferring the convenience of virtual sessions. ^{1 2 3 8 9}

Who Is on the Research Team?

Amanda E Wood, PhD

Principal Investigator

VA Puget Sound Health Care System

Are You a Good Fit for This Trial?

This trial is for Veterans aged 18-75 who have experienced military sexual trauma and are currently receiving care from a VA provider. They must be able to attend virtual group therapy, speak English, and not have severe mental health conditions like schizophrenia or active substance abuse disorders.

Inclusion Criteria

Has established care with VA medical or mental health provider

I can attend all study visits and follow the 8-week treatment plan.

Reports having experienced military sexual trauma

Exclusion Criteria

I am currently in trauma-focused therapy.

Concurrently enrolled in another research protocol involving a mental health intervention during this study

Unable to read English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive group treatment sessions once weekly for 8 weeks, either in the Warrior Renew or Health & Wellness groups

8 weeks

8 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in PTSD symptoms using the PCL-5 assessment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Warrior Renew
• Wellness and Health

Trial Overview The study compares two group therapies: Warrior Renew and Health & Wellness, to see which is more effective at reducing mental health symptoms in Veterans with military sexual trauma. Participants will engage in one of these treatments over the course of 16 weeks.

How Is the Trial Designed?

Group I: Warrior Renew Experimental Treatment 1 Intervention

8 weeks, once weekly 90 minute sessions, groups of 8-10 subjects, gender stratified

Group II: Health & Wellness Active Control 1 Intervention

8 weeks, once weekly 90 minute sessions, groups of 8-10 subjects, gender stratified

Warrior Renew is already approved in United States for the following indications:

Approved in United States as Warrior Renew for:

• Military Sexual Trauma (MST)
• Post-Traumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

Seattle Institute for Biomedical and Clinical Research

Lead Sponsor

Trials

55

Recruited

13,700+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

The Warrior Renew treatment protocol, designed for female veterans who are survivors of military sexual trauma, showed significant reductions in anxiety, depression, negative thinking, and PTSD symptoms among participants, with large effect sizes reported.

Out of 34 participants who completed the program, 75% experienced reliable clinical improvement, indicating that this treatment may effectively address the unique challenges faced by survivors of military sexual trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Warrior Renew group therapy for female veterans who have experienced military sexual trauma. Katz, LS.[2019]

The eight-session virtual 'warrior renew' treatment for women veterans who experienced military sexual trauma showed significant improvements in mental health, with large effect sizes in reducing depression (PHQ-9) and anxiety (GAD-7) symptoms.

Participant feedback indicated a strong preference for the virtual format, with 96% finding it effective and convenient, suggesting that virtual care can be a valuable option for veterans, despite some challenges with technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering brief warrior renew over video teleconferencing to women veterans with military sexual trauma: A pragmatic trial. Katz, LS.[2023]

A specialized outpatient program at a VA Medical Center, based on Herman's three-phased recovery model, effectively treats military sexual trauma (MST) survivors, as demonstrated in a case study of a female veteran.

Post-treatment, the veteran showed significant improvements in PTSD symptoms, quality of life, and socialization, indicating the program's potential efficacy for MST survivors with PTSD and related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evolving integrative treatment program for military sexual trauma (MST) and one veteran's experience. Ferdinand, LG., Kelly, UA., Skelton, K., et al.[2011]

The Brief Warrior Renew treatment, a condensed version of a program for military sexual trauma, was delivered in 8 sessions to 39 female veterans, showing significant reductions in anxiety, depression, PTSD, and negative thinking with large effect sizes.

With a completion rate of 77% and 73.3% of participants experiencing reliable clinical improvement in negative thinking, the treatment was found to be feasible and well-received, indicating a need for further formal investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic trial of brief warrior renew group therapy for military sexual trauma in VA primary care. Katz, LS., Sawyer, WN.[2021]

A 10-week trauma-informed yoga program for veterans showed high retention (100%) and participation (85%) rates, indicating that it is feasible as a complementary treatment for combat-related trauma.

Preliminary results suggest that therapeutic yoga may significantly improve trauma-related symptoms and body connection for participants, with three out of four showing clinically meaningful enhancements by the end of the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging Body and Mind: Case Series of a 10-Week Trauma-Informed Yoga Protocol for Veterans. Justice, L., Brems, C.[2019]

Warrior Resilience Training (WRT) effectively enhances resilience and posttraumatic growth among Soldiers deployed in Operation Iraqi Freedom, utilizing techniques from rational emotive behavior therapy and positive psychology.

Feedback from 1168 participants indicates that WRT is well-received and suggests that integrating behavioral health services with military leadership can improve combat stress resiliency and promote overall force preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Warrior Resilience Training in Operation Iraqi Freedom: combining rational emotive behavior therapy, resiliency, and positive psychology. Jarrett, T.[2013]

The Comprehensive Soldier Fitness program aims to enhance posttraumatic growth in U.S. Army combat veterans, based on evidence from studies showing this phenomenon in veterans.

The authors recommend conducting randomized controlled trials to test the program's efficacy before it is implemented, ensuring its effectiveness in promoting mental resilience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can we facilitate posttraumatic growth in combat veterans? Tedeschi, RG., McNally, RJ.[2022]

Trauma-informed yoga (TIY) was found to be feasible and acceptable for women veterans who are survivors of military sexual trauma (MST), as demonstrated in a quality improvement project involving 7 participants at a New England Vet Center.

Participants reported significant improvements in various areas such as symptom severity, stress reduction, and mindfulness, along with acute reductions in negative affect after yoga sessions, suggesting that TIY may effectively support mental health in MST survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"We really need this": Trauma-informed yoga for Veteran women with a history of military sexual trauma. Braun, TD., Uebelacker, LA., Ward, M., et al.[2022]

A total of 364 veteran-partner dyads were recruited for a remote randomized controlled trial assessing a self-directed intervention for managing chronic pain and PTSD, but 26.6% did not complete onboarding due to issues like partner buy-in and difficulties with remote methods.

Qualitative interviews revealed that confusion about the intervention's intent and complicated registration materials were significant barriers to participation, highlighting the need for clearer communication and support in future remote health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial. Haun, JN., Venkatachalam, HH., Fowler, CA., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Warrior Renew group therapy for female veterans who have experienced military sexual trauma. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Delivering brief warrior renew over video teleconferencing to women veterans with military sexual trauma: A pragmatic trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

An evolving integrative treatment program for military sexual trauma (MST) and one veteran's experience. [2011]

4. United States pubmed.ncbi.nlm.nih.gov

Pragmatic trial of brief warrior renew group therapy for military sexual trauma in VA primary care. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Bridging Body and Mind: Case Series of a 10-Week Trauma-Informed Yoga Protocol for Veterans. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Warrior Resilience Training in Operation Iraqi Freedom: combining rational emotive behavior therapy, resiliency, and positive psychology. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Can we facilitate posttraumatic growth in combat veterans? [2022]

8. Scotland pubmed.ncbi.nlm.nih.gov

"We really need this": Trauma-informed yoga for Veteran women with a history of military sexual trauma. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial. [2023]