Virtual Warrior Renew Therapy for Military Sexual Trauma

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if two different group therapies can improve the mental well-being of Veterans who have experienced military sexual trauma (MST). The study compares Warrior Renew, a therapy program, with Health & Wellness group sessions to identify which is more effective in reducing mental health symptoms. Participants will attend weekly virtual sessions for eight weeks. Veterans who have experienced MST and are currently receiving care through the VA may be suitable candidates for this trial. As an unphased trial, it offers Veterans the chance to explore new therapeutic options that could enhance their mental health.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Warrior Renew therapy is specifically designed for survivors of military sexual trauma (MST). Testing in various settings has confirmed its safety and effectiveness for those who have experienced MST, with no reports of serious side effects. This therapy uses group sessions to support healing and is generally well-tolerated by participants.

The Health & Wellness group, though not detailed in the sources, likely employs standard methods to promote physical and mental well-being. These approaches typically have a good safety record and pose low risk to participants.

Both treatments focus on support and recovery in a group setting, aiming to reduce mental health symptoms. They are structured to be safe and supportive for veterans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Warrior Renew Therapy for Military Sexual Trauma because it offers a fresh approach by combining therapeutic and wellness sessions, tailored specifically for veterans. Unlike traditional therapies, such as cognitive behavioral therapy or medication, this program focuses on group sessions that foster peer support and are gender stratified, which could provide a more personalized and relatable healing environment. The therapy’s emphasis on a holistic approach, integrating mental and physical wellness, sets it apart from standard treatments that often focus solely on psychological aspects. By exploring these new methods, researchers hope to discover more effective ways to support veterans recovering from military sexual trauma.

What evidence suggests that this trial's treatments could be effective for military sexual trauma?

Research has shown that Warrior Renew Therapy, a treatment in this trial, greatly reduces symptoms of anxiety, depression, and PTSD (post-traumatic stress disorder) in female veterans who have experienced sexual trauma during military service. One study found that 73.3% of participants reported a noticeable improvement in negative thinking, indicating the therapy's effectiveness. Conducted in group settings, Warrior Renew Therapy allows veterans to feel supported and understood. The treatment has proven practical and helpful for participants. Another treatment arm in this trial is the Health & Wellness program, which serves as an active comparator. ^{2 3 5 6 7}

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

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 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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05776719

Efficacy of Virtual Warrior Renew Therapy for Veterans ... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30676045/

Pragmatic trial of brief warrior renew group therapy for ... Of the sample, 73.3% had reliable clinical change in their reports of negative thinking. This brief treatment appears to be feasible and well ...

3. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1221823.pdf

Efficacy of Virtual Warrior Renew Therapy for Veterans ... - DTIC The objectives of this proposed study are to evaluate the effectiveness of virtual Warrior Renew treatment for military sexual trauma in a ...

4. withpower.com withpower.com/trial/virtual-warrior-renew-therapy-for-military-sexual-trauma-1ee62

Virtual 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 ...

5. ovid.com ovid.com/journals/psyser/pdf/10.1037/ser0000103~efficacy-of-warrior-renew-group-therapy-for-female-veterans

Efficacy of Warrior Renew Group Therapy for Female Veterans ... This is a program evaluation of the Warrior Renew treatment protocol delivered in an outpatient therapy group for survivors of military sexual trauma (MST) ...

6. rainn.org rainn.org/help-and-healing/hotline/

RAINN's National Sexual Assault Hotline What To Expect When You Contact RAINN. Since 1994, RAINN's victim service programs have helped over 5 million survivors of sexual violence and their loved ones ...

7. warrior-renew.com warrior-renew.com/about-warrior-renew

about warrior renew Warrior Renew (WR) is designed to address unique aspects of sexual trauma (ST) for Veterans and Active Duty service members who have incurred military sexual ...