134 Participants Needed

Virtual Warrior Renew Therapy for Military Sexual Trauma

Recruiting at 2 trial locations
AE
MN
Overseen ByMyduyen N Nguyen, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Seattle Institute for Biomedical and Clinical Research
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.12467

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.12689

Research Team

AE

Amanda E Wood, PhD

Principal Investigator

VA Puget Sound Health Care System

Eligibility Criteria

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
See 3 more

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
See 5 more

Timeline

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

Treatment Details

Interventions

  • Warrior Renew
  • Wellness and Health
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Warrior RenewExperimental Treatment1 Intervention
8 weeks, once weekly 90 minute sessions, groups of 8-10 subjects, gender stratified
Group II: Health & WellnessActive Control1 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)

Find a Clinic Near You

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+

Findings from Research

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

References

Efficacy of Warrior Renew group therapy for female veterans who have experienced military sexual trauma. [2019]
Delivering brief warrior renew over video teleconferencing to women veterans with military sexual trauma: A pragmatic trial. [2023]
An evolving integrative treatment program for military sexual trauma (MST) and one veteran's experience. [2011]
Pragmatic trial of brief warrior renew group therapy for military sexual trauma in VA primary care. [2021]
Bridging Body and Mind: Case Series of a 10-Week Trauma-Informed Yoga Protocol for Veterans. [2019]
Warrior Resilience Training in Operation Iraqi Freedom: combining rational emotive behavior therapy, resiliency, and positive psychology. [2013]
Can we facilitate posttraumatic growth in combat veterans? [2022]
"We really need this": Trauma-informed yoga for Veteran women with a history of military sexual trauma. [2022]
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]