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

NCT ID: NCT05776719

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-17
• Study Completion Date: 2026-10-30

Brief 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 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.

Conditions

Military Sexual Trauma (MST); Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Health & Wellness

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

Group Type: ACTIVE_COMPARATOR

Health & Wellness

Intervention Type: BEHAVIORAL

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 Renew

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

Group Type: EXPERIMENTAL

Warrior Renew

Intervention Type: BEHAVIORAL

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.

Interventions

Health & Wellness

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.

Intervention Type: BEHAVIORAL

Warrior Renew

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Has established care with VA medical or mental health provider.

2. Reports having experienced military sexual trauma.

3. Between the ages of 18 and 75.

4. Is an outpatient and is able to comply with all study procedures, including the eight weeks of group treatment and the assessment measures.

5. Positive screen on the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).

6. Able to participate in virtual group therapy via telehealth.

Exclusion Criteria

1. Impaired decision-making capacity that in the clinical judgment of their provider would affect their ability to provide informed consent.

2. 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.

3. 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.

4. 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).

5. Unable to read English.

6. 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).

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

8. Has had previous Warrior Renew treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Seattle Institute for Biomedical and Clinical Research

OTHER

Sponsor Role: lead

Responsible Party

Amanda Wood

Clinical Research Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amanda E Wood, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System

Locations

VA Portland Health Care System

Portland, Oregon, United States

VA Puget Sound Health Care System

Seattle, Washington, United States

Countries

United States

Other Identifiers

W81XWH-22-1-1114

Identifier Type: -

Identifier Source: org_study_id