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

Seattle Institute for Biomedical and Clinical Research

Status: Active, not recruiting

Conditions: Post Traumatic Stress Disorder; Military Sexual Trauma (MST)

Treatments: Behavioral: Warrior Renew; Behavioral: Health & Wellness

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05776719

W81XWH-22-1-1114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 191 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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191 participants in 2 patient groups

Health & Wellness

Active Comparator group

Description:

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

Treatment:

Behavioral: Health & Wellness

Warrior Renew

Experimental group

Description:

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

Treatment:

Behavioral: Warrior Renew