Clinical trial NCT05776719: Efficacy of Virtual Warrior Renew Therapy for Veterans Who Experienced Military Sexual Trauma
Official title: Efficacy of Virtual Warrior Renew Therapy for Veterans Who Experienced Military Sexual Trauma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Military Sexual Trauma (MST)
Post Traumatic Stress Disorder
Keywords: group therapy
military sexual trauma
randomized clinical trial
PTSD
MST
Lead sponsor: Seattle Institute for Biomedical and Clinical Research
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-03-20
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization to either targeted group intervention or control group intervention; groups separated by gender
Primary purpose: TREATMENT

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.

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. Current or past diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, psychotic or dissociative disorders.
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).66
5. Unable to read English.
6. Currently receiving trauma-focused group or individual psychotherapy treatment. (Previous psychotherapy or current pharmacotherapy is acceptable).
7. Concurrently enrolled in another research protocol involving a mental health intervention during this study
8. Has had previous Warrior Renew treatment.

Primary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Changes from baseline at week 8
measure: PTSD Checklist for DSM-5
timeFrame: Changes from baseline at week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
city: Tacoma
country: United States
facility: VA Puget Sound Health Care System American Lake Division
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: Amanda E Wood, PhD
role: PRINCIPAL_INVESTIGATOR
References: