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

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776719
• Other study ID #: W81XWH-22-1-1114
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: January 30, 2030

Study information

• Verified date: June 2023
• Source: Seattle Institute for Biomedical and Clinical Research
• Contact: Amanda E Wood, PhD
• Phone: 253-583-1651
• Email: amanda.wood[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: January 30, 2030
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Wounds and Injuries

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	VA Portland Health Care System	Portland	Oregon
United States	VA Puget Sound Health Care System	Seattle	Washington
United States	VA Puget Sound Health Care System American Lake Division	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Institute for Biomedical and Clinical Research	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Checklist for DSM-5 (PCL-5)	The 20-item PCL-550 will be used to assess symptoms of PTSD using items consistent with the Diagnostic and Statistical Manual 5 (DSM-5, 2013) criteria for PTSD. The wording of PCL-5 items reflects both changes to existing symptoms and the addition of new symptoms in DSM-5. The PCL-5 uses a self-report Likert rating scale of 0-4 for each symptom, including the anchors of: "Not at all," "A little bit," "Moderately," "Quite a bit," and "Extremely." A score of 31-33 has been identified as the optimally efficient cutoff for a probable diagnosis of PTSD (VA National Center for PTSD, 2015).	Changes from baseline at week 8
Primary	PTSD Checklist for DSM-5	The 20-item PCL-550 will be used to assess symptoms of PTSD using items consistent with the Diagnostic and Statistical Manual 5 (DSM-5, 2013) criteria for PTSD. The wording of PCL-5 items reflects both changes to existing symptoms and the addition of new symptoms in DSM-5. The PCL-5 uses a self-report Likert rating scale of 0-4 for each symptom, including the anchors of: "Not at all," "A little bit," "Moderately," "Quite a bit," and "Extremely." A score of 31-33 has been identified as the optimally efficient cutoff for a probable diagnosis of PTSD (VA National Center for PTSD, 2015).	Changes from baseline at week 16