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

Sponsor
Seattle Institute for Biomedical and Clinical Research (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05776719
Collaborator
United States Department of Defense (U.S. Fed)
134
2
81.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Wellness and Health
  • Behavioral: Warrior Renew
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
134 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1:1 randomization to either targeted group intervention or control group intervention; groups separated by gender1:1 randomization to either targeted group intervention or control group intervention; groups separated by gender
Masking:
Single (Participant)
Masking Description:
Study participants will be informed that they will be randomized to one of two groups but will not be informed which group is expected to perform better.
Primary Purpose:
Treatment
Official Title:
Efficacy of Virtual Warrior Renew Therapy for Veterans Who Experienced Military Sexual Trauma
Anticipated Study Start Date :
Apr 15, 2023
Anticipated Primary Completion Date :
Nov 30, 2026
Anticipated Study Completion Date :
Jan 30, 2030

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Wellness Health

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

Behavioral: Wellness and Health
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.

Experimental: Warrior Renew

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

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.

Outcome Measures

Primary Outcome Measures

  1. PTSD Checklist for DSM-5 (PCL-5) [Changes from baseline at week 8]

    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).

  2. PTSD Checklist for DSM-5 [Changes from baseline at week 16]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Seattle Institute for Biomedical and Clinical Research
  • United States Department of Defense

Investigators

  • Principal Investigator: Amanda E Wood, PhD, VA Puget Sound Health Care System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amanda Wood, Clinical Research Psychologist, VA Puget Sound Health Care System
ClinicalTrials.gov Identifier:
NCT05776719
Other Study ID Numbers:
  • W81XWH-22-1-1114
First Posted:
Mar 20, 2023
Last Update Posted:
Mar 20, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amanda Wood, Clinical Research Psychologist, VA Puget Sound Health Care System
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 20, 2023