NCT05776719

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jul 2023Oct 2026

First Submitted

Initial submission to the registry

February 23, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

July 17, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Expected
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

February 23, 2023

Last Update Submit

August 5, 2025

Conditions

Military Sexual Trauma (MST)Post Traumatic Stress Disorder

Keywords

group therapymilitary sexual traumarandomized clinical trialPTSDMST

Outcome Measures

Primary Outcomes (1)

  • 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 to end of 8-week treatment.

Secondary Outcomes (9)

  • Patient Health Questionnaire - 9 (PHQ-9)

    Changes from baseline to after 8-week treatment and at end of 16-week follow up.

  • Generalized Anxiety Disorder Assessment (GAD-7)

    Changes from baseline to after 8-week treatment and at end of 16-week follow up.

  • Dimensions of Anger Reactions-5 (DAR-5)

    Changes from baseline to after 8-week treatment and at end of 16-week follow up.

  • Internalized Shame Scale (ISS)

    Changes from baseline to after 8-week treatment and at end of 16-week follow up.

  • Posttraumatic Cognitions Inventory (PTCI)

    Changes from baseline to after 8-week treatment and at end of 16-week follow up.

  • +4 more secondary outcomes

Study Arms (2)

Health & Wellness

ACTIVE COMPARATOR

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

Behavioral: Health & Wellness

Warrior Renew

EXPERIMENTAL

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

Behavioral: Warrior Renew

Interventions

Health & WellnessBEHAVIORAL

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.

Health & Wellness
Warrior RenewBEHAVIORAL

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.

Warrior Renew

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThe groups will be separated by sex (e.g., men's group or women's group). Participants of all identities are invited to participate and will choose their group. Dividing the groups by sex respects possible issues of discomfort and allows for gender-specific nuanced conversations.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has established care with VA medical or mental health provider.
  • Reports having experienced military sexual trauma.
  • Between the ages of 18 and 75.
  • Is an outpatient and is able to comply with all study procedures, including the eight weeks of group treatment and the assessment measures.
  • Positive screen on the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).
  • Able to participate in virtual group therapy via telehealth.

You may not qualify if:

  • Impaired decision-making capacity that in the clinical judgment of their provider would affect their ability to provide informed consent.
  • 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.
  • 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.
  • 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).
  • Unable to read English.
  • 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).
  • Concurrently enrolled in another research protocol involving a mental health intervention during this study.
  • Has had previous Warrior Renew treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Portland Health Care System

Portland, Oregon, 97239, United States

Location

VA Puget Sound Health Care System

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Military Sexual TraumaStress Disorders, Post-Traumatic

Interventions

Health

Condition Hierarchy (Ancestors)

Sexual TraumaStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Amanda E Wood, PhD

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 randomization to either targeted group intervention or control group intervention; groups separated by gender
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Psychologist

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 20, 2023

Study Start

July 17, 2023

Primary Completion

July 30, 2025

Study Completion (Estimated)

October 30, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

As per our current IRB restrictions, no individual participant data will be available to outside researchers.

Locations

US(2)