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

Primary Purpose

Military Sexual Trauma (MST), Post Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health & Wellness
Warrior Renew
Sponsored by
Seattle Institute for Biomedical and Clinical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Military Sexual Trauma (MST) focused on measuring group therapy, military sexual trauma, randomized clinical trial, PTSD, MST

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Portland Health Care SystemRecruiting
  • VA Puget Sound Health Care SystemRecruiting
  • VA Puget Sound Health Care System American Lake DivisionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Health & Wellness

Warrior Renew

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Full Information

First Posted
February 23, 2023
Last Updated
June 13, 2023
Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT05776719
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
January 30, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Military Sexual Trauma (MST), Post Traumatic Stress Disorder
Keywords
group therapy, military sexual trauma, randomized clinical trial, PTSD, MST

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomization to either targeted group intervention or control group intervention; groups separated by gender
Masking
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.
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health & Wellness
Arm Type
Active Comparator
Arm Description
8 weeks, once weekly 90 minute sessions, groups of 8-10 subjects, gender stratified
Arm Title
Warrior Renew
Arm Type
Experimental
Arm Description
8 weeks, once weekly 90 minute sessions, groups of 8-10 subjects, gender stratified
Intervention Type
Behavioral
Intervention Name(s)
Health & Wellness
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Warrior Renew
Intervention Description
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.
Primary Outcome Measure Information:
Title
PTSD Checklist for DSM-5 (PCL-5)
Description
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).
Time Frame
Changes from baseline at week 8
Title
PTSD Checklist for DSM-5
Description
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).
Time Frame
Changes from baseline at week 16

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
The groups will be separated by gender (e.g., men's group or women's group). Those who identify as non-binary or transgender will choose which group they would like to attend. Gender separation respects possible issues of discomfort and allows for gender-specific nuanced conversations.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Current or past diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, psychotic or dissociative disorders. 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 Unable to read English. Currently receiving trauma-focused group or individual psychotherapy treatment. (Previous psychotherapy or current pharmacotherapy is acceptable). Concurrently enrolled in another research protocol involving a mental health intervention during this study Has had previous Warrior Renew treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda E Wood, PhD
Phone
253-583-1651
Email
amanda.wood@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Myduyen N Nguyen, BS
Phone
253-583-1971
Email
myduyen.nguyen@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda E Wood, PhD
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miles S Evanisko, BA
Phone
503-220-8262
Ext
58593
Email
miles.evanisko@va.gov
First Name & Middle Initial & Last Name & Degree
Belle Zaccari, PsyD
Phone
503-220-8262
Ext
58593
Email
belle.zaccari@va.gov
First Name & Middle Initial & Last Name & Degree
Belle Zaccari, PsyD
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myduyen N Nguyen, BS
Phone
253-583-1971
Email
myduyen.nguyen@va.gov
First Name & Middle Initial & Last Name & Degree
Amanda E Wood, PhD
Phone
253-583-1651
Email
amanda.wood@va.gov
First Name & Middle Initial & Last Name & Degree
Amanda E Wood, PhD
Facility Name
VA Puget Sound Health Care System American Lake Division
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98483
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myduyen N Nguyen, BS
Phone
253-583-1971
Email
myduyen.nguyen@va.gov
First Name & Middle Initial & Last Name & Degree
Amanda E Wood, PhD
Phone
253-583-1651
Email
amanda.wood@va.gov
First Name & Middle Initial & Last Name & Degree
Amanda E Wood, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
As per our current IRB restrictions, no individual participant data will be available to outside researchers.

Learn more about this trial

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

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