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

N/AActive Not RecruitingNCT05776719

Seattle Institute for Biomedical and Clinical Research191 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

191

Conditions

Military Sexual Trauma (MST)Post Traumatic Stress Disorder

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.

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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. 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. 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). 5. Unable to read English. 6. 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). 7. Concurrently enrolled in another research protocol involving a mental health intervention during this study. 8. Has had previous Warrior Renew treatment.

Locations (2)

VA Portland Health Care System

Portland, Oregon, United States

VA Puget Sound Health Care System

Seattle, Washington, United States

Outcomes

Primary Outcomes

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).

Time frame: Changes from baseline to end of 8-week treatment.

Secondary Outcomes

Patient Health Questionnaire - 9 (PHQ-9)

The PHQ-9 is self-report, nine-item screening tool for depression. The tool rates the frequency of depressive symptoms based on DSM-5 criteria for major depression, asking respondents rate each item according to the following instructions, "Over the last 2 weeks how often have you been bothered by any of the following:" Items are rated via four choices: 0= not at all, 1= several days, 2 = more than half the days, and 3= nearly every day. Scores are summed with higher scores indicating higher level of psychological distress. The PHQ-9 has been shown to have a sensitivity of 88% and specificity of 88% for Major Depression, with a Cronbach alpha of .89 (Kroenke et al., 2001). It has suggested interpretations of 5-9 = mild, 10-14 = moderate, 15-19 = moderate severe, and 20-27 = severe depression.