Efficacy of Virtual Warrior Renew Therapy for Veterans Who Experienced Military Sexual Trauma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 191
- 试验地点
- 4
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has established care with VA medical or mental health provider.
- •Reports having experienced military sexual trauma.
- •Between the ages of 18 and
- •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.
排除标准
- •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.
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5)
时间窗: Changes from baseline to end of 8-week treatment.
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).
次要结局
- Patient Health Questionnaire - 9 (PHQ-9)(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.)
- Generalized Anxiety Disorder Assessment (GAD-7)(Changes from baseline to after 8-week treatment and at end of 16-week follow up.)
- Pain, Enjoyment of Life and General Activity Scale (PEG)(Changes from baseline to after 8-week treatment and at end of 16-week follow up.)
- Pain Self-Efficacy Questionnaire (PSEQ)(Changes from baseline to after 8-week treatment and at end of 16-week follow up.)
- Attitudes towards Emotional Expression Scale (AEE)(Changes from baseline to after 8-week treatment and at end of 16-week follow up.)
- Veteran RAND 12-Item Health Survey (VR-12)(Changes from baseline to after 8-week treatment and at end of 16-week follow up.)
研究者
Amanda Wood
Clinical Research Psychologist
VA Puget Sound Health Care System