Multifaceted Intervention to Restore Resilience and Overcome Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Difficulties in Emotion Regulation Scale (DERS)
研究概览
简要总结
The MIRROR study will compare the effectiveness of two interventions in improving emotion regulation and reducing PTSD symptoms in female Veterans with military sexual trauma (MST) and/or intimate partner violence (IPV) and co-occurring brain injury.
详细描述
Female Veterans (FVets) face disproportionately high rates of exposure to intimate partner violence (IPV) and military sexual trauma (MST). Studies suggest that a substantial proportion of women with MST and IPV exposure also experience co-occurring brain injury (BI) due to IPV/MST and from non-violent etiologies. Exposure to MST, IPV, and co-occurring BI, coupled with their effects on psychological outcomes, represents a significant health concern to both the military and public, yet there is a lack of effective interventions to treat the cumulative effects of MST, IPV and BI in FVets. The Multifaceted Intervention to Restore Resilience and Overcome Risk (MIRROR) study seeks to overcome this challenge by examining the effectiveness of a multifaceted intervention that combines a web-based emotion regulation (EmReg) intervention (Skills Training in Affective Regulation and Interpersonal Relationships program [webSTAIR]) and a Veteran's Affairs (VA) supported evidence-based practice (EBP), exposure therapy (ExpoTx), for treating post-traumatic stress disorder (PTSD) associated with MST, IPV, and BI in FVets. FVets who screen positive for exposure to MST and/or IPV, have a history of at least one BI, sub-threshold PTSD, and documented emotional dysregulation will be included and randomly assigned to either one of two intervention arms: 1) webSTAIR+ ExpoTx or 2) PsychEd+ ExpoTx. Aim 1 will examine the effectiveness of webSTAIR relative to psychoeducation (PsychEd) on EmReg in FVets with MST and/or IPV and BI. Aim 2 will examine whether improvements in EmReg lead to improved treatment outcomes in FVets. Aim 3 will examine the effectiveness of the interventions in maintaining treatment gains at the 3-month follow-up. The study will include lived experience consultants as research partners and involve a community advisory board (CAB) that includes FVets and key stakeholders.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to consent as determined by UBACC, are English-speaking FVets who are 18+ years old
- •Screen positive for exposure to IPV and/or MST using the VA Intimate Partner Violence Assistance Program (VA IPVAP) and MST Screening Protocol,
- •Have a history of at least one BI assessed using the BISQ+IPV,
- •Sub-threshold PTSD (operationalized as a total score of >33 on the PTSD Checklist Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5),
- •Report deficits in Emotion Regulation (operationalized as a score of 0.5 SD above published means on the DERS).
排除标准
- •FVets at high risk for suicide (respond yes to items 3, 4, 5, or 8 on the Columbia Suicide Severity Rating Scale [C-SSRS]), will be initially excluded until a secondary risk and safety assessment is completed by one of the Texas licensed study psychologists, who will use the VA Comprehensive Suicide Risk Evaluation (CSRE) to determine planning and intentions. Veterans who endorse chronic thoughts of death found among those with PTSD and depression, but who have no suicidal behaviors with intent to act, based on secondary risk assessment, will be included in the study.
- •Observable active psychosis (e.g., auditory hallucinations, grandiose delusions),
- •Those determined to have problematic substance use (score > 27 on the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) will be referred to substance use dependence programs for concurrent treatment. The PI and Co-Is will collaborate with the substance use dependence program to determine continued participation.
研究组 & 干预措施
webSTAIR+ExpoTx
Web-based technology "webSTAIR" (Web-Based Skills Training in Affective Regulation and Interpersonal Relationships Program) will be used to guide Female Veterans (FVets) through each of the 10 webSTAIR skill modules for 5-weeks followed by 5 weeks of standard, patient-centered, exposure therapy (ExpoTx) delivered by a therapist.
干预措施: webSTAIR (Behavioral)
webSTAIR+ExpoTx
Web-based technology "webSTAIR" (Web-Based Skills Training in Affective Regulation and Interpersonal Relationships Program) will be used to guide Female Veterans (FVets) through each of the 10 webSTAIR skill modules for 5-weeks followed by 5 weeks of standard, patient-centered, exposure therapy (ExpoTx) delivered by a therapist.
干预措施: ExpoTx (Behavioral)
PsychoEd+ExpoTx
5 online sessions of psycho-education followed by 5 online sessions of exposure therapy
干预措施: ExpoTx (Behavioral)
PsychoEd+ExpoTx
5 online sessions of psycho-education followed by 5 online sessions of exposure therapy
干预措施: PsychoEd (Other)
结局指标
主要结局
Difficulties in Emotion Regulation Scale (DERS)
时间窗: At week 0, week 2.5, week 5, week 7.5, week 10, and month 3
The DERS is a 36-item self-report measure that assesses emotion dysregulation in six domains: nonacceptance of emotional responses (subscale score 6-30), difficulties engaging in goal directed behavior (subscale score 5-25), impulse control difficulties (subscale score 6-30), lack of emotional awareness (subscale score 6-30), limited access to emotion regulation strategies (subscale score 8-40), and lack of emotional clarity (subscale score 5-25). Items are rated on a scale of 1 ("almost never \[0-10%\]") to 5 ("almost always \[91-100%\]"). Total Score range from 36-180, with higher scores indicating more difficulty in emotion regulation.
次要结局
- Post-Traumatic Stress Disorder Checklist for the DSM-5 (PCL-5)(At week 0, week 2.5, week 5, week 7.5, week 10, and month 3)
- Depression and Anxiety Stress Scale (DASS)(At week 0, week 5, week 10, and month 3)
- Inventory of Interpersonal Problems (IIP-32)(At week 0, week 5, week 10, and month 3)
- Dysexecutive Questionnaire (DEX)(At week 0, week 5, week 10, and month 3)
- Quality of Life after Brain Injury Overall Scale (QoLABRIOS)(At week 0, week 5, week 10, and month 3)
研究者
Maria Kajankova
Assistant Professor
Icahn School of Medicine at Mount Sinai