Multifaceted Intervention to Restore Resilience and Overcome Risk

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое webSTAIR
  Ten web-based modules that are completed independently by participants (\~2 modules per week) and receive therapist support via video-telehealth after the completion of every 2 skill modules (1x per week for a total of 5 meetings). The first five modules review emotional awareness, emotion management, and distress tolerance while the final five modules raise awareness about relationship patterns and provide interpersonal skills training regarding effective assertiveness, interpersonal flexibili
• Поведенческое ExpoTx
  A real-time, present-focused, intervention that does not require participants to relive or focus on past trauma(s), but rather on current social functioning; ie, how they are doing in day-to-day life, and current cognitive and psychological functioning. Therapist will meet individually with the participant for 5 sessions, 60 minutes each conducted virtually. During the 5 sessions, participants will be guided to use in vivo or in the moment ExpoTx to identified fear-based triggers. In each consec
• Другое PsychoEd
  Psycho-education (PsychEd) orientation that provides an overview of PsychEd as a process for learning about mental health symptoms and disease management related to trauma. During PsychEd sessions, therapists will focus on the following 5 areas: 1) Defining trauma and PTSD. 2) Brain Basics and Brain Injury. 3) Understanding the Role of Stress and Its impact on trauma symptoms. 4) The Role of Nutrition and Exercise in Disease Management. 5) Information on other Programs.

Первичные конечные точки

• Difficulties in Emotion Regulation Scale (DERS) [Срок оценки: At week 0, week 2.5, week 5, week 7.5, week 10, and month 3]

Вторичные конечные точки (5)

• Post-Traumatic Stress Disorder Checklist for the DSM-5 (PCL-5) [Срок оценки: At week 0, week 2.5, week 5, week 7.5, week 10, and month 3]
• Depression and Anxiety Stress Scale (DASS) [Срок оценки: At week 0, week 5, week 10, and month 3]
• Inventory of Interpersonal Problems (IIP-32) [Срок оценки: At week 0, week 5, week 10, and month 3]
• Dysexecutive Questionnaire (DEX) [Срок оценки: At week 0, week 5, week 10, and month 3]
• Quality of Life after Brain Injury Overall Scale (QoLABRIOS) [Срок оценки: At week 0, week 5, week 10, and month 3]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• FVets at high risk for suicide (respond yes to items 3, 4, 5, or 8 on the Columbia Suicide Severity Rating Scale \[C-SSRS\]),
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Baylor College of Medicine — Houston

Идентификаторы

NCT: NCT06988787 · GCO 23-1671 · HT94252410478

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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