NCT06988787NARecruiting

Multifaceted Intervention to Restore Resilience and Overcome Risk

Icahn School of Medicine at Mount Sinai

Start Date

9/12/2025

Completion Date

8/1/2028

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

Interventions

BEHAVIORAL

webSTAIR

BEHAVIORAL

ExpoTx

OTHER

PsychoEd

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Conditions

Military Sexual TraumaIntimate Partner ViolenceBrain InjuryPost Traumatic Stress Disorder

Locations

Baylor College of Medicine

Houston, Texas 77030

United States