RecruitingNot ApplicableNCT06988787

Multifaceted Intervention to Restore Resilience and Overcome Risk


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

136 participants

Start Date

Sep 12, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • 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 Criteria3

  • 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

BEHAVIORALwebSTAIR

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 flexibility, and compassion for self and others.

BEHAVIORALExpoTx

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 consecutive session, the therapist will engage the Veteran to explore cognitions that interfered with, reinforced, or diminished fear responses. Participants will be asked about their use of coping skills during exposure practice. Intentional participation in exposure for one target at least 30 minutes per day, or until SUDs lower by half. At the end of ExpoTx, the therapist will engage the Veteran in self-determining future goals and offer referrals in the community or at VA for additional support.

OTHERPsychoEd

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.


Locations(1)

Baylor College of Medicine

Houston, Texas, United States

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NCT06988787


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