Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Program to restore resilience and reduce PTSD after military sexual trauma or intimate partner violence with brain injury

Official title: Multifaceted Intervention to Restore Resilience and Overcome Risk

Run by Icahn School of Medicine at Mount Sinai · NCT06988787 · Data updated 2026-11-12

This trial tests whether adding a web-based emotion regulation program to exposure therapy helps female Veterans with military sexual trauma or intimate partner violence and a history of brain injury reduce PTSD symptoms.

More Brain Injury trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment136 (estimated)
SponsorIcahn School of Medicine at Mount Sinai
Academic / other
Locations1 site (Houston, Texas)
StatusRecruiting
StartedSeptember 12, 2025
Main results expectedAugust 31, 2028
Study endsAugust 31, 2028
Registry record updatedSeptember 21, 2026
Trial IDNCT06988787 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are English-speaking female Veterans age 18 or older who screen positive for MST and/or IPV, have a history of at least one brain injury, score >33 on the PCL-5, show elevated emotion regulation difficulties on the DERS, and can consent.

Probably not a fit

Patients at high suicide risk, with observable active psychosis, severe substance use problems, non-English speakers, or those unable to attend the Houston site are unlikely to be eligible or to receive benefit from the study interventions.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The MIRROR trial randomizes English-speaking female Veterans who report MST and/or IPV exposure, have a history of at least one brain injury, sub-threshold PTSD (PCL-5 >33), and measurable emotion regulation deficits to one of two treatment arms. Both arms receive VA-supported exposure therapy (ExpoTx), and participants are randomized to either webSTAIR (an online Skills Training in Affective Regulation and Interpersonal Relationships program) plus ExpoTx or a psychoeducation (PsychEd) module plus ExpoTx. Primary outcomes include changes in emotion regulation and PTSD symptom severity measured with the DERS and PCL-5, and secondary outcomes may include functional status and safety assessments. The trial excludes individuals at high suicide risk, with active psychosis, or with severe substance use requiring referral, and is run through Baylor College of Medicine in Houston with Icahn School of Medicine at Mount Sinai as lead sponsor.

Why it matters

Potential benefit: If successful, the combined web-based emotion regulation program and exposure therapy could improve emotion regulation and reduce PTSD symptoms in female Veterans with MST/IPV and co-occurring brain injury, helping them function better day-to-day.

How similar studies have gone: Prior research supports web-based emotion-regulation approaches like STAIR and exposure therapy separately for PTSD, but combining webSTAIR with VA exposure therapy specifically for female Veterans with MST/IPV and brain injury is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 \[C-SSRS\]), 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.

Where it's running

  • Baylor College of Medicine
    Houston, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.