Program to restore resilience and reduce PTSD after military sexual trauma or intimate partner violence with brain injury
Multifaceted Intervention to Restore Resilience and Overcome Risk
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06988787 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 \[C-SSRS\]), * 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 this trial is running
Houston, Texas
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Maria Kajankova, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Maria Kajankova, PhD
- Email: maria.kajankova@mountsinai.org
- Phone: 212-241-3379
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.