Recruiting

Emotion Regulation vs. PTSD

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06988787

Conditions

Military Sexual Trauma

Intimate Partner Violence

Brain Injury

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

webSTAIR

ExpoTx

PsychoEd

Study Details

Brief 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.

Conditions

Military Sexual Trauma

Intimate Partner Violence

Brain Injury

Post Traumatic Stress Disorder

Study ID

NCT06988787

Start date

Sep 12, 2025

Status verified date

Dec, 2025

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: webSTAIR+ExpoTx

Web-based technology "webSTAIR" (Web-Based Skills Training in Affective Regulation and Interpersonal Relationships Program) will be used to guide Female Veterans (FVets) through each of the 10 webSTAIR skill modules for 5-weeks followed by 5 weeks of standard, patient-centered, exposure therapy (ExpoTx) delivered by a therapist.

active comparator: PsychoEd+ExpoTx

5 online sessions of psycho-education followed by 5 online sessions of exposure therapy

Interventions

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 flexibility, and compassion for self and others.

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 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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Maria Kajankova, PhD

212-241-3379maria.kajankova@mountsinai.org

Madelyn Olis, BA

212-241-4820madelyn.olis@mountsinai.org

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Kameron Simmons, M.S.

281-410-1792kameron.simmons@bcm.edu

Principal Investigator:

Deleene Menefee, PhD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Keywords

  • Military Sexual Trauma
  • Intimate Partner Violence
  • Female Veterans
  • Emotion Regulation
  • Brain Injury
  • Exposure Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-12-10.