Multifaceted Intervention to Restore Resilience and Overcome Risk

NCT06988787 | Recruiting

• 2 other identifiers: GCO 23-1671HT94252410478
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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

Brain Injury; Post Traumatic Stress Disorder; Intimate Partner Violence; Military Sexual Trauma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Difficulties in Emotion Regulation Scale (DERS)

  The DERS is a 36-item self-report measure that assesses emotion dysregulation in six domains: nonacceptance of emotional responses (subscale score 6-30), difficulties engaging in goal directed behavior (subscale score 5-25), impulse control difficulties (subscale score 6-30), lack of emotional awareness (subscale score 6-30), limited access to emotion regulation strategies (subscale score 8-40), and lack of emotional clarity (subscale score 5-25). Items are rated on a scale of 1 ("almost never \[0-10%\]") to 5 ("almost always \[91-100%\]"). Total Score range from 36-180, with higher scores indicating more difficulty in emotion regulation.

  At week 0, week 2.5, week 5, week 7.5, week 10, and month 3

Secondary Outcomes (5)

• Post-Traumatic Stress Disorder Checklist for the DSM-5 (PCL-5)

  At week 0, week 2.5, week 5, week 7.5, week 10, and month 3

• Depression and Anxiety Stress Scale (DASS)

  At week 0, week 5, week 10, and month 3

• Inventory of Interpersonal Problems (IIP-32)

  At week 0, week 5, week 10, and month 3

• Dysexecutive Questionnaire (DEX)

  At week 0, week 5, week 10, and month 3

• Quality of Life after Brain Injury Overall Scale (QoLABRIOS)

  At week 0, week 5, week 10, and month 3

Study Arms (2)

webSTAIR+ExpoTx

EXPERIMENTAL

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.

Behavioral: webSTAIR; Behavioral: ExpoTx

PsychoEd+ExpoTx

ACTIVE COMPARATOR

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

Behavioral: ExpoTx; Other: PsychoEd

Interventions

ExpoTx BEHAVIORAL

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.

Also known as: Exposure therapy

PsychoEd+ExpoTx; webSTAIR+ExpoTx

PsychoEd OTHER

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.

Also known as: Psycho-education

PsychoEd+ExpoTx

webSTAIR BEHAVIORAL

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.

Also known as: Web-Based Skills Training in Affective Regulation and Interpersonal Relationships Program

webSTAIR+ExpoTx

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: collaborator
• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Military Sexual Trauma; Brain Injuries; Stress Disorders, Post-Traumatic; Emotional Regulation

Interventions

Implosive Therapy

Condition Hierarchy (Ancestors)

Sexual Trauma; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Maria Kajankova, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Kajankova, PhD

CONTACT

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

Madelyn Olis, BA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The proposed treatment study will employ a phase II RCT to evaluate whether the inclusion of an intervention that specifically targets EmReg (i.e., webSTAIR) prior to engaging in ExpoTx (webSTAIR+ ExpoTx) is more effective in improving outcomes/treatment effectiveness (PTSD symptomology and engagement) in FVets with MST and/or IPV and BI exposure. This treatment combination, (webSTAIR+ ExpoTx), will be compared to the standard EBP combination (PsychEd+ExpoTx). Participants will be randomized to one of the two intervention arms.

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)