Multifaceted Intervention to Restore Resilience and Overcome Risk

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06988787
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Female Veterans (FVets) face disproportionately high rates of exposure to intimate partner violence (IPV) and military sexual trauma (MST). Studies suggest that a substantial proportion of women with MST and IPV exposure also experience co-occurring brain injury (BI) due to IPV/MST and from non-violent etiologies. Exposure to MST, IPV, and co-occurring BI, coupled with their effects on psychological outcomes, represents a significant health concern to both the military and public, yet there is a lack of effective interventions to treat the cumulative effects of MST, IPV and BI in FVets. The Multifaceted Intervention to Restore Resilience and Overcome Risk (MIRROR) study seeks to overcome this challenge by examining the effectiveness of a multifaceted intervention that combines a web-based emotion regulation (EmReg) intervention (Skills Training in Affective Regulation and Interpersonal Relationships program \[webSTAIR\]) and a Veteran's Affairs (VA) supported evidence-based practice (EBP), exposure therapy (ExpoTx), for treating post-traumatic stress disorder (PTSD) associated with MST, IPV, and BI in FVets. FVets who screen positive for exposure to MST and/or IPV, have a history of at least one BI, sub-threshold PTSD, and documented emotional dysregulation will be included and randomly assigned to either one of two intervention arms: 1) webSTAIR+ ExpoTx or 2) PsychEd+ ExpoTx. Aim 1 will examine the effectiveness of webSTAIR relative to psychoeducation (PsychEd) on EmReg in FVets with MST and/or IPV and BI. Aim 2 will examine whether improvements in EmReg lead to improved treatment outcomes in FVets. Aim 3 will examine the effectiveness of the interventions in maintaining treatment gains at the 3-month follow-up. The study will include lived experience consultants as research partners and involve a community advisory board (CAB) that includes FVets and key stakeholders.

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05
• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 136

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difficulties in Emotion Regulation Scale (DERS)	At week 0, week 2.5, week 5, week 7.5, week 10, and month 3	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.

Secondary Outcome Measures

Name	Time	Method
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	The PCL-5 is a 20-item self-report measure that assesses DSM-5 criteria PTSD symptoms. Items are rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely), and summed to compute the total scale that ranges from 0 to 80. Higher scores are indicative of greater symptom severity.
Depression and Anxiety Stress Scale (DASS)	At week 0, week 5, week 10, and month 3	Depression Anxiety Stress Scales (DASS-42): A 42-item self-report measure assessing depression, anxiety, and stress. Each scale (14 items) is scored 0-3 per item, with total scores ranging 0-42 per domain. (Depression: Normal 0-9, Mild 10-13, Moderate 14-20, Severe 21-27, Extremely Severe 28+; Anxiety: Normal 0-7, Mild 8-9, Moderate 10-14, Severe 15-19, Extremely Severe 20+; Stress: Normal 0-14, Mild 15-18, Moderate 19-25, Severe 26-33, Extremely Severe 34+). Full scale from 0-126. Higher scores indicate greater severity.
Inventory of Interpersonal Problems (IIP-32)	At week 0, week 5, week 10, and month 3	A 32-item measure used to screen for difficulties individuals experience in their interactions and relationships with others. The measure yields eight subscales of interpersonal problems including domineering/controlling, vindictive/self-centered, cold/distant, socially inhibited, nonassertive, overly accommodating, self-sacrificing, and intrusive/needy. Items are scored on a five-point scale from 0 (not at all) to 4 (extremely). Subscales ranges are 0-16, with full scale range 0-128, where higher score indicates greater intensity or frequency of interpersonal problems.
Dysexecutive Questionnaire (DEX)	At week 0, week 5, week 10, and month 3	A 20-item self-report tool used to measure everyday problems associated with executive functioning difficulties. The DEX focuses on four domains: emotional, motivational, behavioral, and cognitive. Items are scored on a five-point scale from 0 (not at all) to 4 (extremely). Higher scores indicating greater reports of dysexecutive problems
Quality of Life after Brain Injury Overall Scale (QoLABRIOS)	At week 0, week 5, week 10, and month 3	Six item self-report measure of global health related aspects of QoL after BI including physical condition, cognition, emotions, function in daily life, personal and social life, and current situation and future prospects. Full scale from 0-100, higher score indicates better quality of life.