Clinical trial NCT06988787: Multifaceted Intervention to Restore Resilience and Overcome Risk
Official title: Multifaceted Intervention to Restore Resilience and Overcome Risk
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Military Sexual Trauma
Intimate Partner Violence
Brain Injury
Post Traumatic Stress Disorder
Keywords: Military Sexual Trauma
Intimate Partner Violence
Female Veterans
Emotion Regulation
Brain Injury
Exposure Therapy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
First posted: 2025-05-25
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: At week 0, week 2.5, week 5, week 7.5, week 10, and month 3
Secondary outcomes:
measure: Post-Traumatic Stress Disorder Checklist for the DSM-5 (PCL-5)
timeFrame: At week 0, week 2.5, week 5, week 7.5, week 10, and month 3
measure: Depression and Anxiety Stress Scale (DASS)
timeFrame: At week 0, week 5, week 10, and month 3
measure: Inventory of Interpersonal Problems (IIP-32)
timeFrame: At week 0, week 5, week 10, and month 3
measure: Dysexecutive Questionnaire (DEX)
timeFrame: At week 0, week 5, week 10, and month 3
measure: Quality of Life after Brain Injury Overall Scale (QoLABRIOS)
timeFrame: At week 0, week 5, week 10, and month 3
Other outcomes:
Locations:
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Maria Kajankova, PhD
role: PRINCIPAL_INVESTIGATOR
References: