Multifaceted Intervention to Restore Resilience and Overcome Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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),
Disqualifiers
FVets at high risk for suicide (respond yes to items 3, 4, 5, or 8 on the Columbia Suicide Severity Rating Scale [C-SSRS]), will be initially excluded until a secondary risk and safety assessment is completed by one of the Texas licensed study psychologists, who will use the VA Comprehensive Suicide Risk Evaluation (CSRE) to determine planning and intentions. Veterans who endorse chronic thoughts of death found among those with PTSD and depression, but who have no suicidal behaviors with intent to act, based on secondary risk assessment, will be included in the study.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
webSTAIR
BehavioralTen 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
BehavioralA 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
Other interventionPsycho-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.
Treatment groups
136 Participants
are divided into 2 treatment groupsGroup A: webSTAIR+ExpoTxExperimental treatment 2 interventions
Group B: PsychoEd+ExpoTxActive comparator 2 interventions
Trial outcomes
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.
Time frame
At week 0, week 2.5, week 5, week 7.5, week 10, and month 3Secondary outcomes
1
Post-Traumatic Stress Disorder Checklist for the DSM-5 (PCL-5)
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.
Time frame
At week 0, week 2.5, week 5, week 7.5, week 10, and month 32
Depression and Anxiety Stress Scale (DASS)
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.
Time frame
At week 0, week 5, week 10, and month 33
Inventory of Interpersonal Problems (IIP-32)
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.
Time frame
At week 0, week 5, week 10, and month 34
Dysexecutive Questionnaire (DEX)
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
Time frame
At week 0, week 5, week 10, and month 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Icahn School of Medicine at Mount Sinai
Lead sponsor
Baylor College of Medicine
Collaborator
Source ClinicalTrials.gov