[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592081":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":45,"locations":55,"responsibleParty":77,"collaborators":80,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":49,"enrollmentInfo":91,"targetDuration":49,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":103,"overallStatus":58,"whyStopped":49,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14],"Behavioral: webSTAIR","Behavioral: ExpoTx",{"label":16,"type":17,"description":18,"interventionNames":19},"PsychoEd+ExpoTx","ACTIVE_COMPARATOR","5 online sessions of psycho-education followed by 5 online sessions of exposure therapy",[14,20],"Other: PsychoEd",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BEHAVIORAL","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).\n\nThe 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.",[9],[28],"Web-Based Skills Training in Affective Regulation and Interpersonal Relationships Program",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"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.",[16,9],[34],"Exposure therapy",{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"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.",[16],[40],"Psycho-education",[42],{"name":43,"affiliation":5,"role":44},"Maria Kajankova, PhD","PRINCIPAL_INVESTIGATOR",[46,51],{"name":43,"role":47,"phone":48,"phoneExt":49,"email":50},"CONTACT","212-241-3379",null,"maria.kajankova@mountsinai.org",{"name":52,"role":47,"phone":53,"phoneExt":49,"email":54},"Madelyn Olis, BA","212-241-4820","madelyn.olis@mountsinai.org",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Baylor College of Medicine","RECRUITING","Houston","Texas","77030","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-95.36327,29.76328,{"lat":68,"lon":67},[71,75],{"name":72,"role":47,"phone":73,"phoneExt":49,"email":74},"Kameron Simmons, M.S.","281-410-1792","kameron.simmons@bcm.edu",{"name":76,"role":44,"phone":49,"phoneExt":49,"email":49},"Deleene Menefee, PhD",{"type":44,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"Maria Kajankova","Assistant Professor",[81],{"name":57,"class":6},"100592081","multifaceted-intervention-to-restore-resilience-and-overcome-risk-100592081",false,"NCT06988787","Multifaceted Intervention to Restore Resilience and Overcome Risk","MIRROR","Inclusion Criteria:\n\n* Able to consent as determined by UBACC, are English-speaking FVets who are 18+ years old\n* Screen positive for exposure to IPV and\u002For MST using the VA Intimate Partner Violence Assistance Program (VA IPVAP) and MST Screening Protocol,\n* Have a history of at least one BI assessed using the BISQ+IPV,\n* Sub-threshold PTSD (operationalized as a total score of \\>33 on the PTSD Checklist Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5),\n* Report deficits in Emotion Regulation (operationalized as a score of 0.5 SD above published means on the DERS).\n\nExclusion Criteria:\n\n* FVets at high risk for suicide (respond yes to items 3, 4, 5, or 8 on the Columbia Suicide Severity Rating Scale \\[C-SSRS\\]),\n* Observable active psychosis (e.g., auditory hallucinations, grandiose delusions),\n* 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.","FEMALE","18 Years",{"count":92,"type":93},136,"ESTIMATED","INTERVENTIONAL",[96],"NA","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\u002For intimate partner violence (IPV) and co-occurring brain injury.",[99,100,101,102],"Military Sexual Trauma","Intimate Partner Violence","Brain Injury","Post Traumatic Stress Disorder",[99,100,104,105,101,106],"Female Veterans","Emotion Regulation","Exposure Therapy","2025-12-03",{"date":109,"type":110},"2025-12-10","ACTUAL",{"date":112,"type":110},"2025-09-12",{"date":114,"type":93},"2028-08-01",{"name":5,"class":6},1]