[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stress-disorders-post-traumatic-mental-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stress-disorders-post-traumatic-mental-disorders":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100491091","ptsd-treatment-for-veterans-with-serious-mental-illness-to-improve-functional-outcomes-100491091",false,"NCT05674617","PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes","Inclusion Criteria:\n\n* enrolled in outpatient mental health services within the VAMHCS (including general outpatient Mental Health Clinic (MHC), Psychosocial Rehabilitation and Recovery Centers (PRRCs), Mental Health Intensive Case Management (MHICM), and PTSD Clinical Teams (PCTs))\n* diagnosis of PTSD as confirmed by assessment with the Clinician-administered PTSD Scale for DSM-5 (CAPS-5) past month version\n* SMI diagnosis as defined by VHA Directive 1160 (i.e., psychotic spectrum or bipolar disorders) as confirmed by the medical record\n* regular telephone access\n\nExclusion Criteria:\n\n* are engaging in moderate-to-severe substance use that would impact their ability to participate and\u002For would require a higher level of care\n* already engaged in trauma-focused EBP for PTSD (e.g., WET, CPT, PE, or EMDR) or completed an EBP for PTSD within the past 6 months","ALL","18 Years",{"count":18,"type":19},48,"ESTIMATED","INTERVENTIONAL",[22],"NA","PTSD is common among Veterans with serious mental illness (SMI). Co-occurring PTSD and SMI lead to poorer mental health and physical functioning than either diagnosis alone. Despite known high prevalence rates of PTSD in SMI populations as well as disparities in prevalence and treatment use for Black, Indigenous, and other people of color (BIPOC), little research has been done to: a) evaluate leading treatments for PTSD in individuals with SMI, and b) develop culturally responsive methods to integrate with PTSD treatments for SMI Veterans. This study aims to address research and clinical gaps by: a) testing the feasibility and acceptability of Written Exposure Therapy (WET), a VA evidence-based psychotherapy for PTSD in Veterans with SMI, and b) incorporating culturally responsive assessment methods. Results from this study will inform whether WET and culturally responsive assessment are feasible to implement, acceptable to Veterans with SMI, and worth examining in standard or optimized form in a larger clinical trial.",[25],"Stress Disorders, Post-Traumatic; Mental Disorders",[27,28,29],"Stress Disorders, Post-Traumatic","Mental Disorders","Culturally responsive assessment","RECRUITING","2026-04-29",{"date":33,"type":34},"2026-05-06","ACTUAL",{"date":36,"type":34},"2023-12-01",{"date":38,"type":19},"2028-03-31",{"name":40,"class":41},"VA Office of Research and Development","FED",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100608373","effect-study-of-smart-treatment-for-youth-100608373","NCT07200713","Effect Study of SMART Treatment for Youth","A Randomized Controlled Evaluation of Sensory Motor Arousal Regulation Treatment (SMART) for Youth With Developmental Trauma and Self-regulation Difficulties","UTVID","Inclusion criteria:\n\nThese are based on the Developmental Trauma Disorder Semistructured Interview (DTD-SI), which has four domains (A-D). Based on the DTD-SI, which is detailed below, inclusion requires:\n\n* The presence of developmental trauma history (domain A)\n* One symptom in each of the domains B-D\n* At least four symptoms (of a maximum 15) in domains B-D considered together\n\nDomains A to D above refers to the following:\n\n* Domain A. Lifetime contemporaneous exposure to developmental trauma, defined as either (i) Interpersonal victimization: physical or sexual abuse or assault, domestic\u002Fintimate partner violence, bullying, harassment, exploitation, trafficking, hate crimes, or racial\u002Fethnic\u002Fidentity trauma, or (ii) Primary caregiving system attachment disruption: caregiver change or prolonged separation, gross neglect (physical, medical, emotional), psychological maltreatment (emotional abuse, emotional neglect, parental hostility or over-controlling), caregiver impairment due to mental illness or substance abuse, or chronic medical condition (by child or caregiver)\n* Domain B. Affective and somatic dysregulation: (i) Emotion dysregulation, (ii) Somatic dysregulation, (iii) Impaired awareness or dissociation of emotions and body, (iv) Impaired capacity to describe emotions or bodily states\n* Domain C. Attentional and behavioral dysregulation: (i) Threat-related rumination, (ii) Impaired capacity for self protection, (iii) Maladaptive self-soothing, (iv) Habitual or reactive self-harm, (v) Inability to initiate or sustain goal-directed behavior\n* Domain D. Self and relational dysregulation: (i) Persistent extreme negative self-perception, (ii) attachment insecurity and disorganization, (iii) Extreme persistent distrust, defiance or lack of reciprocity in close relationships, (iv) Reactive physical or verbal aggression, (v) Psychological boundary deficits, (vi) Impaired capacity to regulate empathic arousal\n\nExclusion Criteria:\n\n* Active psychosis\n* Not fluent in Norwegian language\n* Developmental challenges - IQ \\\u003C 70\n* Has previously used SMART room","7 Years","17 Years",{"count":54,"type":19},120,[22],"The goal of this clinical trial is to learn if Sensory motor arousal regulation treatment (SMART) works better than treatment as usual (TAU) to treat youth 7-17 years with complex trauma histories and self-regulation difficulties. The study also will investigate which patients will benefit more from SMART (treatment effect heterogeneity) and whether therapeutic alliance mediates effect. The main hypotheses the trial aims to answer are:\n\n1. Main effects: The SMART model approach will be more effective than ordinary treatment (control condition), in terms of improvement from therapy starts to 6 and 12 months follow up, for:\n\n   1. Regulatory capacities of emotions and bodily states, attention and behavior, and self and social relations\n   2. Trauma symptoms of re-experiencing, avoidance\u002F numbness and hyperarousal and sense of threat (core PTSD symptoms) and disturbances in self-organization (affect, self-concept; relations - core complex PTSD symptoms)\n   3. Internalizing symptoms (somatic complaints, anxiety symptoms and depression symptom severity) and Externalizing symptoms (conduct problems, aggression, inattention, and social problem severity)\n   4. Psychosocial strengths - prosocial behavior, subjective well-being and impairment in peer relationships, family relationships, and academic\u002Fschool functioning\n2. Exploration of mediation: When comparing SMART and ordinary treatment (TAU), (i) therapeutic alliance is higher in SMART, and (ii) a better treatment effect in SMART is partially mediated by therapeutic alliance\n\n3\\. Exploration of treatment effect heterogeneity (moderators): Effects of SMART treatment compared to TAU vary between: patients with low versus high level of self-regulation difficulties (full vs partial Developmental trauma disorder), patients with extensive vs less extensive developmental trauma exposure, adolescents (13-17 years) vs younger children (7-12 years), and patients exposed to trauma early in life vs in their teens\n\nAt each site, eligible participants are randomized to SMART or ordinary treatment\u002F TAU. Investigators acquire study data at baseline and outcome data at follow up after 6 and 12 months, and measure therapeutic alliance twice during the treatment process.",[58,59,60,25],"Stress Disorders, Traumatic","Psychological Trauma","Sexual Trauma",[62,63,64,65,66,67,68,69,70],"Randomized controlled trial","Developmental trauma disorder","self-regulation difficulties","trauma treatment","Sensory motor arousal regulation treatment (SMART)","Children","Youth","Outpatient treatment","Treatment as usual","NOT_YET_RECRUITING","2025-09-22",{"date":74,"type":34},"2025-10-01",{"date":76,"type":19},"2025-09-25",{"date":78,"type":19},"2027-12-31",{"name":80,"class":81},"Vestre Viken Hospital Trust","OTHER",4]