[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stress-disorders-traumatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stress-disorders-traumatic":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100641098","early-intervention-to-prevent-development-of-ptsd-in-burn-survivors-and-their-caregivers-100641098",false,"NCT07656545","Early Intervention to Prevent Development of PTSD in Burn Survivors and Their Caregivers","Inclusion Criteria:\n\n* Alert, oriented, \\& not withdrawing from substance at time of screening\n* Can read and write in English\n* Hospitalized within 10 days of burn injury\n* Anticipated discharge \\\u003C=4 weeks\n* Have an email, mailing address, and at least 1 smart device for telehealth sessions\n* PTSD risk score of 2 or greater (patient-only)\n* Willing to attend therapy sessions with a loved one\n\nExclusion Criteria:\n\n* Currently incarcerated or in police custody\n* \\> 10 days post-burn\n* Lifetime diagnosis of primary psychosis or intellectual disability\n* Ongoing reported domestic violence in the dyad\n* Unstable bipolar disorder, severe substance use disorder, or acute suicidality with imminent intent that does not remit within 10 days of burn-injury\n* Inflammation Confounds (patient-only) of BMI \\> 40, metabolic syndrome, admission A1C of \\>= 6.5%\n* Currently receiving couples therapy",true,"ALL","18 Years",{"count":19,"type":20},44,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this clinical trial is to adapt and test a brief patient-caregiver early intervention designed to reduce posttraumatic stress symptoms in hospitalized burn patients and their caregivers. This intervention is a brief, 4-session cognitive-behavioral intervention designed for burn patients and their loved one to complete together, during and after hospitalization. The intervention targets relational communication and functioning through reduction of invalidating, negative statements and avoidant coping by teaching patients and their loved ones to engage in adaptive natural disclosures, supportive responses, and approach coping after the burn trauma. The intervention uses evidence-based psychotherapy techniques, including psychoeducation, motivational interviewing, and skills coaching. The clinical trial will occur in two sequential phases. In the first phase of the study (case series), the intervention will be provided to two burn patient-caregiver dyads (four adults) to pilot test the intervention, seek patient and provider feedback, and refine the intervention. All four adults will receive the intervention. In the second phase of the study, the randomized controlled trial (RCT) phase, investigators will enroll 20 more burn patient-caregiver dyads (40 more adults) who will be randomly assigned (like the flip of a coin) at the dyad level to receive the intervention or a burn survivor-only minimally enhanced usual care psychoeducation control condition (mEUC). The goals of the RCT phase are to study whether the intervention is acceptable to patients, feasible to conduct, and whether the intervention improves burn survivor-caregiver healthy relationship communication about difficult events and treatment outcomes compared to mEUC.",[26,27,28,29,30,31,32,33,34,35,36],"Posttraumatic Stress Disorder","Burns","Traumatic Injury","Acute Stress Disorder","Trauma and Stressor Related Disorders","Trauma and Stress Related Disorders","Stress Disorder","Stress Disorders, Post-Traumatic","Stress Disorders, Traumatic","Stress Disorders, Traumatic, Acute","Relationship, Social","NOT_YET_RECRUITING","2026-06-14",{"date":40,"type":41},"2026-06-18","ACTUAL",{"date":43,"type":20},"2026-08-01",{"date":45,"type":20},"2029-02-28",{"name":47,"class":48},"University of Southern California","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"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":61,"type":20},120,[23],"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.",[34,65,66,67],"Psychological Trauma","Sexual Trauma","Stress Disorders, Post-Traumatic; Mental Disorders",[69,70,71,72,73,74,75,76,77],"Randomized controlled trial","Developmental trauma disorder","self-regulation difficulties","trauma treatment","Sensory motor arousal regulation treatment (SMART)","Children","Youth","Outpatient treatment","Treatment as usual","2025-09-22",{"date":80,"type":41},"2025-10-01",{"date":82,"type":20},"2025-09-25",{"date":84,"type":20},"2027-12-31",{"name":86,"class":48},"Vestre Viken Hospital Trust",4,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":49},"100564429","cognitive-control-training-for-extinction-in-ptsd-100564429","NCT06629064","Cognitive Control Training for Extinction in PTSD","Identifying Clinically Relevant Neural Circuit Mechanisms of Cognitive Control Training for PTSD","Inclusion Criteria:\n\n* Fluent in English\n* Meet current DSM-5 criteria for Posttraumatic Stress Disorder\n* Are willing to attend 8 total remote sessions of working memory training over course of four weeks\n* Are willing to attend MRI scans pre and post working memory training\n* 4-week stability on pharmacological and psychosocial treatments\n\nExclusion Criteria:\n\n* A lifetime history of psychotic disorders, lifetime history of bipolar disorder\n* Past-year severe substance use and severe alcohol use disorder. Mild-to-moderate alcohol use disorder will be allowed to enhance generalizability in our sample due to the high comorbidity of alcohol use and PTSD\n* History of any neurological disorder that might be associated with cognitive dysfunction (e.g., cerebrovascular accident, intracranial surgery, aneurysm, seizure disorder)\n* Acute suicidality requiring immediate clinical intervention\n* Moderate to severe traumatic brain injury (TBI). However, mild to moderate levels of TBI (mTBI) will be included.\n* Receiving benzodiazepines or medications with anticholinergic effects that may affect fear learning measures\n* Inability to safely complete fMRI session (i.e., metal in body, medical implants)","65 Years",{"count":61,"type":20},[23],"The proposed study will test whether a working memory training (WMT) program improves fear extinction learning and its underlying neural circuitry in Veterans with posttraumatic stress disorder (PTSD). WMT is designed to improves the ability to maintain task-relevant information in mind. The project will further validate the relationship between working memory and fear extinction using novel computational and multivariate analyses that link to specific PTSD symptoms. If WMT can enhance fear extinction learning, then WMT may be a powerful adjunctive treatment that can enhance exposure therapy outcomes or be leveraged as a stand-alone treatment. This project supports the Department of Veteran Affairs mission of developing viable targets of treatment for Veterans with PTSD.",[100,34,101,102,30],"Post-Traumatic Stress Disorders","Post Traumatic Stress Disorder","PTSD",[30,102,104,105,106],"cognitive training","working memory","Fear Extinction","RECRUITING","2025-09-04",{"date":110,"type":41},"2025-09-08",{"date":112,"type":41},"2024-10-01",{"date":114,"type":20},"2028-09-30",{"name":116,"class":117},"VA Office of Research and Development","FED"]