[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"trauma-and-stressor-related-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:trauma-and-stressor-related-disorders":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,51,81,114,139,169,193,220,244,278,307,339,374,399],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100622025","finding-emotional-empowerment-and-lifelong-strength-100622025",false,"NCT07378254","Finding Emotional Empowerment and Lifelong Strength","Co-Producing a Trauma and Substance Use Mental Health Literacy Intervention","FEELS","Inclusion Criteria:\n\n1. Self-identify as Black or African American\n2. Be between the ages of 18 and 35 years old\n3. Endorse previous lifetime trauma exposure\n4. Participants must speak English\n5. Participants are capable of giving informed consent and capable of complying with study procedures.",true,"ALL","18 Years","35 Years",{"count":22,"type":23},80,"ESTIMATED","INTERVENTIONAL",[26],"NA","This study will build a partnership with a Community Advisory Board to co-produce, and then pilot test, a theory-guided mental health literacy intervention focused on trauma and substance use. Participants will take part in educational group sessions for 12 weeks and complete assessments at baseline and two follow-up time points (mid-intervention and post-intervention). Intervention participants will be randomly invited to post-study focus groups to gather feedback on their experiences in the program.",[29,30],"Trauma and Stressor Related Disorders","Substance Use",[32,33,34,35,36,37],"mental health literacy","trauma","substance use","psychoeducation","Black and African American","young adults","RECRUITING","2026-06-16",{"date":41,"type":42},"2026-06-18","ACTUAL",{"date":44,"type":42},"2026-03-10",{"date":46,"type":23},"2028-06",{"name":48,"class":49},"Rutgers, The State University of New Jersey","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":24,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":50},"100641098","early-intervention-to-prevent-development-of-ptsd-in-burn-survivors-and-their-caregivers-100641098","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",{"count":58,"type":23},44,[26],"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.",[62,63,64,65,29,66,67,68,69,70,71],"Posttraumatic Stress Disorder","Burns","Traumatic Injury","Acute Stress Disorder","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":41,"type":42},{"date":76,"type":23},"2026-08-01",{"date":78,"type":23},"2029-02-28",{"name":80,"class":49},"University of Southern California",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":18,"minAge":88,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":24,"phases":91,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":50},"100625272","tf-cbt-for-autistic-youth-pilot-implementation---open-pilot-100625272","NCT07420478","TF-CBT for Autistic Youth Pilot Implementation - Open Pilot","Implementation Science-Guided Pilot Study of Trauma-Focused Cognitive Behavioral Therapy for Autistic Youth in Community Mental Health Settings","Inclusion Criteria for Therapists\n\n1. Employed as a clinician at a participating Community Mental Health Center (CMHC; publicly-funded mental health program) for at least 6 months.\n2. Trained in TF-CBT.\n3. Has an eligible autistic youth on current caseload (see below).\n\nInclusion Criteria for Child Participants\n\n1. Between 6 and 18 years old (up to 17 years, 11 months).\n2. Current medical diagnosis of autism.\n3. Has a non-offending caregiver who is able to participate in treatment (i.e., caregiver who is not the perpetrator of the abuse\u002Fother trauma).\n4. Initiated outpatient psychotherapy services from participating therapist within enrolled CMHC.\n5. A moderate level of trauma-related distress as measured by the Child and Adolescent Trauma Screen-2 (CATS-2).\n\nExclusion Criteria for Child Participants\n\n1\\. Does not present with trauma-related distress (score falls within the \"Normal\" range as measured by the Child and Adolescent Trauma Screen-2 Self- and Parent-Report).","6 Years",{"count":90,"type":23},24,[26],"Compared to the general population, autistic youth are at increased risk for both exposure to potentially traumatic events and trauma-related symptoms following trauma exposure. Autistic people identify approaches to effectively addressing trauma as a top mental health research priority, yet providers in community settings often report inadequate training in trauma treatment. The purpose of this study is to conduct an open pilot to evaluate the feasibility and acceptability of an evidence-based intervention for youth affected by trauma, Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), that has been modified for autistic youth served in Community Mental Health Centers.",[94,95,96,29,97],"Autism Spectrum Disorder","PTSD and Trauma-related Symptoms","Autism","Mental Health Services",[96,99,100,101,102,103,104],"Trauma","PTSD","Mental health symptoms","TF-CBT","Implementation science","Trauma-Focused Cognitive Behavioral Therapy","2026-05-11",{"date":107,"type":42},"2026-05-13",{"date":109,"type":42},"2026-05-05",{"date":111,"type":23},"2027-02-28",{"name":113,"class":49},"Dartmouth-Hitchcock Medical Center",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":24,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":50},"100353874","group-based-stabilization-and-skill-training-for-patients-with-lasting-posttraumatic-reactions-in-mental-health-care-100353874","NCT03887559","Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care","Adding a Group Based Stabilization and Skill Training Intervention for Patients With Long Lasting Posttraumatic Reactions Receiving Outpatient Treatment in Specialized Mental Health Care - A Randomized Controlled Trial","Inclusion Criteria:\n\n* Receiving treatment in ordinary out-patient clinics\n* Having been exposed to or witnessing to traumatic event(s) defined as \"one or several extremely threatening or horrific events or series of events or situations being of such a character which is likely to overwhelming distress in almost anyone in a similar situation\", measured by Stressful Life Events Screening Questionnaire\n* Presenting with posttraumatic reactions such as hyperarousal, avoidance, intrusions, emotional dysregulation or interpersonal difficulties.\n* Symptom duration for a minimum of six months.\n* Understand and speak Norwegian to an extent that is required to participate in a stabilization- and skill-training group.\n\nExclusion Criteria:\n\n* Active psychotic symptoms.\n* Substance or drug addiction or abuse.\n* High suicidal risk considered by the individual therapist.\n* Having participated in the course previously.","75 Years",{"count":123,"type":23},160,[26],"This study evaluates the addition of a group based stabilization and skill-training intervention to individual out-patient treatment for long lasting post-traumatic reactions. Half of the participants will receive the combined treatment while the other half will receive individual treatment as usual.",[68,127,29],"Mental Disorders",[129],"Psychotherapy","2026-04-24",{"date":132,"type":42},"2026-04-30",{"date":134,"type":42},"2019-03-25",{"date":136,"type":23},"2027-12",{"name":138,"class":49},"St. Olavs Hospital",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":17,"sex":146,"minAge":19,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":24,"phases":149,"briefSummary":150,"conditions":151,"keywords":158,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":50},"100602905","trauma-informed-care-for-smoking-cessation-for-pregnancy-100602905","NCT07129590","Trauma-Informed Care for Smoking Cessation for Pregnancy","TRauma-Informed Care in Smoking cEssation for Pregnancy (RISE Pregnancy)","Inclusion Criteria:\n\nClinician Eligibility Criteria (Aims 1 - 3):\n\nIn Aims 1-3, will be recruiting clinicians working in our clinic sites.\n\n1. Nurse practitioner, physician assistant, nurse-midwife, medical doctor, registered nurse, clinical pharmacist, behavioral health professional, social worker, or any other healthcare professional caring for pregnant patient-participants.\n2. Age ≥ 18 years old.\n\nPatient-participant Eligibility Criteria (Aim 1):\n\nIn Aim 1, will be recruiting pregnant women (ages 18+) who:\n\n1. Currently smoking or report having smoked during a previous pregnancy\n2. Age ≥18 years old.\n3. Currently Pregnant.\n4. Identifies as a cisgender woman, or female at birth.\n5. Reports having experienced trauma aligned with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) definition for traumatic exposure.\n6. Proficient in English or Spanish languages.\n\nPatient-Participant Eligibility Criteria (Aim 2):\n\nPatient-participants will be recruited to give feedback on our intervention using Evidence-Based Quality Improvement (EBQI) meetings.\n\nInclusion criteria:\n\n1. Current or former patient in the participating clinical sites.\n2. Age ≥18 years old.\n3. Proficient in English or Spanish languages.\n\nPatient-Participant Eligibility Criteria (Aim 3): In Aim 3, will be recruiting pregnant women who are actively smoking and have histories of trauma (ages 18+).\n\nInclusion criteria:\n\n1. Currently smoking (ever smoked 100 cigarettes in their lifetime, smoked in the past 7 days and at least 1 cigarette per day, verified by CO≥6ppm)\n2. ≥18 years old\n3. Currently Pregnant\n4. Identifies as a cisgender women, or female at birth\n5. Meets DSM-5 Criterion A for trauma exposure on the Brief Trauma Questionnaire (BTQ)\n6. English or Spanish Proficient\n\nExclusion Criteria:\n\nClinician- and Patient-participant Exclusion criteria (Aims 1 - 3):\n\n1\\. Any condition, including active mental health crises or cognitive impairment, that would interfere with the ability to provide informed consent or safely complete the study.","FEMALE",{"count":148,"type":23},20,[26],"Trauma-informed approaches have been shown to support recovery from other substance use disorders and involve four key elements: (1) Realizing the prevalence of trauma and pathways to recovery, (2) Recognizing symptoms of trauma, (3) Responding by embedding knowledge of trauma into practices and policies and (4) Resisting re-traumatization (the 4Rs). In close partnership with Breathe California and a public safety-net clinic in San Francisco that serves primarily racial and ethnic minoritized (REM) pregnant women, the 4Rs along with the Ask, Advise, Assess, Assist and Arrange (the 5As) evidence-based intervention for tobacco cessation that is delivered by health care professionals and is a US Public Health Services clinical practice guideline for treating tobacco will be used to create and implement a smoking cessation intervention for pregnant women with experiences of trauma.",[152,153,154,155,156,157,29],"Smoking Cessation","Tobacco Smoking","Tobacco Use Cessation","Smoking Reduction","Smoking, Cigarette","Trauma, Psychological",[159],"Pregnancy","2026-04-20",{"date":162,"type":42},"2026-04-23",{"date":164,"type":42},"2025-11-19",{"date":166,"type":23},"2026-07-31",{"name":168,"class":49},"University of California, San Francisco",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":18,"minAge":176,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":24,"phases":179,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":50},"100588440","systematic-redesign-of-trauma-focused-cognitive-behavioral-therapy-tf-cbt-100588440","NCT06941428","Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)","Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) to Enhance Usability, Engagement, Appropriateness, and Impact in Schools","INCLUSION CRITERIA\n\nDiscover, Design\u002FBuild Phase:\n\n* Providers. Providers will be included if they (a) deliver mental health treatment on school grounds; (b) English speaking.\n* Students. Youth participants will meet eligibility criteria for this study, including (a) be within the TF-CBT developmental range, ages 7-19; (b) are receiving, or have previously received, school mental health services; and (c) are English speaking.\n\nTest Phase:\n\n* Providers. Providers will be included if they (a) deliver mental health treatment on school grounds; (b) have not previously received formal training in TF-CBT; and (c) are English speaking\n* Students. Youth participants will meet eligibility criteria for this study, including (a) be within the TF-CBT developmental range, ages 7-19; (b) have traumatic event exposure (e.g., exposure to violence); (c) demonstrate significant post-traumatic stress symptoms (have a trauma history as defined as a score \\>31 on the Child PTSD Symptoms Scale for DSM-V \\[CPSS-V\\]); and (d) are English speaking.\n\nEXCLUSION CRITERIA\n\nDiscover, Design\u002FBuild Phase:\n\n\\- Students with intellectual impairments documented in education or mental health records.\n\nTest Phase:\n\n* Providers. Providers will be excluded if they participated in the redesign process for TF-CBT.\n* Students. Students will be excluded if they (a) have intellectual impairments documented in education or mental health records and (2) are not trauma exposed.","7 Years",{"count":178,"type":23},102,[26],"Trauma-focused cognitive behavior therapy (TF-CBT) has the strongest evidence of any clinical intervention for youth trauma but is rarely adopted in the education sector - the most common setting for youth mental healthcare. Use of TF-CBT in schools is limited by (1) problems with its usability (e.g., rigid structures, complicated patient identification workflows) and (2) provider perceptions that some core elements (e.g., exposure) are not contextually appropriate for schools; both of which hinder provider and student engagement with TF-CBT. Our preliminary studies identified that TF-CBT demonstrates \"below average\" usability, suggesting that many providers are likely to experience it as excessively onerous (e.g., due to lengthy sessions, low caregiver engagement). Without a systematic process for redesign, treatment adaptations made to improve intervention-setting fit can be reactive and risk omitting their core elements or functions. Locally driven, user focused redesign of TF-CBT for schools that maintains its core functions can enhance the accessibility and impact of evidence-based trauma treatment for youth. In light of the need for usable, contextually appropriate, and engaging interventions for youth trauma, the current project will iteratively adapt TF-CBT for use by school-based providers (e.g., school counselors, school social workers) via the University of Washington ALACRITY Center's (UWAC) Discover, Design\u002FBuild, Test (DDBT) approach and methods drawn from the field of human-centered design.",[157,29],[183,104],"School Mental Health","2026-02-23",{"date":186,"type":42},"2026-02-27",{"date":188,"type":42},"2025-06-22",{"date":190,"type":23},"2027-03-01",{"name":192,"class":49},"University of Washington",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":24,"phases":203,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":219},"100550780","effects-of-alliance180-program-on-well-being-100550780","NCT06451523","Effects of \"Alliance180 Program\" on Well-Being","Effects of \"Alliance180 Program\" on Psychological and Physical Well-Being","Inclusion Criteria:\n\n* 18 years or older\n* Enrollment in an upcoming \"Alliance180 Program\". (Enrollment is limited to adults who currently or formerly serve as US Veterans, First Responders and\u002For Front Line Healthcare Workers and are currently experiencing symptoms related to trauma exposure)\n\nExclusion Criteria:\n\n\\- Individuals who have previously completed the \"Alliance180 Program\"","99 Years",{"count":202,"type":23},50,[26],"The goal of this clinical trial is to evaluate the effects of the Alliance180 Program on physical and psychological well-being on adults who are\u002Fwere US Veterans, First Responders and\u002For Front Line Healthcare Workers.\n\nThe study aims are:\n\n* Aim #1: to evaluate the effect of the Alliance180 Program on physical and psychological well-being in adults who are\u002Fwere US Veterans, First Responders and\u002For Front Line Healthcare Workers;\n* Aim #2: to evaluate the relationship between between feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before and after the intervention.\n\nParticipants will be asked to complete self-report measures of feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before participating in the Alliance180 Program (i.e., baseline research session) and 1 week, 1 month, 3 months and 6 months after completing the Alliance180 Program. Demographic information will be documented during the baseline research session.",[29],[207,208,209],"Anxiety Depression","Autonomic Reactivity","Polyvagal Theory","2026-02-16",{"date":212,"type":42},"2026-02-18",{"date":214,"type":42},"2024-06-24",{"date":216,"type":23},"2026-09",{"name":218,"class":49},"University of North Carolina, Chapel Hill",2,{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":24,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":219},"100544336","emotion-and-symptom-focused-engagement-ease-for-caregivers-100544336","NCT06367556","Emotion and Symptom-Focused Engagement (EASE) for Caregivers","Emotion and Symptom-Focused Engagement (EASE) for Caregivers: A Phase III Randomized Controlled Trial of an Intervention Targeting Traumatic Stress in Parents of Children With Cancer","EASE","Inclusion Criteria:\n\n* Self-identified primary family caregiver\u002Fguardian (i.e., parent assuming the majority of care activities) of a child: i) \\\u003C18yo; ii) diagnosed with a new or relapsed life-threatening cancer within the preceding six months (disease-type eligibility per the Pediatric Oncology Group of Ontario Networked Information System); and iii) receiving active cancer therapy;\n* Age ≥18 years; and,\n* Able to complete outcome measures and engage in EASE in English, which need not be their first language.\n\nExclusion Criteria:\n\n* Impairment in cognitive functioning or communication that would preclude participation in EASE sessions or outcome measure completion, as determined by the research team;\n* Receiving formal ongoing psychotherapy at the time of recruitment;\n* Active suicidal intention, based on an item in the Distress Assessment and Response Tool (DART) that has been widely used in suicidal intention screening in cancer; or,\n* Child not expected to survive past the duration of trial, as determined by the child's medical team.",{"count":229,"type":23},306,[26],"The goal of this Phase III randomized controlled trial is to evaluate the effectiveness of a novel psychotherapeutic intervention called Emotion and Symptom-focused Engagement (EASE) in parents caring for a child or adolescent with cancer. The main question it aims to answer is:\n\n\\- Is EASE plus usual care associated with less severe traumatic stress symptoms over six months, measured by area under the curve, when compared to usual care alone in the parents of children diagnosed with cancer in the preceding six months?\n\nFor the primary outcome analysis, area under the curve will be calculated for each participant. The statistical significance of the difference between arms will also be evaluated. Participants in both groups will complete questionnaires package at enrolment, and 4, 8, and 12 weeks, and 6 months after enrolment. They will also be invited to participate in optional qualitative interviews to better understand their experience.",[29,233,234],"Pediatric Cancer","Caregiver Burden","2025-12-09",{"date":237,"type":42},"2025-12-17",{"date":239,"type":42},"2025-02-14",{"date":241,"type":23},"2028-10-01",{"name":243,"class":49},"University Health Network, Toronto",{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":24,"phases":254,"briefSummary":255,"conditions":256,"keywords":260,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":50},"100590547","project-comet-massed-prolonged-exposure-for-ptsd-and-sud-100590547","NCT06968832","Project COMET: Massed Prolonged Exposure for PTSD and SUD","Project COMET: Hybrid Effectiveness-Implementation Trial of Massed PTSD Treatment in a Community Substance Use Program","PROJECT COMET","Inclusion Criteria:\n\n* Age 18+\n* Enrolled in SUD treatment at Gateway Community Services\n* Meet DSM-5 criteria for a SUD (Tobacco Use Disorder alone not sufficient for inclusion)\n* Meet DSM-5 criteria for PTSD\n* Able to give informed consent\n\nExclusion Criteria:\n\n* severe cognitive impairment\n* current suicidal or homicidal intent requiring immediate treatment\n* current unstable psychotic or manic symptoms not attributable to SUD",{"count":253,"type":23},168,[26],"The goal of this clinical trial is to learn if Massed Prolonged Exposure Therapy (M-PE) can improve PTSD symptoms and reduce substance use in adults receiving intensive outpatient (IOP) treatment for substance use disorder (SUD). The main questions it aims to answer are:\n\n* Does M-PE reduce PTSD symptoms more effectively than trauma treatment as usual (TAU)?\n* Does M-PE reduce the number of days participants use substances?\n* How do patient-centered outcomes (such as depression, suicidal thoughts, and quality of life) differ between M-PE and trauma TAU?\n* Researchers will compare M-PE to treatment as usual to see if M-PE leads to better mental health and substance use outcomes and lower dropout rates.\n\nParticipants will:\n\n* Attend multiple therapy sessions per week (M-PE) or receive usual care\n* Complete assessments at baseline, during treatment, end-of-treatment, 1-month, 3-month, and 6-month follow-up\n* Share feedback through surveys and interviews about their experience in the program",[257,258,259,29],"Posttraumatic Stress Disorder (PTSD)","Substance Use Disorders (SUD)","Comorbidity",[257,261,262,263,264,265,266,267,268,269],"Substance Use Disorder (SUD)","PTSD\u002FSUD Comorbidity","Prolonged Exposure Therapy (PE)","Massed Prolonged Exposure (M-PE)","Randomized Clinical Trial (RCT)","Treatment as Usual (TAU)","Integrated PTSD and SUD Treatment","Implementation Science","Trauma-Focused Treatment","2025-10-23",{"date":272,"type":42},"2025-10-27",{"date":274,"type":42},"2025-09-02",{"date":276,"type":23},"2029-06-30",{"name":48,"class":49},{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":285,"enrollmentInfo":286,"targetDuration":4,"studyType":24,"phases":288,"briefSummary":289,"conditions":290,"keywords":293,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":50},"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":287,"type":23},120,[26],"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.",[291,69,292,100,29],"Post-Traumatic Stress Disorders","Post Traumatic Stress Disorder",[29,100,294,295,296],"cognitive training","working memory","Fear Extinction","2025-09-04",{"date":299,"type":42},"2025-09-08",{"date":301,"type":42},"2024-10-01",{"date":303,"type":23},"2028-09-30",{"name":305,"class":306},"VA Office of Research and Development","FED",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":17,"sex":146,"minAge":314,"maxAge":315,"enrollmentInfo":316,"targetDuration":4,"studyType":24,"phases":318,"briefSummary":319,"conditions":320,"keywords":328,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":219},"100594558","nightware-and-cardiovascular-health-in-women-with-ptsd-100594558","NCT07021014","NightWare and Cardiovascular Health in Women With PTSD","Improving Cardiovascular Health in Women With PTSD by Treating Trauma-Related Nightmares With NightWare","Inclusion Criteria:\n\n* Healthy, as determined by medical history\n* Group Specific Eligibility\n* PTSD Group\n* Lifetime PTSD: screened using Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and confirmed via Clinician Administered PTSD Scale for DSM-5 (CAPS-5)\n* Prior trauma exposure: screened using Brief Trauma Questionnaire (BTQ)\n* Self-report having repetitive nightmares contributing to disrupted sleep\n* Poor overall sleep quality: PSQI score 6 or higher\n* Control Group\n* No lifetime PTSD: screened using PC-PTSD-5\n* No prior trauma exposure: screened using BTQ\n* Do not self-report having repetitive nightmares contributing to disturbed sleep\n\nExclusion Criteria:\n\n* Pre-existing (e.g., diabetes, liver, kidney disease) or unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer) or systemic illness that would interfere with interpretation of the study outcomes\n* Body Mass Index ≥ 40 kg\u002Fm2\n* Use of medications that might influence cardiovascular or renal function (i.e., antihypertensive, lipid lowering medications, GLP-1\u002FGIP RAs)\n* Active infection (note, anyone with an active infection would become eligible once the infection has ended)\n* Abnormal thyroid, liver, or kidney function testing during the screening examination or bloodwork. Abnormal kidney function defined as creatinine \\>1.3mg\u002FdL. Abnormal liver function tests within 1.5x ULN. UCH Clinical Lab ULN for AST and ALT are 39 and 52, respectively. Women with TSH levels outside of the normal range (0.5-5.0 mLU\u002FL) will be referred to their PCP and will be allowed study entry once their TSH levels are normalized \\> 3 months\n* Plasma glucose \\>126 mg\u002Fdl under fasting conditions\n* Use of insulin or sulfonylureas\n* Pregnant, within 12 months postpartum or currently breast feeding\n* Current history of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate.\n* Report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the C-SSRS).\n* Shift workers\n* Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy\n* Nocturia that causes awakening from sleep\n* Epworth Sleepiness Scale: Question #8 score above \"0\" will prompt an additional question: Do you drive (\"get behind the wheel\") when you are drowsy? The answer must be \"No\" to be enrolled in the study due to safety concerns\n* Known sleep walking or acting out dreams (contraindication to NightWare use)\n* Diagnosis or suspicion of dementia\n* Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)\n* Current use of vitamin\u002Fsupplements (including melatonin) or anti-inflammatory medications, participants will be included if they are willing to stop taking vitamin\u002Fsupplements or anti-inflammatory medications 2 weeks prior to the first vascular visit.\n* Current or planned participation in an interventional study during the present study\n* Participants must have access to wireless internet and two power outlets where they sleep","22 Years","40 Years",{"count":317,"type":23},36,[26],"The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular and renal function in premenopausal women with PTSD-related nightmares, and examine whether these improvements restore them to levels observed in age-matched women without PTSD.",[292,321,322,323,324,325,326,327,29],"Cardiovascular Diseases","Autonomic Dysfunction","Vascular Stiffness","Nightmare","Endothelial Dysfunction","Kidney Diseases","Renal Dysfunction",[329,29,292,321,326,327,322],"Sleep","2025-06-05",{"date":332,"type":42},"2025-06-13",{"date":334,"type":23},"2025-07",{"date":336,"type":23},"2028-07",{"name":338,"class":49},"University of Colorado, Denver",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":18,"minAge":346,"maxAge":347,"enrollmentInfo":348,"targetDuration":4,"studyType":24,"phases":350,"briefSummary":351,"conditions":352,"keywords":360,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":219},"100488223","big-feelings-a-study-on-childrens-emotions-in-therapy-100488223","NCT05637320","Big Feelings: A Study on Children's Emotions in Therapy","Biobehavioural Regulation of Negative Emotion as a Transdiagnostic Mechanism of Children's Psychotherapy","Inclusion Criteria:\n\n* Child must be between the ages of 8 and 15 years old and have English proficiency\n* Parents must be over the age of 18 and have English proficiency\n* Must be seeking psychosocial treatment for concerns related to anxiety, depression, or disruptive behaviours\n\nExclusion Criteria:\n\n* Child has low cognitive functioning that would prevent active participation in research tasks\n* Child reports active suicidality that requiring acute care or hospital intervention\n* Child meets criteria for psychosis, schizophrenia spectrum disorders, eating disorders or autism spectrum disorders\n* Child does not assent to participate in the study","8 Years","15 Years",{"count":349,"type":23},202,[26],"The goal of this clinical trial is to learn about how psychotherapy works for children and adolescents aged 8 - 15 with anxiety, depression, trauma, or disruptive behaviour. The main question it aims to answer is:\n\n• Is the biobehavioural regulation of negative emotion a transdiagnostic mechanism of treatment response in psychotherapy for children with anxiety, depression, trauma and\u002For disruptive behaviour?\n\nChildren and their parents will be randomly assigned to an evidence-based, transdiagnostic treatment (the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems; MATCH-ADTC) or a waitlist control condition. Participants in both groups will complete a baseline assessment, weekly measures consisting of brief symptom scales and medication tracking, and quarterly assessments every 3 months. Following the intervention\u002Fwaitlist period, our team will conduct post-test assessments. All assessments, except for the weekly surveys, will consist of symptom scales, clinical interviews, experimental tasks and physiological measures.",[353,354,355,356,357,358,359,29],"Anxiety Disorders","Depressive Disorder","Mood Disorders","Conduct Disorder","Oppositional Defiant Disorder","Regulation, Emotion","Child Behavior Disorders",[361,362,363,364],"Child psychotherapy","Emotion regulation","Physiology","Mechanism of change","2025-01-27",{"date":367,"type":42},"2025-01-29",{"date":369,"type":42},"2022-10-01",{"date":371,"type":23},"2027-12-31",{"name":373,"class":49},"University of Guelph",{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":380,"enrollmentInfo":381,"targetDuration":4,"studyType":24,"phases":382,"briefSummary":383,"conditions":384,"keywords":386,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":50},"100554071","development-of-a-virtual-stress-inoculation-training-sit-platform-and-mobile-health-app-100554071","NCT06494319","Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App","Inclusion Criteria:\n\n* US Military Veterans \u002F Service Members\n* diagnosis of PTSD as measured by a Posttraumatic Symptom Checklist for DSM-5 (PCL-5) score of \\>33\n* history of combat trauma and\u002For military service in an imminent danger pay area\n* be fluent in English.\n* be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.\n* have access to a SmartPhone or tablet to utilize the mobile health app and\u002FOR access the virtual classroom.\n* agree to undergo psychometric testing and participate in ongoing assessments throughout the study duration.\n* be willing to comply with all study procedures, able to complete all assessments independently, and available for the duration of the study.\n\nExclusion Criteria:\n\n* Active suicidal ideation as assessed by the Investigator at screening or as identified during the study.\n* Clinically significant history of psychotic disorder, bipolar spectrum disorder, or neurodegenerative disease\u002Fdementia as assessed by the Investigator.\n* Active severe substance abuse as assessed by the investigator in accordance with DSM-5 Substance Abuse Disorder criteria, an AUDIT score \\> 15, or partial Brief Addiction Monitor (BAM) indicating the presence of illicit substance use other than cannabis (\\\u003C 3 times weekly).\n* They are currently undergoing another form of treatment other than supportive therapy (\\> 2 times per month).\n* Engaged in active trauma-focused therapy including Cognitive Processing Therapy (CPT)Prolonged Exposure (PE), or Eye Movement Desensitization and Reprocessing (EMDR).\n* Any other condition\u002Fsituation that the Investigator believes may interfere with participant safety, study conduct, or interpretation of study data.","79 Years",{"count":148,"type":23},[26],"The purpose of this study is to demonstrate the feasibility and utility of SIT delivered asynchronously (self-paced) via fully virtual platform with and without the aid of a mobile health application and to determine initial change over baseline in terms of reduction in PTSD symptoms and improvement in resiliency in participants receiving the virtual SIT prototype, using Linear Mixed Models (LMMs),",[100,29,385],"Traumatic Brain Injury",[387,388,385,389],"veteran","Post Traumatic Stress Disorder (PTSD)","Military","2024-07-02",{"date":392,"type":42},"2024-07-10",{"date":394,"type":42},"2024-05-28",{"date":396,"type":23},"2025-06-30",{"name":398,"class":49},"The University of Texas Health Science Center, Houston",{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":285,"enrollmentInfo":406,"targetDuration":4,"studyType":24,"phases":408,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":50},"100549118","efficacy-feasibility-and-acceptability-of-the-dest-act-trauma-focused-acceptance-and-commitment-therapy-program-100549118","NCT06429852","Efficacy, Feasibility, and Acceptability of the DeST-ACT: Trauma-Focused Acceptance and Commitment Therapy Program","Examining the Efficacy, Feasibility, and Acceptability of the DeST-ACT: Trauma-Focused Acceptance and Commitment Therapy Program on Life Satisfaction in Earthquake Survivors","Inclusion Criteria:\n\n* Volunteering to participate in the research\n* Being present in cities such as Kahramanmaras, Gaziantep, Hatay, Adiyaman, or Malatya during the earthquake on February 6, where destruction occurred\n* Being literate\n* Being able to have an online interview with the therapist\n* Having sub-threshold PTSD or PTSD\n\nExclusion Criteria:\n\n* Being in other cities at the time of the earthquake and not being exposed to the earthquake\n* Having visual and\u002For hearing problems\n* Having any psychotic disorder, experiencing an active mood episode, or having conditions such as intellectual disability or dementia that would prevent participation in therapy\n* Starting a new psychiatric treatment during the research period or having a change in medication or dosage within the last 3 months.",{"count":407,"type":23},40,[26],"The aim of this study is to develop a post-earthquake, trauma-focused Acceptance and Commitment Therapy (ACT)-based psychosocial intervention program (DeST-ACT) and to examine its effectiveness, feasibility, and acceptability of this program in enhancing life satisfaction and psychological flexibility in individuals exposed to earthquake trauma.\n\nIn this regard, the main hypothesis is that the DeST-ACT psychosocial intervention program is effective, feasible, and acceptable among individuals exposed to earthquake trauma, including both primary and secondary outcomes of the program.",[29],"2024-06-03",{"date":413,"type":42},"2024-06-04",{"date":415,"type":23},"2024-06",{"date":417,"type":23},"2024-10",{"name":419,"class":49},"CanSagligi Foundation"]