[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psychological-trauma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psychological-trauma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,46,81,107,128,158,201,229,265,294,330],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100636627","the-prevent-resilience-study-100636627",false,"NCT07568145","The PREVENT Resilience Study","PREVENT Study: Promoting Resilience Via Early Neurostimulation After Trauma","Inclusion Criteria:\n\n* Men and women 18-65 years of age. (Assessed via self-reported and medical record-based Date of Birth)\n* Trauma exposed within the last 2 weeks (Endorsement of having experienced an event that could have caused death, serious injury, or sexual violence)\n* High initial symptoms of PTSD related to the index trauma - PCL-5 \\>30 AND meeting for all four DSM-5 clusters.\n* Low symptoms of PTSD related to a previous lifetime trauma - PCL-5\\\u003C31AND does not meet for all four DSM-5 clusters.\n* Participants may be on psychotropic medication, including antidepressants, antipsychotics, benzodiazepines and anticonvulsants, but the dosage of the medication must be stable for at least 6 weeks and not change during the course of the study (Assessed via self-report during the screening phone call).\n* Capable and willing to provide informed consent.\n\nExclusion Criteria:\n\n* Having active suicidal intent or plan, or in the clinician's opinion, is likely to attempt suicide within the next six months. (Assessed via the Patient Health Questionnaire-9 (PHQ-9) during the screening phone call)\n* Lifetime diagnosis of psychotic disorder or bipolar disorder per psychiatric screener. (Assessed via self-report during the screening phone call)\n* Diagnosed with the following conditions: a neurological disorder, including a history of seizures, cerebrovascular disease, primary or secondary tumors in the central nervous system (CNS), stroke, cerebral aneurysm or movement disorder or any lifetime history of loss of consciousness for more than 5 minutes due to head injury (Assessed via self-report during the screening phone call)\n* History of cranial surgery, metallic particles in the eye or head (exclusive of mouth), implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intra-cranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes), or implanted medical pumps. (Assessed via self-report during the screening phone call)\n* For women, being pregnant. (Assessed via self-report during the screening phone call, the medical record, and cycling females will undergo a pregnancy test at TMS Day 1)",true,"ALL","18 Years","65 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"NA","PTSD is one of the most universal and severe psychiatric disorders whose incidence continues to rise due to the common exposure to severe trauma in the United States and worldwide. After trauma, a proportion of individuals maintains high symptoms of PTSD and depression, which can persist for years. The early weeks following trauma present a unique opportunity to deliver early interventions that can prevent chronic PTSD and depression from occurring, and the researchers propose a brain-based intervention that will reduce reactivity to threat, an early risk mechanism for chronic PTSD. This study is being done to learn more about whether brain stimulation in the weeks after a trauma can change brain activity that is linked to Post-Traumatic Stress Disorder (PTSD).",[28],"Psychological Trauma",[30,31,32],"Post-Traumatic Stress Disorder","Transcranial Magnetic Stimulation (TMS)","Resilience","RECRUITING","2026-06-26",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":37},"2026-06-18",{"date":41,"type":22},"2028-03",{"name":43,"class":44},"Emory University","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100639928","postnatal-debriefing-after-adverse-obstetric-events-100639928","NCT07579273","Postnatal Debriefing After Adverse Obstetric Events","Effect of a Structured Postnatal Debriefing on Psychological Outcomes and Birth Experience in Women After Adverse or Unexpected Obstetric Events","DBIRTH","Inclusion Criteria:\n\n* Women aged 18 years or older.\n* Women who have experienced an adverse or unexpected obstetric event during labor or the immediate postpartum period.\n* Admitted to the maternity unit of Hospital del Mar and clinically stable within the first 24 hours postpartum.\n* Able to understand and communicate in Spanish, Catalan, or English.\n* Willing to participate and able to provide written informed consent.\n* Access to an email account for follow-up assessments.\n\nExclusion Criteria:\n\n* Inability to communicate verbally.\n* Maternal-neonatal separation due to social reasons.\n* Unstable or severe psychiatric condition.\n* Immediate perinatal loss (intrapartum fetal death or early neonatal death).\n* Admission to intensive care within the first 24 hours postpartum.","FEMALE",{"count":56,"type":22},142,[25],"Adverse or unexpected obstetric events can negatively affect women's psychological well-being and childbirth experience, increasing the risk of postpartum traumatic stress. However, structured postnatal debriefing is not routinely implemented in clinical practice, and evidence regarding its effectiveness remains limited.\n\nThis study aims to evaluate the effect of a structured postnatal debriefing conducted within the first 24 hours after childbirth in women who have experienced an adverse or unexpected obstetric event.\n\nThis quasi-experimental pretest-posttest study will include two consecutive groups: a control group receiving usual postpartum care during the pre-implementation phase and an intervention group receiving structured postnatal debriefing during the implementation phase.\n\nThe primary outcome is childbirth-related trauma at 6 weeks postpartum. Secondary outcomes include birth satisfaction, early post-traumatic stress symptoms, satisfaction with information and emotional support received after childbirth, and clinical maternal and neonatal outcomes.\n\nThis study will provide evidence on whether structured postnatal debriefing improves psychological outcomes and contributes to more patient-centered obstetric care.",[60,28,61,62],"Stress Disorders, Post-Traumatic","Obstetric Labor Complications","Postpartum Period",[64,65,66,67,68,69,70],"Traumatic Birth","Birth Experience","Postpartum PTSD","Postnatal Debriefing","Obstetric Debriefing","Patient-Centered Care","Maternal Mental Health","NOT_YET_RECRUITING","2026-06-22",{"date":74,"type":37},"2026-06-25",{"date":76,"type":22},"2026-10",{"date":78,"type":22},"2029-01",{"name":80,"class":44},"Parc de Salut Mar",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100372256","internet-delivered-cognitive-behaviour-therapy-for-public-safety-personnel-100372256","NCT04127032","Internet-Delivered Cognitive Behaviour Therapy for Public Safety Personnel","Internet-Delivered Cognitive Behaviour Therapy (ICBT) for Public Safety Personnel (PSP): Examination of Engagement, Outcomes, Strengths and Challenges","Inclusion Criteria:\n\n* 18 years of age or older\n* residing in a Canadian province or territory in which PSPNET is able to offer services\n* endorsing symptoms of anxiety, depression, or post-traumatic stress\n* able to access a computer and internet service\n* willing to provide a physician as emergency contact unless the participant does not have a physician and the clinician conducting the telephone screening assesses the need for an emergency contact to be low.\n\nExclusion Criteria:\n\n* high suicide risk\n* suicide attempt or hospitalization in the last year\n* primary problems with psychosis, alcohol or drug problems, mania\n* currently receiving regular psychological treatment for anxiety or depression\n* not present in Canada during treatment\n* concerns about ICBT",{"count":89,"type":22},250,[25],"This study evaluates a transdiagnostic Internet-delivered cognitive behavioural therapy (ICBT) recently tailored for Canadian public safety personnel (PSP) reporting symptoms of depression, anxiety, or posttraumatic stress. Outcomes of interest include engagement with the intervention, changes in symptoms and functioning, and strengths and limitations of implementing ICBT with Canadian PSP.",[93,28],"Depression, Anxiety",[95,96,97],"Internet","Cognitive Behavioral Therapy","Telemedicine","2026-06-16",{"date":39,"type":37},{"date":101,"type":37},"2019-12-01",{"date":103,"type":22},"2028-03-31",{"name":105,"class":44},"University of Regina",1,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":4},"100544231","psychotrauma-prevention-algorithm--randomized-controlled-pilot-study-100544231","NCT06366191","Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study","A2P","Inclusion Criteria:\n\n* Person who the vital prognosis has or could have been committed or having felt a threat to his physical and\u002For psychological integrity\n* After a potentially traumatic event dating from a minimum of 72 hours to a maximum of 1 week\n* for which the CUMP or the psychotrauma regulation platform has been requested\n* having lived or being a direct witness of the event\n* knowing how to read and write\n* affiliate or beneficiary of a social security scheme\n* having signed a consent\n\nNon-inclusion Criteria:\n\n* guardianship or curatorship\n* unable to receive phone calls\n* unable to go to a place for consultation",{"count":115,"type":22},40,[25],"A randomized pilot study which proposes to patients having suffered a traumatic event to have either only the standard care or the standard care associated with adaptated psychotrauma watch and prevention system.",[28],"2026-03-17",{"date":121,"type":37},"2026-03-19",{"date":123,"type":22},"2026-06",{"date":125,"type":22},"2026-11",{"name":127,"class":44},"Centre Hospitalier Universitaire de la Réunion",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":106},"100471789","neural-connectivity-during-therapy-for-adolescent-ptsd-100471789","NCT05423444","Neural Connectivity During Therapy for Adolescent PTSD","Neural Connectivity Before and After Each of the Three Treatment Phases of Trauma-focused Therapy for Adolescent Posttraumatic Stress","Inclusion Criteria:\n\n* ages 12-17 and Tanner stage 2 or above\n* history of interpersonal trauma\n* PTSD symptoms with a rating of '2' or higher on at least one symptom from each of the 4 clusters, using the Clinician-Administered PTSD Scale for Children and Adolescents, and having a duration of at least one month\n\nExclusion Criteria:\n\n* current or past use of psychiatric medications\n* severe suicidal\u002Fhomicidal ideation\n* current hospitalization\n* other current psychotherapy or previous treatment with TF-CBT\n* history of head injury with loss of consciousness for \\>5 minutes\n* IQ\\\u003C85\n* major medical illness\n* MRI contraindications (metal in body; braces on teeth)\n* psychosis, bipolar 1, autism, developmental disorder, panic disorder\n* first-degree family member with diagnosis of psychosis or bipolar I disorder\n* substance dependence within the past 3 months or current drug use that is frequent","12 Years","17 Years",{"count":138,"type":22},180,[25],"Posttraumatic stress disorder in adolescence impairs neurobiological networks underlying cognitive, social and emotional skills. Neuroimaging research that seeks to identify the neural mechanisms of treatments for PTSD could lead to novel treatments, but progress has been slow using current methods. The proposed study uses an innovative approach to identify neural mechanisms of specific phases of trauma-focused therapy for youth with PTSD, allowing a new understanding of brain changes associated with the process of therapy.",[142,143,28],"PTSD","Adolescent",[145,146,147,148],"neuroimaging","psychotherapy","trauma","adolescent","2026-01-09",{"date":151,"type":37},"2026-01-13",{"date":153,"type":37},"2022-11-29",{"date":155,"type":22},"2027-02-28",{"name":157,"class":44},"The University of Texas Health Science Center at San Antonio",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":170,"briefSummary":171,"conditions":172,"keywords":183,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":106},"100579744","culturally-adapted-i-cbt-for-farsidari-speaking-migrants-100579744","NCT06828276","Culturally Adapted i-CBT for Farsi\u002FDari Speaking Migrants","Culturally and Language-Adapted i-CBT for Common Mental Health Problems: A Randomized Controlled Study With Farsi\u002FDari-Speaking Migrants","i-CBT","Inclusion Criteria:\n\n* Between the ages of 15 and 29.\n* A score above the cut-off 1.75 on HSCL-25\n* Has a refugee or migrant background\n* Has a good and stable internet connection\n* Has access to a computer, tablet or smartphone\n* Is fluent in reading and writing Arabic\n* Has the ability to dedicate time to take part in the intervention for 6-10 weeks.\n\nExclusion Criteria:\n\n* Is suffering from a severe mental illness, such as psychosis or severe depression.\n* Is suffering from substance abuse\n* Is undergoing a psychological treatment\n* Has a high risk of suicide","15 Years","29 Years",{"count":169,"type":22},128,[25],"The aim of this randomized controlled trial (RCT) is to investigate the effectiveness of a culturally adapted internet-based cognitive behavioral therapy (i-CBT) intervention in reducing symptoms of common mental health issues among Farsi\u002FDari-speaking youth migrants and refugees. Investigator hypothesizes that there will be a significant decrease in psychological symptoms after participants receive the intervention compared to a control group.",[173,174,175,28,176,32,177,178,179,180,181,182],"Depressive Symptoms","Anxiety Symptoms","Grief","Insomnia","Stress","Psychological Well Being","Marital Relationship","Wellbeing","Common Mental Health Problems","Rumination",[184,185,186,187,188,189,190,32,191],"Refugee","Cognitive behavioral therapy","Psychological problems","Persian speaking","Psychological well-being","Youth","Mental problems","Asylum seeker","2025-12-05",{"date":194,"type":37},"2025-12-12",{"date":196,"type":37},"2025-03-25",{"date":198,"type":22},"2026-12-31",{"name":200,"class":44},"Karolinska Institutet",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":167,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":106},"100550996","the-iowa-aces-and-sleep-cohort-and-manipulating-sleep-in-young-adults-with-aces-studies-100550996","NCT06454344","The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies","Associations of Adverse Childhood Experiences, Sleep Disruption, and Vascular Dysfunction in Young Adults: The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies","AIM 1\n\nInclusion Criteria:\n\n1. 18-29 years of age\n2. SBP \\\u003C129 and DBP \\\u003C90 mmHg\n3. Body Mass Index \\> 18.5 kg\u002Fm2 and \\\u003C35 kg\u002Fm2\n4. Willing to complete in-home sleep studies\n\nExclusion Criteria:\n\n1. Currently undergoing treatment for a sleep disorder or diagnosed with restless leg syndrome, hypersomnia, parasomnia or narcolepsy, or obstructive sleep apnea\n2. Currently performing overnight shift work\n3. Lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, currently undergoing treatment for substance-induced mood disorder\n4. Endorsed suicidal ideation as indicated by a Moderate or High risk determination on the Columbia Suicide Risk Protocol\n5. Diagnosed neurological disorder or illness affecting the central nervous system\n6. Diagnosed acute or chronic autoimmune disease or chronic inflammatory condition\n7. Current or previous cancer diagnosis\n8. History of moderate or severe traumatic brain injury\n9. Current or previous history of CBT-I treatment or sleep restriction or cognitive restructuring therapy for sleep\n10. History of cardiometabolic disease (e.g., ischemic heart disease, coronary artery disease, stroke, chronic kidney disease, diabetes mellitus), pulmonary disease, or renal disease\n11. Current or recent (within past month) use of anti-hypertensive (including clonidine), lipid lowering, glucose- controlling, or prescription anti-inflammatory medications\n12. Current or recent (within past month) opiates, benzodiazepine or benzodiazepine receptor agonists, or trazodone\n13. Recent changes to or unstable treatment (changes within last 6 mo.) with prescription medications\n14. Currently smoking or using nicotine\n15. Current use of hormone therapy\n16. Current heavy alcohol use, as defined as binge drinking on 5 or more days in the last month, or consuming more than 7 (women) or 14 (men) drinks per week in the last month (per NIAAA definition)\n17. Current or recent (within the last 6 mo.) illicit drug use disorder as indicated by a score of 3 or greater on the Drug Abuse Screening Test (DAST-10)\n18. Current or recent (within 6 mo.) pregnancy OR current or recent breastfeeding (within 3 mo.) OR children under the age of 2 years old in the home\n19. Currently completing greater than 300 minutes of moderate intensity, or greater than 150 minutes of vigorous intensity physical activity, or an equal combination per week\n20. Unstable housing\n\nAIM 2\n\nInclusion Criteria:\n\n1. 18-29 years of age\n2. SBP \\\u003C129 and DBP \\\u003C90 mmHg\n3. Body Mass Index \\> 18.5 kg\u002Fm2 and \\\u003C35 kg\u002Fm2\n4. Willing to complete in-home sleep studies\n5. \\>= 3 Adverse Childhood Experiences\n6. PSQI Global Score \\>5\n7. Sleep Efficiency Score \\\u003C90%\n\nExclusion Criteria:\n\n1. Currently undergoing treatment for a sleep disorder or diagnosed with restless leg syndrome, hypersomnia, parasomnia or narcolepsy, or obstructive sleep apnea\n2. Currently performing overnight shift work\n3. Lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, currently undergoing treatment for substance-induced mood disorder\n4. Endorsed suicidal ideation as indicated by a Moderate or High risk determination on the Columbia Suicide Risk Protocol\n5. Diagnosed neurological disorder or illness affecting the central nervous system\n6. Diagnosed acute or chronic autoimmune disease or chronic inflammatory condition\n7. Current or previous cancer diagnosis\n8. History of moderate or severe traumatic brain injury\n9. Current or previous history of CBT-I treatment or sleep restriction or cognitive restructuring therapy for sleep\n10. History of cardiometabolic disease (e.g., ischemic heart disease, coronary artery disease, stroke, chronic kidney disease, diabetes mellitus), pulmonary disease, or renal disease\n11. Current or recent (within past month) use of anti-hypertensive (including clonidine), lipid lowering, glucose- controlling, or prescription anti-inflammatory medications\n12. Current or recent (within past month) opiates, benzodiazepine or benzodiazepine receptor agonists, or trazodone\n13. Recent changes to or unstable treatment (changes within last 6 mo.) with prescription medications\n14. Currently smoking or using nicotine\n15. Current use of hormone therapy\n16. Current heavy alcohol use, as defined as binge drinking on 5 or more days in the last month, or consuming more than 7 (women) or 14 (men) drinks per week in the last month (per NIAAA definition)\n17. Current or recent (within the last 6 mo.) illicit drug use disorder as indicated by a score of 3 or greater on the Drug Abuse Screening Test (DAST-10)\n18. Current or recent (within 6 mo.) pregnancy OR current or recent breastfeeding (within 3 mo.) OR children under the age of 2 years old in the home\n19. Currently completing greater than 300 minutes of moderate intensity, or greater than 150 minutes of vigorous intensity physical activity, or an equal combination per week\n20. Unstable housing\n21. Likely Obstructive Sleep Apnea, as indicated by an apnea-hypopnea index (AHI) \\>= 15 events\u002Fhour or persistent hypoxemia, as indicated by an arterial oxygen saturation \\\u003C= 88% for \\>5 minutes per night.",{"count":209,"type":22},70,[25],"The overall purpose of this study is to understand the role of disrupted sleep in the association of exposure to early life adversity (adverse childhood experiences (ACEs)) with vascular endothelial (dys)function.\n\nIn Aim 1 (The Iowa ACEs and Sleep Cohort Study), the investigators will utilize a cross-sectional cohort design with a state-of-the-art translational approach. Participants will be recruited to objectively characterize the degree to which lower sleep quality and quantity contribute to ACEs-related endothelial dysfunction, inflammation, and oxidative stress in young adults using:\n\n1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration,\n2. in vivo assessment of endothelial function via flow-mediated dilation testing, and\n3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells. This study to achieve this Aim.\n\nIn Aim 2, approximately 70 eligible participants from Aim 1 (The Iowa ACEs and Sleep Cohort Study) will then be randomized to either a 6-week behavioral sleep intervention (cognitive behavioral therapy for insomnia) or a wait-list control to determine the mechanistic contribution of sleep disruption to vascular dysfunction in young adults with moderate-to-high exposure to adverse childhood experiences (ACEs). Following the intervention, participants will again complete:\n\n1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration,\n2. in vivo assessment of endothelial function via flow-mediated dilation testing, and\n3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.",[213,214,215,216,217,28,218,219,220],"Adverse Childhood Experiences","Vascular Dilatation","Sleep","Sleep Disturbance","Psychosocial Stressor","Endothelial Dysfunction","Inflammation","Oxidative Stress",{"date":222,"type":37},"2025-12-11",{"date":224,"type":37},"2024-05-01",{"date":226,"type":22},"2028-10-31",{"name":228,"class":44},"Nathaniel Jenkins",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":17,"minAge":237,"maxAge":136,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":241,"conditions":242,"keywords":246,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":264},"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",{"count":239,"type":22},120,[25],"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.",[243,28,244,245],"Stress Disorders, Traumatic","Sexual Trauma","Stress Disorders, Post-Traumatic; Mental Disorders",[247,248,249,250,251,252,189,253,254],"Randomized controlled trial","Developmental trauma disorder","self-regulation difficulties","trauma treatment","Sensory motor arousal regulation treatment (SMART)","Children","Outpatient treatment","Treatment as usual","2025-09-22",{"date":257,"type":37},"2025-10-01",{"date":259,"type":22},"2025-09-25",{"date":261,"type":22},"2027-12-31",{"name":263,"class":44},"Vestre Viken Hospital Trust",4,{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":276,"conditions":277,"keywords":280,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":293,"locationsCount":106},"100369013","augmentation-of-emdr-with-tdcs-in-the-treatment-of-fibromyalgia-100369013","NCT04084795","Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia","Augmentation of EMDR With Transcranial Direct Current Stimulation (tDCS) in the Treatment of Fibromyalgia: a Double-blind Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 18 and 70 years old\n* Mean pain score of at least 4 on the visual analog scale (VAS) in the two weeks preceding the clinical trial\n* Presence of one or more traumatic events causing current trauma-related symptoms\n* Current clinical symptoms of depression and\u002For anxiety\n* 2 weeks of stable medication\n\nExclusion Criteria:\n\n* Comorbid autoimmune or chronic inflammatory disease\n* Neurological or serious medical diseases\n* Bipolar disorder, schizoaffective disorder and schizophrenia\n* Suicidal ideation\n* Previous EMDR therapy in the past two years\n* Substance abuse\u002Fdependency within 1 month prior to participation (except for nicotine abuse\u002Fdependency),\n* Pending FM-related litigation or disability\n* Metallic implants in the head\n* Positive test for pregnancy\n* Skin sensitivity diseases (psoriasis, eczema, dermatitis, etc.)","70 Years",{"count":274,"type":22},96,[25],"Fibromyalgia (FM) is a generalized, widespread chronic pain disorder and has an estimated prevalence of 2%-4% in the general population. Current pharmacological and psychological interventions frequently produce limited benefits in FM patients. Due to FM's strong association with psychological trauma causing neurobiological alterations in stress response, a trauma-focused psychotherapy is an innovative alternative treatment option. Eye Movement Desensitization and Reprocessing (EMDR) has been recognized by the World Health Organization as a first-line therapeutic tool for post-traumatic stress disorder and first evidence suggests that it is also beneficial for patients with FM. Given the complex etiology of FM, a combination of psychotherapy with other treatment options can maximize a potential therapeutic success. A possible candidate herby is transcranial Direct Current Stimulation (tDCS), a non-invasive stimulation technique, which can modify neural activities related to pain and which has shown short-term positive effects on chronic pain and quality of life in FM patients. The patient sample will consist of 96 female patients meeting 2016 American College of Rheumatology criteria for FM based on a clinical interview. They will be randomized to 20 sessions of EMDR plus tDCS or EMDR plus sham-tDCS, or Treatment as Usual (TAU). Therapists, raters, and patients will be kept blind to tDCS treatment conditions. Evaluations will be at baseline, post treatment at 6 months, and follow-up at 12 months. Hypotheses are that EMDR improves pain intensity and clinical symptoms at short and long-term, and that tDCS enhances this effect, which will be superior to tDCS-sham.",[278,28,173,279],"Fibromyalgia","Anxiety",[278,281,282,283,284,285,286],"Psychological trauma","Posttraumatic stress disorder","Major depressive disorder","Anxiety disorder","Eye Movement Desensitization and Reprocessing","transcranial Direct Current Stimulation","2025-07-29",{"date":289,"type":37},"2025-08-03",{"date":291,"type":37},"2025-01-21",{"date":198,"type":22},{"name":80,"class":44},{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":23,"phases":304,"briefSummary":305,"conditions":306,"keywords":317,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":106},"100420789","neurorehabilitation-through-hippotherapy-of-a-brain-stroke-100420789","NCT04759326","Neurorehabilitation Through Hippotherapy of a Brain Stroke","Neurorehabilitation Through Hippotherapy on Neurofunctional Sequels of Brain Stroke: (i) Effect on Patient's Functional Independence, Sensorimotor and Cognitive Capacities and Quality of Life (ii) Effect on Caregivers' Quality of Life","HippoPostCVA","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Ischemic or haemorrhagic stroke according to ICD 10 I61-I69 (30)\n* Inclusion \\> 3 months post-stroke\n* Deficit still existing (Rankin score ≥ 3 and ≤ 4 at inclusion)\n* Existing declaration of informed consent\n* Affiliation of the patient to a social security scheme\n* Minimal abduction of the hip of 25 degrees bilateral with no history of hip dislocation and\u002For dysplasia\n* Certificate of non-contraindication issued by the referring physician\n\nExclusion Criteria:\n\n* Major cognitive impairment affecting comprehension (Mini Mental State Examination test \\\u003C 24 points)\n* Global or sensory aphasia\n* Neurological or psychiatric co-morbidity (other than mild-to-moderate post-stroke depression)\n* Evidence of an uncontrolled seizure disorder\n* Substance abuse\n* History of uncontrolled pain\n* History of allergic reactions to dust and\u002For horsehair, or severe asthma\n* Overweight (≥ 110 kg)\n* Contraindications to physical activity\n* Inability or medical contraindication to travel to the Equiphoria Institute by personal car or taxi\n* History of horse riding or hippotherapy care during the last 6 months\n* Pregnant or lactating women\n* Patients participating in other biomedical research or in a period of exclusion",{"count":303,"type":22},52,[25],"Cerebrovascular accident \\[CVA\\] (medical term for stroke) is a high burden worldwide disorder and the second leading cause of disability. As illustrated by the number of survivors that remain disabled after a CVA (2 out of 3 according to the US National Stroke Association), recovery is limited, and novel neurorehabilitation approaches are urgently needed. Hippotherapy is an emerging specialized rehabilitation approach, performed by accredited health professionals on a specially trained horse via its movement. A body of scientific evidence has gradually emerged in recent years, showing robust benefits of hippotherapy in various massive neurological disabling conditions including brain stroke.\n\nThe aim of the study is to analyze the effect of a hippotherapy program of several cycles delivered during 22 weeks in total, on the functional and global evolution of post-stroke patients (with a score of Rankin ≥ 3 at inclusion) during the outpatient rehabilitation phase. A second purpose is to measure the impact of the intervention on the quality of life of their close caregivers.\n\nA prospective clinical trial on the effectiveness of hippotherapy versus conventional outpatient rehabilitation alone will be carried out. The 22-weeks program includes three cycles of hippotherapy as follows: an initial 2-weeks cycle, an intermediate 1-week cycle and a final 1-week cycle. One-hour daily sessions will be conducted during each cycle exclusive additional rehabilitation care. After each cycle, the patients will have a 9-weeks rest period where they will continue their conventional therapy. A battery of clinical tests will measure both functional and psychological outcome. The primary end point will be the functional independence of the patient. The secondary end points will consider the patient's sensorimotor and cognitive function, the severity of stroke and the quality of life, as well as the caregivers' burden and quality of life.\n\nProgram evaluation is important in neurorehabilitation to ensure that patients are achieving meaningful outcomes from the care. A primary question is how do stroke patients clinically evolve after being discharged from the hospital and how stable is the achieved rehabilitation outcome. Hippotherapy optimizes brain plasticity and has a strong impact on the global rehabilitation process and functional outcome of these patients. A remaining question concerns the improvement of the caregivers' quality of life.",[307,308,309,310,311,312,313,28,314,315,316],"Cerebrovascular Accident","Neurorehabilitation","Neuroplasticity","Hippotherapy","Silent Neurofunctional Barriers","Functional Deficit","Cognitive Deficit","Autonomy","Quality of Life","Caregiver Burnout",[318,319,320],"NeuroRehabilitation through hippotherapy","Brain plasticity","Functional recovery","2024-07-30",{"date":323,"type":37},"2024-07-31",{"date":325,"type":37},"2022-04-27",{"date":327,"type":22},"2026-03",{"name":329,"class":44},"Alliance Equiphoria",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":16,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":345,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":353,"leadSponsor":355,"locationsCount":106},"100551975","self-help-plus-and-post-migration-living-difficulties-support-intervention-100551975","NCT06467071","Self Help Plus and Post-Migration Living Difficulties Support Intervention","Self Help Plus and Post-Migration Living Difficulties Support Intervention: A Randomized Controlled Trial With Syrian Women Under Temporary Protection in Turkey","Inclusion Criteria:\n\n* Participants must be adults (18 years and above),\n* Selected among Syrian women residing in Turkey under temporary protection,\n* Speak Arabic,\n* Have not received any services from the Refugee Association before,\n* A score of more than 16 on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0),\n* A score of more than 15 on the Kessler-10 (K10) Psychological Distress Scale.\n\nExclusion Criteria:\n\n* Have an acute medical condition,\n* At risk of suicide,\n* Have a severe mental disorder,\n* Have severe cognitive impairment",{"count":338,"type":22},210,[25],"This study will conduct a two-arm, single-blind, randomized controlled trial among Syrian refugee women living in Turkey who experience psychological distress. In the study, participants will be randomly assigned to either the SH+ intervention (n = 105) combined with a session on Post-Migration Living Difficulties (PMLD) or Treatment as Usual (TAU) (n = 105). SH+ is a five-session guided self-help intervention focusing on stress management based on Acceptance and Commitment Therapy (ACT). In addition, a session discussing post-migration difficulties and possible problem-management techniques will be integrated after the SH+ intervention. This study aims to fill an important gap in refugee health and well-being research by focusing on the integrated expansion and implementation of an intervention program to address the psychosocial challenges faced by refugee Syrian women. The results will assess the effectiveness of the intervention on psychological distress, focusing on its potential positive effects on psychological distress, stress management, and adaptation processes. Furthermore, the impact of the intervention on the use of association services and psychological flexibility will be examined.",[342,28,343,344],"Psychological Distress","Mental Health","Refugee Health",[346,347,348],"Syrian Women Refugees","Self Help Plus","Post Migration Living Difficulties","2024-06-19",{"date":351,"type":37},"2024-06-20",{"date":351,"type":22},{"date":354,"type":22},"2025-03-30",{"name":356,"class":44},"Medipol University"]