[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-traumatic-stress-disorder-ptsd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-traumatic-stress-disorder-ptsd":58},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,51,0,25,[9,47,76,105,129,157,178,213,243,272,295,324,357,381,412,434,457,478,502,519,553,574,600,625,658],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100589382","shared-decision-making-in-ptsd-treatment-100589382",false,"NCT06953687","Shared Decision Making in PTSD Treatment","Implementing and Evaluating a Patient-Centered PTSD Treatment Program for Military Personnel","Inclusion Criteria:\n\n1. Adult active duty military service members aged 18 or older.\n2. Meets diagnostic criteria for PTSD based on the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS-5).\n\nExclusion Criteria:\n\n1. Acute suicidality or homicidality requiring immediate intervention, such as hospitalization.\n2. Moderate to severe brain injury as assessed by the History of Head Injury Form\n3. Severe alcohol consumption patterns as assessed using the Alcohol Use Disorders Identification Test and warranting immediate intervention as determined by clinical judgement.\n4. Experiencing active psychosis or mania as determined by scores on the Prodromal Questionnaire and Mood Disorder Questionnaire in combination with clinical judgement.","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this research study is to learn about how Shared Decision Making, when used to decide treatment, impacts treatment engagement, retention, and outcomes for active duty military personnel seeking treatment for posttraumatic stress disorder (PTSD).\n\nShared Decision Making between the service member and the therapists will be used to match patients to 1 of 3 different types of therapy for PTSD: (1) Prolonged Exposure (PE) therapy, (2) Cognitive Processing Therapy (CPT), or (3) Written Exposure Therapy (WET) in 1 of 2 different frequencies: (1) massed (daily) or (2) spaced (weekly).",[27],"Post Traumatic Stress Disorder PTSD",[29,30,31,32,33],"Shared Decision Making","Patient Characteristics","Patient Treatment preference","Treatment engagement","Treatment outcomes","RECRUITING","2026-08-17",{"date":37,"type":38},"2026-08-19","ACTUAL",{"date":40,"type":38},"2025-05-09",{"date":42,"type":21},"2028-09",{"name":44,"class":45},"The University of Texas Health Science Center at San Antonio","OTHER",2,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100528589","type-i-hybrid-effectiveness-implementation-trial-of-primary-care-brief-mindfulness-training-for-veterans-100528589","NCT06162741","Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans","Inclusion Criteria:\n\nTo be eligible, participants must be:\n\n* enrolled in VA primary care through the local VA site\n* report clinically significant psychological distress as measured in at least one of three areas:\n\n  * PTSD operationalized by 30 on the PCL-5 plus endorsing a criteria A stressor\n  * depression operationalized as 10 on the PHQ-9\n  * anxiety operationalized by 10 on the GAD-7\n\nExclusion Criteria:\n\nExclusion criteria are minimized to allow inclusion of any primary care patients with psychological distress that would normally receive treatment in primary care. Patients will be excluded if they demonstrate symptoms that would not allow them to actively participate in the interventions:\n\n* gross cognitive impairment\n* suicide attempt or desire to commit suicide in the last month\n\nTo allow the study to isolate the effects of the intervention and ensure patient treatment preferences are honored, patients will be excluded if they:\n\n* had a psychotherapy appointment outside of primary care within the last month and have future appointment scheduled\n* had a change in psychiatric medication outside of VHA primary care in the last 2 months\n* voice a preference to be directly referred to specialty mental health care\n\nVeterans with mild TBI, and alcohol\u002F substance use disorders will not be excluded because these problems commonly co-occur with psychological distress, and individuals with these conditions have previously benefited from mindfulness and problem-solving training. Patients who receive Primary Care Mental Health Integration (PCMHI) services will not be excluded as this is part of the usual primary care services that all Veterans receive.",{"count":54,"type":21},300,[24],"The VA wants to understand what type of integrative and whole health approaches are helpful for Veterans. The study is comparing two primary care based mental health treatments, a mindfulness class that teaches mindfulness meditation and a problem-solving class that teaches problem-solving skills and how to build resilience, for Veterans who are experiencing symptoms of anxiety, depression, and\u002For PTSD. The goal of the study is to understand if the classes reduce symptoms of anxiety, depression, and\u002For PTSD and increase overall functioning.",[58,59,60],"Post Traumatic Stress Disorder (PTSD)","Depression","Anxiety",[62,58,63,64,65,59,60,66],"Psychological Distress","Mindfulness","Primary Care","Brief Intervention","Problem-solving training",{"date":37,"type":38},{"date":69,"type":38},"2024-08-19",{"date":71,"type":21},"2027-12-31",{"name":73,"class":74},"VA Office of Research and Development","FED",4,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100611827","targeted-accelerated-tms-for-post-traumatic-stress-disorder-100611827","NCT07245641","Targeted Accelerated TMS for Post-Traumatic Stress Disorder","TAP","Inclusion Criteria\n\n* Age 18-65\n* DSM-5 diagnosis of PTSD per PTSD Checklist for DSM-5 (CAPS-5)\n* At least moderate symptoms of PTSD per PCL-5 (≥21)\n* English proficiency sufficient to understand risks\u002Fbenefits\n* No new medications or medication increases before, during, or after aTMS\n* Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial\n* Agreement to lifestyle considerations:\n* Abstain from becoming pregnant from screening to one-month after treatment (the MRI visit)\n* Continue usual intake patterns of caffeine- or xanthine-containing products (e.g. coffee, tea, soft drinks, chocolate) throughout treatment\n* No changes to routine intake of alcohol, tobacco, and recreational drugs if patients are using them at baseline for at least 24 hours before the start of each MRI and TMS session","65 Years",{"count":85,"type":21},40,[24],"Post-traumatic stress disorder (PTSD) is a highly prevalent and debilitating condition among veterans and active-duty military personnel, with rates as high as 30% in certain combat-exposed populations. Conventional treatments such as prolonged exposure therapy and pharmacotherapy have limited efficacy and high dropout rates, highlighting the need for novel, rapidly effective interventions.\n\nTranscranial magnetic stimulation (TMS) has been well established for treatment-resistant depression (TRD). Traditional TMS, which involves 6 to 7 weeks of daily, weekday scalp-targeted treatment, shows open-label response and remission rates of 58.1% and 30%, respectively. However, such protocols may be impractical for military personnel with limited medical leave. A new form of accelerated TMS (aTMS) that involves 10 imaging-guided treatments per day for 5 consecutive days has demonstrated substantial antidepressant benefits within days and response rates of 69% at 1-month follow-up. This protocol has not been tested for PTSD, in part because there was no causally informed brain circuit target. In this study, the investigators will test aTMS for PTSD using a novel PTSD circuit that the investigators have derived.",[58],[90,91,92,93,94],"Accelerated Transcranial Magnetic Stimulation","Post traumatic stress disorder","PTSD","TMS","Neuromodulation","2026-08-12",{"date":97,"type":38},"2026-08-13",{"date":99,"type":38},"2025-12-15",{"date":101,"type":21},"2028-01",{"name":103,"class":45},"Brigham and Women's Hospital",1,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":4},"100652063","eye-movement-intervention-with-different-memory-reactivation-procedures-for-intrusive-traumatic-memories-100652063","NCT07767396","Eye Movement Intervention With Different Memory Reactivation Procedures for Intrusive Traumatic Memories","The Effects of Different Memory Reactivation Procedures Combined With Bilateral Eye Movements on Intrusive Memories and PTSD Symptoms: A Three-Arm Randomized Controlled Trial","Inclusion Criteria:\n\n1. Meet DSM-5 PTSD Criterion A, such as exposure to actual or threatened death, serious injury, or sexual violence; have experienced one or more traumatic events.\n2. Experienced five or more trauma-related intrusive memories during the baseline week.\n3. Have internet access and access to a personal computer suitable for completing the online study tasks.\n4. Have normal or corrected-to-normal vision and be able to complete computerized visual and eye movement tasks.\n5. Be willing to provide informed consent, able to complete study procedures, and able to be contacted by the study team.\n\nExclusion Criteria:\n\n1. Have fewer than five trauma-related intrusive memories during the baseline week.\n2. Have a current or past psychotic disorder, current manic episode, severe obsessive-compulsive disorder, severe personality disorder, or another severe psychiatric condition judged to interfere with study participation, adherence, or safety.\n3. Have current acute suicidal ideation or behavior, significant risk of harm to self or others, or any condition requiring urgent clinical intervention.\n4. Have current severe substance use disorder or severe substance dependence judged to interfere with study participation or safety.\n5. Have a current organic disorder, neurological condition, history of epilepsy or seizures, significant brain injury, or other medical condition judged to interfere with safe participation or completion of the computerized visual or eye movement tasks.\n6. Have visual impairment or other condition that prevents completion of the computerized visual or eye movement tasks.\n7. Current participation in another intervention study or current treatment judged by the research team to interfere with study participation, safety, or outcome assessment.","50 Years",{"count":114,"type":21},117,[24],"Post-Traumatic Stress Disorder (PTSD) and trauma-related symptoms are often characterized by recurrent intrusive memories that cause distress and interfere with daily functioning. Although trauma-focused interventions such as Eye Movement Desensitization and Reprocessing (EMDR) may be effective, they often involve engagement with trauma-related memories, which can be distressing for some individuals and may affect treatment acceptability. This randomized controlled trial will evaluate a standardized eye-movement-based procedure for trauma-exposed individuals experiencing recurrent intrusive memories. Participants will be randomly assigned to one of several memory-related task conditions involving eye movements. The study will assess the frequency and distress of trauma-related intrusive memories at prespecified assessment points, as well as PTSD symptoms, intervention-related distress, acceptability, and safety. Findings from this trial may help inform the development of tolerable approaches for targeting trauma-related intrusive memories.",[118,119],"Post-traumatic Stress Disorder (PTSD)","Intrusive Memories of Traumatic Event(s)","NOT_YET_RECRUITING","2026-08-11",{"date":35,"type":38},{"date":124,"type":21},"2026-08-15",{"date":126,"type":21},"2028-12-15",{"name":128,"class":45},"Shaanxi Normal University",{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100610216","phase-2-inhaled-cannabis-for-treatment-of-ptsd-100610216","NCT07224698","Inhaled Cannabis for Treatment of PTSD","Phase 2 Multicenter Randomized Placebo-controlled, Double-blind, Parallel Study to Assess the Safety and Efficacy of Inhaled Cannabis in Veterans for Treatment of Posttraumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n1. Be at least 18 years old.\n2. Be a veteran with PTSD lasting 6 months in duration.\n3. Meet DSM-5 criteria for PTSD with symptoms\n4. Have PTSD of at least moderate severity at the time of screening.\n5. For participants assigned female sex at birth:\n\n   a) A participant is eligible to participate if not pregnant, and one of the following conditions applies: i) Is not able to become pregnant as defined in protocol (Appendix 2) OR ii) Is a person able to be pregnant (PABP) and using a contraceptive method that is highly effective, with a failure rate of \\\u003C1%, as described in the protocol (Appendix 2) during the study intervention period and for at least 14 days after the Study Termination visit. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n\n   b) A PABP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at Screening, Introductory Session 1, Resupply, and EoT visits c) The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant with an early undetected pregnancy.\n6. Be stable on any pre-study medications and\u002For psychotherapy prior to study entry, agree to inform physician(s)\u002Fclinician(s) providing current care about participation in the study, and agree to report any changes in medication or psychotherapy treatment regimen during the study-to-study staff.\n7. Have previously inhaled cannabis (e.g. smoked or vaporized cannabis).\n8. Be willing to commit to medication dosing and delivery method, to complete evaluation instruments, and attend all study visits.\n9. Agree to use only cannabis provided by site staff and agree to required follow up periods for the duration of the study.\n10. Agree to keep all cannabis provided by site staff securely stored in the provided lock box and not to share\u002Fdistribute cannabis to any other individual.\n11. Be proficient in reading and writing in English and able to effectively communicate with site staff.\n12. Agree not to participate in any other interventional clinical trials during the study.\n13. Must agree to inform the investigators within 48 hours of any medical conditions and procedures.\n14. Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.\n15. Must be able and willing to record information digitally on a personal device (phone or computer) with internet access.\n\nExclusion Criteria:\n\n1. Are pregnant, nursing, or are a person able to become pregnant who are not practicing an effective means of birth control.\n2. Have current major depressive disorder with primary psychotic features\n3. Have current or past DSM-5 diagnosis of eating disorder with active purging, personality disorders, primary psychotic disorder, or bipolar affective disorder type 1\n4. Have current or past DSM-5 diagnosis of dissociative identity disorder, positive family history (first degree relative) of psychotic disorder or bipolar affective disorder type 1\n5. Are at high risk of suicide attempt: any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to Columbia Suicide Severity Rating Scale (C-SSRS), and clinical judgment of the investigator will be excluded; however, history of suicide attempts is not an exclusion. Any participant who is likely to require hospitalization related to suicidal ideation and behavior, in the judgment of the investigator, will not be enrolled.\n6. Would present serious risk to others as established by clinical interview and contact with treating psychiatrist.\n7. Have a current moderate or severe alcohol or cannabis use disorder within the 12 months prior to enrollment. Participants with a substance use disorder other than alcohol or cannabis are excluded.\n8. Have a positive urine drug screen for opiates, methamphetamine, cocaine, THC, and amphetamines (unless prescribed). Participants with a positive THC urine analysis test are excluded from the study, but will be allowed to rescreen once after a 1-month cessation of cannabis use\n9. Have a history of arrhythmia, other than occasional premature atrial contractions (PACs) and PVCs in the absence of ischemic heart disease, within 12 months of screening.\n\n   * Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have been successfully treated with ablation and have not had recurrent arrhythmia for at least one year off all antiarrhythmic drugs, or are under adequate and stable pharmacologic treatment for atrial fibrillation for at least a year, as confirmed by a cardiologist.\n10. Have a current or history of chronic obstructive pulmonary disease or asthma.\n11. Have a current diagnosis or evidence of significant or uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal, renal, hepatic, immunocompromising, or neurological disease according to CI's discretion.\n12. Have any current problem or presence of clinical feature which, in the opinion of the CI or Medical Monitor, might interfere with or prevent appropriate study participation.\n13. Have any known allergies to cannabis or contraindication for inhalation of cannabis.\n14. Are not able to give adequate informed consent.\n15. Insufficient ability to report on symptoms to make a valid assessment on any required instrument.\n16. Are not able to attend required face-to-face visits or those who plan to move out of the area within the treatment period.",{"count":137,"type":21},320,[139],"PHASE2","The rationale for the use of inhalational cannabis to potentially treat PTSD symptoms is based on the many reports of cannabis attenuating PTSD symptom expression among individuals with PTSD, including veterans. Study MJP2 is intended to build off MJP-1 through use of a larger sample size, a parallel study design, and subjective bias mitigation methods to re-examine the use of inhaled high THC-containing cannabis versus placebo for management of PTSD symptoms in a U.S. Veteran sample. Together these studies are intended to provide valuable insights on the already widespread use of cannabis in individuals with PTSD, for which there is currently a lack of controlled evidence available reflective of this real-world use.",[27],[92,143,144,145,146,147,148],"Veteran","cannabis","inhaled cannabis","THC","posttraumatic stress disorder","Veteran Affairs","2026-08-06",{"date":121,"type":38},{"date":152,"type":21},"2027-02",{"date":154,"type":21},"2028-12-30",{"name":156,"class":45},"Multidisciplinary Association for Psychedelic Studies",{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":164,"targetDuration":166,"studyType":167,"phases":4,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":174,"leadSponsor":176,"locationsCount":104},"100650389","ptsd-risk-prediction-model-for-eicu-survivors-100650389","NCT07747415","PTSD Risk Prediction Model for EICU Survivors","Development and Validation of a Risk Prediction Model for Post-Discharge Post-Traumatic Stress Disorder in EICU Survivors","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Admitted to the emergency department and subsequently transferred to the EICU at a participating center\n* Availability of emergency department-to-EICU clinical data suitable for model development\n* Proficient in the communication language, able to communicate normally, without cognitive impairment, dementia, or history of primary psychiatric disorders\n* Survive to EICU discharge\n* Glasgow Coma Scale (GCS) score ≥ 12 at EICU discharge or at follow-up\n* Willing to participate and able to provide informed consent (or consent obtained from a legally authorized representative or witness if the participant is unable to provide consent)\n\nExclusion Criteria:\n\n* Voluntary withdrawal by the participant\n* Severe dementia, persistent coma, chronic vegetative state, or severe aphasia that precludes completion of PTSD assessment\n* Inability to establish any form of follow-up after discharge\n* Death prior to ICU discharge\n* Vulnerable populations other than elderly\u002Fcritically ill patients (e.g., those with psychiatric disorders, cognitive impairment, pregnant women, illiterate individuals)\n* Other conditions deemed by the investigator to be unsuitable for participation or unable to ensure follow-up quality",{"count":165,"type":21},800,"1 Month","OBSERVATIONAL","Brief Title: PTSD Risk Prediction Model for EICU Survivors\n\nOfficial Title: Development and Validation of a Risk Prediction Model for Post-Discharge Post-Traumatic Stress Disorder in Emergency Department-Admitted EICU Survivors\n\nStudy Type: Observational\n\nBrief Summary: This study aims to develop and validate a risk prediction model for post-traumatic stress disorder (PTSD) at 1 month after hospital discharge in adult survivors of emergency intensive care unit (EICU) care. PTSD is a common and serious psychological condition that can occur after a life-threatening medical event. Many EICU survivors experience persistent stress responses, sleep problems, avoidance behaviors, and difficulty returning to normal life after leaving the hospital. This prospective observational cohort study will enroll approximately 800 adult patients who are admitted to the EICU through the emergency department at Sir Run Run Shaw Hospital and other participating centers. Participants will be followed up at 1 month after EICU discharge to complete the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), a diagnostic interview for PTSD. Clinical data collected during the emergency department stay and EICU course-including vital signs, laboratory tests, treatments, and severity of illness-will be used to build statistical models to predict which patients are most likely to develop PTSD. The study does not involve any experimental treatments or additional procedures beyond routine clinical care. Results from this study may help healthcare providers identify high-risk patients early and provide timely psychological support and follow-up care.\n\nDetailed Description: Background: Advances in critical care medicine have enabled an increasing number of emergency critical care patients to survive to ICU or hospital discharge. However, a substantial proportion of survivors experience persistent psychological sequelae, including post-traumatic stress disorder (PTSD), which significantly impairs quality of life. Patients admitted to the EICU via the emergency department are exposed to multiple stressors during the early phase-sudden life-threatening illness, pain, hypoxia, altered consciousness, mechanical ventilation, sedation, and separation from family-which may serve as important risk factors for subsequent PTSD. Objectives: To develop and validate a risk prediction model for predicting 1-month post-discharge PTSD in adult patients admitted to the EICU via the emergency department. Study Design: This is a prospective observational cohort study conducted at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (coordinating center) and multiple other centers. Study Population: Adult patients (≥18 years) admitted to the emergency department and subsequently transferred to the EICU, with an ICU length of stay of at least 24 hours, who survive to EICU discharge and have a Glasgow Coma Scale score ≥12 at discharge or follow-up. Sample Size: Approximately 800 patients (approximately 200 per center if 4 centers participate), calculated based on an estimated 25% PTSD prevalence at 1 month post-discharge, with 6-8 candidate predictors, expected Nagelkerke R² of 0.15, target shrinkage of 0.90, and accounting for 15%-20% attrition. Data Collection: All variables are routine clinical observation and laboratory parameters, categorized into six domains: (1) baseline susceptibility variables (demographics, social support, psychiatric history, trauma history, prior ICU admission, substance use, chronic disease burden); (2) emergency admission phase variables (mode of admission, severity, vital signs, etiology, early labs, emergency treatments); (3) first 24 hours in EICU variables (severity scores, organ support, sedation\u002Fanalgesia, neurological status, nursing exposures, early complications); (4) cumulative EICU exposure variables (duration of organ support, cumulative sedation\u002Fanalgesia, mechanical ventilation duration, physical restraints, delirium, infections, major complications); (5) disease process and treatment-related variables (severe infection, respiratory failure, AKI, ARDS, transfusion, emergency surgery, intubation, CPR); and (6) 1-month post-discharge follow-up (CAPS-5 diagnostic PTSD assessment). Primary Outcome Measure: CAPS-5-diagnosed PTSD at 1 month post-EICU discharge. Statistical Analysis: Three types of prediction models will be developed: (1) an early model using variables available within the first 6 hours from emergency department presentation to EICU admission; (2) a discharge-updated model adding ICU exposure, treatment interventions, complications, and pre-discharge information; and (3) a dynamic digital model further adding post-discharge electronic follow-up and digital phenotyping data. Candidate modeling approaches include logistic regression, LASSO\u002FElasticNet penalized regression, random forest, gradient boosting trees, XGBoost\u002FLightGBM, and support vector machines. Model performance will be evaluated for di",[118],"2026-07-31",{"date":172,"type":38},"2026-08-05",{"date":124,"type":21},{"date":175,"type":21},"2027-06-30",{"name":177,"class":45},"Sir Run Run Shaw Hospital",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":186,"maxAge":83,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":104},"100649639","early-phase-1-trauma-informed-psilocybin-assisted-psychotherapy-tipap-for-ptsd-100649639","NCT07737054","Trauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for PTSD","Trauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for Post-Traumatic Stress Disorder","TiPAP-PTSD","Inclusion Criteria:\n\n* Age 21-65 years.\n* Diagnosis of post-traumatic stress disorder (PTSD) according to DSM-5 criteria, as assessed by CAPS-5.\n* At least 1 year since the traumatic event.\n* Moderate or greater PTSD severity (CAPS-5 score ≥ 25).\n* Ability to provide written informed consent.\n* Ability to read, write, speak, and understand Hebrew.\n* Prior trauma-focused psychotherapy.\n* Medically healthy at screening, as determined by a study physician, including:\n\n  * No exclusionary medical conditions.\n  * Resting blood pressure between 90\u002F60 and 150\u002F90 mmHg and heart rate between 45-100 bpm.\n  * Normal laboratory results (including liver function, renal function, and electrolytes).\n\nExclusion Criteria:\n\n* Current or past diagnosis of psychotic disorders, bipolar disorder, schizoaffective disorder, dissociative identity disorder, or borderline personality disorder (as assessed by MINI or SCID-5-SPQ).\n* Current psychotic features.\n* First-degree relative with a history of a psychotic disorder.\n* History of antidepressant-induced mania or hypomania.\n* Significant suicidal risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS), including active suicidal ideation with intent or plan, or suicidal behavior within the past 6 months.\n* Substance use disorder (excluding nicotine and caffeine); mild-to-moderate alcohol or cannabis use may be permitted under monitoring and PI approval.\n* Use of psychedelic substances within 3 months before enrollment\n* Participation in a clinical trial involving administration of a psychedelic substance within the past 12 months.\n* History of adverse psychological reaction to psychedelics requiring hospitalization.\n* Significant cardiovascular disease, including ischemic heart disease, uncontrolled hypertension, arrhythmia, or heart failure (NYHA class ≥3).\n* Dementia or suspected cognitive impairment.\n* Traumatic brain injury with loss of consciousness \\>24 hours or post-traumatic amnesia \\>7 days (unless cleared by neurological evaluation).\n* Pregnancy, breastfeeding, or positive pregnancy\u002Fdrug test (excluding cannabis) on the day of dosing.\n* BMI \\\u003C18 or \\>33\n* Abnormal liver or renal function tests.\n* Use of medications contraindicated with psilocybin.\n* Changes in psychiatric medication (dose or type) within one month before enrollment.\n* Needle phobia or inability to undergo blood testing.","21 Years",{"count":188,"type":21},13,[190],"EARLY_PHASE1","This is an open-label pilot study designed to evaluate the safety, tolerability, and preliminary clinical effects of psilocybin-enhanced trauma-focused psychotherapy in individuals with post-traumatic stress disorder (PTSD).\n\nParticipants will receive a structured therapeutic protocol that includes preparatory sessions, two psilocybin administration sessions (15 mg followed by 25 mg), and integration sessions based on a trauma-focused therapeutic approach.\n\nThe primary objective of the study is to assess the safety and tolerability of psilocybin administration in this clinical population. Secondary objectives include evaluating changes in PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale (CAPS-5), at 30 days following treatment.\n\nThis pilot study will include 13 participants and is intended to inform the feasibility and design of a subsequent randomized controlled trial.",[193],"Post-Traumatic Stress Disorder, PTSD",[195,196,197,198,92,199,200,201,202],"Psilocybin","Psychedelic-Assisted Therapy","Trauma-Focused Therapy","Acceptance and Commitment Therapy","ACT","Rapid-Acting Treatment","Psychotherapy","Pilot Study","2026-07-26",{"date":205,"type":38},"2026-07-30",{"date":207,"type":38},"2025-07-22",{"date":209,"type":21},"2026-12-31",{"name":211,"class":212},"Tel-Aviv Sourasky Medical Center","OTHER_GOV",{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":167,"phases":4,"briefSummary":223,"conditions":224,"keywords":228,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":4},"100648341","prognosis-of-epilepsy-with-post-traumatic-stress-disorder-and-surgery-100648341","NCT07718542","Prognosis of Epilepsy With Post-traumatic Stress Disorder and Surgery","Surgical Prognosis for Drug-resistant Focal Epilepsy Associated With Post-traumatic Stress Disorder (PTSD): a Multidimensional Assessment of the Success of Resective Surgery.","PEPSY","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Individuals informed about the study who do not object to participation\n* Individuals with drug-resistant focal epilepsy (failure of at least two appropriately selected and adequately administered anti-seizure medications)\n* Eligible for resective epilepsy surgery and awaiting surgery\n* Covered by the French health insurance system\n\nExclusion Criteria:\n\n* Concurrent participation in another research study that precludes enrollment\n* Individuals unable to provide informed participation according to French regulations, covered by Articles L1121-5 to L1121-8 of the French Public Health Code\n* Individuals who do not understand French\n* Individuals with generalized epilepsy\n* Individuals whose epilepsy is controlled with anti-seizure medication\n* Contraindication to resective epilepsy surgery",{"count":222,"type":21},42,"Why is this study being conducted? For people with drug-resistant focal epilepsy, surgery, to remove the part of the brain where seizures start, is currently the most effective treatment. In many people, especially those with temporal lobe epilepsy, surgery can stop seizures completely and improve quality of life. However, doctors usually predict the chances of surgical success using brain scans and other neurological tests, while the possible influence of psychological and social factors remains less well understood.\n\nMental health is an important part of overall health. People living with epilepsy are more likely than the general population to experience anxiety, depression, and post-traumatic stress disorder (PTSD). PTSD can develop after experiencing traumatic events and may affect emotional well-being, daily activities, relationships, and physical health.\n\nSome studies suggest that PTSD may affect brain networks involved in epilepsy. This raises an important question: could PTSD influence the success of epilepsy surgery? We hypothesize that PTSD and other psychological or social factors may affect surgical outcomes and recovery after surgery. At present, there is limited evidence available to answer this question.\n\nWhat is the aim of the study? The main objective of this study is to determine whether PTSD affects the success of epilepsy surgery two years after the operation.\n\nThe study also aims to:\n\n* Describe the medical, psychological, and social characteristics of people undergoing epilepsy surgery and estimate how common traumatic experiences and PTSD are in this population;\n* Assess changes in PTSD symptoms, anxiety, depression, quality of life, social vulnerability, and patient satisfaction before and after surgery;\n* Identify biological, psychological, and social factors associated with successful surgical outcomes.\n\nRather than focusing only on seizure control, this study aims to improve understanding of the factors that contribute to recovery, quality of life, and long-term well-being after epilepsy surgery. The findings may help healthcare professionals provide more personalized support before and after surgery.\n\nWho can take part? Between September 2026 and September 2028, the study will recruit 42 adults with drug-resistant focal epilepsy who are being evaluated for resective epilepsy surgery at Timone University Hospital in Marseille, France.\n\nWhat does participation involve? Participants will join the study approximately three months before surgery and will be followed for two years after the operation.\n\nDuring routine pre-operative and post-operative follow-up visits, participants will complete validated self-report questionnaires about:\n\n* Traumatic experiences and PTSD symptoms;\n* Anxiety and depression;\n* Quality of life;\n* Social vulnerability;\n* Satisfaction with surgery. Participants whose questionnaire results suggest possible PTSD will be offered a routine psychiatric assessment to confirm the diagnosis. Based on these assessments, participants will be classified into one of two groups: people with PTSD and people without PTSD.\n\nThe study will also use clinical information routinely collected as part of epilepsy care, including brain imaging, electroencephalography (EEG), and neuropsychological assessments.\n\nWhat are the expected benefits of this research? This study may improve understanding of how psychological and social factors influence epilepsy surgery outcomes. The results may help healthcare professionals better identify patients who could benefit from additional support before and after surgery.\n\nIn the future, the findings could contribute to the development of more personalized care pathways, including advanced practice nursing follow-up, improved mental health screening, and targeted support to enhance seizure outcomes, quality of life, emotional well-being, and patient satisfaction after epilepsy surgery",[225,226,227,118],"Epilepsies, Focal","Drug Restistant Epilepsie","Anxiety Disorders",[229,230,231,232,233],"Epilepsy surgery","Drug-resistant focal epilepsy","Post-traumatic stress disorder","Surgical outcomes","Advanced practice nursing","2026-07-17",{"date":236,"type":38},"2026-07-22",{"date":238,"type":21},"2026-09",{"date":240,"type":21},"2031-05",{"name":242,"class":45},"Assistance Publique Hopitaux De Marseille",{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":250,"minAge":18,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":258,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":271},"100601787","project-stronger-stepped-care-for-opioid-use-disorder-treatment-engagement-and-recovery-100601787","NCT07115030","Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery","STRONGER","Inclusion Criteria:\n\n* Woman;\n* Are ≥ 18 years old;\n* Receive MOUD treatment at one of the participating sites;\n* Have received MOUD for \\>14 days to allow for initial stabilization;\n* Have initiated the current treatment episode within the past 12 months;\n* Experienced physical or psychological IPV in their lifetime;\n* Have at least moderate impairment in psychosocial functioning (on B-IPF) as a result of PTSD symptoms;\n* Available during the date\u002Ftime of the intervention group\n* Able to read\u002Funderstand English; and\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Fail a capacity-to-consent questionnaire;\n* Have an unstable medical condition (e.g., hospitalization, planned surgery, newly starting chemotherapy, plans for palliative care) and\u002For unstable psychiatric illness (e.g., untreated psychosis) that would interfere with their ability to participate in study activities;\n* Will be unavailable for \\>4 consecutive weeks during the study period (e.g., anticipated move, planned surgery);\n* Are unable to read\u002Funderstand English;\n* Inability to provide at least one form of contact","FEMALE",{"count":252,"type":21},532,[24],"Using a hybrid type 1 effectiveness-implementation approach, this study aims to evaluate the impact of a novel stepped care model (\"PCT+2HOPE\") versus treatment as usual (TAU) on increasing retention in community-based medication for opioid use disorder (MOUD) treatment among women who have experienced intimate partner violence (W-IPV). PCT+2HOPE includes Present-Centered Therapy (PCT+) with stepped care as indicated by moderate, severe, or extreme PTSD-related impairment in psychosocial functioning to Helping to Overcome PTSD through Empowerment (HOPE), two evidence-based behavioral interventions adapted for women with opioid use disorder (OUD). We will examine the effectiveness of PCT+2HOPE vs. TAU on the primary outcome (i.e., retention in MOUD treatment) and secondary outcomes related to trauma (i.e., PTSD-related impairment in psychosocial functioning and depression), substance use (i.e. OUD symptom severity, extra-medical opioid use \\[i.e., use of prescription opioids without a doctor's prescription; in greater amounts, more often, longer than prescribed, or for a reason other than a doctor said they should be used\\], and recovery), and empowerment. We will explore the extent to which the effectiveness of PCT+2HOPE vs. treatment as usual differs based on access to basic needs. We will also conduct an implementation-focused process evaluation.",[256,257,27],"Opioid Use Disorder","Intimate Partner Violence (IPV)",[259,260,261],"opioid use disorder","intimate partner violence","domestic violence","2026-07-14",{"date":264,"type":38},"2026-07-16",{"date":266,"type":38},"2026-06-01",{"date":268,"type":21},"2029-08-31",{"name":270,"class":45},"Yale University",3,{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":75},"100514141","evaluating-treatments-for-suicidal-veterans-with-ptsd-100514141","NCT05974631","Evaluating Treatments for Suicidal Veterans With PTSD","A Hybrid Effectiveness-Implementation Trial of Treatments for Veterans With PTSD at Elevated Acute Risk for Suicide","Inclusion Criteria:\n\n* PTSD\n* Recent and repeated self-directed violence\n* Current suicidal ideation\n* Emotion dysregulation\n* Veteran eligible for VHA mental health care at participating site\n* Willing to participate in all study activities\n\nExclusion Criteria:\n\n* Unable to maintain safety independently\n* Currently engaged in and\u002For recent (past year) history of receiving a sufficient dose of DBT or PE\n* Plan to move away or be unavailable for \\>4 weeks in the next 18 months\n* Unable to sufficiently comprehend study procedures due to lack of English proficiency or moderate to severe cognitive impairment",{"count":280,"type":21},125,[24],"Posttraumatic Stress Disorder (PTSD) is a significant driver of suicide risk among Veterans, but there is a critical knowledge gap about how to treat PTSD among people at elevated risk for suicide. Although evidence-based treatments for PTSD reduce suicide risk, Veterans at high risk for suicidal behavior rarely receive these potentially life-saving treatments. Prior research suggests that a treatment that combines Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure protocol (DBT PE) for PTSD improves both PTSD and suicide-related outcomes. This study will evaluate whether DBT + DBT PE improves these outcomes more than Prolonged Exposure plus suicide risk management, the gold standard VA care for this population. The proposed study will also examine factors that make it easier and harder to implement these treatments in VA settings. The results will help to inform treatment guidelines for this high-priority Veteran population.",[284,118],"Self-directed Violence",[286,287,288],"Stress Disorders, Post-Traumatic","Suicide","Self-Injurious Behavior",{"date":264,"type":38},{"date":291,"type":38},"2024-07-08",{"date":293,"type":21},"2028-08-31",{"name":73,"class":74},{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":302,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":307,"conditions":308,"keywords":311,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":271},"100645471","phase-3-effect-of-psilocybin-and-structured-integrated-reframing-therapy-on-gut-brain-axis-biomarkers-and-depression-in-major-depressive-disorder-100645471","NCT07703722","Effect of Psilocybin and Structured Integrated Reframing Therapy on Gut-Brain Axis Biomarkers and Depression in Major Depressive Disorder","Effect of Psilocybin and Structured Integrated Reframing Therapy on Gut-Brain Axis Biomarkers and Depression in Trauma-Related Major Depressive Disorder: Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged 18-60 years.\n* Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria.\n* Trauma-related depression with clinically significant trauma symptoms.\n* Hamilton Depression Rating Scale (HAM-D) score \\>16.\n* PTSD Checklist for DSM-5 (PCL-5) score \\>33.\n* Generalized Anxiety Disorder-7 (GAD-7) score \\>10.\n* Receiving a stable single SSRI antidepressant regimen for at least 6 weeks before enrollment with adequate treatment adherence.\n* Able and willing to provide written informed consent.\n* Willing to comply with all study procedures and follow-up visits.\n* Women of childbearing potential must agree to use effective contraception throughout the study.\n\nExclusion Criteria:\n\n* Significant cardiovascular disease.\n* Clinically significant hepatic or renal impairment.\n* Significant neurological disorders.\n* Current or past psychotic disorder or bipolar disorder.\n* Current substance or alcohol use disorder, including ketamine or psychedelic drug use.\n* Use of more than one antidepressant medication.\n* Pregnancy, planned pregnancy, or breastfeeding.\n* Known hypersensitivity or contraindication to psilocybin.\n* Participation in another interventional clinical trial within the previous 30 days.\n* Inability or unwillingness to provide informed consent.\n* Any medical or psychiatric condition that, in the investigator's opinion, would interfere with safe participation or study assessments.","60 Years",{"count":304,"type":21},60,[306],"PHASE3","Trauma-related Major Depressive Disorder (MDD) is frequently associated with poor response to conventional antidepressants, persistent psychological distress, and alterations in gut-brain axis function. Existing assessment tools primarily diagnose depression or PTSD but provide limited guidance for integrated clinical management. This study aims to develop and validate the Trauma Anxiety Depression Emotion (TADE) management tool while simultaneously evaluating the effectiveness of psilocybin-assisted Structured Integrated Reframing Therapy (SIRT) in improving clinical and biological outcomes.\n\nThis prospective, four-arm randomized controlled trial will compare conventional therapy, psilocybin therapy, SIRT, and psilocybin-assisted SIRT. Participants will undergo assessment using the newly developed TADE tool together with established psychometric scales including HAM-D, PCL-5, and GAD-7. Biological outcomes will include serum gut-brain axis and inflammatory biomarkers, including Short-Chain Fatty Acids (SCFAs), Interleukin-6 (IL-6), Interleukin-10 (IL-10), Zonulin, Occludin, and Glial Cell Line-Derived Neurotrophic Factor (GDNF). Assessments will be performed at baseline, during treatment, and at 12-week follow-up. The study aims to determine whether combining psilocybin with SIRT provides superior clinical improvement and favorable biological changes compared with either intervention alone while establishing the validity and clinical utility of the TADE management tool.",[309,310],"Major Depressive Disorder","Post-Traumatic Stress Disorder (PTSD)",[195,312,313,314,315],"TADE Tool","Trauma","Biomarkers","Randomized Controlled Trial","2026-07-12",{"date":262,"type":38},{"date":319,"type":38},"2026-04-01",{"date":321,"type":21},"2027-11-22",{"name":323,"class":45},"Khyber Medical University Peshawar",{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":22,"phases":333,"briefSummary":334,"conditions":335,"keywords":337,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":4},"100647183","phase-2-clinical-trial-of-mdma-assisted-therapy-for-military-service-members-with-posttraumatic-stress-disorder-100647183","NCT07704762","Clinical Trial of MDMA-Assisted Therapy for Military Service Members With Posttraumatic Stress Disorder","A Randomized, Double-Blind, Active-Controlled, Clinical Trial of the Safety, Efficacy, and Durability of MDMA-Assisted Therapy for Military Service Members With Posttraumatic Stress Disorder","Inclusion Criteria:\n\n1. Positive endorsement of at least 1 index trauma on the LEC-5.\n2. Have a PCL-5 total score of 38 or greater at screening.\n3. Meet DSM-5-TR criteria for current PTSD per Mini International Neuropsychiatric Interview (MINI) at screening with a symptom duration of 6 months or longer.\n4. Meet criteria for PTSD diagnosis per CAPS-5-R with a score of 26 or greater.\n5. Are at least 18 years old at the time of enrollment.\n6. Weigh greater than 48 kilograms.\n7. Are able to swallow pills.\n8. Are fluent in speaking, reading, and comprehending English.\n9. Must agree to inform the investigators within 48 hours of any new medications, medical conditions, and procedures.\n10. Females of childbearing potential must have a negative pregnancy test at study entry and prior to each Dosing Session and must agree to use adequate birth control for the duration of the study until at least 30 days after the final dosing session. Adequate birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Non-childbearing potential is defined as permanent sterilization, postmenopausal, or assigned male at birth.\n11. Males must agree to use adequate birth control for the duration of the study until at least 30 days after the final dosing session. Adequate birth control methods for males include double barrier contraception (condom with spermicidal gel or foam), surgical sterility (defined as a vasectomy at least 3 months prior to the screening visit), or abstinence.\n12. Must agree to refrain from sperm, egg, blood, and bone marrow donations for at least 30 days after the final dosing session.\n13. Must have a 12-lead electrocardiogram (EKG) with QTc \\\u003C 450 ms and no clinically significant abnormalities, as determined by a cardiologist.\n14. Are able to demonstrate comprehension of consent form and study instructions, and provide informed consent.\n15. Agree to have study visits recorded, including Dosing Sessions, Independent Rater assessments, and non-drug therapy sessions.\n16. Must provide an emergency contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event a participant is imminently unsafe or unreachable.\n17. Agree to the following lifestyle modifications (described in more detail in the Informed Consent Form): comply with requirements for fasting and refraining from certain medications prior to Dosing Sessions; not participate in any other interventional clinical trials during the duration of this study without prior approval of the Independent Safety Monitor; remain overnight at the study site or have an identified support person that can remain with the participant and escort them to the therapy session the day after each dosing; and commit to medication dosing, therapy, and study procedures.\n18. Must be Active Duty, National Guard, or Reserve in the United States military.\n19. Must receive approval from their command to participate in the study.\n20. Must be DEERS eligible.\n\nExclusion Criteria:\n\n1. History of or current primary psychotic disorder to include Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder 1 assessed via MINI or clinical evaluation.\n2. Current Major Depressive Disorder with Psychotic Features assessed via MINI or clinical evaluation.\n3. Current eating disorder with active purging assessed via MINI or clinical evaluation.\n4. Current Borderline Personality Disorder assessed via SCID-5-PD or clinical evaluation.\n5. Any of the following findings on Screening C-SSRS:\n\n   1. Suicidal ideation score of 5 within the last month\n   2. Suicidal ideation score of 4 or greater in the last month at a frequency of once per week or more\n   3. Any suicidal behaviors within the last 3 months. The exception is that non suicidal self-injurious behavior is not exclusionary if approved by the PI.\n6. Current high suicide risk or is likely to require psychiatric hospitalization, as determined through C-SSRS, clinical interview, or clinical judgment of the investigator. Distant history of suicide attempts without current high suicide risk factors is not exclusionary.\n7. Current severe substance use disorder (6 or more criteria per MINI) not in sustained remission (criteria not met for past 12 months) at time of enrollment. I.e., severe substance use disorders may only be included if in sustained remission. Tobacco\u002Fnicotine use disorders may be included regardless of severity.\n8. Current moderate substance use disorder (4-5 criteria per MINI) not in early remission (criteria not met for past 3-12 months) or sustained remission (criteria not met for past 12 months) at time of enrollment. I.e., moderate substance use disorders may only be included if in early or sustained remission (criteria not met for 3 or more months). Tobacco\u002Fnicotine use disorders may be included.\n9. For any illicit or prescribed substance: current substance use disorder of any severity, not in sustained remission (criteria not met for past 12 months). I.e., substance use disorders of any severity with illicit or prescribed substances may only be included if in sustained remission.\n10. Any urine drug testing during screening or enrollment that is confirmed positive for a non-prescribed substance, and the result cannot be better explained as a false positive due to another concomitant prescribed medication or proven dietary practice.\n11. Have current or history of psychiatric diagnoses or symptoms that may negatively affect study participation.\n12. Clinically significant abnormalities on screening 12-lead EKG or 1 minute 12-lead rhythm strip that precludes administration of MDMA, stimulants, or sympathomimetics, as determined by a cardiologist.\n13. Two or more premature ventricular contractions (PVCs) on 1-minute rhythm strip. 1 minute 12-lead rhythm strip will be obtained when there are one or more PVCs on screening EKG or when indicated by a cardiologist.\n14. Resting QTc ≥ 450 ms.\n15. History of drug-induced QTc prolongation.\n16. Inability to hold or discontinue concomitant medications that significantly prolong the QTc interval.\n17. Clinically significant cardiac or cardiovascular abnormalities, including history of myocardial infarction, unexplained exertional syncope, Torsade de Pointes, congenital long QT syndrome, hypertrophic cardiomyopathy, congestive heart failure, family history of Long QT Syndrome, persistent atrial fibrillation, symptomatic valvular heart disease, asymptomatic severe aortic stenosis, asymptomatic severe mitral stenosis, history of diagnosis of aortic dissection or asymptomatic aortic aneurysm \\> 4.5 cm at the sinus of Valsalva, or history of untreated angina pectoris or unrevascularized coronary stenosis \\> 70%.\n18. Current clinically significant electrolyte abnormalities, to include hyponatremia and hypokalemia.\n19. Has clinically significant abnormal laboratory results during screening that indicate impaired liver function, to include ALT or AST \\>2x ULN or Total bilirubin \\>1.5 mg\u002FdL unless history of Gilbert's Syndrome\n20. Renal disease defined as eGFR \\\u003C45 mL\u002Fmin\u002F1.73m² or creatinine \\>2.0 mg\u002FdL, end-stage kidney disease, dialysis, history of renal transplant, clinically significant or progressive renal disease deemed to increase risk, or recent\u002Funstable renal function consistent with acute kidney injury at screening. Participants with eGFR 45-59 mL\u002Fmin\u002F1.73m² may be eligible only if renal function is stable and cleared by the study physician.\n21. Uncontrolled essential hypertension defined as blood pressures of greater than 140\u002F90 mmHg assessed on three separate occasions. May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if additional screening is passed to rule out underlying cardiovascular disease.\n22. Uncontrolled hypothyroidism. May have hypothyroidism if taking adequate and stable thyroid replacement medication.\n23. Type 2 Diabetes Mellitus with comorbid cardiovascular disease. May have a history of or current Type 2 Diabetes Mellitus if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval by the Independent Safety Monitor.\n24. Glaucoma without approval from an ophthalmologist. May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist.\n25. History of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to, a history of cerebrovascular disorders (cerebrovascular accident, aneurysm, arteriovenous malformations, or carotid stenosis). Participants with other mild, stable chronic medical conditions may be enrolled if the study physician and Independent Safety Monitor agree the condition is unlikely to confer a significant additional health risk with administration of MDMA. This includes conditions such as gastroesophageal reflux disease and chronic low back pain.\n26. Current medical diagnoses or physical health symptoms that may negatively affect study participation.\n27. Report any prescribed or non-prescribed lifetime personal use history of MDMA, 3,4 methylenedioxymethamphetamine, midomafetamine, \"Ecstasy,\" \"Molly,\" \"Mandy,\" or \"Adam.\"\n28. Lack adequate social support, in the judgement of the PI.\n29. Unable to safely taper off prohibited concomitant medications.\n30. Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control.\n31. Have any current or anticipated problem which, in the opinion of the PI or Independent Safety Monitor, may interfere with study participation.",{"count":332,"type":21},86,[139],"This study is a Phase 2, randomized, double-blind, active-controlled, two-arm, single-site clinical trial designed to evaluate the safety, tolerability, and feasibility of MDMA-Assisted Therapy (MDMA-AT) for Service Members (Active Duty, Guard, or Reserve) diagnosed with moderate-to-severe Post-Traumatic Stress Disorder (PTSD) within a Military Health System (MHS) setting.\n\nThe trial incorporates Acceptance and Commitment Therapy (ACT) as a core therapeutic modality. Participants will receive MDMA-AT utilizing either full-dose or active-control low-dose MDMA. The trial will also assess a regional referral center model by recruiting participants locally from the National Capital Region and non-locally across the MHS.",[92,27,336],"Post Traumatic Stress Disorder",[310,338,339,313,340,341,342,343,344,345,346,347,196],"Acceptance and Commitment Therapy (ACT)","Service Members","Psychotherapy Modality","Psychiatric Disorders","3,4-Methylenedioxymethamphetamine","MDMA","Active Duty","MDMA-Assisted Therapy","Phase II","Active Controlled","2026-07-09",{"date":350,"type":38},"2026-07-15",{"date":352,"type":21},"2026-10-01",{"date":354,"type":21},"2028-10-01",{"name":356,"class":74},"U.S. Army Medical Research and Development Command",{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":17,"minAge":364,"maxAge":365,"enrollmentInfo":366,"targetDuration":4,"studyType":22,"phases":368,"briefSummary":369,"conditions":370,"keywords":371,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":104},"100623791","tms-for-ptsd-in-youth-100623791","NCT07401225","TMS for PTSD in Youth","Transcranial Magnetic Stimulation as Treatment for Persistent PTSD in Texas Youth","Inclusion Criteria:\n\n1. Males and females; Age 12-20\n2. Have previously completed at least 9 sessions of trauma-focused therapy in our clinical trial or in the community\n3. Have current self-reported symptom score of 20 or greater on the UCLA PTSD Reaction index\n4. Willing to attend 10 TMS treatment sessions within a 30-day period\n5. Fluent in English\n\nExclusion Criteria:\n\n1. History of seizures\n2. History of head injury with loss of consciousness and concussive sequelae\n3. Brain abnormality such as tumor or other observable abnormality\n4. Currently receiving psychotherapy or TMS treatment\n5. Currently pregnant\n6. MRI contraindications (metal in body, orthodontic braces)\n7. Diagnosis of bipolar 1 or a psychotic disorder","12 Years","20 Years",{"count":367,"type":21},20,[24],"The purpose of this study is to test whether transcranial magnetic stimulation, or TMS, is an acceptable and helpful treatment for ongoing symptoms of posttraumatic stress syndrome disorder (PTSD) in 12-20 year olds. Ongoing PTSD refers to symptoms that continue after completing trauma-focused psychotherapy. About 1 in 4 patients need additional help to overcome PTSD after completing psychotherapy. Currently, scientists do not know the best way to help adolescents with persistent PTSD, and this study will test TMS as a possible treatment, and hopefully lead to future studies including more people.",[58],[372,373],"Transcranial Magnetic Stimulation","Transcranial Magnetic Stimulation (TMS)",{"date":375,"type":38},"2026-07-13",{"date":377,"type":38},"2026-05-09",{"date":379,"type":21},"2027-08-31",{"name":44,"class":45},{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":22,"phases":390,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":104},"100645324","accelerated-itbs-for-ptsd-and-depression-100645324","NCT07682207","Accelerated iTBS for PTSD and Depression","Accelerated Intermittent Theta Burst Stimulation for Depression in Post-Traumatic Stress Disorder: A Single-Arm, Open-Label Feasibility Study","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Current post-traumatic stress disorder (PTSD) and current major depressive disorder (MDD), confirmed by a structured diagnostic interview (e.g., MINI 6.0 using the PTSD and MDD modules).\n* Minimum symptom severity at baseline: HAMD-17 score ≥14 (moderate depression) and\u002For PCL-5 score ≥33 (probable PTSD).\n* On a stable pharmacologic and\u002For psychotherapeutic regimen for at least 4 weeks prior to baseline, and willing to maintain stability during the treatment phase, unless medically necessary.\n* Capacity to provide informed consent and comply with study procedures and visits at St. Joseph's Health Care, London\u002FParkwood Institute.\n* Sufficient English proficiency to complete consent and study assessments.\n\nExclusion Criteria:\n\n* Neurologic or device-related risks, including seizure history, traumatic brain injury with loss of consciousness greater than 5 minutes, major neurologic illness, or metal\u002Felectronic implants contraindicated for transcranial magnetic stimulation.\n* Psychiatric or substance-related risks, including current psychotic disorder, acute mania, diagnosis of Bipolar I or Bipolar II disorder, recent substance use disorder, or imminent suicide risk.\n* Medical or medication-related risks, including unstable severe illness, high-risk medications, hearing impairment, unwillingness to use ear protection, or prior non-response to an adequate course of theta burst stimulation for the current depression\u002FPTSD episode.\n* Enrollment in another interventional trial.\n* Inability to comply with the study schedule.",{"count":389,"type":21},16,[24],"The goal of this pilot clinical trial is to learn if a faster brain stimulation schedule is practical, safe, tolerable, and acceptable. This study looks at accelerated intermittent theta burst stimulation, or accelerated iTBS. This is a non-invasive type of magnetic brain stimulation. This study is for adults with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD).\n\nThe main questions this study aims to answer are:\n\n1. Can participants complete six short brain stimulation sessions per day for five days?\n2. Is this treatment schedule safe and tolerable for participants?\n3. What changes occur in depression symptoms, PTSD symptoms, anxiety, quality of life, and brain activity over time?\n\nParticipants will:\n\n1. Complete health screening and baseline assessments.\n2. Receive six short sessions of magnetic brain stimulation per day for five days.\n3. Have their brain activity measured using an EEG recording.\n4. Return for a post-treatment assessment at Week 2 and follow-up visits at Week 5 and Week 12.",[27,393],"Major Depressive Disorder (MDD)",[92,395,59,396,397,398,399,400,93,401,402],"MDD","Feasibility study","Accelerated intermittent theta burst stimulation","iTBS","Theta burst stimulation","Transcranial magnetic stimulation","Brain stimulation","EEG","2026-06-26",{"date":405,"type":38},"2026-07-02",{"date":407,"type":21},"2026-07",{"date":409,"type":21},"2027-09",{"name":411,"class":45},"Lawson Research Institute of St. Joseph's",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":419,"targetDuration":4,"studyType":167,"phases":4,"briefSummary":420,"conditions":421,"keywords":422,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":433,"locationsCount":46},"100643969","the-effects-of-stellate-ganglion-block-sleep-in-us-active-duty-service-members-and-veterans-receiving-prolonged-exposure-therapy-for-ptsd-100643969","NCT07667309","The Effects of Stellate Ganglion Block Sleep in U.S. Active Duty Service Members and Veterans Receiving Prolonged Exposure Therapy for PTSD","The Effects of Stellate Ganglion Block on Sleep in U.S. Active Duty Service Members and Veterans Receiving Prolonged Exposure Therapy for Posttraumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n1. Ability to provide informed consent and follow study-related instructions.\n2. Be randomized into the study titled \"Combining Stellate Ganglion Block with Prolonged Exposure for PTSD: A Randomized Clinical Trial.\" NCT05889741\n3. Indicates willingness to wear the Sleep Profiler sleep monitor and to complete self-report assessments.\n\nExclusion Criteria:\n\n1\\. Pre-existing skin or soft tissue condition that precludes the ability to wear the Sleep Profiler headband.",{"count":85,"type":21},"Participants in this study will have already been enrolled in another research study: Combining Stellate Ganglion Block with Prolonged Exposure for PTSD, NCT05889741. The investigators are using a Sleep Profiler, EEG headband to monitor a participants brainwaves while they sleep to see what effects the Stellate Ganglion Block injection has on their sleep. Participants will wear the headband for 3 nights before the injection and then 3 nights after the injection. Participants will also complete self-report questionnaires regarding their sleep prior to the injection and following the injection. Approximately 40 participants will be included in this study. This study is a nested observational study whereby participants in the parent study who elect to participate will have their sleep assessed using the EEG headband device and self-reported sleep measures performed.",[27],[423,424,92,425,426],"Stellate Ganglion Block","Sleep Profiler","Sleep","Sleep architecture","2026-06-18",{"date":429,"type":38},"2026-06-25",{"date":431,"type":21},"2026-06-15",{"date":175,"type":21},{"name":44,"class":45},{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":17,"minAge":186,"maxAge":83,"enrollmentInfo":442,"targetDuration":4,"studyType":22,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":46},"100568272","phase-2-suvorexant-for-treatment-of-aud-and-ptsd-100568272","NCT06679062","Suvorexant for Treatment of AUD and PTSD","A Double-masked, Randomized, Phase II Study to Compare the Effectiveness of 20mg Oral Suvorexant (SUV) Versus Placebo (1:1) in Participants With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)","SUV","Inclusion Criteria:\n\n* Age between 21 and 65.\n* Meet current (i.e., past 12-month at Day -7\u002F-6) DSM-5 diagnostic criteria for moderate or severe AUD as determined by the MINI.\n* Currently experiencing PTSD symptoms at screening (Day -7\u002F-6) as indicated by PCL-5 cut-score \\> 30.\n* Intrinsic motivation to reduce or quit drinking (defined as self-reported intention at screening to reduce or quit drinking within the next 6 months) and to receive PTSD treatment.\n* Must have an ISI score equal to or \\> 7 (subthreshold insomnia). ISI score below 7 at screening will not be included or proceed beyond the screening day.\n* Agree to abstain from all other sleep medications (starting at Day -7).\n* Have a place to live in the 2 weeks prior to randomization (Day 0) and not be at risk that s\u002Fhe will lose his\u002Fher housing in the next month.\n\nExclusion Criteria:\n\n* A current (past 12-month at Day -7\u002F-6) DSM-5 diagnosis via the MINI of substance use disorder for any substances other than alcohol, nicotine, or marijuana (\\\u003C moderate level on DSM 5).\n* A lifetime DSM-5 diagnosis via the MINI of schizophrenia, bipolar disorder, or psychotic disorder.\n* Positive urine test for any recreational drugs other than marijuana at screening (Day -7\u002F-6).\n* Current clinically significant alcohol withdrawal (i.e., score ≥ 10 on the CIWA-Ar).\n* Currently pregnant, nursing, or no reliable method of birth control (females only).\n* Any clinically significant medical condition that would preclude safe participation in the study (e.g. narcolepsy, seizure disorder, or other clinically significant cardiovascular, hematologic, hepatic, renal, neurological, or endocrine disorders).\n* Use of suvorexant (within 30 days of Day -7).\n* Currently on prescription medication that contraindicates use of suvorexant (including moderate or strong Cytochrome P450 3A modulators (CYP3A inhibitors and inducers))\n* Hepatic insufficiency (AST\u002FALT \\> 5x upper limit of normal (ULN)).\n* Suicidal Ideation determined by greater than moderate Columbia Suicide Severity Rating Scale.\n* Inability to provide evidence of 48-hour alcohol abstinence (self-report, BrAC, EtG) at Day 0 AND failure after second attempt at 48-hour abstinence.",{"count":443,"type":21},76,[139],"This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.",[447,58,448],"Alcohol Use Disorder (AUD)","Insomnia",{"date":450,"type":38},"2026-06-23",{"date":452,"type":38},"2025-07-16",{"date":454,"type":21},"2027-03",{"name":456,"class":45},"Pharmacotherapies for Alcohol and Substance Use Disorders Alliance",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":464,"sex":17,"minAge":18,"maxAge":465,"enrollmentInfo":466,"targetDuration":4,"studyType":167,"phases":4,"briefSummary":468,"conditions":469,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":104},"100630526","imaging-phosphodiesterase-4b-pde4b-in-people-with-psychiatric-disorders-with-positron-emission-tomography-pet-and-the-radiotracer-18fpf974-100630526","NCT07488819","Imaging Phosphodiesterase 4B (PDE4B) in People With Psychiatric Disorders With Positron Emission Tomography (PET) and the Radiotracer [18F]PF974","Imaging PDE4B in People With Psychiatric Disorders With PET and the Radiotracer [18F]PF974","Inclusion Criteria:\n\n1. Willing and able to give voluntary written informed consent.\n2. Is able to read and write, able to communicate effectively with the investigator, and comply with all study requirements, restrictions, and directions of the research staff.\n3. Men or women, aged 18 to 70, at screening.\n4. In good general health as evidenced by medical history, physical examination, electrocardiogram, serum\u002Furine biochemistry, hematology, and serology tests.\n5. Participants with AUD will have a current diagnosis of AUD according to DSM-5 criteria (i.e., Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) (SCID-5) ascertained diagnosis, confirmed by the Principal Investigators).\n6. Participants with AUD will meet the following drinking criteria: males will drink \\> 14 drinks per week and exceed 4 drinks per day at least twice per week; females will drink \\> 7 drinks per week and exceed 3 drinks per day at least twice per week. They must meet drinking criteria during a consecutive 30-day period within the 90 days prior to intake.\n7. Participants with PTSD will have a current diagnosis of PTSD according to DSM-5 criteria (CAPS-5 ascertained diagnosis, confirmed by the Principal Investigators. TC subjects must have a DSM-5 criteria traumatic event with no PTSD diagnosis.\n8. Healthy control subjects will have no current or past diagnosis of AUD or other significant substance use disorder. They will drink less than 5 alcoholic drinks per week with no heavy drinking days (i.e., \\>4 drinks\u002Fday for men; \\>3 drinks\u002Fday for women) in the last 30 days. Subjects who have have a DSM-5 criteria traumatic event with no PTSD diagnosis may also be considered healthy controls for Aim 1.\n9. Renal function and hepatic function will be within normal limits (for age and sex) on the laboratory tests. Elevated liver enzymes for individuals with alcohol use disorder are permitted at the discretion of the study physician.\n\nExclusion Criteria:\n\n1. Current significant medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology that would impact the integrity of the data (note that elevated liver enzymes for individuals with AUD will not be exclusionary).\n2. Past or current neurological disorder or disorders affecting the brain including but not limited to multiple sclerosis, history of stroke, brain tumors, traumatic brain injury with loss of consciousness, seizure disorder.\n3. Current significant psychiatric disorder including severe substance use disorder (other than alcohol or tobacco use disorders\\*) and past or current psychotic symptoms.\n4. Regular use in the past 6 months of any prescription, psychoactive or herbal medications (e.g., antidepressants, antipsychotics, anxiolytics) that would impact the integrity of the data; No subject will be asked to stop taking medication to participate in the study. Participants who are regularly taking P-gp and BCRP inhibitors will be excluded.\n5. Pregnancy or lactation.\n6. Blood donation within eight weeks of the start of the study.\n7. History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).\n8. Unable to safely discontinue or hold aspirin and other NSAID use.\n9. MRI incompatible implants (i.e., such as pacemaker, artificial joints, non-removable body piercings) and other contraindications for MRI, such as claustrophobia, having implanted or embedded metal objects\u002Ffragments or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist).\n10. Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits for healthy volunteers.\n11. Subject who has current, past, or anticipated exposure to radiation in the work place within one year of the proposed research scans that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.\n12. Has any condition that, in the opinion of the investigator, would prevent compliance with the study protocol.\n13. History of complicated alcohol withdrawal including history of delirium tremens; seizure, hospitalization for withdrawal.\n14. A CIWA score ≥8 at intake or on scan day.\n15. Subjects who are, in the opinion of the study physician, unable to safely abstain from alcohol overnight prior to their study visits.\n16. Subjects with a significant history of repeated alcohol withdrawal, defined as 4 or more medicated detoxifications in the previous 5 years",true,"70 Years",{"count":467,"type":21},160,"Imaging PDE4B in people with psychiatric disorders with PET and the radiotracer \\[18F\\]PF974",[193,447],"2026-06-10",{"date":472,"type":38},"2026-06-11",{"date":474,"type":38},"2025-07-07",{"date":476,"type":21},"2032-03-01",{"name":270,"class":45},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":486,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":488,"conditions":489,"keywords":491,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":104},"100510705","open-trial-of-trauma-focused-psychodynamic-psychotherapy-for-people-living-with-hiv-and-ptsd-100510705","NCT05929911","Open Trial of Trauma-focused Psychodynamic Psychotherapy for People Living With HIV and PTSD","Pilot Feasibility Proposal to Adapt Trauma-focused Psychodynamic Psychotherapy (TFPP) for PLWH and PTSD","TFPP-PLWH","Inclusion Criteria:\n\n* Diagnosis of DSM-5 defined PTSD, per the Clinician Administered PTSD Scale \\& CAPS-5 total severity score greater than or equal to 25\n* HIV diagnosis (by medical records or HIV testing)\n* Stable psychiatric\u002Fpsychotropic medication for \\>=2 months and ongoing during treatment\n\nExclusion Criteria:\n\n* Psychosis\n* Bipolar I\n* Acute suicidality\n* Current substance use disorder\n* Organic mental syndrome or intellectual disability\n* Unstable non-HIV medical conditions",{"count":367,"type":21},[24],"People living with HIV (PLWH) have a higher rate of post-traumatic stress disorder (PTSD) diagnosis than the general population. Comorbid PTSD is also associated with negative HIV-related health outcomes. Unfortunately, little outcome research has examined the usefulness of PTSD treatments for PTSD. This pilot study adapts for PLWH a non-exposure based psychotherapy for PTSD focused on reflecting on one's emotions and relationships and understanding and working through how trauma may have disrupted them. The study team is interested in better understanding the needs of PLWH with PTSD, learning whether PLWH with PTSD find this treatment acceptable and helpful, and beginning to understand the relationship between HIV-related health factors (e.g., inflammation and stress biology) and PTSD, and how these health factors may improve during treatment.",[58,490],"HIV",[490,492,493],"psychotherapy","trauma",{"date":495,"type":38},"2026-06-12",{"date":497,"type":38},"2024-04-26",{"date":499,"type":21},"2027-06",{"name":501,"class":45},"Montefiore Medical Center",{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":508,"targetDuration":4,"studyType":22,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":516,"leadSponsor":517,"locationsCount":104},"100643368","the-efficacy-and-safety-of-temporal-interference-stimulation-in-the-treatment-of-post-traumatic-stress-disorder-100643368","NCT07644338","The Efficacy and Safety of Temporal Interference Stimulation in the Treatment of Post-Traumatic Stress Disorder","Inclusion Criteria:\n\n1. Age 18-50 years, male or female\n2. Diagnosis of PTSD per DSM-5 (assessed by CAPS-5), with symptom duration of at least 3 months, and PTSD as the current primary diagnosis; comorbid depressive disorder or anxiety disorder is allowed\n3. If currently receiving psychiatric medication, the dosage must be stable for at least 4 weeks prior to enrollment\n4. At least 9 years of education (junior high school or above)\n\nExclusion Criteria:\n\n1. Any DSM-5 diagnosis other than PTSD, depressive disorder, or anxiety disorder\n2. PTSD symptoms too severe to complete required assessments\n3. Received electroconvulsive therapy (ECT) within the past 6 months\n4. Received any other form of neuromodulation within the past 2 months (see Item 3 for ECT)\n5. Severe medical illness or any condition that may induce seizures or intracranial hypertension (e.g., cardiovascular or respiratory diseases)\n6. History of neurological disorders (e.g., epilepsy, cerebrovascular accident) or brain injury\u002Fsurgery\n7. Presence of intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, or any other MRI-incompatible implants\n8. Current significant suicidal behavior risk per investigator judgment\n9. Pregnancy or planning to become pregnant during the study period\n10. Initiation of structured psychotherapy for PTSD within 3 months prior to screening, with expected change during the 10-week treatment period",{"count":509,"type":21},5,[24],"This study aims to evaluate the efficacy and safety of Temporal Interference (TI) stimulation in treating patients with post-traumatic stress disorder (PTSD) and to explore its potential neural mechanisms using magnetic resonance imaging (MRI) ,magnetoencephalography（MEG）,electroencephalography (EEG).",[118],"2026-06-08",{"date":495,"type":38},{"date":513,"type":38},{"date":499,"type":21},{"name":518,"class":45},"Shanghai Mental Health Center",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":526,"enrollmentInfo":527,"targetDuration":4,"studyType":22,"phases":529,"briefSummary":530,"conditions":531,"keywords":532,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":104},"100616722","psychosocial-factors-and-efficacy-of-remote-cognitive-remediation-for-post-traumatic-stress-disorder-100616722","NCT07309302","Psychosocial Factors and Efficacy of Remote Cognitive Remediation for Post-Traumatic Stress Disorder","Psychosocial Determinants and Impact of a Synchronous Remote Cognitive Remediation Program on Individuals With Post-Traumatic Stress Disorder.","Inclusion Criteria\n\n* Age 18 to 45 years\n* Able to speak and read French fluently\n* Access to a computer with a camera and a secure Internet connection\n* Access to a private space for assessment and intervention sessions\n* Available for the complete treatment protocol\n* Confirmed current PTSD diagnosis using the Structured Clinical Interview for DSM-5 (SCID-5)\n* Residing in Canada\n\nExclusion Criteria\n\n* History of neurological disorders (stroke, intracranial surgery, aneurysm, epilepsy)\n* Moderate to severe traumatic brain injury OR hospitalization due to traumatic brain injury\n* Mild traumatic brain injury less than 6 months ago with persistent symptoms\n* Psychotic disorders\n* Alcohol abuse or substance dependence disorders\n* Video game addiction\n* Hospitalization for major depression or suicide risk within the past 3 months\n* Regular use of medications that impact neurocognition, including: benzodiazepines (diazepam, lorazepam, alprazolam, Ativan, Xanax, Rivotril)\n* Residence outside Canada","45 Years",{"count":528,"type":21},64,[24],"The goal of this clinical trial is to evaluate whether computer-based brain training can help adults with post-traumatic stress disorder (PTSD). Individuals with PTSD often experience difficulties with memory, attention, concentration, and problem-solving, which can significantly affect their daily lives, work performance, and overall quality of life. These cognitive challenges can hinder trauma recovery and reduce the effectiveness of standard PTSD treatments.\n\nThe main questions this study seeks to address are:\n\nDoes specialized brain training improve PTSD symptoms compared to regular computer games? Does brain training enhance cognitive functions such as memory, attention, processing speed, and executive functioning? Does brain training improve quality of life and daily functioning? Do participants' self-efficacy and perceived social support influence treatment outcomes?\n\nResearchers will compare two approaches: a specialized cognitive training program (HAPPYneuron Pro) with strategy teachings and quality-of-life discussions, versus engaging computer games with quality-of-life discussions, to determine which is more effective for people with PTSD.\n\nStudy Design\n\nParticipants will be randomly assigned to one of two groups for an 8-week program:\n\nCognitive remediation training group: Complete computerized cognitive exercises and strategy teachings specifically designed to strengthen memory, attention, and executive functions, combined with quality-of-life discussions.\n\nControl group: Complete engaging computer games combined with quality-of-life discussions.\n\nSchedule\n\nBoth groups will follow the same schedule:\n\nOne online session per week, in small and consistent groups of 4-8 participants. Each 60-minute session consists of 30 minutes of computer activities followed by 45 minutes of group discussion.\n\nOne at-home individual homework exercise per week (30 minutes at home).\n\nTotal time commitment: 1h45 per week for 8 weeks.\n\nAssessments All participants will complete three comprehensive assessment sessions: before treatment, immediately after the 8-week program, and 3 months later. Assessments include neuropsychological testing and questionnaires on PTSD symptoms, depression, anxiety, quality of life, satisfaction with life, social support, cognitive failures, and self-efficacy.\n\nSignificance This research evaluates a new, accessible and remotely deliverable approach for PTSD treatment. Current evidence-based treatments often do not directly target the cognitive impairments experienced by many individuals with PTSD.\n\nCompensation Participants will receive $35 for each completed assessment (maximum $105). Control group participants will gain access to the cognitive remediation training program after completing their participation.",[27],[533,534,535,536,537,59,60,538,539,540,541,542,543],"Cognitive remediation","Social Support","Quality of Life","Online Intervention","Self-Efficacy","Attention","Verbal Memory","Executive Functions","Life Satisfaction","Post-Traumatic Stress Disorder","Neuropsychological functions","2026-05-13",{"date":546,"type":38},"2026-05-18",{"date":548,"type":38},"2025-08-03",{"date":550,"type":21},"2026-12",{"name":552,"class":45},"Université du Québec a Montréal",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":560,"targetDuration":4,"studyType":22,"phases":561,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":46},"100584181","phase-2-psilocybin-assisted-therapy-for-post-traumatic-stress-disorder-in-survivors-of-intimate-partner-violence-100584181","NCT06885996","Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence","PsiPTSD","Inclusion Criteria:\n\n* Individuals of all sexes, gender identities, and ethnicities\n* Ages 19 to 65 years at the time of screening\n* At least 6 months since last IPV incident\n* A score of 1 on the Composite Abuse Scale with repetition of abusive events\n* Minimum PCL-5 score of ≥ 33\n* Limited lifetime use of serotonergic hallucinogens\n* Ability to read\u002Fwrite English\n\nExclusion Criteria:\n\n* Severe or moderate substance use disorder other than nicotine in past 6 months\n* Lifetime diagnosis of schizophrenia or bipolar disorders (or first or second-degree relative)\n* Active suicidal ideation or serious attempt within the past 1 year.\n* Current pregnancy or nursing, trying to become pregnant\n* Any notable abnormality on ECG or routine medical blood laboratory test\n* Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia\n* Epilepsy with a history of seizures\n* Current or recent (within 12 weeks) participation in a clinical trial\n* Cognitive impairment (SLUMS score \\\u003C20)\n* Suffered a moderate\u002Fsevere TBI at least once in lifetime\n* Suffered a mild TBI within the last 6 months\n* Any other circumstances that, in the opinion of the investigators, compromises participant safety\n* Not compelled to enter treatment to avoid legal consequences",{"count":443,"type":21},[139],"The goal of this randomized controlled trial is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in adult (aged 18-65) survivors of intimate partner violence (IPV).\n\nThis trail will test the following 2 aims:\n\nAIM 1 : To compare the efficacy of a therapeutic psilocybin dose at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose in IPV survivors with chronic PTSD.\n\nAIM 2: To evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility.\n\nParticipants will be asked to:\n\n* Complete a 2 part screening process\n* Attend a baseline assessment\n* Complete a psychoeducation preparation session(s)\n* Attend psilocybin administration session (receive high dose \\[25mg\\] or low dose psilocybin \\[1mg\\])\n* Complete 5-6 weekly sessions of ACT\n* Repeat outcome measures at 1-week, 4 weeks, 3 months (online questionnaires only), and 6 months post-psilocybin administration.",[27,257],[201,195,198],"2026-05-11",{"date":567,"type":38},"2026-05-14",{"date":569,"type":21},"2026-08-01",{"date":571,"type":21},"2029-08-01",{"name":573,"class":45},"University of Calgary",{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":22,"phases":584,"briefSummary":585,"conditions":586,"keywords":587,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":104},"100531058","phase-2-examining-intranasal-oxytocin-augmentation-of-brief-couples-therapy-for-veterans-with-ptsd-100531058","NCT06194851","Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD","A Randomized Clinical Trial Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD","CBCT-OT RCT","Inclusion Criteria:\n\nInclusion criteria for Veteran:\n\n1. Be a Veteran (age 18 or older) with a current DSM-5 diagnosis of PTSD (as assessed by the CAPS-5 with a minimum severity score of 25) no less than 3 months after the index trauma occurred (to allow for potential natural recovery)\n2. Be on a stable psychoactive medication regimen for at least 4 weeks (if applicable)\n3. Be enrolled and eligible to receive care at the VASDHS\n\n   Inclusion criteria for Partner:\n4. Be an intimate partner (age 18 or older) who is willing to participate in the intervention (partners can also be Veterans but cannot meet criteria for possible PTSD per the PCL-5)\n\n   Inclusion criteria for Veteran and Partner:\n5. Be married, or cohabitating for at least 6 months\n6. Willing to be randomized into either treatment condition (bCBCT + OT or bCBCT + PL)\n7. Agree to have assessment and treatment sessions audio\u002Fvideo recorded\n8. Agree not to receive other individual trauma-focused psychotherapy for PTSD or any form of conjoint therapy during the treatment portion of the study\n9. Have the capacity to participate in virtual care (access to internet via DSL or a cable provider, private space)\n\n   Exclusion Criteria:\n\n   Exclusion criteria for Veteran and Partner:\n10. Current substance dependence in either member of the couple not in remission for at least 3 months, as assessed by the Alcohol Use Disorders Identification Test (AUDIT)74 and Drug Abuse Screening Test (DAST)75\n11. Any current uncontrolled psychotic disorder in either member of the couple as assessed by positive screen on the Prime Screen-Revised (PS-R). Exclusion to be determined following case consult by PI or other clinician.\n12. Imminent suicidality or homicidality in either member of the couple (e.g., C-SSRS)\n13. Any severe cognitive or medical impairment in either member of the couple making it difficult to regularly attend weekly couples psychotherapy\n14. Any perpetration of severe physical or sexual relationship aggression (as assessed by the CTS-2) or fear\u002Fintimidation (3-item IPV screen, Couples Questionnaire) in the past year\n\n    Exclusion criteria for Veteran:\n15. Severe ongoing medical problems, including heart disease, uncontrolled hypotension (systolic blood pressure \\\u003C100 mm Hg) or hypertension (systolic BP \\>130 or diastolic BP \\> 80 mm Hg), and neuroendocrinological disorders (e.g., diabetes). Exclusion to be determined in collaboration with study physician following completion of physician's one-on-one appointment with Veteran and review of all relevant information (e.g., risk factors, health history, concomitant medications, etc.) from Veteran's VA medical record and study screening\u002Fassessment processes including selfreport measures and blood pressure measurement. Additionally, Veterans for whom the study physician has elevated concern, will be asked to attend an in-person visit at a VA medical center, clinic, or the Veterans Medical Research Foundation before enrollment.\n16. Positive screen (7+) for borderline personality disorder (BPD) as assessed by the MacLean Screening Instrument for BPD76. Exclusion to be determined following case consult by PI or other clinician.\n17. Pregnancy, delivery in the past 6 months, current breastfeeding, or the ability to become pregnant while not practicing an effective method of contraception. If able to become pregnant, Veteran must have a highly sensitive negative urine pregnancy test verified visually via telehealth or in-person at the Veterans Medical Research Foundation by research staff at study entry and prior to each medication administration during treatment. Veteran must verbally confirm that they completed the test themselves that day. Veteran must also agree to use an effective birth control method from study entry until conclusion of treatment to prevent pregnancy. The ability to become pregnant is defined as: assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.\n\n    Effective birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, oral hormones, a barrier contraception method (e.g., male or female condoms, diaphragm, cap), or vasectomized sole sexual partner.\n\n    Pregnancy tests will be purchased by the study and mailed to Veteran unless PI has approved waiver of testing requirement.\n18. Known allergy to preservatives (i.e., Methylparaben, Propylparaben, Glycerin, Sodium Benzoate, Potassium Sorbate, and Disodium EDTA) utilized in oxytocin nasal spray.",{"count":583,"type":21},240,[139],"Leveraging veterans' intimate relationships during treatment for posttraumatic stress disorder (PTSD) has the potential to concurrently improve PTSD symptoms and relationship quality. Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) is a manualized treatment designed to simultaneously improve PTSD and relationship functioning for couples in which one partner has PTSD. Although efficacious in improving PTSD, the effects of CBCT on relationship satisfaction are small, especially among Veterans. Pharmacological augmentation of bCBCT with intranasal oxytocin, a neurohormone that influences mechanisms of trauma recovery and social behavior, may help improve the efficacy of bCBCT. The purpose of this randomized placebo-controlled trial is to compare the clinical and functional outcomes of bCBCT augmented with intranasal oxytocin (bCBCT + OT) versus bCBCT plus placebo (bCBCT + PL). The investigators will also explore potential mechanisms of action: communication, empathy, and trust.",[310],[58,588,589,590,591],"Oxytocin","Relational Problems","Brief Cognitive Behavioral Conjoint Therapy","Veterans","2026-04-27",{"date":594,"type":38},"2026-05-04",{"date":596,"type":38},"2024-10-28",{"date":598,"type":21},"2028-09-30",{"name":73,"class":74},{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":22,"phases":609,"briefSummary":610,"conditions":611,"keywords":612,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":46},"100626055","nurse-led-ptsd-treatment-in-primary-care-100626055","NCT07430657","Nurse-Led PTSD Treatment in Primary Care","A Hybrid Implementation-Effectiveness Trial of Nurse-Delivered Post-Traumatic Stress Disorder Treatment in Primary Care","Inclusion Criteria:\n\n* o PTSD + trauma exposure (PCL-5 score ≥28, plus trauma endorsed on LEC-5\u002FCAPS)\n\n  * Life-threatening CV event in the last 90 days (including myocardial infarction\u002Fheart attack, acute cerebrovascular accident\u002Fstroke, sudden cardiac arrest, acute decompensated heart failure, or life-threatening arrhythmia requiring cardioversion or defibrillation).\n  * Primary care patient at Rush University Medical Center\n\nExclusion Criteria:\n\n* o Safety risk (documented suicidal ideation\u002Fneed for acute psychiatric care)\n\n  * NET conflict (actively receiving psychotherapy\u002FPTSD treatment)\n  * Cognitive\u002Fdecisional non-capacity (University of California, San Diego Brief Assessment of Capacity to Consent \\[UBACC\\] ≤ 14.5)",{"count":608,"type":21},100,[24],"Purpose of the Study Post-traumatic stress disorder (PTSD) is a common and serious condition, but many people cannot get the help they need because there are not enough mental health specialists (like psychologists or psychiatrists) available. This study is testing a new program called NurseNET. The goal of NurseNET is to train nurses to provide a proven, short-term trauma treatment called Narrative Exposure Therapy (NET).\n\nWhy This Study is Important Most people see their nurse or doctor for health concerns. Because nurses are highly trusted and already work on the front lines of healthcare, they may be in the best position to offer PTSD treatment quickly and conveniently. This study aims to see if nurse-led care can bridge the gap between patients and the treatment they deserve.\n\nWhat the Study Involves Researchers will enroll 100 participants who have symptoms of PTSD. Participants will work with a trained nurse in a primary care setting to complete the NurseNET program.\n\nThe Treatment: The program consists of 4 to 6 sessions. During these sessions, the nurse helps the patient talk through their life story and process difficult memories in a safe, supportive way.\n\nWhat We Are Measuring: The research team will look at several factors to see if the program is successful:\n\nEffectiveness: Do PTSD symptoms improve after working with the nurse?\n\nFeasibility and Acceptability: Do patients and nurses find this type of care easy to use and helpful?\n\nHealth Impact: Since PTSD is linked to heart health, the study will also look at whether the treatment improves things like blood pressure or physical activity levels.\n\nGoal of the Research By the end of this study, researchers hope to show that nurses can safely and effectively provide trauma care. If successful, this model could be used across the United States to make PTSD treatment much easier to access for everyone.",[27],[613,614,615],"post traumatic stress disorder","primary care","nurse","2026-04-23",{"date":618,"type":38},"2026-04-29",{"date":620,"type":38},"2026-03-30",{"date":622,"type":21},"2029-09",{"name":624,"class":45},"Rush University Medical Center",{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":465,"enrollmentInfo":632,"targetDuration":4,"studyType":22,"phases":633,"briefSummary":634,"conditions":635,"keywords":638,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":655,"locationsCount":104},"100633207","non-invasive-vagus-nerve-stimulation-nvns-for-post-traumatic-stress-disorder-ptsd-100633207","NCT07523685","Non-invasive Vagus Nerve Stimulation (nVNS) for Post-Traumatic Stress Disorder (PTSD)","Non-invasive Vagus Nerve Stimulation (nVNS) for Adjunctive Treatment of Symptoms Associated With Post-Traumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n* PTSD diagnosis as determined by the Structured Clinical Interview for DSM-5 (SCID) interview for PTSD\n* CAPS-5 score \\> or = 35\n* Between the ages of 18 and 70 years\n* Has PTSD symptoms and either is not taking PTSD medications or stable on PTSD medications for 3 months.\n* Agrees to refrain from initiating or changing the type, dosage, or frequency of any prophylactic medications for indications other than PTSD that, in the opinion of the clinician may interfere with the study objectives (e.g., antidepressants, anticonvulsants, beta-adrenergic blockers, etc.)\n* Agrees to use nVNS as instructed and follow all of the requirements of the study including Follow-up Visit requirements\n* Able to provide written informed consent\n* Must have a primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial\n\nExclusion Criteria:\n\n* Psychiatric or cognitive disorder and\u002For behavioral problems that, in the opinion of the clinician, may interfere with the study, such as symptoms of suicidal or homicidal risk.\n* Evidence of a major medical or neurological illness on physical examination or as a result of laboratory studies (CBC, BUN, creatinine, blood sugar, electrolytes, liver and thyroid function tests, urinalysis, and EKG), such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness; which in the opinion of the investigator or industry partner interferes with the study\n* Cervical vagotomy or structural abnormality at the nVNS treatment site (e.g., lymphadenopathy, previous surgery, abnormal anatomy)\n* Pain at the nVNS treatment site (e.g., dysesthesia, neuralgia, cervicalgia)\n* Currently implanted with an electrical and\u002For neurostimulator device (e.g., cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, cochlear implant, sphenopalatine ganglion stimulator, occipital nerve stimulator)\n* Pregnant or thinking of becoming pregnant during the study period, or of childbearing years and unwilling to use an accepted form of birth control\n* Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner)\n* Patients with a stellate ganglion block (SGB)\n* An employee of the Investigator or the clinical study site\n* Recent (within 4 weeks) or concurrent use of a rapid-acting antidepressant agent (e.g., ketamine, esketamine, ECT) and\u002For other non-invasive stimulation therapy (e.g., TMS, transcranial focused ultrasound)",{"count":85,"type":21},[24],"The goal of this clinical trial is to evaluate the safety and effectiveness of the gammaCore non-invasive vagus nerve stimulation (nVNS) device as an additional treatment for symptoms of post-traumatic stress disorder (PTSD) in adults.\n\nThe vagus nerve connects the brain with many organs and systems in the body and plays a role in regulating stress and emotional responses. The gammaCore device is a handheld, rechargeable medical device that delivers gentle electrical stimulation to the vagus nerve through the skin on the side of the neck. By stimulating this nerve, the device may help reduce PTSD symptoms.\n\ngammaCore is cleared by the U.S. Food and Drug Administration (FDA) for the treatment and prevention of migraine and cluster headache. It has not yet been approved for the treatment of PTSD. This study is being conducted to better understand whether this type of stimulation may help improve PTSD symptoms and to evaluate its safety when used for this purpose.\n\nThe main questions this study aims to answer are:\n\n* Is non-invasive vagus nerve stimulation safe for people with PTSD when used regularly at home?\n* Does treatment with the gammaCore device improve PTSD symptom severity over time?\n\nIn this study, approximately 40 adults with PTSD will participate in an open-label pilot study.\n\nParticipants will first complete a 4-week baseline period in which their PTSD symptoms are monitored. This allows researchers to understand each participant's symptoms before starting the intervention.\n\nParticipants will then begin a 12-week treatment period using the gammaCore device at home. During this time, participants will apply the device to the side of the neck for short stimulation sessions each day as instructed by the study team.\n\nParticipants will attend six study visits, some conducted remotely and some in person. These visits include screening, training on how to use the device, and follow-up assessments. During the study, participants will complete questionnaires and clinician-administered assessments that measure PTSD symptoms and quality of life. Researchers will also monitor participants for any side effects or medical problems related to the device.\n\nBy collecting information on symptoms, safety, and device use, this study will help researchers understand whether non-invasive vagus nerve stimulation could become a useful treatment option for people living with PTSD.",[92,27,636,336,637,118,193],"PTSD - Post Traumatic Stress Disorder","Post Traumatic Stress Disorders",[92,639,640,641,642,231,643,644,645,646,647,648,649],"nVNS","Non-invasive","vagus nerve stimulation","vagus nerve stimulator","neuromodulation","non-invasive vagus nerve stimulation (nVNS)","Adjunctive treatment of post traumatic stress disorder","gammaCore","VNS","peripheral nerve stimulation","brain stimulation","2026-04-22",{"date":592,"type":38},{"date":653,"type":38},"2026-03-02",{"date":454,"type":21},{"name":656,"class":657},"Acacia Clinics","INDUSTRY",{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":4,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":665,"targetDuration":4,"studyType":22,"phases":667,"briefSummary":668,"conditions":669,"keywords":674,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":679,"lastUpdatePostDateStruct":680,"startDateStruct":682,"completionDateStruct":684,"leadSponsor":686,"locationsCount":104},"100628166","the-step-mied-trial-digital-stepped-care-for-emotional-disorders-100628166","NCT07458100","The STEP-MIED Trial: Digital Stepped-Care for Emotional Disorders","Effectiveness and Cost-effectiveness of a Digital Stepped-care Mindfulness Intervention for Recovery From Emotional Disorders: a Multicentre Pragmatic Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age: 18-65 years.\n2. Diagnosed with an emotional disorder by a outpatient psychiatrist, including depressive disorders, anxiety disorders (e.g., generalized anxiety disorder, panic disorder, agoraphobia, social anxiety disorder), obsessive-compulsive disorder, post-traumatic stress disorder, and eating disorders (e.g., anorexia nervosa, bulimia nervosa).\n3. Symptom severity meeting the threshold: PHQ-9 score ≥10 or GAD-7 score ≥8.\n\nExclusion Criteria:\n\n1. Current diagnosis of psychotic disorders or bipolar disorder.\n2. Current organic mental disorders, pervasive developmental disorders, severe cognitive impairment, or substance use disorders.\n3. Current suicide risk (PHQ-9 item 9 score \\>2).\n4. Antisocial personality disorder.\n5. Severe medical illnesses that may affect intervention participation or require recent hospitalization.\n6. Previous participation in a systematic 8-week mindfulness course.\n7. Inability to access the internet.",{"count":666,"type":21},464,[24],"The goal of this clinical trial is to evaluate the effectiveness and cost-effectiveness of a digital mindfulness-based intervention in adults (aged 18-65) diagnosed with emotional disorders like depression or anxiety. The main questions it aims to answer are:\n\n* Does adding a digital mindfulness intervention to usual care help people recover from emotional disorders faster and more sustainably over two years?\n* Is this combined approach more cost-effective than usual care alone? Researchers will compare the group receiving the digital mindfulness intervention plus their usual treatment to the group receiving only their usual treatment to see if the intervention leads to better long-term recovery and represents good value for money.\n\nParticipants in the intervention group will:\n\n* Attend eight weekly 2-hour online group mindfulness sessions.\n* Use a WeChat mini-program for 49 days of guided mindfulness exercises and daily tasks.\n* Patients who have not achieved reliable recovery after group retraining voluntarily participate in individual UP\\&MIED counseling.\n* Complete regular questionnaires and interviews over two years to track their progress.\n\nAll participants will continue to receive their usual medical care from their doctors throughout the study.",[670,671,227,672,193,673],"Emotional Disorders","Depressive Disorder","Obsessive-Compulsive Disorder","Eating Disorders",[675,63,676,677,678,670],"Cost-effectiveness","Recovery","randomized controlled trial","stepped-care","2026-04-18",{"date":681,"type":38},"2026-04-21",{"date":683,"type":38},"2026-03-23",{"date":685,"type":21},"2028-05",{"name":687,"class":45},"Peking University"]