[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ptsd---post-traumatic-stress-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ptsd---post-traumatic-stress-disorder":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,51,0,25,[9,49,68,98,129,155,184,214,235,261,282,306,334,359,385,416,446,473,494,523,559,592,620,642,664],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100652702","phase-2-one-p-tms-military-veterans-100652702",false,"NCT07777380","ONE-P TMS Military Veterans","One-day rTMS + D-cycloserine to Treat PTSD in Military Personnel and Veterans","ONE-P","Inclusion Criteria:\n\n* are outpatients between the ages of 19-60;\n* are voluntary and competent to consent;\n* are military personnel or veterans;\n* have DSM-5 diagnosis of PTSD with a CAPS for DSM-5 (CAPS-5) score ≥ 25;\n* 17-item Hamilton Depression Rating Scale score ≤ 23;\n* have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;\n* if participating in psychotherapy, must have been in stable treatment for at least 1 month prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study;\n* able to adhere to the treatment schedule;\n* Pass the TMS adult safety screening (TASS) questionnaire, and the MRI safety screening.\n\nExclusion Criteria:\n\n* have a Severe Substance Use Disorder (except tobacco) within the last three (3) months;\n* have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump;\n* have active suicidal intent;\n* are pregnant;\n* have a lifetime MINI diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms;\n* have a MINI diagnosis of OCD, or mood disorder that is assessed by a study investigator to be primary and causing greater impairment than PTSD;\n* have a diagnosis of any personality disorder, assessed by a study investigator to be primary and causing greater impairment than MDD;\n* have failed a course of ECT in the current episode or previous episode;\n* have received rTMS for any previous indication;\n* have any significant neurological disorder, history of seizure disorder (except those therapeutically induced by ECT), or any significant head trauma with clear radiological evidence of cerebrovascular injury on imaging;\n* have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;\n* clinically significant laboratory abnormality, in the opinion of the one of the principal investigators or study physicians (including but not limited to abnormal blood urea nitrogen (BUN), creatinine, estimated glomerular filtration rate (eGFR));\n* currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy;\n* currently take dicumarol, gingko biloba, isoniazid, ethionamide, fluphenazine, metrizamide, tramadol, warfarin due to potential interactions with D-Cycloserine;\n* planned vaccination with Bacille Calmette-Guérin, cholera or typhoid or planned imaging procedure with an injectable die, within one week following the treatment days, due to potential interactions with DCS.\n* allergy to DCS","ALL","19 Years","60 Years",{"count":22,"type":23},50,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","The aim of this study is to examine the feasibility and tolerability of a one-day protocol of repetitive transcranial magnetic stimulation with D-cycloserine (DCS) as an augmentation strategy in military personnel and veterans who have PTSD.",[29],"PTSD - Post Traumatic Stress Disorder",[31,32,33,34,35],"Transcranial Magnetic Stimulation","iTBS","PTSD","Post Traumatic Stress Disorder","Neuroplastogen","NOT_YET_RECRUITING","2026-08-18",{"date":39,"type":40},"2026-08-20","ACTUAL",{"date":42,"type":23},"2026-11-01",{"date":44,"type":23},"2029-01-01",{"name":46,"class":47},"Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":57,"targetDuration":4,"studyType":24,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":66,"leadSponsor":67,"locationsCount":48},"100652520","phase-2-one-p-tms-first-responders-100652520","NCT07773935","ONE-P TMS First Responders","One-day rTMS + D-cycloserine to Treat PTSD in First Responders","ONE-P_FR","Inclusion Criteria:\n\n* are outpatients between the ages of 19-60;\n* are voluntary and competent to consent;\n* are first responders (active, on leave or retired);\n* have DSM-5 diagnosis of PTSD with a CAPS for DSM-5 (CAPS-5) score ≥ 25;\n* 17-item Hamilton Depression Rating Scale score ≤ 23;\n* have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;\n* if participating in psychotherapy, must have been in stable treatment for at least 1 month prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study;\n* able to adhere to the treatment schedule;\n* Pass the TMS adult safety screening (TASS) questionnaire, and the MRI safety screening.\n\nExclusion Criteria:\n\n* have a Severe Substance Use Disorder (except tobacco) within the last three (3) months;\n* have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump;\n* have active suicidal intent;\n* are pregnant;\n* have a lifetime MINI diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms;\n* have a MINI diagnosis of OCD, or mood disorder that is assessed by a study investigator to be primary and causing greater impairment than PTSD;\n* have a diagnosis of any personality disorder, assessed by a study investigator to be primary and causing greater impairment than MDD;\n* have failed a course of ECT in the current episode or previous episode;\n* have received rTMS for any previous indication;\n* have any significant neurological disorder, history of seizure disorder (except those therapeutically induced by ECT), or any significant head trauma with clear radiological evidence of cerebrovascular injury on imaging;\n* have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;\n* clinically significant laboratory abnormality, in the opinion of the one of the principal investigators or study physicians (including but not limited to abnormal blood urea nitrogen (BUN), creatinine, estimated glomerular filtration rate (eGFR));\n* currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy;\n* currently take dicumarol, gingko biloba, isoniazid, ethionamide, fluphenazine, metrizamide, tramadol, warfarin due to potential interactions with D-Cycloserine;\n* planned vaccination with Bacille Calmette-Guérin, cholera or typhoid or planned imaging procedure with an injectable die, within one week following the treatment days, due to potential interactions with DCS.\n* allergy to DCS",{"count":22,"type":23},[26],"The aim of this study is to examine the feasibility and tolerability of a one-day protocol of repetitive transcranial magnetic stimulation with D-cycloserine (DCS) as an augmentation strategy in first responders who have PTSD.",[29],[31,32,33,34,35],"2026-08-14",{"date":64,"type":40},"2026-08-19",{"date":42,"type":23},{"date":44,"type":23},{"name":46,"class":47},{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":24,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":48},"100636820","phase-2-redefine-study-a-study-evaluating-the-efficacy-safety-and-tolerability-of-comp360-in-participants-with-post-traumatic-stress-disorder-100636820","NCT07570654","Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder","A Phase 2b\u002F3, Multicentre, Randomised, Double-blind, Controlled Trial, With an Open Label Extension, to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder","Redefine","Inclusion Criteria:\n\n* 18 years or older\n* Diagnosed with PTSD at least 6 months ago\n\nExclusion Criteria:\n\n\\- Diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions","18 Years",{"count":78,"type":23},300,[26,80],"PHASE3","The Redefine Study (COMP202) is testing COMP360 to see if it may reduce post-traumatic stress disorder (PTSD) symptoms when administered alongside monitoring and support from a trained study team. COMP360 is a lab-made form of the naturally occurring chemical compound psilocybin.",[29,33,83,84],"PTSD Symptoms","PTSD, Post Traumatic Stress Disorder",[86,87,74,33,88],"COMP360","psilocybin","trauma","RECRUITING",{"date":37,"type":40},{"date":92,"type":23},"2026-09",{"date":94,"type":23},"2029-09",{"name":96,"class":97},"COMPASS Pathways","INDUSTRY",{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":24,"phases":109,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":48},"100578051","study-of-the-effectiveness-of-vret-combined-with-tdcs-in-the-treatment-of-ptsd-in-ukrainian-veterans-and-civilians-100578051","NCT06806267","Study of the Effectiveness of VRET Combined With tDCS in the Treatment of PTSD in Ukrainian Veterans and Civilians","Study of the Effectiveness of Virtual Exposure Therapy (VRET) in Combination With Transcranial Direct Current Stimulation (tDCS) in the Treatment of Veterans and Civilians With PTSD in Wartime Ukraine","AVRE-U","Inclusion Criteria:\n\n* Participants are eligible to be included in the study only if all of the following criteria apply:\n\nAge · The participant is 18 to 75 years of age, inclusive, at the time the informed consent form (ICF) is signed.\n\nType of Participant and Disease Characteristics:\n\n* The participant has a current diagnosis of PTSD as defined by the CAPS-5, with a CAPS-5 Total Symptom Severity Score of ≥30 at the Screening Visit and Baseline Visit and no \\>25% change in score from Screening to Baseline.\n* The participant's index trauma event must have occurred when the participant was ≥13 years of age.\n\n  1. In the opinion of the Investigator the participant has a high probability for adherence with and completion of the study.\n  2. The participant has the ability to comply with study procedures.\n  3. The participant is fluent in Ukrainian and able to understand and comply with written and verbal protocol-related requirements.\n  4. The participant has received study inclusion approval through an adjudication process as to final suitability for the study.\n\nExclusion Criteria:\n\n1. Individuals with Epilepsy, Seizures or Severe Brain Injuries\n2. Individuals with Implanted Electronic Devices (Pacemakers, Cochlear Implants, etc.)\n3. Individuals with Scalp or Skin Issues at electrode placement sites\n4. Pregnant Individuals\n5. Individuals with tinnitus\n\nMedical Conditions\n\n1. It has been less than 6 months since the participant's index trauma event occurred, at the time of the Screening Visit.\n2. The participant has current and ongoing exposure to the trauma that caused their PTSD.\n3. The participant has complex PTSD, defined as a condition that may develop following exposure to an event or series of events of an extreme and prolonged or repetitive nature, which the participant experienced as extremely threatening or horrific and from which escape was difficult or impossible (e.g., torture, slavery, genocide campaigns, prolonged domestic violence, repeated childhood sexual or physical abuse). If affect dysregulation and interpersonal dysfunction are primary over other core PTSD symptoms, in the Investigator's opinion, participants should be excluded.\n4. The participant has severe depression as measured by a score of ≥35 on the Montgomery-Åsberg Depression Rating Scale (MADRS) at the Screening Visit.\n5. The participant has bipolar disorder, borderline personality disorder and other psychotic disorders as identified at the Screening Visit using the Structured Clinical Interview for DSM-5 Disorders - Clinical Trials Version (SCID-5-CT) and Personality Disorders (SCID-5-PD).\n6. The participant has a history of moderate to severe traumatic brain injury.\n7. The participant has a history of seizure disorders, uncontrolled sleep apnea or severe neurologic disease.\n8. The participant has any moderate or severe substance use disorder according to DSM-5 in the 12 months prior to the Screening Visit.\n9. The participant has a score of \\>15 points on the Alcohol Use Disorders Identification Test (AUDIT) at the Screening Visit.\n10. The participant is at an increased risk of suicide, defined as:\n\n    * Any suicide attempt in the 12 months prior to the Screening Visit disclosed by the participant using the Columbia Suicide Severity Rating Scale (C-SSRS)\n    * Any suicidal ideation with intent (yes to item 4 and\u002For 5) in the past 6 months or suicidal behaviour in the past 12 months, as captured at the Screening Visit or Baseline Visit using the C-SSRS\n    * A score \\>4 on item 10 of the MADRS at the Screening Visit.\n11. The participant has a systolic blood pressure value \\>140 mmHg or diastolic blood pressure value \\>90 mmHg at the Screening Visit or Baseline Visit. Two repeat measures are allowed at the discretion of the Investigator.\n12. The participant has negative experience or reaction to VR technology.\n13. The participant has significant cognitive impairments affecting instruction comprehension.\n14. The participant has any clinically significant ECG abnormality as determined by the Investigator at the Screening Visit.\n15. The participant has pronounced adverse physiological reactions to VR that remain unmanageable\n16. The participant is receiving concurrent trauma-based psychotherapy such as Cognitive Behaviour Therapy, Prolonged Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy.\n\nPrior\u002FConcomitant Therapy\n\n1. The participant is receiving concurrent trauma-based psychotherapy such as Cognitive Behaviour Therapy, Prolonged Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy.\n2. The participant has used marijuana or cannabinoid containing products daily (occasional use is allowed) for recreational use or self-medication (prescribed or otherwise) for the treatment of symptoms of PTSD or any other CNS disorder within 60 days of the Screening Visit.\n\nPrior\u002FConcurrent Clinical Study Experience\n\n1\\. The participant is currently enrolled in OR has previously participated in another investigational study in which an investigational medication (e.g., drug, vaccine, invasive device) was administered within 30 days before the ICF for this study is signed.\n\nOther Exclusions\n\n1. The participant is a member of the Ukrainian military currently serving on active duty.\n2. The participant is in the process of litigating for compensation for a psychiatric disorder. Participants who are in the process of applying for medical or Veterans Affairs benefits and\u002For those who have settled a disability claim prior to enrolment in the trial are eligible.\n3. The participant is not suitable to participate in the study, in the opinion of the investigator, because of clinically significant findings on medical history that could interfere with the objectives of the study or put the participant at risk or for any other reason the investigator deems applicable.","75 Years",{"count":108,"type":23},100,[110],"NA","A new method is being tested to assist individuals in Ukraine with Post-Traumatic Stress Disorder (PTSD), including veterans and civilians affected by war. The study is a collaboration among Ukrainian healthcare institutions and the Charité Berlin.\n\nWhat is PTSD?\n\nPTSD can occur after a distressing or traumatic experience, such as exposure to war. It can result in persistent negative memories, nightmares, heightened nervousness, or avoidance of reminders associated with the event.\n\nPurpose of the Study\n\nTwo innovative treatments for PTSD are being tested:\n\n1. Virtual Reality Therapy: This approach uses specialized goggles to create a safe and realistic virtual environment where individuals can confront memories and process emotions with guidance from a therapist.\n2. Brain Stimulation Therapy (tDCS): This method applies a gentle electrical current to the scalp to support improved emotional regulation by the brain.\n\nThe study aims to determine whether combining these two treatments is more effective than using virtual reality therapy alone.\n\nParticipant Involvement\n\nParticipants will:\n\n* Attend 10 therapy sessions over several weeks.\n* Use virtual reality goggles to engage with safe scenarios related to their memories, guided by a therapist.\n* Potentially receive brain stimulation therapy during some virtual reality sessions.\n* Learn relaxation techniques to help manage stress and enhance emotional control.\n\nPotential Benefits for Participants\n\n* These treatments may reduce symptoms such as intrusive memories, anxiety, and depression.\n* Participants may experience increased calmness, resilience, and improved ability to manage daily life.\n\nThis study also has the potential to advance PTSD treatment methods for others in the future.",[29],[33,114,115,116,117,118,119],"VRET","tDCS","Virtual Reality","Exposure therapy","Veterans","Ukraine","2026-08-07",{"date":122,"type":40},"2026-08-11",{"date":124,"type":40},"2025-04-22",{"date":126,"type":23},"2027-06-30",{"name":128,"class":47},"Malek Bajbouj",{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":24,"phases":138,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":48},"100640443","evaluation-of-restory---an-online-trauma-treatment-for-victims-of-sexual-abuse-100640443","NCT07610187","Evaluation of Restory - an Online Trauma Treatment for Victims of Sexual Abuse","A Randomised Waitlist Controlled Clinical Trial of the Restory Trauma Treatment Program","Inclusion Criteria:\n\n* 18+ years\n* exposure to sexual violence where a minimum of 1 month has passed since the incident\n* self-reported total PCL-5 of minimum 30\n* current stable dose of psychotropic medication (for at least 4 weeks) or medication free\n* sufficient Swedish skills\n* willingness and availability to participate\n\nExclusion Criteria:\n\n* Ongoing trauma-related threat (e.g. living with a violent spouse)\n* severe psychiatric illness requiring immediate alternative treatment (such as high acute suicide risk or presence of psychotic episode, assessed during screening interview)\n* current participation in other trauma-focused CBT or Eye Movement Desensitization and Reprocessing therapy\n* current benzodiazepine treatment\n* no trauma memory",{"count":137,"type":23},140,[110],"This project aims to evaluate Restory - a newly developed anonymous, iCBT prolonged exposure therapy program specifically tailored for victims of sexual abuse - using a pre-registered randomized controlled trial with waitlist control. The primary research question is whether Restory is more effective than a waitlist control in reducing PTSD symptom severity score, as measured by PCL-5.",[29,141],"Sexual Abuse",[143,144,141,145,146],"PTSD treatment","Anonymous","Trauma","Online","2026-08-04",{"date":120,"type":40},{"date":150,"type":40},"2026-05-04",{"date":152,"type":23},"2027-11-04",{"name":154,"class":47},"Karolinska Institutet",{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":24,"phases":166,"briefSummary":167,"conditions":168,"keywords":171,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":4},"100650222","phase-2-assessing-of-behavioral-risk-and-response-to-electromagnetic-and-psychedelic-therapies-100650222","NCT07745569","Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies","Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies","PRE-EMPT","Inclusion Criteria:\n\n1. 18-69 years old\n2. Have been on a stable psychiatric medication regimen for at least four weeks prior to study participation.\n3. Formal diagnosis of major depressive disorder or post-traumatic stress disorder by a mental health professional.\n4. Must be under the care of a medical provider (ex: primary care, therapist, psychiatrist, psychiatric nurse practitioner) for mental health treatment who can provide contact information and written confirmation that they will be willing and able to care for participant during their entire involvement in the study.\n\nExclusion Criteria:\n\n1. A prior history of other central nervous system disease or any history of seizures;\n2. history of psychotic disorders (e.g., schizophrenia, schizoaffective disorder, bipolar disorder type I);\n3. history of current or recent (within one year) substance\u002Falcohol use disorder, with the exception of tobacco use disorder;\n4. meet criteria for Very High risk of suicide, or require inpatient hospital-level care for psychiatric reasons at time of consent, to reduce exacerbation of risk of harm to self during study;\n5. presence of any implanted metal or electrical device (e.g. pacemaker);\n6. recent medical hospitalization (within three weeks);\n7. any condition that would prevent the participant from completing the protocol, such as significant agitation;\n8. appointment of a legal representative or treatment guardian;\n9. any ongoing litigation related to a health condition;\n10. any other contraindication to exposure to strong magnetic fields or MRI, such as severe claustrophobia;\n11. pregnancy or lactation;\n12. a family history of schizophrenia or schizoaffective disorder (first or second degree relatives), or bipolar disorder type 1 (first degree relatives), to reduce risk of exacerbation of an undiagnosed psychotic condition;\n13. other medical conditions that would preclude safe participation in the trial (e.g., decompensated heart failure);\n14. starting or planning to start psychotherapy or changing the frequency or intensity of existing psychotherapy during the trial (current psychotherapy can be continued provided the frequency and intensity has been stable for ≥2 months prior to screening);\n15. membership in a vulnerable population (minors, prisoners);\n16. any contraindication for blood draws.\n\nArm 1:\n\nInclusion:\n\n1. PRE-EMPT Risk Level Low or Intermediate (recent suicidal ideation, but no intent\u002Fplan; C-SSRS level low; mild-to-moderate depression (QIDS score 6-15) or PTSD (PCL-5 score 20-32))\n2. Right-handed.\n\nArm 2:\n\nInclusion:\n\n1\\) PRE-EMPT Risk Level Intermediate or High (recent suicidal ideation, but no intent or plan; C-SSRS level low to moderate; moderate to severe depression (QIDS score \\>16) or PTSD (PCL-5 score greater than or equal to 33))\n\nArm 3:\n\nInclusion:\n\n1\\) PRE-EMPT Risk Level Intermediate or High (recent suicidal ideation, but no intent or plan; C-SSRS level low to moderate; moderate to severe depression (QIDS score ≥16) or PTSD (PCL-5 score greater than or equal to 33))\n\nExclusions:\n\n1. Other additional medical conditions that would preclude safe participation in this arm of the trial:\n\n   1. significantly impaired liver function,\n   2. severe coronary artery disease,\n   3. heart failure,\n   4. uncontrolled hypertension (above 140\u002F90 mmHg upon screening) ,\n\n   i. If blood pressure is consistently elevated \\> 140\u002F90 mmHg across 3 attempts, subjects may be referred to their primary care provider for management of hypertension. Upon management of blood pressure, subjects will have an opportunity to return once within the 30 day screening window to make 3 additional attempts at a blood pressure reading ≤ 140\u002F90 mmHg. Subjects will be considered eligible upon registering 1 blood pressure reading ≤ 140\u002F90 mmHg during the screening period. Blood pressure will be reassessed on Day 0 prior to dosing, and must be less than or equal to 140 systolic, 90 diastolic, with resting pulse ≤ 100 (ascertained within 20 minutes of IP administration in order for the participant to receive study medication.) e. history of cerebrovascular accident, f. severe obesity (BMI ≥ 35), g. untreated asthma, h. untreated hyperthyroidism, i. narrow-angle glaucoma, j. stenosing peptic ulcer, k. pyloroduodenal obstruction, l. symptomatic prostatichypertrophy, or m. bladder-neck obstruction, n. history of valvular heart disease or any heart condition that affects the valves\n2. serious ECG abnormalities (e.g., evidence of ischemia, myocardial infarction, QT interval corrected for heart rate \\[QTc\\] prolongation (QTc \\> 0.45 seconds), arrhythmia, or conduction abnormalities that increase the risk of arrhythmia);\n3. allergy or hypersensitivity to psilocybin or chocolate","69 Years",{"count":165,"type":23},150,[26],"PRE-EMPT will assemble a cohort of 150 participants from three populations (low risk, intermediate risk, and high risk for self-harm). We will obtain clinical assessments, structural and functional MRI utilizing tasks pioneered by our team to assess cognitive control (CC) and emotion regulation (ER), and peripheral circular RNA (circRNA) levels to characterize the molecular brain states associated with behavioral risk. The clinical, imaging, and transcriptomic data will be fused and jointly analyzed to increase the accuracy of our risk prediction models. PRE-EMPT in three separate Aims will then prospectively assess three promising and innovative interventions for their potential to reduce suicidal ideation and alter activity in key neural networks: 1) neurofeedback (NF) using real-time fMRI with simultaneous electroencephalography (EEG), 2) a form of transcranial magnetic stimulation (TMS) called accelerated intermittent theta burst stimulation (aiTBS) with dose optimization through electric field modeling; and 3) psilocybin assisted therapy (PSI), with flexible dosing plan to maximize the depth of psychedelic experience. These therapies were chosen based on our team's prior work in all three interventions demonstrating rapid action and large effects.",[33,29,169,170],"Major Depression","Suicidality",[172,173,174,87,175],"TMS","Transcranial magnetic stimulation","neuromodulation","neurofeedback","2026-07-29",{"date":147,"type":40},{"date":179,"type":23},"2026-08-31",{"date":181,"type":23},"2030-06-30",{"name":183,"class":47},"University of New Mexico",{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":192,"minAge":76,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":24,"phases":195,"briefSummary":196,"conditions":197,"keywords":200,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":48},"100649350","self-compassion-health-and-empowerment-100649350","NCT07733531","Self-Compassion, Health, and Empowerment","Self-Compassion, Health, and Empowerment: A Randomized Controlled Trial for Chinese Immigrant Women Experiencing Intimate Partner Violence","SHE RCT","Inclusion Criteria:\n\n* Age 18 or older;\n* Self-identify as a woman;\n* Self-identify as Chinese;\n* Reside in the U.S.;\n* Self-report experiences of any physical, emotional, or sexual violence from an intimate partner within the past year;\n* Self-report symptoms of depression, anxiety, or post-traumatic stress disorder (PTSD).\n\nExclusion Criteria:\n\n* Those who cannot speak or understand Mandarin or English;\n* Those with substance use, suicidality, or who have been in mental health care for severe mental illness.","FEMALE",{"count":194,"type":23},364,[110],"Intimate partner violence (IPV) can have serious and lasting effects on women's mental health and well-being. Chinese immigrant women in the United States often face additional barriers to obtaining IPV and mental health support, including language, cultural, and social challenges. There is a need for culturally appropriate interventions that improve access to care and address the mental health needs of this underserved population.\n\nThe purpose of this study is to evaluate the efficacy of the Self-Compassion, Health, and Empowerment (SHE) intervention, a culturally tailored mobile health (mHealth) program designed for Chinese immigrant women experiencing IPV. Participants will be randomly assigned to either the SHE intervention or an attention control program and will complete study assessments over a 12-month follow-up period.\n\nThe results of this study will help determine whether the SHE intervention improves mental health and well-being among Chinese immigrant women experiencing IPV and may provide evidence for an accessible, culturally appropriate intervention that can be implemented more broadly.",[198,199,29],"Intimate Partner Violence (IPV)","Depression and\u002For Anxiety Symptoms",[201,202,203,204],"Empowerment","Self-compassion","mindfulness","safety","2026-07-28",{"date":207,"type":40},"2026-07-30",{"date":209,"type":23},"2026-09-01",{"date":211,"type":23},"2030-08-31",{"name":213,"class":47},"Yang Li",{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":24,"phases":224,"briefSummary":225,"conditions":226,"keywords":227,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":231,"leadSponsor":233,"locationsCount":48},"100628597","accelerated-transcranial-magnetic-stimulation-for-post-traumatic-stress-disorder-100628597","NCT07463703","Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder","Feasibility and Preliminary Efficacy of Functional MRI-Guided Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder: A Pilot Study","Inclusion Criteria\n\nParticipants must meet ALL of the following criteria:\n\n1. Age 18-65 years (inclusive)\n2. DSM-5 diagnosis of PTSD confirmed by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)\n3. PCL-5 total score ≥33 (indicating at least moderate symptom severity)\n4. PTSD symptom duration ≥3 months\n5. If taking psychotropic medications, stable dose for ≥6 weeks prior to enrollment with no planned changes during study participation\n6. Able to provide written informed consent\n7. English-speaking (required for validated assessment measures)\n8. Able to attend daily treatment sessions for 5 consecutive weekdays\n9. Eligible for 1.5T MRI scanning (no contraindications)\n\nExclusion Criteria\n\nParticipants meeting ANY of the following criteria will be excluded:\n\nTMS Contraindications:\n\n1. Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head or within 30 cm of the TMS coil (excluding the mouth), including:\n\n   * Cochlear implants\n   * Deep brain stimulators\n   * Vagus nerve stimulators\n   * Aneurysm clips or coils\n   * Stents in the neck or brain\n   * Electrodes\n   * Any implanted electronic devices\n2. History of seizure disorder (excluding single childhood febrile seizure)\n3. First-degree family member with epilepsy\n4. History of significant head trauma with loss of consciousness \\>10 minutes\n5. History of stroke, brain tumor, or other neurological disorder\n6. Neurosurgical procedures involving brain tissue\n\nMRI Contraindications:\n\n1. Implanted medical devices incompatible with MRI\n2. Claustrophobia preventing MRI scan completion\n3. Body size preventing MRI scanner entry\n\nPsychiatric Exclusions:\n\n1. Lifetime history of psychotic disorder (schizophrenia, schizoaffective disorder, delusional disorder)\n2. Lifetime history of bipolar I disorder\n3. Current (within past month) moderate or severe substance use disorder per DSM-5 criteria\n4. Current active suicidal ideation with intent or plan (Columbia Suicide Severity Rating Scale score ≥4)\n5. Psychiatric hospitalization within past 3 months\n\n   Medical Exclusions:\n6. Unstable medical condition that, in the investigator's judgment, would interfere with study participation or pose safety risk\n7. Pregnancy or breastfeeding (females of childbearing potential must have negative urine pregnancy test at screening)\n8. Prior TMS treatment within past 3 months\n9. Current participation in another interventional research study\n10. Initiation of psychotherapy specifically for PTSD within past 3 months (stable ongoing therapy is permitted)","65 Years",{"count":223,"type":23},15,[110],"This study tests a new brain stimulation treatment for post-traumatic stress disorder (PTSD), a condition that affects millions after trauma, causing symptoms like flashbacks, avoidance, mood changes, and heightened alertness.\n\nThe investigators will enroll 15 adults (ages 18-65) with PTSD. First, participants get a brain scan (fMRI) to map their unique brain connections between areas involved in fear and control-the right amygdala (fear center) and right dorsolateral prefrontal cortex (control area). Using this personalized map, the investigators will apply accelerated transcranial magnetic stimulation (TMS), a safe, non-invasive method using magnetic pulses to adjust brain activity. Treatment lasts 5 days (10 short sessions daily, totaling 90,000 pulses) targeting the identified spot to strengthen control over fear responses.\n\nThe study checks if this approach is practical, safe (tracking side effects like headaches), and shows early signs of reducing PTSD symptoms (measured by questionnaires and interviews). Follow-up lasts 3 months, with repeat scans to see brain changes.\n\nThis study will see if personalized, fast-paced TMS targeting the disrupted fear-control brain circuit in PTSD can be feasible and safe, and preliminarily reduce symptoms by improving brain connectivity, potentially offering a quicker alternative to standard treatments.",[29],[34],"2026-07-27",{"date":205,"type":40},{"date":62,"type":23},{"date":232,"type":23},"2027-01",{"name":234,"class":97},"Cognitive FX",{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":24,"phases":244,"briefSummary":245,"conditions":246,"keywords":249,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":48},"100647470","the-effect-of-early-intervention-on-the-incidence-of-posttraumatic-stress-disorder-after-intensive-care-hospitalization-due-to-sepsis-100647470","NCT07707765","The Effect of Early Intervention on the Incidence of Posttraumatic Stress Disorder After Intensive Care Hospitalization Due to Sepsis","Inclusion Criteria:\n\n* Discharged from ICU due to sepsis\n* Age over 18 years old\n\nExclusion Criteria:\n\n* Age under 18 years old\n* Lack of consent\n* Dementia\u002F mental retardation or any other condition due to which the patient cannot fill the questionnaires or participate in the psychiatric interview.\n* A cute psychosis or other psychiatric condition nesiccating psychiatric treatment.","120 Years",{"count":243,"type":23},60,[110],"In recent years, the survival rate among intensive care patients has improved due to advancements in diagnosing severe infections and the use of broad-spectrum antibiotics. However, many survivors face long-term complications, known as Post-Intensive Care Syndrome (PICS), including physical, cognitive, and psychological impairments such as post-traumatic stress disorder (PTSD), anxiety, and depression. Approximately 9-27% of ICU survivors develop these symptoms, particularly those hospitalized due to sepsis. Common risk factors include traumatic hospital experiences, delirium, and extended mechanical ventilation. Despite the prevalence of these issues, most medical centers lack structured models for screening and early intervention, highlighting the need for evaluations of early intervention strategies to support at-risk patients post-discharge and improve their quality of life.",[29,247,248],"Sepsis","ICU",[33,250,248,251],"SEPSIS","EARLY INTERVENTION","2026-07-16",{"date":254,"type":40},"2026-07-17",{"date":256,"type":40},"2026-07-01",{"date":258,"type":23},"2026-12-31",{"name":260,"class":47},"Barzilai Medical Center",{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":24,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":48},"100628490","mentalgym-and-neurobrave-guided-wearable-assisted-physiology-regulation-training-for-ptsd-prtp-100628490","NCT07462312","MentalGym™ and NeuroBrave™ Guided Wearable-Assisted Physiology Regulation Training for PTSD (PRTP)","Evaluating the Efficacy of the MentalGym™ and NeuroBrave™ Guided Wearable-Assisted Physiology Regulation Training for PTSD: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Sex: All\n* Age: 18 Years and older.\n* Diagnosis: Clinical diagnosis of Posttraumatic Stress Disorder (PTSD) with mild to moderate-severe symptom intensity.\n* Symptom Severity: A PCL-5 total score of up to 60 at screening.\n* Traumatic Event: PTSD diagnosis based on a traumatic event that occurred in the year 2000 or later.\n* Service Eligibility: Eligibility for Ministry of Defense (MOD) rehabilitation services.\n* Technical Proficiency: Ability to use a smartphone and a wearable device.\n\nExclusion Criteria:\n\n* High Symptom Severity: PTSD symptom severity exceeding the moderate-severe range (PCL-5 score \\> 60) or requiring more intensive clinical intervention.\n* Psychiatric Stability: Acute psychiatric instability, including active suicidal ideation or psychosis.\n* Medication: Current use of Olanzapine (Zyprexa) or Quetiapine (Seroquel).\n* Sleep Disturbances: Severe sleep impairment (score \\> 7 on the The Insomnia Severity Index).\n* Functional Impairment: Severe impairment in concentration or cognitive processing that precludes the use of digital biofeedback tools.","50 Years",{"count":270,"type":23},80,[110],"This randomized controlled trial (RCT) will evaluate the effectiveness of a digital biofeedback-based intervention (\"Mental Gym®\") designed to reduce Posttraumatic Stress Disorder (PTSD) symptoms and improve mental health. The intervention combines daily HRV biofeedback exercises using a wearable device (Garmin watch), a dedicated mobile application, and weekly group guidance sessions. A delayed-intervention control group design will be used. To account for expected attrition and ensure a final sample of 60 participants, approximately 80 subjects will be recruited. Physiological and self-report data will be collected pre- and post-intervention, weekly during the intervention, and at follow-ups (3 months post-intervention). The study population consists of combat veterans diagnosed with PTSD.",[29],"2026-07-14",{"date":252,"type":40},{"date":277,"type":40},"2025-09-15",{"date":279,"type":23},"2026-09-30",{"name":281,"class":97},"NeuroBrave ltd.",{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":290,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":24,"phases":292,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":48},"100647515","advancing-skills-through-consultation-education-and-novel-technologies-100647515","NCT07707102","Advancing Skills Through Consultation, Education, and Novel Technologies","Increasing the Reach of Evidence-Based PTSD Treatment: Development and Clinical Trial of Artificial Intelligence (AI)-Facilitated, Web-Based Written Exposure Therapy Training","ASCENT","Inclusion Criteria:\n\n1. mental health provider;\n2. serves veterans and\u002For service members with PTSD (by self-report);\n3. willing to participate in either live or web-based training.\n\nExclusion Criteria:\n\n1\\. has already completed formal training in Written Exposure Therapy",true,{"count":78,"type":23},[110],"This research study tests strategies to train behavioral health providers in Written Exposure Therapy (WET), an evidence-based treatment for posttraumatic stress disorder (PTSD). There are a number of evidence-based treatments for posttraumatic stress disorder (PTSD). However, most behavioral health providers have not received training in these PTSD treatments and do not offer them regularly to their patients.\n\nThe researchers hope to learn about the optimal way to train behavioral providers in this type of treatment. This study is designed to determine the comparative effectiveness of different training strategies on key outcomes such as how much competency providers develop in the therapy and to how many patients they deliver the therapy. This study will help the researchers understand if we can help more providers learn to competently delivery Written Exposure Therapy by using strategies that are more convenient and cost less money, including web-based and AI-facilitated training supports. This study will also help us learn which training strategies work best for which providers so that in the future we can make personalized training recommendations.",[29],[296,297],"Written Exposure Therapy","AI-facilitated training","2026-07-10",{"date":252,"type":40},{"date":301,"type":23},"2026-08-03",{"date":303,"type":23},"2028-08-31",{"name":305,"class":47},"The University of Texas Health Science Center at San Antonio",{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":314,"enrollmentInfo":315,"targetDuration":4,"studyType":24,"phases":316,"briefSummary":318,"conditions":319,"keywords":320,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":48},"100589359","early-phase-1-understanding-non-invasive-vagus-nerve-stimulation-effects-in-ptsd-100589359","NCT06953388","Understanding Non-invasive Vagus Nerve Stimulation Effects in PTSD","SPARK-VNS: Facilitating Adaptive Posttraumatic Processing With Non-Invasive Vagus Nerve Stimulation","SPARK-VNS","Inclusion Criteria:\n\n1. Ages 18-80\n2. Fluent in English\n3. Experience with a DSM-5 Criterion A trauma (LEC-5)\n4. Probable PTSD (PCL-5 ≥ 32)\n\nExclusion Criteria:\n\n1. Visual or Auditory impairment\n2. Major injury at time of screen or study procedures\n3. Taking ≥20 mg morphine per day\n4. Current substance use or intoxication (12-panel drug test)\n5. Intellectual disability (MoCA)\n6. Self-inflicted injury\n7. Occupational injury\n8. Prisoner\n9. Ongoing domestic violence\n10. Pregnant or breastfeeding\n11. Contraindications for taVNS","80 Years",{"count":243,"type":23},[317],"EARLY_PHASE1","The goal of this study is to determine how non-invasive brain stimulation (delivered through the ear called vagus nerve stimulation) affects fear learning processes in people who have experienced psychological trauma. To answer these questions, we measure bodily responses (heart rate, sweat, startle) and questionnaires. The main questions it aims to answer are:\n\nDoes non-invasive vagus nerve stimulation help reduce anxious arousal? Does non-invasive vagus nerve stimulation help dampen learned fear?",[29],[33,321,322,323,324],"brain stimulation","fear learning","autonomics","fear potentiated startle","2026-07-09",{"date":327,"type":40},"2026-07-13",{"date":329,"type":23},"2027-04-01",{"date":331,"type":23},"2031-03-01",{"name":333,"class":47},"Wayne State University",{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":24,"phases":343,"briefSummary":344,"conditions":345,"keywords":346,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":358},"100646353","intermittent-theta-burst-stimulation-itbs-as-an-add-on-to-eye-movement-desensitization-and-reprocessing-emdr-in-the-treatment-of-post-traumatic-stress-disorder-ptsd-100646353","NCT07693088","Intermittent Theta-Burst Stimulation (iTBS) as an add-on to Eye Movement Desensitization and Reprocessing (EMDR) in the Treatment of Post-traumatic Stress Disorder (PTSD)","Intermittent Theta-Burst Stimulation (iTBS) as an add-on to Eye Movement Desensitization and Reprocessing (EMDR) in the Treatment of Post-traumatic Stress Disorder (PTSD): An Open-label Pilot Study","Inclusion Criteria:\n\n* Age 18-70 years\n* ICD-10 criteria for PTSD (F43.1)\n* A minimum total score of 4 (moderately ill) on the Clinical Global Impression-Severity (CGI-S)\n* Likely to be able to complete trial participation (16 weeks) without modifications to psychopharmacological treatment, as per the referring doctor's or psychologist's assessment\n* Participants must be able and willing to abstain from alcohol consumption during the iTBS treatment period, as required by the TMS Safety Checklist.\n\nExclusion Criteria:\n\n* Organic mental disorders (F0)\n* Currently fulfills the criteria of Active psychoactive substance use or dependence (F1)\n* Schizophrenia, schizotypal and delusional disorders (F2), manic episode (F30), or bipolar affective disorder (F31); iv) Mental retardation (estimated IQ \\\u003C70, as per the referring doctor's or psychologist's assessment)\n* Active suicidality\n* Any ongoing involuntary\u002Fcoercive measures\n* Any contraindications listed on the TMS Safety Checklist","70 Years",{"count":223,"type":23},[110],"This open-label pilot study will evaluate the feasibility, safety, tolerability, and preliminary clinical outcomes of adding intermittent theta-burst stimulation (iTBS) to Eye Movement Desensitization and Reprocessing (EMDR) therapy in adults with post-traumatic stress disorder (PTSD), who show insufficient improvement after an initial course of EMDR.\n\nParticipants will receive weekly EMDR therapy. After seven EMDR sessions, treatment response will be assessed using the Clinical Global Impression-Improvement scale (CGI-I). Participants with insufficient response will receive add-on iTBS targeted to the right dorsolateral prefrontal cortex (DLPFC) for four weeks while continuing EMDR. Feasibility outcomes include adherence, treatment completion, and dropout rates. Clinical outcomes will include clinician-rated and self-reported measures of PTSD symptoms, depressive symptoms, well-being, and adverse events.",[29],[347,31,348,349],"Eye Movement Desensitization Reprocessing","Intermittent Theta-Burst Stimulation (iTBS)","Post-Traumatic Stress Disorder","2026-07-07",{"date":325,"type":40},{"date":353,"type":23},"2026-07",{"date":355,"type":23},"2027-06",{"name":357,"class":47},"Aarhus University Hospital",3,{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":18,"minAge":366,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":24,"phases":369,"briefSummary":370,"conditions":371,"keywords":373,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":381,"leadSponsor":383,"locationsCount":48},"100645317","cbits-rtm-pilot-study-100645317","NCT07682441","CBITS-RTM Pilot Study","Preventing Substance Use Among Incarcerated Youth Through Addressing Posttraumatic Stress","Inclusion Criteria:\n\n* Youth must 1) be currently incarcerated in a partnering juvenile detention center, 2) be between 13-18 years of age, and 3) have a minimum of 3 months remaining on their sentence (i.e., sufficient time required to complete CBITS-RTM). Youth will complete a screening with a study team member involving the 2-item Abbreviated PTSD Checklist-Civilian version, with scores ≥4 considered a positive screen\n* Clinicians are eligible if they are behavioral health staff working with youth at the detention school..\n\nExclusion Criteria:\n\n* Observable cognitive or developmental delays or active psychosis that would interfere with completing consent, assessment or intervention.","13 Years",{"count":368,"type":23},28,[110],"This pilot study, conducted in partnership with juvenile detention centers, evaluates an adapted CBITS-RTM intervention delivered in a detention school setting.",[29,372],"Substance Use",[374,375,376],"Incarcerated youth","Juvenile detention school","CBITS-RTM","2026-07-02",{"date":379,"type":40},"2026-07-06",{"date":209,"type":23},{"date":382,"type":23},"2027-12-31",{"name":384,"class":47},"University of California, San Francisco",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":106,"enrollmentInfo":392,"targetDuration":4,"studyType":24,"phases":394,"briefSummary":396,"conditions":397,"keywords":400,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":412,"leadSponsor":414,"locationsCount":48},"100646627","phase-4-suvorexant-3---pe-pc-100646627","NCT07686731","Suvorexant 3 - PE-PC","Suvorexant: Targeting Orexin to Augment Exposure Therapy in Veterans With PTSD and Insomnia","Inclusion Criteria:\n\n1. Adults 18-75 years who are U.S. military Veterans; able to read\u002Funderstand English and provide written informed consent;\n2. Exposure to a DSM-5 Criterion A traumatic event;\n3. Current PTSD, duration \\> 3 months, CAPS-5 total score ≥ 12\n4. Insomnia diagnosis indicated by ISI score \\>14\n5. If taking non-exclusionary psychotropics (e.g., SSRI\u002FSNRI, tetracyclic antidepressants, tricyclics, antipsychotics, and mood stabilizers, insomnia medication, neuroleptics, anti-psychotics) must be on a dose stable ≥ 4 weeks before randomization.\n6. If in supportive psychotherapy, stable ≥ 6 weeks before randomization (no concurrent exposure-based PTSD or CBT-I).\n7. Women of childbearing potential: negative urine pregnancy test at screening; agree to use a medically acceptable contraception method during treatment.\n\nExclusion Criteria:\n\n1. DSM-5 alcohol, marijuana, and\u002For other substance use disorder in the last 3 months. Mild alcohol and marijuana use not meeting criteria for disorder permissible;\n2. Lifetime bipolar disorder I or II, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or major depressive disorder with psychotic features;\n3. Exposure to trauma in the last 3 months;\n4. Prominent suicidal or homicidal ideation, any suicidal behavior in the past 3 months on the Columbia Suicide Severity Rating Scale (C-SSRS)83, or increased risk of suicide that necessitates additional therapy or inpatient treatment;\n5. Pre-existing sleep apnea by type III device with AHI \\>15 in the absence of adherence to effective treatment (such as CPAP or oral device);\n6. Night shift work or extreme morning or evening tendencies;\n7. Neurologic disorder or systemic illness affecting CNS function;\n8. Chronic or unstable medical illness (i.e., angina, myocardial infarction within the past 6 months, congestive heart failure, preexisting hypotension or orthostatic hypotension, heart block or arrhythmia, chronic renal or hepatic failure, pancreatitis, and severe chronic obstructive pulmonary disease);\n9. Severe cognitive impairment as assessed by the MoCA (or alternative validated threshold per site SOP)\n10. Pregnancy or breastfeeding, or unwillingness to use effective contraception (women of childbearing potential).\n11. Previous adverse reaction to a hypnotic;\n12. Current use of sedative-hypnotics, benzodiazepines, moderate or strong CYP3A inhibitors, or strong CYP3A inducers or Digoxin;\n13. Current participation in exposure-based PTSD or behavioral insomnia treatments.",{"count":393,"type":23},142,[395],"PHASE4","The goal of this clinical trial is to learn if combining suvorexant (a sleep medication) with a shorter form of prolonged exposure therapy called PE-PC works to treat PTSD symptoms and improve sleep in Veterans and military personnel with PTSD and insomnia, with and without mild-to-moderate traumatic brain injury (TBI). The main questions it aims to answer are:\n\nDoes suvorexant, when combined with PE-PC therapy, reduce PTSD symptoms more than PE-PC with a placebo (a look-alike substance that contains no drug)? Does suvorexant, when combined with PE-PC therapy, improve psychosocial and physical functioning more than PE-PC with a placebo?\n\nResearchers will compare PE-PC combined with suvorexant to PE-PC combined with a placebo to see if adding suvorexant improves PTSD symptoms, sleep, and overall functioning in Veterans.\n\nParticipants will:\n\nReceive weekly PE-PC therapy sessions for 8 weeks Take suvorexant (10-20 mg) or a placebo each night during the 8-week treatment period.\n\nComplete repeated assessments of PTSD symptoms, sleep, and psychosocial and physical functioning throughout the study.",[29,398,399],"Insomnia","TBI (Traumatic Brain Injury)",[33,398,401,118,402,403,404,405,406,407,408],"Sleep","TBI","Prolonged Exposure Therapy for Primary Care (PE-PC)","Stress Disorders, Post-Traumatic","suvorexant","Sleep Initiation and Maintenance Disorders","Orexin Receptor Antagonists","Dual Orexin Receptor Antagonists (DORA)","2026-06-29",{"date":350,"type":40},{"date":209,"type":23},{"date":413,"type":23},"2029-08-30",{"name":415,"class":47},"Northern California Institute of Research and Education",{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":24,"phases":425,"briefSummary":426,"conditions":427,"keywords":432,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":442,"leadSponsor":444,"locationsCount":48},"100614420","deaf-cbt-ts-to-reduce-suicide-risk-100614420","NCT07279363","Deaf CBT-TS to Reduce Suicide Risk","Cognitive Behavioral Therapy for Treatment-Seeking to Improve Treatment Engagement and Reduce Suicide Risk Among Deaf Individuals","Inclusion criteria:\n\n* adult (aged 18 years or older)\n* Self-identify as Deaf or hard of hearing (any degree of hearing loss)\n* Primary method of communication is American Sign Language\n* Positive screen for one or more mental health disorders including depression (PHQ-9 \\> 10), anxiety (GAD-7 \\> 10), posttraumatic stress disorder (PCL-5 \\> 31), insomnia (ISI \\> 15), or alcohol use disorder (AUDIT \\> 16)\n* No current professional mental health or alcohol specialty treatment (e.g., counseling, psychiatric services) per standardized self-report\n* Access to video chat technology with internet and webcam.\n\nExclusion criteria:\n\n* unable to communicate with the researcher in American Sign Language\n* current alcohol withdrawal necessitating medical evaluation\n* current psychiatric impairment necessitating emergency services or inpatient admission (i.e., imminent danger of harm to self or others)\n* unable to comprehend the nature of the study",{"count":424,"type":23},110,[110],"The goal of this clinical trial is to learn if a short, Zoom-based intervention, Cognitive Behavioral Therapy for Treatment-Seeking for Deaf Individuals (Deaf CBT-TS) can change beliefs about mental health treatment and increase treatment-seeking behaviors in Deaf adults with untreated mental health or alcohol use problems. It will also see if Deaf CBT-TS may reduce suicide risk and explore factors that may increase the effectiveness of Deaf CBT-TS. The main questions it aims to answer are:\n\n* Does Deaf CBT-TS increase positive beliefs about treatment and increase treatment-seeking behaviors?\n* Does Deaf CBT-TS increase hope and reduce mental health symptoms, suicide ideation, and alcohol use?\n* Is Deaf CBT-TS more effective for individuals with less cultural stress compared to those with high levels of cultural stress?\n* Is Deaf CBT-TS more effective for Deaf individuals in residential areas with more Deaf resources than those with less Deaf resources? Researchers will compare individuals who complete Deaf CBT-TS to those on a waitlist to see if Deaf CBT-TS works to increase positive beliefs about treatment and treatment-seeking behaviors.\n\nParticipants will:\n\n* Complete a baseline assessment including demographic information, measures of hope, general mental health and functioning, alcohol use, suicide ideation, cultural stress, and beliefs about treatment.\n* Receive Deaf CBT-TS (2 sessions) or be placed on a waitlist with the option of receiving Deaf CBT-Ts after 4 months\n* Complete two follow-up assessments in 2 and 4 months.",[428,429,29,398,430,431],"Depression - Major Depressive Disorder","Anxiety","Alcohol Use Disorder (AUD)","Suicide Ideation",[433,434,435,436,437],"Deaf","Mental Health","Treatment-Seeking","Suicide","Cognitive Behavioral Therapy for Treatment-Seeking","2026-06-17",{"date":440,"type":40},"2026-06-22",{"date":92,"type":23},{"date":443,"type":23},"2029-05",{"name":445,"class":47},"University of Rochester",{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":192,"minAge":76,"maxAge":268,"enrollmentInfo":453,"targetDuration":4,"studyType":24,"phases":455,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":48},"100606397","the-new-empowerment-after-exposure-to-trauma-next-study-100606397","NCT07175025","The New Empowerment After eXposure to Trauma (NEXT) Study","NEXT","Inclusion Criteria:\n\n* 18 years of age or older\n* able to read and speak English\n* diagnosis of probable PTSD as determined by the PTSD Checklist for DSM-5 (PCL-5)\n* pregnant or postpartum (delivered within 12 weeks) at the time of the eligibility screen Exclusion criteria\n* current severe suicide risk as determined by the Columbia Suicide Severity Rating Scale Screener (C-SSRS)\n* current psychotic or manic symptoms as determined by the DIAMOND screener and the Mood Disorder Questionnaire for Bipolar Disorder\n* cognitive impairment\n* concurrent trauma-focused psychotherapy\n* medical advice limiting participation in exposure therapy\n* current legal actions related to trauma\n* does not meet criteria for PTSD\n* not pregnant or delivered more than 12 weeks after timing of eligibility screening",{"count":454,"type":23},106,[110],"The NEXT Study is a randomized controlled pilot examining the feasibility and acceptability of a revised perinatal PTSD protocol. This study will randomize perinatal participants with PTSD to receive NET (n=45); treatment group) and will be compared to perinatal women randomized to usual care (n=45; comparator group). The overall objective of this project is to determine the most feasible and acceptable protocol for a brief virtual perinatal PTSD intervention.",[29,458],"PTSD (Childbirth-Related)",[460,461,462,349,463],"Pregnancy","Postpartum Period","Narrative Exposure Therapy","Brief interventions","2026-06-16",{"date":466,"type":40},"2026-06-18",{"date":468,"type":40},"2025-09-24",{"date":470,"type":23},"2028-07-31",{"name":472,"class":47},"Indiana University",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":341,"enrollmentInfo":480,"targetDuration":4,"studyType":24,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":491,"locationsCount":48},"100618794","transcranial-magnetic-stimulation-in-veterans-with-ptsd-100618794","NCT07336251","Transcranial Magnetic Stimulation in Veterans With PTSD","Transcranial Magnetic Stimulation in Veterans With PTSD: A Pilot Study to Examine Mechanism of Effect","Inclusion Criteria:\n\n* Age between 19 and 70\n* Eligible for VA healthcare\n* Moderate to severe PTSD as determined by a total score of at least 25 on the CAPS within 7 days of randomization.\n* Agree to have CAPS audio recorded.\n* Ability to obtain a Motor Threshold using the TMS device during screening.\n* If female with childbearing potential, use of acceptable method of birth control (i.e., use of contraceptives, abstinence).\n* Able to read, understand, and sign the informed consent document.\n\nExclusion Criteria:\n\n* Pregnant or lactating woman.\n* MRI is contraindicated\n* Current use of clozapine (any dose) or bupropion (more than 300mg per day).\n* Cardiac pacemaker or implantable defibrillator.\n* Presence of any metal object in the head, including cochlear implants, but excluding dental work in the mouth.\n* Significant central nervous system disorder (stroke, brain mass, epilepsy).\n* Seizure in past one year.\n* Current psychosis or mania.\n* Significant suicidal ideation.\n* Unstable medical conditions.\n* Current alcohol or substance use disorder (except nicotine) that interferes with the patient's ability to participate.\n* CPT or PE for PTSD in the past 2 months.\n* Changes in Fluoxetine, Paroxetine, Sertraline, or Venlafaxine in the past 2 months.\n* Color blind\n* Currently participating in other research studies.\n* Aneurysm Clip\n* Ocular foreign body (e.g., metal shavings)\n* Any implanted device (pumps, infusion devices, etc.)\n* Shrapnel injuries or metal fragments",{"count":481,"type":23},20,[110],"With this research investigators hope to begin to understand how rTMS can improve posttraumatic stress disorder (PTSD) symptoms. TMS improves PTSD through two interrelated mechanisms: change in brain limbic system function and change in systemic inflammatory activation. Participants who decide to join this study, will receive ten rTMS treatments. All participants will undergo a 40-minute rTMS procedure with a member of the study team 10 times over 2-4 weeks. Participants will undergo fMRI scans of the head in order to help researchers better understand potential effects of rTMS on brain activity. In addition, participants will be asked to give two breath and blood samples to look for signs of general inflammation.",[29],"2026-06-11",{"date":487,"type":40},"2026-06-15",{"date":489,"type":40},"2026-01-15",{"date":232,"type":23},{"name":492,"class":493},"White River Junction Veterans Affairs Medical Center","FED",{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":290,"sex":18,"minAge":76,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":24,"phases":503,"briefSummary":504,"conditions":505,"keywords":506,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":522},"100614474","phase-3-reveal-study---diagnostic-testing-for-ptsd-using-the-senseye-diagnostic-tool-100614474","NCT07280065","REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool","Diagnostic Testing of Post-Traumatic Stress Disorder (PTSD) Using the Senseye Diagnostic Tool in Adults : United States, Australia, and Decentralized Trial (DCT) Protocol","Inclusion Criteria:\n\n1. The participant is willing and able to read, understand, and sign the approved Informed Consent Form (ICF).\n2. Age 18 years old or older.\n3. In the past month, participant presents with at least one of the following:\n\n   * nightmares or unwanted, intrusive thoughts\n   * avoidance of specific thoughts or situations\n   * feelings of being constantly on guard, watchful, or easily startled\n   * feeling numb or detached from people, activities, or surroundings; and\u002For\n   * persistent feelings of guilt or self blame for things that have happened.\n   * excessive anxiety and worry (apprehensive expectation), occurring more days than not for at least 6 months, about a number of events or activities (such as work or school performance)\n   * sleep disturbance (difficulty falling or staying asleep, or restless unsatisfying sleep)\n   * depressed mood: most of the day, nearly every day, feeling sad, empty, or hopeless\n   * markedly diminished interest or pleasure in activities: loss of interest or pleasure in most activities, nearly every day\n   * self-report of significant weight loss or gain and\u002For changes in appetite\n   * insomnia or hypersomnia: sleeping too little or too much\n   * psychomotor agitation or retardation: observable restlessness or slowed movements\n   * abnormal fatigue or loss of energy: feeling tired or lacking energy more than usual\n4. Deemed likely to comply with the study protocol by the study team, including willing communication of adverse events (AEs), mental health history, current and past psychiatric medication \\& treatments, and ability to attend all study visits.\n5. Participant agrees to provide emergency contact information at Screening Visit and their physical location at each visit (if they are joining the visit remotely).\n6. Participant is psychologically stable as determined by the investigator or delegate.\n7. Participant has access to the following:\n\n   * a device with stable internet and Wi-Fi connection capable of supporting video calls (e.g., tablet, computer with webcam, etc.)\n   * a second smart device that must be an iPhone 13 or newer (Not inclusive of the iPhone13 Mini)\n8. Participant home\u002Fenvironment meets criteria for Senseye DT setup (remote visits only)\n\nExclusion Criteria:\n\n1. Current diagnosis of epilepsy and\u002For other seizure disorders.\n2. A history of at Screening OR positive at Visit 1 for bipolar I or II, mania, or one or more schizophrenia-spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, delusional disorder, psychotic depression, and psychosis.\n3. Compromised facial neuro-ophthalmic integrity (e.g., due to stroke, MS, ALS, or other neurological conditions).\n4. Current diagnosis of dementia, delirium, amnestic disorders, autism, hydrocephalus, posterior cortical atrophy, aphasia, multiple sclerosis, or stroke-related cognitive dysfunction.\n5. Current eye disorders which prevent the patient from using the Senseye DT:\n\n   * Vision impairment preventing ability to read with correction (including corneal disease, dense cataract, diabetic retinopathy, macular degeneration, glaucoma, etc.).\n   * Use of corrective lenses including glasses and contacts is permitted. Colored contacts and cosmetic lenses that obscure or enhance the pupil are not permitted.\n   * Significant eye lid droop blocking the pupil.\n   * Persistent blurry vision, headaches, and\u002For light sensitivity resulting from conditions including abnormal pupil dilation or reactivity (e.g, mydriasis).\n   * Recent eye surgeries (within 2 weeks) or planned eye surgeries within the study duration.\n   * Intraocular inflammation, including iritis and anterior uveitis.\n   * Ocular trauma resulting in uncorrected or permanent bilateral damage.\n6. Active suicidal and\u002For homicidal intent or other self-injurious behavior which may put the participant and\u002For others at risk per the investigator's clinical judgement, or has suicidal ideation of level 4 or 5 as determined by the C-SSRS.\n7. Suicidal behavior within the last year as determined by the C-SSRS at the time of screening.\n8. Significant suicidal ideation within the last 6 months as determined by ideation of level 4 or 5 by the C-SSRS at the time of screening.\n9. Current reported usage (within 2 weeks of Screening Visit and\u002For planned ongoing usage during the study) of psychotropic drugs and\u002For non-psychotropic drugs or medication which may affect use of the Senseye DT:\n\n   * Narcotics\u002Fopioids (e.g., Heroin, Vicodin, oxycodone, codeine, Tramadol, etc.).\n   * Tricyclic antidepressants (TCAs) (e.g., Tofranil, Pamelor, amitriptyline, doxeprin, etc.).\n   * Monoamine Oxidase Inhibitors (MAOIs) (e.g., Emsam, Parnate, Nardil, Marplan, etc.).\n   * Select antihypertensive medications (alpha-2 receptor agonists, clonidine, peripheral adrenergic inhibitors, Alpha \\& Beta blockers, and Rauwolfia alkaloids). Note: If Prazosin can be abstained from for \\> 24 hours prior to the Senseye DT visit, the exclusion does not apply for that medication.\n\n   Stimulants (e.g., Amphetamines, Ritalin, Focalin, pseudoephedrine\u002FSudafed, ecstasy, cocaine, methamphetamines, cathinones, etc.). Note: Caffeine or nicotine use is not exclusionary. Note: that if Sudafed, pseudoephedrine, and stimulants commonly used to treat ADHD (e.g., Ritalin, Focalin, Adderall, etc. can be abstained from for \\> 24 hours prior to the Senseye DT visit, the exclusion does not apply for those medications.\n   * Psychedelics\u002Fpsychotomimetics (Lysergic acid, psilocybin, mescaline, phencyclidine, methoxetamine, etc.).\n   * Cholinergic or anticholinergic agents (e.g., Urecholine, Pilocar, Aricept, Miostat, Evoxac, ipratropium\u002FAtrovent, oxybutynin\u002FDitropan, scopolamine, etc.), except antihistamines other than Benadryl or diphenhydramine. Note: If Benadryl\u002Fdiphenhydramine can be abstained from for \\> 24 hours prior to the Senseye DT visit, the exclusion does not apply.\n   * Spravato or Ketamine.\n   * Eye drops unless the participant is able to abstain from use for \\> 72 hours prior to the Senseye DT visit. Note: Artificial tears can be used if needed during the Senseye DT use.\n   * Central Nervous System (CNS) depressants (Benzodiazepines and Barbiturates)\n10. Current reported usage (within 2 weeks of Screening Visit and\u002For planned ongoing usage during the study) of vagal nerve stimulation, deep brain stimulation, transcranial magnetic stimulation, or other stimulation or energy-based therapies.\n11. Any condition which precludes the ability for patients to safely and accurately complete clinical assessments, questionnaires, or to follow instructions necessary to administer the Senseye DT (e.g., significant developmental disabilities, language disorders, cognitive deficiencies, or other neurodevelopmental disorders).\n12. Medical diagnosis of Traumatic Brain Injury (TBI) within the last 12 months based on participant self-report.\n13. Lifetime history of any of the following: surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder (e.g., Alzheimer's Disease, Parkinson's Disease), or any other disease\u002Fprocedure\u002Faccident\u002Fintervention that, according to the clinician, is deemed associated with significant injury to, or malfunction of, the CNS.\n14. Involved in active litigation related to the participant's psychiatric symptoms\n15. Pregnancy as determined by self-report.\n16. Currently incarcerated.\n17. Participant requires a legal authorized representative to consent.\n18. Prior enrollment in this study or in other Senseye Machine Learning (ML) studies within the last 12 months.\n19. Unwilling or unable to comply with all study related procedures, in the opinion of the investigator, including medical and non-medical procedures.",{"count":502,"type":23},1900,[80],"The goal of the REVEAL PTSD study is to test how well the Senseye DT works as a diagnostic test for Post-traumatic Stress Disorder (PTSD) in adults 18 and older who are experiencing one or more symptoms that might be related to PTSD.\n\nThe Senseye DT is software as a medical device (SaMD) and is an iPhone app that administers a series of simple tasks on the phone while recording video during the tasks through the front-facing camera. The videos are analyzed by a an Artificial Intelligence (AI) algorithm to identify physiologic signals that might be indicative of PTSD. Data collected in this study will be used to train and tune the AI algorithm, then test it for accuracy.\n\nThe main questions this study aims to answer are:\n\n1. How accurate is the Senseye DT in detecting PTSD compared to structured clinical interviews, the current clinical standard for diagnostic testing?\n2. How accurately does the Senseye DT predict PTSD severity?\n3. How fast is the Senseye DT to use compared to structured clinical interviews?\n\nParticipants will attend a virtual screening visit via video call to determine eligibility and consent to participate. Once enrolled, participants will attend 2 or 3 additional study visits:\n\n* Visit 1: A virtual visit where standard mental health assessments will be given by clinical raters trained in mental health and administering these structured clinical interviews. These assessments include the Structured Interview Guide for the Montgomery-Asburg Depression Rating Scale (SIGMA), the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A), and the MINI International Neurodiagnostic Interview. The Clinician-Administered PTSD Scale for DSM-5 Revised Version (CAPS-5-R) may also be conducted, if randomly selected.\n* Visit 2: A visit to use the Senseye DT. For participants near one of the study's physical site locations, this visit will be done in person at the site. For all others, this visit will be conducted virtually.\n* Visit 3: For participants not randomly selected to have the CAPS-5-R administered at Visit 1, a third and final visit will be scheduled for this assessment. This visit will be conducted virtually.\n\nThe total expected participation time for enrolled participants is 6-7 hours over the course of 2-3 weeks.",[29],[33,145,507,508,509,429,510,511,512],"MDD","Depression","GAD","Nightmares","Major Depressive Disorder","Avoidance","2026-04-28",{"date":515,"type":40},"2026-04-29",{"date":517,"type":40},"2026-02-23",{"date":519,"type":23},"2026-10",{"name":521,"class":97},"Senseye, Inc.",6,{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":341,"enrollmentInfo":530,"targetDuration":4,"studyType":24,"phases":532,"briefSummary":533,"conditions":534,"keywords":539,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":48},"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":531,"type":23},40,[110],"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.",[33,535,29,34,536,537,538],"Post Traumatic Stress Disorder PTSD","Post Traumatic Stress Disorders","Post-traumatic Stress Disorder (PTSD)","Post-Traumatic Stress Disorder, PTSD",[33,540,541,542,543,544,174,545,546,547,548,549,321],"nVNS","Non-invasive","vagus nerve stimulation","vagus nerve stimulator","Post-traumatic stress disorder","non-invasive vagus nerve stimulation (nVNS)","Adjunctive treatment of post traumatic stress disorder","gammaCore","VNS","peripheral nerve stimulation","2026-04-22",{"date":552,"type":40},"2026-04-27",{"date":554,"type":40},"2026-03-02",{"date":556,"type":23},"2027-03",{"name":558,"class":97},"Acacia Clinics",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":20,"enrollmentInfo":565,"targetDuration":4,"studyType":24,"phases":567,"briefSummary":568,"conditions":569,"keywords":575,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":4},"100631852","implementing-action-based-cognitive-remediation-for-transdiagnostic-cognitive-difficulties-in-a-tertiary-mental-health-hospital-100631852","NCT07506070","Implementing Action-Based Cognitive Remediation for Transdiagnostic Cognitive Difficulties in a Tertiary Mental Health Hospital","Inclusion Criteria:\n\n* Participants must have been given a diagnosis of a psychiatric disorder (such as mood anxiety, psychotic disorders, etc.\n* Participants must have reported subjective cognitive difficulties associated with their psychiatric disorder\n* Participants must be capable of providing informed consent\n* Participants must have the ability to speak and read in either English or French\n* Participants must have no changes to their medication intake (such as starting or stopping medication or changing doses) within the past month before providing consent for participation\n\nExclusion Criteria:\n\n* Participants will be excluded if they are hospitalized at the time of recruitment\n* Participants will be excluded if they have a confirmed diagnosis of an intellectual disability",{"count":566,"type":23},160,[110],"Psychiatric conditions are each defined by different set of symptoms, however, they often share common characteristics such as impairments in cognitive and social functioning. These impairments can cause significant distress and disrupt daily functioning by preventing individuals from actively participating in school or work, maintaining healthy relationships with others, and engaging in everyday activities independently. The goal of this clinical trial is to examine if action-based cognitive remediation (ABCR) therapy, a type of cognitive training program, works to treat cognitive impairments in participants with psychiatric disorders.\n\nThe main questions it aims to answer are:\n\n* Whether the intervention will improve the thinking skills of participants with different types of psychiatric conditions\n* Whether the intervention will improve social skills and work performance\n* Can this program be easily used in a regular hospital, and do the people who take part in it find it helpful and worth their time\n* Whether the improvements from the intervention last for a long time after the training is over.\n\nResearchers will compare how much the thinking skills of participants change during an 8-week waiting period (where they get no treatment) to how much they change during the 8-week training program to see if the training makes a bigger difference in helping them think and live better.\n\nParticipants will :\n\n* Complete a series of questionnaires on memory, thinking skills, and mental health at the beginning of the study\n* Wait 8 weeks without any intervention or training\n* Complete the series of questionnaires again\n* Complete an 8-week training intervention of ABCR where they will use special computer programs to practice real-life skills and tasks like planning a meal or making an appointment\n* Complete the series of questionnaires and an additional structured interview to assess acceptability and feasibility of the intervention.\n* 3 month later, complete questionnaires for a final time.",[570,428,571,572,573,29,574],"Psychiatric Disorders","Schizophrenia and Other Psychotic Disorders","Anxiety and Mood Disorders","Bipolar and Related Disorders","Autism Spectrum Disorder",[576,577,578,570,579,580,581,582],"Transdiagnostic","Action-Based Cognitive Remediation","Cognitive Remediation Therapy","Cognitive Impairments","Cognitive Deficits","Neurocognition","Social Cognition","2026-04-15",{"date":585,"type":40},"2026-04-20",{"date":587,"type":23},"2026-05-01",{"date":589,"type":23},"2031-05-01",{"name":591,"class":47},"The Royal Ottawa Mental Health Centre",{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":18,"minAge":600,"maxAge":601,"enrollmentInfo":602,"targetDuration":4,"studyType":24,"phases":604,"briefSummary":605,"conditions":606,"keywords":607,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":48},"100580251","multi-component-family-intervention-to-lower-depression-and-address-intimate-partner-violence-in-nepal-100580251","NCT06834867","Multi-component Family Intervention to Lower Depression and Address Intimate Partner Violence in Nepal","A Randomized Controlled Trial of a Multi-component Family Intervention to Lower Depression and Address Intimate Partner Violence (MILAP) Among Young Women in Nepal","MILAP","Inclusion Criteria:\n\n* Married women aged 15-24 years, their husbands and MILs sharing a household;\n* Living in the catchment area with no stated intention of leaving during the study period;\n* Participants speaking in Maithili or Nepali;\n* Wife reporting Intimate Partner Violence (physical, sexual or abusive control) in last 12 months as measured by three questions from the International Violence Against Women Survey (IVAWS);\n* Expressing desire to remain in the current relationship\u002Ffamily\n\nExclusion Criteria:\n\n* Pregnant women;\n* History of IPV severe enough to result in hospitalization in the past 12 months;\n* Significant cognitive problems\u002Fdisability precluding participation;\n* Any participant with Severe Alcohol Dependence, defined as Severity of Alcohol Dependence Questionnaire (SADQ) \\> 31 (those with mild to moderate dependance will be referred but not excluded)","15 Years","24 Years",{"count":603,"type":23},900,[110],"Intimate Partner Violence (IPV) is a major public health problem in low- and middle-income countries (LMICs). Globally, an estimated 30% of women report physical or sexual violence by an intimate partner in their lifetime. IPV is a well-established social driver of mental health problems, and doubles the rate of depression and post-traumatic stress disorder (PTSD). Interventions like cognitive behavioral therapy (CBT) can improve depression after women experiencing IPV exit abusive relationships. However, despite ongoing violence, many young women in LMICs are less likely to divorce or separate from their husband. But ongoing IPV severely limits mental health recovery and increases the risks of suicide. Another important factor in many LMICs is that young women often live in extended, multi-generational households, where studies have shown that mother-in-laws (MILs) play a critical role in young married women's autonomy and freedom of movement, substantially affecting her mental health. The pathways via which multiple family members and ongoing IPV affect young women's mental health in LMICs is very poorly understood. There is an urgent need to design and assess interventions that: a) improve mental health and reduce IPV; b) engage husbands and MILs, and not just women experiencing IPV; and c) elucidate pathways via which IPV-related drivers affect mental health.\n\nThis study's research team, with over 16 years of experience in Nepal, conducted a pilot study introducing the Multi-component family Intervention to Lower depression and Address intimate Partner violence (MILAP). MILAP, which translates to \"unity and reconciliation\" in Nepali, showed promise in reducing depression and IPV among families (comprising women, husbands, and mothers-in-law). Based on these favorable results, the investigators now propose a 12-month randomized controlled trial (RCT) to assess the effectiveness of MILAP in addressing depression, IPV, and PTSD among young married women in Nepal. The goal of this RCT is to assess the effectiveness of MILAP, understand mechanisms of change for MILAP's effectiveness, and conduct a cost-effectiveness analysis. The specific aims of this study are:\n\nAIM 1: Conduct a 12-month RCT to assess the effectiveness of MILAP on depression, IPV, and PTSD among young married women in Nepal.\n\nAIM 2: Conduct a mixed-methods assessment of theorized mechanisms of change for MILAP's effectiveness.\n\nAIM 3: Conduct a cost-effectiveness analysis of MILAP for depression and IPV.\n\nParticipants of this study will receive either MILAP or enhanced usual care, and will answer questions about depression, IPV and PTSD at baseline, at 1 month and every 3 months until 1-year.",[198,508,29],[608,508,609,434,610,598],"Intimate Partner Violence","Family Intervention","Nepal","2026-04-09",{"date":613,"type":40},"2026-04-14",{"date":615,"type":40},"2025-04-04",{"date":617,"type":23},"2028-04-01",{"name":619,"class":47},"Possible",{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":624,"acronym":625,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":24,"phases":629,"briefSummary":630,"conditions":631,"keywords":632,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":640,"locationsCount":48},"100633330","reported-experience-measurement-on-reducing-patient-discomfort-in-intensive-care-100633330","NCT07525284","Reported Experience Measurement on Reducing Patient Discomfort in Intensive Care","PREMREA","Inclusion Criteria:\n\n* Patient, male or female, aged ≥ 18 years\n* Patient discharged alive from intensive care\n* Patient hospitalised in intensive care for at least three calendar days\n* Patient affiliated with or beneficiary of a social security scheme\n* Patient who speaks French and has signed an informed consent form\n\nExclusion Criteria:\n\n* Patients whose situation is incompatible with completing the IPREA questionnaire\n* Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision\n* Patients hospitalised without consent\n* Pregnant and\u002For breastfeeding women",{"count":628,"type":23},1242,[110],"Hospitalisation in intensive care is always traumatic and can lead to a long rehabilitation process, slowed down by symptoms of anxiety and\u002For depression, and\u002For post-traumatic stress disorder (PTSD). These psychiatric disorders, or post-intensive care syndrome (PICS), can persist for several years after hospitalisation in intensive care and cause functional disability. They are associated with the use of psychotropic drugs and mental health services, and impair health-related quality of life.\n\nThis research is based on the hypothesis that the traumatic nature of intensive care hospitalisation can be reduced by implementing programmes to improve intensive care hospitalisation conditions, promoting changes in the practices of all healthcare professionals involved in intensive care.\n\nIPREA3 study (Kalfon et al, 2017) demonstrated that implementation of a tailor-made, multi-component programme, led by a doctor\u002Fnon-medical caregiver significantly reduced the overall discomfort score (derived from the IPREA questionnaire) perceived by patients hospitalised in an intensive care unit with sufficient experience in applying this programme, having used it for at least 5 months (Kalfon et al, 2017) .\n\nThe originality and interest of this research, in comparison with the IPREA3 study, lie in the following aspects:\n\n* the use of the most recent version of the IPREA questionnaire,\n* the questionnaire was completed by the patient themselves without the intervention of a caregiver (self-administration)\n* the fact that new care practices, aimed at humanising a stay in intensive care and making the experience of a stay in intensive care less traumatic, were described after the publication of the IPREA3 study a\n* a longer programme learning period of 9 months (compared to 5 months during the IPREA3 study)\n* the launch of the PREMREA programme with a conference led by a patient expert",[29],[33,633],"IPREA questionnaire","2026-04-07",{"date":636,"type":40},"2026-04-13",{"date":638,"type":40},"2025-12-19",{"date":382,"type":23},{"name":641,"class":47},"Almaviva Sante",{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":649,"enrollmentInfo":650,"targetDuration":4,"studyType":24,"phases":652,"briefSummary":653,"conditions":654,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":48},"100624503","trial-of-acceptance-and-mindfulness-based-exposure-therapy-ambet-and-present-centered-therapy-pct-100624503","NCT07410481","Trial of Acceptance and Mindfulness-based Exposure Therapy (AMBET) and Present Centered Therapy (PCT)","A Randomized Clinical Trial of Acceptance and Mindfulness-based Exposure Therapy (AMBET) and Present Centered Therapy (PCT)","Inclusion Criteria:\n\n1. Between 18 and 81 years old at the time of consent\n2. Fluency in English\n3. Medical history of cardiac arrest \\>3 months ago\n4. Clinically elevated PTSD symptoms (Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score ≥25)\n5. U.S. Resident\n\nExclusion Criteria:\n\n1. Lifetime history of primary psychotic or bipolar disorders\n2. Current substance use disorder (moderate or severe in the past 6 months)\n3. Active suicidal ideation with some intent to act in past 12 months, and\u002For suicide attempt in past 24 months\n4. Substantial cognitive impairment (Mini Mental Status Exam (MMSE) score \\\u003C25)\n5. Initiation of new psychotropic medication \\\u003C3 months ago\n6. Non-cardiac etiology of CA (drowning, bleeding, trauma, drug overdose, etc)\n7. Terminal illness with life expectancy \\\u003C1 year\n8. Concurrent psychotherapy for PTSD","81 Years",{"count":651,"type":23},90,[110],"The goal of this clinical trial is to learn if a new therapy called Acceptance- and Mindfulness-Based Exposure Therapy (AMBET) helps treat post-traumatic stress disorder (PTSD) in people who survived a cardiac arrest. This study will compare AMBET to another psychotherapy treatment called Present Centered Therapy (PCT) to see which therapy is more effective in treating PTSD.\n\nThe main questions it aims to answer are:\n\nDoes AMBET reduce PTSD symptoms in survivors of cardiac arrest? How do the benefits of AMBET compare to PCT?\n\nParticipants will:\n\n* Be randomly assigned to receive either AMBET or PCT\n* Attend 12 hours of individual psychotherapy sessions over about 12 weeks\n* Complete short weekly surveys about their mood and behaviors online\n* Wear a Fitbit device to track sleep and activity during the study\n* Do brief homework assignments between sessions",[29,655],"Cardiac Arrest (CA)","2026-04-04",{"date":611,"type":40},{"date":659,"type":40},"2026-03-31",{"date":661,"type":23},"2029-03-31",{"name":663,"class":47},"Columbia University",{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":668,"acronym":4,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":314,"enrollmentInfo":670,"targetDuration":4,"studyType":24,"phases":672,"briefSummary":673,"conditions":674,"keywords":675,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":685,"locationsCount":48},"100629337","hyperbaric-oxygen-therapy-for-post-traumatic-stress-disorder---a-pragmatic-double-blinded-randomized-trial-100629337","NCT07473362","Hyperbaric Oxygen Therapy for Post Traumatic Stress Disorder - a Pragmatic, Double Blinded Randomized Trial","Inclusion Criteria:\n\n* Age over 18 years and up to 80 years\n* Ability to understand the researcher's explanation and give informed consent.\n* Any sex or gender (unlike previous studies, a significant effort will be made to include women in this study)\n* A diagnosis of PTSD according to DSM-5 criteria with a severity that warrants discharge from military service.\n\nExclusion Criteria:\n\n* The lack of ability to attend 120 daily (5 times\u002Fweek) treatments at the INMI\n* Current or past psychotic disorder\n* Evidence of active suicidal ideation\n* Evidence of past or present manic disorder\n* Difficulty equalizing pressures, including pulmonary emphysema, significant sinusoidal obstruction, eustachian tube dysfunction, or an pneumothorax that is not drained.\n* Known or suspected pregnancy.",{"count":671,"type":23},72,[110],"Post-traumatic stress disorder (PTSD), affecting approximately 6% of the general population and up to one-third of individuals exposed to combat zones and disasters, is a significant contributor to morbidity and mortality among IDF personnel. Hyperbaric oxygen therapy (HBOT), in which patients breathe oxygen at a partial pressure higher than 1 atmosphere in a hyperbaric chamber, has been investigated in the context of treating a wide range of neuropsychiatric disorders, including PTSD and mild traumatic brain injury (mTBI).\n\nFour controlled studies conducted in patients with mTBI, about half of whom also suffered from PTSD, have yielded conflicting conclusions regarding the potential efficacy of hyperbaric therapy. A single study involving approximately 30 patients with PTSD without mTBI demonstrated significant clinical improvement; however, it was characterized by several methodological limitations-chief among them the absence of blinding or a placebo control. None of the studies conducted to date have reported long-term findings (beyond one year), included patients with a short duration of symptoms (\"early PTSD\"), or included female participants.\n\nThe aim of the proposed study is to conduct a prospective, double-blind, controlled investigation of the biological effect of hyperbaric therapy in PTSD, continuously throughout the hyperbaric treatment course, at the end of treatment, and during a substantial follow-up period of two years after treatment completion.\n\nWe intend to include adult participants who are capable of providing informed consent and who meet DSM-5 diagnostic criteria for PTSD. In order to maintain a pragmatic study with high external validity, exclusion criteria will be limited to those indicating risk (concrete suicidality, or a history of manic or psychotic disorder) or factors likely to impair treatment efficacy (incompatibility with hyperbaric chamber treatment, inability to complete the full treatment protocol, or pregnancy). Participants who miss a substantial number of treatments (five consecutively or one-third of the total treatments) will be withdrawn from the study.\n\nThe primary outcome measure will be the CAPS-5 questionnaire. In addition, PTSD symptom questionnaires, surveys assessing cognitive, executive, affective functioning, and health-related quality of life will be administered. An exploratory outcome will focus on sleep quantity and quality and physiological monitoring using wearable devices, currently considered the most promising biomarker in the context of PTSD.\n\nFollowing enrollment and the provision of informed consent, balanced randomization will be performed with respect to covariates previously described as potential confounders (such as age, duration, and severity of symptoms, …). Participants will receive 60 hyperbaric treatments, five days per week, at either 2.0 atmospheres or 2.5 atmospheres. Both the participants and the evaluating clinical staff will be blinded to treatment allocation.",[29],[33,676,677],"HBO","Hyperbaric Oxygen Therapy","2026-03-10",{"date":680,"type":40},"2026-03-16",{"date":682,"type":23},"2026-03-01",{"date":684,"type":23},"2027-08-31",{"name":686,"class":47},"Medical Corps, Israel Defense Force"]