[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-traumatic-stress-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-traumatic-stress-disorder":200},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,123,0,25,[9,51,81,107,136,163,186,216,243,265,291,315,333,358,384,404,438,460,479,503,523,549,577,600,624],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100357341","multi-site-confirmatory-efficacy-treatment-trial-of-combat-related-ptsd-100357341",false,"NCT03932773","Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD","Inclusion Criteria:\n\n* Veterans of Post-9\u002F11 military conflicts\n* with diagnosis of PTSD based on CAPS-5 related to Post-9\u002F11 military combat\n\nExclusion Criteria:\n\n* current enrollment in an acute experimental treatment for PTSD or trauma-focused psychotherapy treatment\n* PTSD-inducing trauma exposure occurring within the last 3 months prior to pre-enrollment evaluation\n* history of epilepsy or seizure disorder, a history of major head trauma,\n* any neurologic condition likely to increase risk of seizures,\n* brain tumors,\n* moderate to severe substance use disorder in last 3 months or any substance use that puts the participant at increased risk or significant impairment\n* stroke, and blood vessel abnormalities in the brain,\n* dementia,\n* Parkinson's disease, Huntington's chorea, or multiple sclerosis\n* a high suicide risk\n* a lifetime history of psychotic disorder or bipolar disorder\n* inability to stop taking any medication that significantly lowers the seizure threshold\n* pregnant or nursing\n* metal fragments in the head, or any metal objects in or near the head that cannot be safely removed\n* We will screen for a history of traumatic brain injury and exclude potential participants from the study if they have a history of severe TBI or are at high risk for seizures.\n* history of seizures\n* non-English speakers because not all of the screening forms, questionnaires, and tests are available in any language except for English\n* cardiac pacemaker, implanted medication pumps of any sort that would increase the risk of rTMS\n* any current medical condition that could preclude being able to safely participate in TMS treatment,\n* use of prescription medication or illegal substances that lower the seizure threshold\n* previous rTMS","ALL","18 Years","60 Years",{"count":20,"type":21},330,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to examine the benefits of combining repetitive Transcranial Magnetic Stimulation (rTMS) coupled with Cognitive Processing Therapy (CPT) in treating combat-related Posttraumatic Stress Disorder (PTSD) symptoms. The study will also examine change in depression, psychosocial functioning, and neurophysiological (i.e., electroencephalography and magnetic resonance images) measures.",[27],"Post Traumatic Stress Disorder",[29,30,31,32,33,34,35,36,37],"PTSD","post-traumatic stress disorder","military-related PTSD","CPT","cognitive processing therapy","rTMS","repetitive transcranial magnetic stimulation","combat","combat-related PTSD","RECRUITING","2026-08-18",{"date":41,"type":42},"2026-08-20","ACTUAL",{"date":44,"type":42},"2019-05-01",{"date":46,"type":21},"2028-01-01",{"name":48,"class":49},"The University of Texas at Dallas","OTHER",3,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":16,"minAge":17,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100519525","phase-2-mdma-assisted-cbct-for-ptsd-vs-cbct-rct-100519525","NCT06044675","MDMA-Assisted CBCT for PTSD vs CBCT RCT","A Randomized Trial of MDMA-Assisted Cognitive-Behavioural Conjoint Therapy (CBCT) Versus CBCT in Dyads in Which One Member Has Posttraumatic Stress Disorder (PTSD)","Inclusion Criteria\n\n* Participant with PTSD\n\n  1. Participant with PTSD\n  2. Meet criteria for PTSD\n  3. Have a close other person who is able and willing to participate in this study\n  4. Are at least 18 years old\n  5. Are a resident of Ontario and live within the Greater Toronto Area (GTA)\n  6. Are in good physical health\n  7. Are proficient in speaking and reading English\n  8. Are willing to have all visits audio and video recorded\n  9. Are able to swallow pills\n  10. Agree to all study rules and commit to all medical and therapy visits\n  11. If in psychotherapy, are willing to allow the study therapists to communicate directly with your therapist\n  12. Are willing to stop taking psychiatric medications, herbal supplements, prescription and nonprescription medications during the study\n  13. Agree to stay overnight on two separate occasions after each full-day MDMA-Assisted Therapy Session, and not to drive for at least 24 hours after taking MDMA\n  14. Are not pregnant and will commit to not becoming pregnant during the study, if you are able to become pregnant\n  15. Have a supportive relative, spouse, close friend or other caregiver not participating in this study who can serve as your emergency contact\n  16. Agree to inform the researchers within 48 hours of any medical conditions and procedures\n  17. Agree to not participate in any other clinical trials during this study\n* Close Significant Other\n\n  1. Have a close other person who meets criteria for PTSD and is able and willing to participate in this study\n  2. Are at least 18 years old\n  3. Are a resident of Ontario and live within the Greater Toronto Area (GTA)\n  4. Are in good physical health\n  5. Are proficient in speaking and reading English\n  6. Are willing to have all visits audio and video recorded\n  7. Are able to swallow pills\n  8. Agree to all study rules and commit to all medical and therapy visits\n  9. If in psychotherapy, are willing to allow the study therapists to communicate directly with your therapist\n  10. Are willing to stop taking psychiatric medications, herbal supplements, prescription and nonprescription medications during the study\n  11. Agree to stay overnight on two separate occasions after each full-day MDMA-Assisted Therapy Session, and not to drive for at least 24 hours after taking MDMA\n  12. Are not pregnant and will commit to not becoming pregnant during the study, if you are able to become pregnant\n  13. Have a supportive relative, spouse, close friend or other caregiver not participating in this study who can serve as your emergency contact\n  14. Agree to inform the researchers within 48 hours of any medical conditions and procedure\n  15. Agree to not participate in any other clinical trials during this study\n\nExclusion Criteria\n\n* Participant with PTSD\n\n  1. Are pregnant or could become pregnant and not using birth control\n  2. Have a history of, or a current psychotic disorder or bipolar 1 disorder or dissociative identity disorder\n  3. Have a history of a medical condition that could make receiving MDMA unsafe (e.g. glaucoma, heart attack, stroke, aneurysm)\n  4. Have a history of Diabetes Mellitus (Type 2) that a doctor determines is not stable\n  5. Have hypothyroidism (low activity in the thyroid gland) and are not on thyroid replacement\n  6. Have high blood pressure, a history of heart disease, heart failure, irregular activity in the heart or require heart medication\n  7. Have liver disease with symptoms\n  8. Have history of hyponatremia (when you have decreased levels of sodium in the blood, which can cause confusion, seizures, fatigue and low levels of consciousness)\n  9. Have history of hyperthermia (when you have a dangerously overheated body, usually in response to hot, humid weather)\n  10. Weigh less than 48 kg\n  11. Have recently engaged in suicidal behaviour or had serious suicidal thoughts (this will be assessed by the study team)\n  12. Require ongoing therapy with a psychiatric medication\n  13. Have a current eating disorder with active purging\n  14. Have current major depressive disorder with psychotic features\n  15. Are a serious risk to others\n  16. Have recently received Electroconvulsive Therapy (ECT)\n  17. Have recently engaged in ketamine-assisted therapy or used ketamine\n  18. Have current substance use disorder with physiological dependence (not including caffeine or nicotine)\n  19. Have recently used \"Ecstasy\" (material represented as containing MDMA)\n  20. Are not able to give adequate informed consent\n  21. Are not able to adhere to the requirements for procedures, attendance and timing of visits, and observe limits regarding study staff time and support as indicated by a time-limited clinical trial\n  22. Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders\n* Close Significant Other\n\n  1. Meet criteria for PTSD\n  2. Are pregnant or could become pregnant and not using birth control\n  3. Have a history of, or a current psychotic disorder or bipolar 1 disorder or dissociative identity disorder\n  4. Have a history of a medical condition that could make receiving MDMA unsafe (e.g. glaucoma, heart attack, stroke, aneurysm)\n  5. Have a history of Diabetes Mellitus (Type 2) that a doctor determines is not stable\n  6. Have hypothyroidism (low activity in the thyroid gland) and are not on thyroid replacement\n  7. Have high blood pressure, a history of heart disease, heart failure, irregular activity in the heart or require heart medication\n  8. Have liver disease with symptoms\n  9. Have history of hyponatremia (when you have decreased levels of sodium in the blood, which can cause confusion, seizures, fatigue and low levels of consciousness)\n  10. Have history of hyperthermia (when you have a dangerously overheated body, usually in response to hot, humid weather)\n  11. Weigh less than 48 kg\n  12. Have recently engaged in suicidal behaviour or had serious suicidal thoughts (this will be assessed by the study team)\n  13. Require ongoing therapy with a psychiatric medication\n  14. Have a current eating disorder with active purging\n  15. Have current major depressive disorder with psychotic features\n  16. Are a serious risk to others\n  17. Have recently received Electroconvulsive Therapy (ECT)\n  18. Have recently engaged in ketamine-assisted therapy or used ketamine\n  19. Have current substance use disorder with physiological dependence (not including caffeine or nicotine)\n  20. Have recently used \"Ecstasy\" (material represented as containing MDMA)\n  21. Are not able to give adequate informed consent\n  22. Are not able to adhere to the requirements for procedures, attendance and timing of visits, and observe limits regarding study staff time and support as indicated by a time-limited clinical trial\n  23. Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders",true,"80 Years",{"count":61,"type":21},60,[63],"PHASE2","This study aims to evaluate the safety, feasibility, acceptability, and effectiveness of MDMA-assisted Cognitive-Behavioral Conjoint Therapy (CBCT) versus CBCT alone for the treatment of Post-Traumatic Stress Disorder (PTSD). PTSD is a debilitating condition that significantly impacts interpersonal relationships and the functioning of individuals and their loved ones. There is also a well-established reciprocal relationship between interpersonal relationships, PTSD, and recovery.\n\nCBCT is a manualized treatment for PTSD that simultaneously addresses PTSD symptoms and relationship satisfaction. It provides dyads with behavioral tools to navigate PTSD-related challenges, as well as the knowledge behind PTSD and how it impacts relationships. Previous research has demonstrated the efficacy of CBCT in improving PTSD symptoms, partner functioning, and relationship satisfaction in both distressed and non-distressed dyads.\n\nMDMA is a drug commonly used recreationally that has been increasingly studied because of its ability to reduce the impact of PTSD symptoms. The effects of MDMA are reduced fear, enhanced communication, trust and introspection, and increased empathy and compassion. The effects of MDMA create a state that enhances the positive effects of therapy by increasing the ability to tolerate negative emotions and allowing clients to stay engaged in therapy without being overwhelmed by the intense emotions surrounding the memories of traumatic events. It is believed that MDMA may help promote the effects of CBCT due to its ability to induce empathy and interpersonal openness.\n\nThis randomized study is the second study designed to explore the efficacy of combining MDMA-assisted therapy with CBCT. This study will enroll 30 dyads, where one individual has symptoms of PTSD. Participants will undergo a 7-week psychotherapy course, in MDMA-assisted CBCT or CBCT alone. In the MDMA-assisted CBCT, participants will go through CBCT sessions, and two doses of MDMA will be used as an adjunct to psychotherapy. Participants assigned to the CBCT-only condition will go through CBCT sessions and will have the opportunity to crossover and receive the two MDMA sessions after follow-up. The primary goal of this research is to contribute to the literature on MDMA-assisted CBCT by investigating its feasibility, safety, acceptability, and effectiveness, and by comparing it to active PTSD treatments.",[27],[67,68,69],"MDMA","Cognitive Behavioural Conjoint Therapy (CBCT)","Relationship functioning","2026-08-17",{"date":72,"type":42},"2026-08-19",{"date":74,"type":42},"2024-11-15",{"date":76,"type":21},"2027-03-31",{"name":78,"class":79},"Remedy","INDUSTRY",1,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":106},"100499975","phase-2-mdma-assisted-therapy-for-veterans-with-moderate-to-severe-post-traumatic-stress-disorder-100499975","NCT05790239","MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder","A Randomized, Double-Blind, Single-Site Phase II 2-Arm Study to Compare the Safety and Preliminary Efficacy of Manualized MDMA-Assisted Therapy to Low Dose D-Amphetamine Assisted Therapy in Veterans For The Treatment of Moderate to Severe PTSD","Inclusion Criteria:\n\n* At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months.\n* Fluent in speaking and reading the predominantly used or recognized language of the study site (English).\n* Must be a veteran enrolled at a VA Healthcare Center in the Greater Los Angeles area.\n* Able to swallow pills.\n* Agree to have study visits audiovisually recorded, including Experimental Sessions, IR assessments, and non-drug therapy sessions.\n* Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable.\n* Able to identify appropriate support person(s) to stay with the participant on the evenings of Experimental Sessions if needed.\n* May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease.\n* May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.\n* Body weight of at least 45 kilograms (kg). Participants with a body weight of 45-48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg\u002Fm2. BMI must be within 18 to 32 kg\u002Fm2 (inclusive).\n* A person able to be pregnant (PABP) must use a highly effective contraceptive method.\n\nExclusion Criteria:\n\n* Are not able to give adequate informed consent.\n* Have evidence or history of significant medical or psychiatric disorders.\n* Are abusing illegal drugs.\n* Unable or unwilling to safely taper off prohibited psychiatric medication.\n* Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician.",{"count":89,"type":21},40,[63],"This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in participants aged 18 years and older with PTSD of at least moderate severity.",[27],[67,27,29,94,95,96,97],"Functional Impairment","Veteran","Substance Use Disorder","Chronic Pain",{"date":72,"type":42},{"date":100,"type":42},"2025-03-01",{"date":102,"type":21},"2028-03-01",{"name":104,"class":105},"Stephen Robert Marder","FED",2,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":80},"100564429","cognitive-control-training-for-extinction-in-ptsd-100564429","NCT06629064","Cognitive Control Training for Extinction in PTSD","Identifying Clinically Relevant Neural Circuit Mechanisms of Cognitive Control Training for PTSD","Inclusion Criteria:\n\n* Fluent in English\n* Meet current DSM-5 criteria for Posttraumatic Stress Disorder\n* Are willing to attend 8 total remote sessions of working memory training over course of four weeks\n* Are willing to attend MRI scans pre and post working memory training\n* 4-week stability on pharmacological and psychosocial treatments\n\nExclusion Criteria:\n\n* A lifetime history of psychotic disorders, lifetime history of bipolar disorder\n* Past-year severe substance use and severe alcohol use disorder. Mild-to-moderate alcohol use disorder will be allowed to enhance generalizability in our sample due to the high comorbidity of alcohol use and PTSD\n* History of any neurological disorder that might be associated with cognitive dysfunction (e.g., cerebrovascular accident, intracranial surgery, aneurysm, seizure disorder)\n* Acute suicidality requiring immediate clinical intervention\n* Moderate to severe traumatic brain injury (TBI). However, mild to moderate levels of TBI (mTBI) will be included\n* Receiving benzodiazepines or medications with anticholinergic effects that may affect fear learning measures\n* Inability to safely complete fMRI session (i.e., metal in body, medical implants)","65 Years",{"count":116,"type":21},120,[24],"The proposed study will test whether a working memory training (WMT) program improves fear extinction learning and its underlying neural circuitry in Veterans with posttraumatic stress disorder (PTSD). WMT is designed to improves the ability to maintain task-relevant information in mind. The project will further validate the relationship between working memory and fear extinction using novel computational and multivariate analyses that link to specific PTSD symptoms. If WMT can enhance fear extinction learning, then WMT may be a powerful adjunctive treatment that can enhance exposure therapy outcomes or be leveraged as a stand-alone treatment. This project supports the Department of Veteran Affairs mission of developing viable targets of treatment for Veterans with PTSD.",[120,121,27,29,122],"Post-Traumatic Stress Disorders","Stress Disorders, Traumatic","Trauma and Stressor Related Disorders",[122,29,124,125,126],"cognitive training","working memory","Fear Extinction","2026-08-04",{"date":129,"type":42},"2026-08-07",{"date":131,"type":42},"2024-10-01",{"date":133,"type":21},"2028-09-30",{"name":135,"class":105},"VA Office of Research and Development",{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":16,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":80},"100545382","phase-1-warrior-care-cannabis-behavioral-health-100545382","NCT06381180","Warrior CARE: Cannabis Behavioral Health","Wayne Warrior CAnnabis Research and Education: Cannabis and Behavioral Health","CBH","Inclusion Criteria:\n\n* a healthy veteran who has served in a branch of the US armed forces\n* report using cannabis within the past year\n* currently meet DSM-5 criteria for PTSD and a score of 25 or greater on the CAPS-5 (the anchor, or index, trauma does not have to be related to military service)\n* between the ages of 19-69 years old\n* not seeking treatment for Cannabis Use Disorder\n* stable (i.e., under the care of a physician or therapist and not experiencing acute symptoms) on psychotropic medications and\u002For psychotherapy before the study begins (participants can be in treatment for PTSD)\n* agree to adhere to study procedures\n\nExclusion Criteria:\n\n* pregnant, lactating, or heterosexually active women and not using medically approved birth control\n* current or past bipolar or psychotic disorder as determined using the SCID-5\n* at immediate high risk for suicide based on the C-SSRS\n* current SUD other than Nicotine Use Disorder and Alcohol Use Disorder (mild or moderate)\n* allergies and\u002For other contradictions for using cannabis\n* any clinically significant medical problems\n* systolic\u002Fdiastolic BP \\>140\u002F90 mmHg or systolic BP \\\u003C95 mmHg\n* elevated liver function tests\n* exhibit cognitive impairment (\\\u003C80 IQ)\n* enrolled in another clinical trial or have received any drug as part of a research study within 30 days of dosing\n* used a prescription medication (with the exception of birth control) within 14 days of study entry that in the opinion of the medically responsible investigator will interfere with the safety of the participant or the study results\n* unable to provide informed consent","19 Years","69 Years",{"count":147,"type":21},500,[149,63],"PHASE1","This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.",[27,152,153,154,155],"Cannabis Use","Suicide","Veterans","Marijuana",{"date":129,"type":42},{"date":158,"type":42},"2025-09-22",{"date":160,"type":21},"2030-12-31",{"name":162,"class":49},"Wayne State University",{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":29,"eligibilityCriteria":168,"healthyVolunteers":58,"sex":16,"minAge":17,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":80},"100532866","the-effects-of-very-brief-exposure-on-ptsd-in-us-combat-veterans-100532866","NCT06218381","The Effects of Very Brief Exposure on PTSD in U.S. Combat Veterans","Inclusion Criteria:\n\nPatient Population\n\n* Males and females ages 18-50\n* Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) diagnosis of PTSD\n* Traumatic event is a combat-based experience (e.g., being injured, watching a buddy be killed)\n* Minimum score of 18 on the Combat Experience Scale (CES)\n* Minimum score of 3 or more on Primary Care (PC)-PTSD-5\n* Participants with other cooccurring psychiatric disorders (e.g., anxiety, ADHD) will be included to ensure a representative sample.\n\nHealthy Population\n\n• Males and Females, ages 18-50\n\nExclusion Criteria:\n\nPatient Population\n\n* Treatment for PTSD, substance abuse, or mental health concerns in the past 6 months\n* 10 or more years since the combat trauma\n* Acute intoxication\n* Severe level of Substance Dependence (6 or more DSM-V symptoms)\n* Prior diagnosis of Autistic Spectrum Disorders\n* Current or past psychotic disorders or active psychotic symptoms\n* Current Bipolar I Disorder\n* Dementia\n* Neurological or serious medical conditions (e.g., stroke, epilepsy\u002F seizure disorder, cancer, Lupus, HIV+);\n* Traumatic brain injury\n\nHealthy Population\n\n* Ferromagnetic implants (e.g., pacemaker), metal braces, retainers, tattoos or permanent make up w\u002F metallic content, transdermal medicinal patches that cannot be removed\n* Neurological or serious medical conditions (e.g., stroke, epilepsy\u002F seizure disorder, cancer, Lupus, HIV+);\n* Lifetime Diagnosis of PTSD, Tourette's Syndrome, Bipolar Disorder, Substance Dependence, Eating Disorder, Autism Spectrum Disorder, a psychotic disorder, Acute Stress Disorder\n* Lifetime history of traumatic event defined as a life-threatening event involving physical attack, guns, fire or explosion (i.e the kinds of traumatic events combat veterans are likely to experience)\n* Traumatic Brain Injury\n* Birth at less than 37 weeks gestational age\n* Claustrophobia\n* Anxiety Disorder, Mood Disorder, Substance Abuse Disorder, Adjustment Disorder in past 2 years\n* Treatment for mental health concern in past 2 years\n* Pregnant Females","50 Years",{"count":171,"type":21},90,[24],"The goal of this clinical trial is to develop a new behavioral treatment for U.S. combat veterans with post-traumatic stress disorder (PTSD), very brief exposure to combat-related stimuli. The main questions it aims to answer are:\n\n1. How does Very Brief Exposure (combat images and control everyday images) and Visible Exposure to combat stimuli affect brain activity and subjective fear ratings?\n2. To what extent are participants aware of the stimuli presented and tolerating the exposures?\n\nAll participants will view both very brief exposure and visible exposure to combat stimuli in the functional magnetic brain imaging (fMRI) scan. They will provide ratings of fear, awareness, and tolerability. Researchers will compare U.S. combat veterans with PTSD and healthy controls to confirm differences in brain region activation and ratings.",[27],[27,95,176],"Very Brief Exposure","2026-07-28",{"date":179,"type":42},"2026-07-29",{"date":181,"type":42},"2024-03-22",{"date":183,"type":21},"2027-07",{"name":185,"class":49},"Children's Hospital Los Angeles",{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":201,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":80},"100649203","phase-2-long-term-outcomes-following-hbot-100649203","NCT07732374","Long-Term Outcomes Following HBOT","Assessing Follow-Up Effects Post-Discontinuation of Hyperbaric Oxygen Therapy on Cognitive Function, Mental Health, and Quality of Life in Veterans","Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Veteran status\n3. Clinically diagnosed with a mTBI, PCS, PTSD, Anxiety, or Depression disorder.\n4. Successfully completed the parent Hyperbaric Oxygen Therapy (HBOT) intervention, consisting of the full study treatment protocol (40 HBOT sessions).\n5. Willing and able to read, understand, and provide written informed consent for participation in the 12-week follow-up study. Additionally, the Participant has clear consciousness and the ability to express self-feelings independently.\n6. Completed cognitive and psychological measurements.\n7. Clinical diagnoses cause significant impairment in social or occupational functioning or some other functional capacity.\n8. Stability on any current psychoactive medications (antidepressants, anti-anxiety medications, antipsychotics, stimulants, and mood stabilizers).\n\nExclusion Criteria:\n\n1. Acute medical illness or infection\n2. Severe or unstable physical disorders or major cognitive deficits\n3. Current manic, psychotic episodes, or serious suicidal ideations\n4. Non-English speakers\n5. Inability to attend scheduled follow-up visits\n6. Significant life events, new neurological injury, or new psychiatric diagnosis or hospitalization occurring after completion of the HBOT intervention that, in the opinion of the investigator, could confound cognitive, psychological, or quality-of-life outcomes.\n7. Participation in another interventional clinical study or receipt of a therapeutic intervention following completion of HBOT that could influence cognitive, psychological, or quality-of-life outcomes.",{"count":194,"type":21},35,[63],"This study is designed to better understand the long-term effects of hyperbaric oxygen therapy (HBOT). Our goal is to determine whether improvements after treatment are maintained over time and whether additional benefits appear months after treatment has ended. We will evaluate changes in cognitive function, mental health, and daily functioning to help strengthen the scientific evidence supporting the use of HBOT and guide future treatment recommendations.",[198,199,200],"Traumatic Brain Injury","Post-Concussive Symptoms","Post-Traumatic Stress Disorder",[202,203,204,205,206,154,198,207],"Hyperbaric Oxygen Therapy","Treatment Durability","Cognitive Function","Mental Health","Quality of Life","Persistent Post-Concussive Symptoms (PCS)","2026-07-23",{"date":177,"type":42},{"date":211,"type":42},"2026-06-18",{"date":213,"type":21},"2027-06-18",{"name":215,"class":49},"Summit Hyperbarics and Wellness",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":80},"100557448","adaptive-coping-skills-training-to-improve-psychological-distress-among-cardiorespiratory-failure-survivors-100557448","NCT06538246","Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors","Self-directed Mobile Adaptive Coping Skills Intervention to Improve Psychological Distress Symptoms Among Cardiorespiratory Failure Survivors: Blueprint 2","Blueprint 2","Inclusion Criteria Inclusion criteria present in the hospital\n\n1. Adult (age ≥18)\n2. Managed in an ICU or stepdown unit for ≥24 hours during the time inclusion criterion #3 is met\n3. Serious acute cardiorespiratory condition, defined as ≥1 of the following:\n\n   * mechanical ventilation via endotracheal tube for ≥4 hours\n   * non-invasive ventilation (CPAP, BiPAP) for ≥4 hours in a 24-hour period provided for acute respiratory failure\n   * new use of supplemental oxygen ≥6 liters per minute (or increase in baseline continuous oxygen)\n   * use of vasopressors for shock of any etiology\n   * use of inotropes for shock of any etiology\n   * use of pulmonary vasodilators\n   * use of aortic balloon pump or cardiac assist device for cardiogenic shock\n   * use of diuretic intravenous drip\n   * evidence of acute coronary ischemia (i.e., elevated troponin level, supporting EKG changes, unstable angina symptoms documented)\n   * urgent cardiac catheterization\n4. Cognitive status intact\n\n   • No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart\n5. Absence of severe mental illness\n\n   * Treatment for severe mental illness (e.g., psychosis, bipolar affective disorder, schizoaffective disorder, schizoid personality disorder, schizophrenia \\[as per medical record\\], hospitalization for any psychiatric disorder) within the 6 months preceding the current hospital admission\n   * Evidence of poorly managed severe mental illness\n   * No endorsement of suicidality at time of admission or informed consent\n6. Functional fluency in English or Spanish (i.e., sufficient knowledge of English or Spanish to complete study tasks like watch videos, complete surveys)\n\nInclusion criteria present after hospital discharge (i.e., at the time of arrival home after discharge from the hospital)\n\n1\\. Elevated baseline psychological distress symptoms, defined as a Hospital Anxiety and Distress Scale (HADS) total score ≥8\n\nExclusion Criteria Exclusion criteria present in the hospital\n\n1. Active alcohol or drug abuse (e.g., admission for alcohol withdrawal, drug-related complication, positive toxicology screening at admission, endorsement of active addiction)\n2. Anticipated complex medical needs after discharge that would be disruptive to intervention and follow up; for example:\n\n   * Anticipated surgical procedures\n   * Anticipated complex medical regiment (e.g., new chemotherapy, new dialysis, need for repeat surgery, pregnant and near term)\n   * Plan for comfort care\n3. Other complex needs anticipated that could interfere with the ability to complete study procedures. Examples include:\n\n   * Anticipated disruptive travel\n   * Inability to use mobile app\n   * Anticipated unstable living situation\n4. Anticipated or actual discharge to a location other than independent in a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility, home hospice)\n5. Persistently impaired cognition as a result of illness (Impairment defined as ≥3 errors on the Callahan cognitive status screen and\u002For the lack of decisional capacity (i.e., patient could be consented by medical team for a procedure if necessary)\n6. Currently imprisoned or incarcerated or in home detention\n7. Lack a reliable smartphone with cellular data plan or access to the internet\n8. Currently enrolled in another study involving an intervention whose objectives conflict with the objectives of this study\n9. Previously enrolled in the trial\n\nExclusion criteria present after hospital discharge (i.e., at T1 Data Collection conducted at the time of arrival home from the hospital)\n\n1. Failure to randomize within 14 days from planned start date (planned start date is within 3 days post-discharge from the hospital to home to accommodate weekends)\n2. Readmission to hospital before randomization completed",{"count":225,"type":21},400,[24],"Conditions treated in intensive care units (ICUs) such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are common. These can lead to high rates of depression, anxiety, and PTSD that worsen quality of life. Yet there are few effective strategies able to overcome barriers of limited access to mental health care. Even less is known about the experiences of patients from racially and ethnically minoritized populations because of they haven't been included well in past research.\n\nTo address this problem, the investigators developed Blueprint, a mobile app that coaches people to use adaptive coping skills to self-manage their symptoms. The investigators found that it reduced depression symptoms and improved quality of life compared to placebo.\n\nTo confirm these promising findings, the investigators are doing a formal test of Blueprint. The investigators will enroll 400 people who received ICU care from 4 hospitals (Duke, UCLA, Colorado, and Oregon). These patients will be randomized to receive either the Blueprint mobile app or a special Education Program mobile app the investigators developed. -both delivered through similar mobile app platforms. Our specific aims are to see which program improves symptoms better across 6 months of follow up.\n\nThis project addresses national research priorities and could advance the field with a personalizable yet population-focused therapy that could be scaled broadly and efficiently to enhance mental health equity.",[229,230,231,232,233,234],"Depression","Anxiety","Post-traumatic Stress Disorder","Stress","Worries; Pain or Disability","Breath Shortness","2026-07-22",{"date":208,"type":42},{"date":238,"type":42},"2024-10-15",{"date":240,"type":21},"2028-04-15",{"name":242,"class":49},"Duke University",{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":251,"briefSummary":252,"conditions":253,"keywords":254,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":80},"100648315","see-far-cbt-intervention-for-adults-with-ptsd-100648315","NCT07720674","SEE FAR CBT Intervention for Adults With PTSD","A Clinical Study Evaluating the Effects of a SEE FAR CBT Intervention on Psychological Outcomes in Adults With Posttraumatic Stress Disorder.","Inclusion Criteria\n\nParticipants must meet all of the following criteria:\n\n* Age 18 years or older\n* PTSD symptoms, defined as a PCL-5 score of 30 or above\n* Able to provide informed consent\n* Willing and able to participate in 12 weekly individual therapy sessions and complete study questionnaires at baseline, post-intervention, and 3-month follow-up Exclusion Criteria\n\nParticipants will be excluded if they meet any of the following criteria:\n\n* Pregnancy at the time of enrollment, due to the potential influence of pregnancy and childbirth during the treatment or follow-up period on psychological outcomes.\n* Currently receiving psychotherapy of any type that began less than 3 months prior to enrolment.\n* Initiation of psychiatric medication less than 3 months prior to enrolment.",{"count":61,"type":21},[24],"This single-arm clinical intervention study evaluates a 12-session SEE FAR CBT intervention for adults aged 18 years and older with posttraumatic stress disorder (PTSD). SEE FAR CBT is a trauma-focused cognitive-behavioral treatment approach. Participants will complete self-report psychological questionnaires at three time points: baseline, after completion of the intervention, and at a 3-month follow-up. The study aims to examine changes in PTSD symptoms and related psychological outcomes over the course of treatment and follow-up.",[27],[29,255,256],"SEE FAR CBT","Intervention","2026-07-17",{"date":235,"type":42},{"date":260,"type":21},"2026-07",{"date":262,"type":21},"2028-03",{"name":264,"class":49},"Community Stress Prevention Center",{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":278,"overallStatus":281,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":80},"100647790","noninvasive-brain-stimulation-combined-with-written-exposure-therapy-for-ptsd-in-military-personnel-with-tbi-100647790","NCT07715799","Noninvasive Brain Stimulation Combined With Written Exposure Therapy for PTSD in Military Personnel With TBI","A Randomized Clinical Trial Using Noninvasive Brain Stimulation Combined With Written Exposure Therapy for PTSD in Military Personnel With TBI","Inclusion Criteria:\n\n1. U.S military service member or veteran (18-70 years old)\n2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5-R)\n3. History of mild to moderate Traumatic Brain Injury (TBI)\n4. Able to speak, read, and write in English (due to assessment measures and writing intervention)\n\nExclusion Criteria:\n\n1. TBI that occurred within the past three months prior to the baseline assessment\n2. History of significant intracranial pathology (e.g., severe TBI)\n3. History of major neurological disorder (e.g., epilepsy, dementia)\n4. Metallic objects other than dental appliances\u002Ffillings above the shoulders.\n5. Electronic implants that could be susceptible to electrical current (e.g., cardiac pacemaker)\n6. History of skin condition at site of stimulation (e.g., psoriasis)\n7. Current suicidal ideation severe enough to warrant immediate attention\n8. Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization\n9. Current substance use requiring stabilization or hospitalization\n10. Change in anti-convulsive or benzodiazepine medication regimen in past month.\n11. History of adverse effects to previous noninvasive brain stimulation.\n12. Concurrent engagement in another noninvasive brain stimulation or trauma focused psychotherapy.\n13. Currently pregnant or breastfeeding.","70 Years",{"count":274,"type":21},150,[24],"In this study, the investigators are evaluating whether transcranial direct current stimulation (tDCS), a brain stimulation technique, can be combined with Written Exposure Therapy (WET), a standard talk therapy for posttraumatic stress disorder (PTSD) to improve treatment response and improve symptom of traumatic brain injury (TBI).\n\nAfter consenting to be in the study, participants will be asked to complete a baseline assessment of your psychological and physical health that will determine whether you are able to participate in the study. Following the baseline, you will be randomly assigned to receive tDCS or a sham\u002Fplacebo. Everyone will also participate in 5 weekly WET psychotherapy sessions for 5 consecutive weeks. The first appointment will be 90 minutes and the subsequent appointments will be 60 minutes. tDCS or sham\u002Fplacebo will occur during the writing portion of the session. All participants will also be asked to complete 1-, 3-, and 6-month posttreatment follow-up assessments.",[27],[29,279,280],"Transcranial Direct Current Stimulation (tDCS)","Written Exposure Therapy (WET)","NOT_YET_RECRUITING","2026-07-16",{"date":284,"type":42},"2026-07-20",{"date":286,"type":21},"2026-09-30",{"date":288,"type":21},"2030-09-01",{"name":290,"class":49},"The University of Texas Health Science Center at San Antonio",{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":281,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":80},"100647936","cognitive-processing-therapy-for-posttraumatic-stress-disorder-and-co-occurring-lived-experience-stress-100647936","NCT07714083","Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress","Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Current diagnosis of PTSD\n* Self-identification as a sexual or gender minority (SGM) individual\n* Endorsement of SGM stress experiences with moderate distress\n* For patients who take psychiatric medication, stable dose one month prior to enrollment\n* Reside in Massachusetts.\n\nExclusion Criteria:\n\n* Current active suicidal or homicidal ideation with intent or plan\n* Unstable bipolar disorder\u002Fcurrent mania\n* Unstable psychotic disorder\u002Fcurrent psychosis\n* Current severe substance use that warrants immediate medical attention\n* Cognitive impairment or organic disorder (e.g., advanced dementia, severe traumatic brain injury) that impairs ability to complete CPT procedures\n* Past completion of CPT or current trauma-focused treatment\n* Unwillingness to consent to audio or video recording of assessment and treatment sessions",{"count":299,"type":21},52,[24],"Populations facing health disparities include groups with significantly higher rates of posttraumatic stress disorder than the general population who frequently experience lived experience stress, which may complicate posttraumatic stress disorder symptom presentations. However, there are currently no posttraumatic stress disorder treatments designed to meet the unique needs of these individuals.\n\nThe proposed study will pilot an adaptation of Cognitive Processing Therapy (a gold-standard treatment for posttraumatic stress disorder) that has been modified to incorporate the impact of lived experience stress as an additional treatment target. This project has the potential to advance our understanding of how to enhance Cognitive Processing Therapy in order to optimize posttraumatic stress disorder treatment response and mitigate health disparities.",[27],[304,305,306,154],"Cognitive Processing Therapy (CPT)","Lived experience stress","Lived Experience Adapted Protocol (LEAP)","2026-07-15",{"date":284,"type":42},{"date":310,"type":21},"2026-10",{"date":312,"type":21},"2030-07",{"name":314,"class":49},"Boston University",{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":324,"conditions":325,"keywords":326,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":331,"leadSponsor":332,"locationsCount":80},"100647726","brief-see-far-cbt-intervention-compared-with-treatment-as-usual-for-adults-with-ptsd-100647726","NCT07710573","Brief SEE FAR CBT Intervention Compared With Treatment as Usual for Adults With PTSD","A Clinical Study Evaluating the Effects of a Brief SEE FAR CBT Intervention Compared With Dynamic Psychotherapy Treatment as Usual on Psychological Outcomes in Adults With Posttraumatic Stress Disorder","Inclusion Criteria\n\nParticipants must meet all of the following criteria:\n\n* Age 18 years or older\n* PTSD symptoms, defined as a PCL-5 score of 30-60\n* Hebrew-speaking\n* Able to provide informed consent\n* Willing and able to participate in the assigned psychological intervention and complete study questionnaires at baseline, after 6 sessions, after 12 sessions, and at 3-month follow-up Exclusion Criteria\n\nParticipants will be excluded if they meet any of the following criteria:\n\n* Pregnancy at the time of enrollment, due to the potential influence of pregnancy and childbirth during the treatment or follow-up period on psychological outcomes\n* Currently receiving psychotherapy of any type that began less than 3 months prior to enrollment\n* Initiation of psychiatric medication less than 3 months prior to enrollment",{"count":61,"type":21},[24],"This clinical intervention study evaluates a newly developed Brief SEE FAR CBT protocol for adults aged 18 years and older with posttraumatic stress disorder (PTSD), compared with dynamic psychotherapy treatment as usual. Participants in the Brief SEE FAR CBT group will receive 6 focused sessions emphasizing intrusive PTSD symptoms and will then continue to complete the full 12-session SEE FAR CBT protocol. Participants in the control group will receive dynamic psychotherapy as treatment as usual. Psychological outcomes will be assessed using self-report questionnaires at four time points: baseline, after 6 sessions, after 12 sessions, and at a 3-month follow-up. The study aims to examine changes in PTSD symptoms, anxiety, depression, perceived stress, resilience, somatic symptoms, sleep quality, and related psychological outcomes over the course of treatment and follow-up.",[27],[29,327,256],"Brief SEE FAR CBT","2026-07-13",{"date":257,"type":42},{"date":260,"type":21},{"date":262,"type":21},{"name":264,"class":49},{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":58,"sex":16,"minAge":340,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":106},"100593861","walk-with-me-wwm-for-perinatal-grief-100593861","NCT07011940","Walk With Me (WWM) for Perinatal Grief","PeriGrief-II","Inclusion Criteria:\n\n* Within the first month of pregnancy or early infant loss\n* Reside in the United State\n* Speak and read either English or Spanish at a 6th grade reading level\n* 15 or older\n\nExclusion Criteria:\n\n* Not pregnant or has not experienced an early infant loss\n* Does not reside in the United State\n* Does not speak and read either English or Spanish at a 6th grade reading level\n* 14 or younger","15 Years",{"count":342,"type":21},300,[24],"The goal of this clinical trial is to learn if the Along With Me web-based intervention works to decrease posttraumatic stress symptoms and suicidal ideation among bereaved parents following pregnancy and early infant loss. It will also learn whether peer guides provide additional improvements on these outcomes.\n\nThe main questions it aims to answer are:\n\n• Do people who receive Along With Me or Along With Me plus a Peer Guide compared to services as usual have lower posttraumatic stress symptoms and suicidal ideation than those who do not receive the intervention?\n\nResearchers will compare Along With Me and Along With Me plus a Peer Guide to services as usual (referrals made in the hospital setting) to see if Along With Me works to prevent and address posttraumatic stress symptoms and suicidal ideation.\n\nParticipants will:\n\n* Receive access to a mobile app with approximately 10 therapeutic modules about how to manage grief and other symptoms.\n* Receive check-ins with a Peer Guide (in the Peer Guide condition only)",[346,27,347,348,349,350],"Grief","Suicidal Ideation","Miscarriage","Stillbirth","Infant Death",{"date":307,"type":42},{"date":353,"type":42},"2025-07-13",{"date":355,"type":21},"2027-08-31",{"name":357,"class":79},"Oregon Research Behavioral Intervention Strategies, Inc.",{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":22,"phases":368,"briefSummary":369,"conditions":370,"keywords":371,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":80},"100588909","stepped-care-for-posttraumatic-stress-disorder-study-100588909","NCT06947538","Stepped Care for Posttraumatic Stress Disorder Study","Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Access, Engagement, and Effectiveness in Routine Care","STEPPS","Inclusion criteria:\n\nAssessed at pre-screening\n\n* Boston Medical Center primary care patient\n* At least 18 years of age\n* Access to computer or mobile device\n* Able to receive treatments in English or Spanish\n* Able to read at 4th grade level\n\nAssessed at baseline\n\n* Endorsement of Criterion A trauma using the Life Events Checklist for the DSM-5 (LEC-5), assessed at baseline\n* PTSD diagnosis, confirmed by the Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) assessed at baseline\n\n  \\- Concordance between CAPS-5 and PCL-5 at baseline\n* Clinically appropriate for outpatient level of care\n* Stable on psychotropic medication for \\>4 weeks\n\nExclusion criteria:\n\nAssessed at pre-screening\n\n• Patient is currently engaged in clinician-administered therapy\n\nAssessed at baseline (clinician interview)\n\n* Patient is not clinically appropriate for outpatient level of care.\n* Acute risk for suicidal thoughts or behaviors, assessed by the Columbia Suicide Severity Rating Scale, administered by research clinician at baseline.",{"count":367,"type":21},428,[24],"Less than 20% of people with PTSD receive any treatment. This study extends a program of research by the investigator focused on developing adaptive (stepped) interventions for PTSD. The adaptive intervention sequences a digital mental health intervention (DMHI) and brief trauma- and skills-focused treatments for PTSD. The selected treatments are brief and scalable and less burdensome to systems of care. These treatments are: web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), Brief STAIR, and Written Exposure Therapy (WET).",[27],[372,373,374,280,375],"Stepped Care","Skills training in affective & interpersonal regulation (STAIR)","Digital Mental Health Intervention","Adaptive Interventions",{"date":377,"type":42},"2026-07-14",{"date":379,"type":42},"2026-03-12",{"date":381,"type":21},"2029-06",{"name":383,"class":49},"Boston Medical Center",{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":58,"sex":16,"minAge":391,"maxAge":17,"enrollmentInfo":392,"targetDuration":4,"studyType":22,"phases":394,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":80},"100542326","sleep-and-emotion-processing-in-adolescent-post-traumatic-stress-disorder-100542326","NCT06341413","Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder","Sleep and Emotion Processing in Adolescent Post-Traumatic Stress Disorder","Inclusion Criteria:\n\nAll participants must meet all of the following criteria:\n\n* Aged 14-18 years old, inclusive\n* Must agree to inform the investigators within 48 hours of any emergent medical conditions and procedures\n* Able to lie still on their back for up to 1 hour\n* Must not be pregnant\n* Must agree not to participate in any other interventional clinical trials during the duration of the study\n* Must be willing to comply with all study procedures\n* Agree to have study visits video and\u002For audio recorded, including consent visit, clinical assessments (for staff training) and in-laboratory sleep visits (recording deleted within one month of study visit).\n* A primary parent or guardian is willing participate in the study and to provide informed consent\n* Are fluent in or predominantly speaking and reading in English\n\nIn addition, PTSD and TEC youth must satisfy the following criteria:\n\n\\- Must have a history of at least one traumatic event of any type, as defined by the DSM-V. This may include exposure to physical or sexual abuse, witnessing violence against loved ones or friends, traumatic accidents, natural disasters, death of a close family member etc.\n\nAdditional criteria for PTSD youth:\n\n\\- At baseline, meet threshold for DSM-5 criteria for current severe PTSD, as determined by the semi-structured clinical interview (KSADS).\n\nExclusion Criteria:\n\n* Caregiver or adolescent is unwilling or unable to give adequate informed consent.\n* Are likely, in the investigator's opinion and via observation during the screening and clinical assessment period, to be re-exposed to their index trauma or other significant trauma, lack social support, or lack a stable living situation during study participation.\n* Any finding(s), based on the screening process, that the PI feels would make the study unsuitable for the participant.\n* Participation in the last 30 days in a clinical study involving an investigational drug\n* MRI contraindication\n* Claustrophobia or inability lie still in the scanner after practice MRI sessions.\n* Any participant presenting current serious suicide risk, as determined through the KSADS, responses to C-SSRS, and\u002For clinical judgment of the investigator, will be excluded; however, history of suicide attempts is not an exclusion. Would present a serious risk to others as established through clinical interview and contact with treating physician.\n* Neurodevelopmental disorders such as autism spectrum disorder\n* Intellectual Disability (IQ less than 70, per self-report)\n* Currently impaired by any medical condition that would prevent study participation\n* Traumatic brain injury with ongoing symptoms, including headache, visual disturbances, and\u002For impairments in concentration.\n* Neurological disorder(s) such as seizures, epilepsy, or brain tumors (Tourette's disorder, as diagnosed in the KSADS, is not exclusionary for TEC\u002FPTSD youth)\n* Current use of medications or other drugs (i.e., alcohol) in a manner that may interfere with sleep.\n* Possible pregnancy\n\nExclusions for Typically developing youth:\n\n* No history of or current psychopathology, as defined in the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS), with exception of past specific phobia and past, resolved episodes of depressive or anxiety disorders. Provided that:\n\n  * The episode is not current (i.e. does not meet current criteria as assessed by the KSADS),\n  * The participant is not currently receiving psychiatric treatment (medication or psychotherapy) for mood\u002Fanxiety, and\n  * There is no current serious suicide risk (per KSADS\u002FC-SSRS).\n* Current diagnosis of a sleep disorder (self-report).\n* Any history of any traumatic experience as defined by the DSM-V, including IPV exposure, neglect, or emotional abuse etc.\n\nPTSD Youth:\n\n\\- Current diagnosis of or history of psychotic disorder, bipolar disorder, or autism spectrum disorder diagnosed by the KSADS interview. No other co-morbid disorders are exclusionary.\n\nTEC Youth:\n\n\\- A current diagnosis of PTSD or a current diagnosis of or history of psychotic disorder, bipolar disorder, or autism spectrum disorder diagnosed by the KSADS interview.","14 Years",{"count":393,"type":21},180,[24],"The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder (PTSD) and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth.\n\nParticipants will attend 4 study visits:\n\n* A clinical and trauma assessment visit\n* A testing day that may include cognitive testing, surveys, and an MRI.\n* An overnight sleep study following one week of at-home sleep recordings with the device in the sham condition\n* An overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition",[27],{"date":307,"type":42},{"date":399,"type":42},"2024-07-16",{"date":401,"type":21},"2028-12-31",{"name":403,"class":49},"University of Wisconsin, Madison",{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":22,"phases":413,"briefSummary":414,"conditions":415,"keywords":417,"overallStatus":281,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":4},"100647183","phase-2-clinical-trial-of-mdma-assisted-therapy-for-military-service-members-with-posttraumatic-stress-disorder-100647183","NCT07704762","Clinical Trial of MDMA-Assisted Therapy for Military Service Members With Posttraumatic Stress Disorder","A Randomized, Double-Blind, Active-Controlled, Clinical Trial of the Safety, Efficacy, and Durability of MDMA-Assisted Therapy for Military Service Members With Posttraumatic Stress Disorder","Inclusion Criteria:\n\n1. Positive endorsement of at least 1 index trauma on the LEC-5.\n2. Have a PCL-5 total score of 38 or greater at screening.\n3. Meet DSM-5-TR criteria for current PTSD per Mini International Neuropsychiatric Interview (MINI) at screening with a symptom duration of 6 months or longer.\n4. Meet criteria for PTSD diagnosis per CAPS-5-R with a score of 26 or greater.\n5. Are at least 18 years old at the time of enrollment.\n6. Weigh greater than 48 kilograms.\n7. Are able to swallow pills.\n8. Are fluent in speaking, reading, and comprehending English.\n9. Must agree to inform the investigators within 48 hours of any new medications, medical conditions, and procedures.\n10. Females of childbearing potential must have a negative pregnancy test at study entry and prior to each Dosing Session and must agree to use adequate birth control for the duration of the study until at least 30 days after the final dosing session. Adequate birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Non-childbearing potential is defined as permanent sterilization, postmenopausal, or assigned male at birth.\n11. Males must agree to use adequate birth control for the duration of the study until at least 30 days after the final dosing session. Adequate birth control methods for males include double barrier contraception (condom with spermicidal gel or foam), surgical sterility (defined as a vasectomy at least 3 months prior to the screening visit), or abstinence.\n12. Must agree to refrain from sperm, egg, blood, and bone marrow donations for at least 30 days after the final dosing session.\n13. Must have a 12-lead electrocardiogram (EKG) with QTc \\\u003C 450 ms and no clinically significant abnormalities, as determined by a cardiologist.\n14. Are able to demonstrate comprehension of consent form and study instructions, and provide informed consent.\n15. Agree to have study visits recorded, including Dosing Sessions, Independent Rater assessments, and non-drug therapy sessions.\n16. Must provide an emergency contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event a participant is imminently unsafe or unreachable.\n17. Agree to the following lifestyle modifications (described in more detail in the Informed Consent Form): comply with requirements for fasting and refraining from certain medications prior to Dosing Sessions; not participate in any other interventional clinical trials during the duration of this study without prior approval of the Independent Safety Monitor; remain overnight at the study site or have an identified support person that can remain with the participant and escort them to the therapy session the day after each dosing; and commit to medication dosing, therapy, and study procedures.\n18. Must be Active Duty, National Guard, or Reserve in the United States military.\n19. Must receive approval from their command to participate in the study.\n20. Must be DEERS eligible.\n\nExclusion Criteria:\n\n1. History of or current primary psychotic disorder to include Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder 1 assessed via MINI or clinical evaluation.\n2. Current Major Depressive Disorder with Psychotic Features assessed via MINI or clinical evaluation.\n3. Current eating disorder with active purging assessed via MINI or clinical evaluation.\n4. Current Borderline Personality Disorder assessed via SCID-5-PD or clinical evaluation.\n5. Any of the following findings on Screening C-SSRS:\n\n   1. Suicidal ideation score of 5 within the last month\n   2. Suicidal ideation score of 4 or greater in the last month at a frequency of once per week or more\n   3. Any suicidal behaviors within the last 3 months. The exception is that non suicidal self-injurious behavior is not exclusionary if approved by the PI.\n6. Current high suicide risk or is likely to require psychiatric hospitalization, as determined through C-SSRS, clinical interview, or clinical judgment of the investigator. Distant history of suicide attempts without current high suicide risk factors is not exclusionary.\n7. Current severe substance use disorder (6 or more criteria per MINI) not in sustained remission (criteria not met for past 12 months) at time of enrollment. I.e., severe substance use disorders may only be included if in sustained remission. Tobacco\u002Fnicotine use disorders may be included regardless of severity.\n8. Current moderate substance use disorder (4-5 criteria per MINI) not in early remission (criteria not met for past 3-12 months) or sustained remission (criteria not met for past 12 months) at time of enrollment. I.e., moderate substance use disorders may only be included if in early or sustained remission (criteria not met for 3 or more months). Tobacco\u002Fnicotine use disorders may be included.\n9. For any illicit or prescribed substance: current substance use disorder of any severity, not in sustained remission (criteria not met for past 12 months). I.e., substance use disorders of any severity with illicit or prescribed substances may only be included if in sustained remission.\n10. Any urine drug testing during screening or enrollment that is confirmed positive for a non-prescribed substance, and the result cannot be better explained as a false positive due to another concomitant prescribed medication or proven dietary practice.\n11. Have current or history of psychiatric diagnoses or symptoms that may negatively affect study participation.\n12. Clinically significant abnormalities on screening 12-lead EKG or 1 minute 12-lead rhythm strip that precludes administration of MDMA, stimulants, or sympathomimetics, as determined by a cardiologist.\n13. Two or more premature ventricular contractions (PVCs) on 1-minute rhythm strip. 1 minute 12-lead rhythm strip will be obtained when there are one or more PVCs on screening EKG or when indicated by a cardiologist.\n14. Resting QTc ≥ 450 ms.\n15. History of drug-induced QTc prolongation.\n16. Inability to hold or discontinue concomitant medications that significantly prolong the QTc interval.\n17. Clinically significant cardiac or cardiovascular abnormalities, including history of myocardial infarction, unexplained exertional syncope, Torsade de Pointes, congenital long QT syndrome, hypertrophic cardiomyopathy, congestive heart failure, family history of Long QT Syndrome, persistent atrial fibrillation, symptomatic valvular heart disease, asymptomatic severe aortic stenosis, asymptomatic severe mitral stenosis, history of diagnosis of aortic dissection or asymptomatic aortic aneurysm \\> 4.5 cm at the sinus of Valsalva, or history of untreated angina pectoris or unrevascularized coronary stenosis \\> 70%.\n18. Current clinically significant electrolyte abnormalities, to include hyponatremia and hypokalemia.\n19. Has clinically significant abnormal laboratory results during screening that indicate impaired liver function, to include ALT or AST \\>2x ULN or Total bilirubin \\>1.5 mg\u002FdL unless history of Gilbert's Syndrome\n20. Renal disease defined as eGFR \\\u003C45 mL\u002Fmin\u002F1.73m² or creatinine \\>2.0 mg\u002FdL, end-stage kidney disease, dialysis, history of renal transplant, clinically significant or progressive renal disease deemed to increase risk, or recent\u002Funstable renal function consistent with acute kidney injury at screening. Participants with eGFR 45-59 mL\u002Fmin\u002F1.73m² may be eligible only if renal function is stable and cleared by the study physician.\n21. Uncontrolled essential hypertension defined as blood pressures of greater than 140\u002F90 mmHg assessed on three separate occasions. May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if additional screening is passed to rule out underlying cardiovascular disease.\n22. Uncontrolled hypothyroidism. May have hypothyroidism if taking adequate and stable thyroid replacement medication.\n23. Type 2 Diabetes Mellitus with comorbid cardiovascular disease. May have a history of or current Type 2 Diabetes Mellitus if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval by the Independent Safety Monitor.\n24. Glaucoma without approval from an ophthalmologist. May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist.\n25. History of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to, a history of cerebrovascular disorders (cerebrovascular accident, aneurysm, arteriovenous malformations, or carotid stenosis). Participants with other mild, stable chronic medical conditions may be enrolled if the study physician and Independent Safety Monitor agree the condition is unlikely to confer a significant additional health risk with administration of MDMA. This includes conditions such as gastroesophageal reflux disease and chronic low back pain.\n26. Current medical diagnoses or physical health symptoms that may negatively affect study participation.\n27. Report any prescribed or non-prescribed lifetime personal use history of MDMA, 3,4 methylenedioxymethamphetamine, midomafetamine, \"Ecstasy,\" \"Molly,\" \"Mandy,\" or \"Adam.\"\n28. Lack adequate social support, in the judgement of the PI.\n29. Unable to safely taper off prohibited concomitant medications.\n30. Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control.\n31. Have any current or anticipated problem which, in the opinion of the PI or Independent Safety Monitor, may interfere with study participation.",{"count":412,"type":21},86,[63],"This study is a Phase 2, randomized, double-blind, active-controlled, two-arm, single-site clinical trial designed to evaluate the safety, tolerability, and feasibility of MDMA-Assisted Therapy (MDMA-AT) for Service Members (Active Duty, Guard, or Reserve) diagnosed with moderate-to-severe Post-Traumatic Stress Disorder (PTSD) within a Military Health System (MHS) setting.\n\nThe trial incorporates Acceptance and Commitment Therapy (ACT) as a core therapeutic modality. Participants will receive MDMA-AT utilizing either full-dose or active-control low-dose MDMA. The trial will also assess a regional referral center model by recruiting participants locally from the National Capital Region and non-locally across the MHS.",[29,416,27],"Post Traumatic Stress Disorder PTSD",[418,419,420,421,422,423,424,67,425,426,427,428,429],"Post-Traumatic Stress Disorder (PTSD)","Acceptance and Commitment Therapy (ACT)","Service Members","Trauma","Psychotherapy Modality","Psychiatric Disorders","3,4-Methylenedioxymethamphetamine","Active Duty","MDMA-Assisted Therapy","Phase II","Active Controlled","Psychedelic-Assisted Therapy","2026-07-09",{"date":307,"type":42},{"date":433,"type":21},"2026-10-01",{"date":435,"type":21},"2028-10-01",{"name":437,"class":105},"U.S. Army Medical Research and Development Command",{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":22,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":80},"100495512","phase-2-preliminary-effectiveness-of-individual-and-group-mdma-assisted-therapy-for-israeli-veterans-with-ptsd-and-moral-injury-100495512","NCT05732155","Preliminary Effectiveness of Individual and Group MDMA-assisted Therapy for Israeli Veterans With PTSD and Moral Injury.","Preliminary Effectiveness of Individual and Group MDMA-assisted Therapy for Israeli Veterans With PTSD and Moral Injury From Special Forces Undercover Units","Inclusion Criteria:\n\n* Are veterans of special forces undercover units in the Israeli army.\n* Are fluent in speaking and reading the predominantly used or recognized language of the study site (Hebrew).\n* Are able to swallow pills.\n* Agree to have study visits recorded, including Experimental Sessions, and non-drug psychotherapy sessions.\n* Must provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.\n* Must agree to inform the investigators within 48 hours of any medical conditions and procedures.\n* Agree to the following lifestyle modifications : comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the study, remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures.\n* At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of 6 months or longer.\n* At Screening, have at least moderate PTSD symptoms in the last month, based on PCL-5 total score of 36 or greater.\n* May have well-controlled hypertension.\n* May have asymptomatic Hepatitis C virus (HCV).\n* May have alcohol or substance use disorder.\n* May have a history of or current Diabetes Mellitus (Type 2).\n* May have hypothyroidism if taking adequate and stable thyroid replacement medication.\n* May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist.\n\nExclusion Criteria:\n\n* Are not able to give adequate informed consent.\n* Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session; or have previously participated in a MAPS-sponsored MDMA clinical trial.\n* Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation.\n* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the sponsor-investigator or study clinician, contraindicates participation in the study.\n* Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.\n* Have a history of or a current primary psychotic disorder.\n* Have a current eating disorder with active purging assessed via MINI and clinical interview.\n* Have current major depressive disorder with psychotic features assessed via MINI.\n* Have a current alcohol or substance use disorder other than caffeine or nicotine that the investigators, therapy team, and\u002For study physician judge to be a safety concern for enrollment in the study.\n* Have an active illicit (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment.\n* Have current Personality Disorders.\n* .Any participant presenting current serious suicide risk,\n* Require ongoing concomitant therapy with a psychiatric medication with exceptions described in protocol section on Concomitant Medications.\n* Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate.\n* Have uncontrolled essential hypertension using the standard criteria of the American Heart Association (values of 140\u002F90 milligrams of Mercury \\[mmHg\\] or higher assessed on three separate occasions).\n* Have a history of ventricular arrhythmia at any time, other than premature ventricular contractions (PVCs) in the absence of ischemic heart disease.\n* Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.\n* Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening.\n* Have a marked Baseline prolongation of QT\u002FQTc interval . QTc interval \\> 450 milliseconds (ms) in males and \\>460 ms in females corrected using Fridericia's formula.\n* Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).\n* Require use of concomitant medications that prolong the QT\u002FQTc interval during Experimental Sessions.\n* Have symptomatic liver disease or have significant liver enzyme elevations.\n* Have history of hyponatremia or hyperthermia.\n* Weigh less than 48 kilograms (kg).\n* Have engaged in ketamine-assisted therapy or used ketamine within 12 weeks of enrollment.",{"count":61,"type":21},[63],"The overall objective of this study is to use standard clinical measures to explore the safety and preliminary effectiveness of open-label MDMA-assisted therapy with a flexible dose of methylenedioxymethamphetaminel, in participants with Post traumatic Stress Disorder and moral injury, in individual and group treatment settings.\n\nThe overall safety objective is to assess the severity, incidence, and frequency of AEs, AEs of Special Interest (AESIs), and Serious Adverse Events (SAEs), concomitant medication use, suicidal ideation and behavior and vital signs .",[27,449,450],"Moral Injury","MDMA ('Ecstasy')","2026-07-07",{"date":453,"type":42},"2026-07-08",{"date":455,"type":42},"2023-06-01",{"date":457,"type":21},"2028-12-01",{"name":459,"class":49},"HaEmek Medical Center, Israel",{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":22,"phases":468,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":475,"leadSponsor":477,"locationsCount":80},"100636705","phase-2-mdma-therapy-in-veterans-with-ptsd-100636705","NCT07569159","MDMA Therapy in Veterans With PTSD","A Phase 2, Open-Label Study Investigating the Safety and Efficacy of MDMA-Assisted Therapy for Veterans With Posttraumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n* Veterans who are at least 18 years old\n* Are able to swallow pills\n* Are able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.\n* Proficient in speaking and reading English.\n\nExclusion Criteria:\n\n* Condition impairing oral intake or digestive absorption.\n* Unable to give adequate informed consent.\n* Significant suicide risk as defined by suicidal ideation with intend and plan as endorsed on items 5 on C-SSRS within the past 3 months\n* Cardiovascular disease, including, but not limited to, coronary artery disease (CAD) and chronic heart failure (CHF)\n* A history of, or a current primary schizophrenia, schizoaffective disorder or any form of psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality disorders.\n* Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control if sexually active with a biologically male partner.\n* Current enrollment in any investigational drug or device study or participation in such within 30 days of screening.",{"count":299,"type":21},[63],"A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.",[27],"2026-06-30",{"date":473,"type":42},"2026-07-01",{"date":471,"type":21},{"date":476,"type":21},"2027-08",{"name":478,"class":49},"Sunstone Medical",{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":487,"minAge":17,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":490,"briefSummary":491,"conditions":492,"keywords":493,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":80},"100585485","phase-2-psilocybin-assisted-therapy-for-sexual-assault-related-ptsd-100585485","NCT06902974","Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD","A Phase 2, Open-Label Study Investigating the Safety and Efficacy of Psilocybin-Assisted Therapy for Sexual Assault-Related Posttraumatic Stress Disorder (PTSD)","SUN004","Inclusion Criteria:\n\n* Cisgender women who are at least 18 years old.\n* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current PTSD secondary to sexual assault (i.e., index trauma is sexual assault that occurred 6 or more months in the past).\n* CAPS-5 score of 25 or higher at Baseline.\n* Are able to swallow pills.\n* Are willing to be driven home after the Dosing Session with a family member or caregiver or trusted transportation.\n* Are able to complete all protocol-required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.\n* If able to become pregnant (i.e., with uterus and associated reproductive organs, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry and prior to the Dosing Session, and must agree to use adequate birth control through 10 days after the Dosing Session if sexually active with a biologically male partner. Adequate birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom).\n* Must agree to inform the clinical investigators within 48 hours of any medical conditions and procedures.\n* Are proficient in speaking and reading English.\n* Agree to have all clinic visit sessions recorded to audio and\u002For video. Participants may opt out of the data analysis of the recordings.\n* Agree to the following lifestyle modifications: a light breakfast 2 to 3 hours before dosing is permitted, however, participants will refrain from caffeine and nicotine 2 hours prior to dosing sessions and at least 6 hours after dosing, abstain from alcohol for 24 hours prior to dosing, not enroll in any other interventional clinical studies during the duration of the study, be driven home after the Dosing Session, and commit to medication dosing, therapy, and study procedures.\n* Agree to refrain from beginning new medication and\u002For psychotherapy treatment.\n* Continued treatment with SSRIs will be permitted if participants have been on a stable dose for 3 months or longer prior to enrollment. However, participants must be tapered off of monoamine oxidase inhibitors (MAOIs) prior to dosing.\n\nIn addition, participants may remain in stable (\\> 3 months) psychotherapy.\n\n* May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines.\n* May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.\n* May have alcohol or substance use disorder if participant is not in withdrawal or requiring detox. Participants must have a plan, agreed upon by the principal investigator or designated physician, to reduce use of alcohol or other substances and to manage symptoms without self-medicating. Enrollment will require that, in the judgment of the principal investigator or designated physician, the plan for decreasing substance use is realistic and has a good chance of succeeding in order to prevent substance use from impacting the safety or efficacy of the investigational treatment.\n* May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval by the principal investigator or designated physician.\n* May have hypothyroidism if taking adequate and stable thyroid replacement medication.\n\nExclusion Criteria:\n\n* Male\n* Condition impairing oral intake or digestive absorption.\n* Are not able to give adequate informed consent.\n* Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on items 5 on the C-SSRS within the past 3 months\n* Have any current problem which, in the opinion of the principal investigator or designated physician, might interfere with participation.\n* Would present a serious risk to others as established through clinical interview and contact with treating therapist.\n* Have a history of, or a current primary, schizophrenia, schizoaffective disorder or any form of psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality disorders.\n* Require ongoing concomitant therapy with a psychiatric medication with exceptions described below (see Section 6.6).\n* Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.\n* Have evidence or history of recent stroke (\\\u003C 6 months from signing of ICF), recent myocardial infarction (\\\u003C 6 months from signing of ICF), or clinically significant arrhythmia within 1 year of signing the ICF.\n* Have evidence or history of significant (controlled or uncontrolled) hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of psilocybin administration.\n* Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140\u002F90 milligrams of Mercury \\[mmHg\\] or higher).\n* Abnormal and clinically significant results on vital signs, ECG, or laboratory tests at screening and baseline\n* Have symptomatic liver disease.\n* Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control if sexually active with a biologically male partner.\n* Have hypersensitivity to any ingredient of the study drug.\n* Positive urine drug screen for illicit drugs or drugs of abuse prior to the Dosing Session. Any positive urine drug test will be reviewed with participants to determine the pattern of use and eligibility will be determined at the investigator's discretion.\n* Current enrollment in any investigational drug or device study or participation in such within 30 days of screening.\n* Other personal circumstances and behavior judged to be incompatible with establishment of rapport or safe exposure to psilocybin or completion of clinical study procedures (e.g., active participation in legal proceedings).","FEMALE",{"count":489,"type":21},70,[63],"A Phase 2, Open-Label Study to explore the efficacy, safety, and tolerability of psilocybin-assisted therapy in women with sexual assault-related Posttraumatic Stress Disorder (PTSD).",[27,29],[29,494,495,496],"sexual assault","psilocybin","posttraumatic stress disorder",{"date":473,"type":42},{"date":499,"type":42},"2026-05-23",{"date":501,"type":21},"2028-05",{"name":478,"class":49},{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":114,"enrollmentInfo":510,"targetDuration":4,"studyType":22,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":80},"100538689","etms-for-veterans-and-first-responders-with-ptsd-100538689","NCT06294106","eTMS for Veterans and First Responders With PTSD","Electroencephalogram (EEG) Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n* Veteran or first responder\n* diagnosed with post-traumatic stress disorder with PCL-5 cutoff of 31 or above\n\nExclusion Criteria:\n\n* Claustrophobia\n* Contraindications to MRI\n* Pregnant\n* Uncontrolled medical, psychological, or neurological conditions\n* Unable to calculate EEG alpha frequency\n* History of ECT or rTMS\n* History of intracranial lesion or increased intracranial pressure\n* History of stroke\n* History of other neurologic conditions\n* Family history of epilepsy\n* Personal history of epilepsy\n* certain medications",{"count":511,"type":21},20,[24],"A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial.",[27],{"date":516,"type":42},"2026-07-02",{"date":518,"type":42},"2024-06-10",{"date":520,"type":21},"2028-09",{"name":522,"class":49},"Virginia Polytechnic Institute and State University",{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":22,"phases":532,"briefSummary":533,"conditions":534,"keywords":535,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":548},"100496994","reducing-posttraumatic-stress-disorder-ptsd-symptoms-in-first-responders-and-frontline-health-care-workers-100496994","NCT05751473","Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in First Responders and Frontline Health Care Workers","Reducing PTSD Symptoms in First Responders and Frontline Healthcare Workers Through Trauma-focused Treatment in Employee Assistance Programs","Inclusion Criteria:\n\n* Are employees at an orginization served by a participating EAP\n* Have a Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score ≥33\n* Have had psychotropic medication stability for at least 4 weeks\n\nInclusion criteria for the qualitative portion of the study:\n\n\\- Enrolled into the randomized clinical trial and were a treatment responder or were a treatment non-responder\n\nExclusion Criteria:\n\n* Severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)\n* High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form: found in protocol)\n* Need for detoxification\n* Active psychosis or unmanaged bipolar disorder, as measured by items 12 and 13 of the cross cutting assessment\n* Currently engagement in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy).\n* Patients who do not speak English will be excluded for logistical reasons.",{"count":531,"type":21},410,[24],"This study addresses PTSD symptoms in First Responders and Healthcare workers. Specifically, it tests whether a brief PTSD treatment (talk therapy) effectively treats PTSD when provided to First Responders and Healthcare workers by counselors in Employee Assistance Programs (EAPs).\n\nThe central hypothesis is that the PTSD treatment, Prolonged Exposure for Primary Care (PE-PC), will reduce PTSD symptoms and improve functioning, compared to EAP Treatment as Usual (TAU).",[27],[536,537,538,539],"Employee Assistance Programs","Frontline Healthcare Workers","Prolonged Exposure for Primary Care","First Responders","2026-06-29",{"date":473,"type":42},{"date":543,"type":42},"2023-05-16",{"date":545,"type":21},"2027-07-30",{"name":547,"class":49},"University of Michigan",14,{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":16,"minAge":556,"maxAge":114,"enrollmentInfo":557,"targetDuration":4,"studyType":22,"phases":559,"briefSummary":560,"conditions":561,"keywords":563,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":573,"leadSponsor":575,"locationsCount":80},"100601009","phase-2-mindfulness-based-psilocybin-therapy-for-ptsd-100601009","NCT07104916","Mindfulness-based Psilocybin Therapy for PTSD","A Pilot Mechanistic RCT of Psilocybin With Mindfulness-based Therapy vs Support for Posttraumatic Stress Disorder (PTSD)","Inclusion Criteria\n\nParticipants meeting the following criteria will be included in the study:\n\n1. Participant is assigned female or male at birth.\n2. Participant is aged between 21 to 65 years, inclusive, at Screening. This is to reduce variability in brain function and connectivity in this small pilot study that may be related to age \u002F developmental factors in persons under 21 and over 65.\n3. Participant has a BMI of 18 to 30 kg\u002Fm2, inclusive, at Screening.\n4. Participant has a diagnosis of PTSD (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \\[DSM-5\\] established through a clinician interview that includes the Mini-International Neuropsychiatric Interview \\[MINI\\]) and the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).\n5. PTSD severity moderate to severe based on CAPS-5 score ≥25, and with moderate depression MADRS ≥20.\n6. Participants capable of producing sperm must use a condom during the trial and for 3 months after their dose of trial medication, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must also use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) from dosing until 3 months following dosing. Condoms alone and abstinence are not considered highly effective methods of contraception.\n7. Participants of childbearing potential must agree to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) in combination with use of a condom by a partner who is capable of producing sperm, during the trial and for 3 months after dosing. Condoms alone and abstinence are not considered highly effective methods of contraception. Such participants must have a negative pregnancy test at Screening and Day 1.\n8. Participants of non-childbearing potential who are or were capable of producing eggs (ova) must be postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy or bilateral oophorectomy. Postmenopausal is defined as spontaneous amenorrhea for at least 12 months, and a serum follicle stimulating hormone (FSH) level in the menopausal range, unless the participant is taking hormone replacement therapy or is using hormonal contraception.\n9. Provision of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.\n\nIf appropriate, describe why certain populations may be excluded (e.g., non-English speaking individuals for studies involving informed consent).\n\nExclusion Criteria\n\nParticipants with the following will be excluded from study participation:\n\n1. Cardiovascular disease, including coronary artery disease (CAD) and congestive heart failure (CHF). This is an FDA requirement.\n2. Current or previously diagnosis of schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder or brief psychotic disorder; current or previous history of bipolar disorder, or current personality disorder (as determined by MINI at Screening). This is an FDA requirement.\n3. Clinically significant risk of suicidality, as determined through a comprehensive psychiatric interview that incorporates the Columbia Suicide Severity Rating Scale (CSSRS); a score of 4 or higher on the suicidal ideation subscale of C-SSRS (past 6 months) or any suicidal behaviour (lifetime), would be exclusionary.\n4. History of substance use disorder within the 12 months, as assessed by a structured clinical interview (Mini International Neuropsychiatric Interview \\[MINI\\], Version 7.0.2) or determined by self-report, or intake of \\>21 units of alcohol weekly, and the inability to refrain from alcohol use from 48 hours before Screening and each scheduled visit until discharge from the study site. One unit is equivalent to a 285 mL glass of full-strength beer or 1 (30 mL) measure of spirits or 1 glass (100 mL) of wine.\n5. Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, other non-SSRI or non-SNRI antidepressants (e.g. bupropion, mirtazapine, etc), an antipsychotic or a mood stabilizer.\n6. Exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, LSD or peyote more than 10 times in the last 10 years, or any psychedelic use within 6 months prior to Screening.\n7. Use of psychotropic medicine\u002Fsupplement (or medicine\u002Fsupplement that would interact with psilocybin) including buspirone and venlafaxine, during the 28 days before dosing. Participants may take a stable chronic dose of other SSRI antidepressant medication(s) and\u002For sedatives\u002Fhypnotics. The Investigator and study team may review medication on a case-by-case basis to determine if its use would compromise participant safety or interfere with study procedures or data interpretation.\n8. Family history of schizophrenia or schizoaffective disorder (first degree relatives), or bipolar disorder type 1 (first degree relatives).\n9. Clinically relevant history of abnormal physical health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including \\[but not limited to\\], neurological, endocrine, cardiovascular, respiratory, gastrointestinal (including dyspepsia or gastroesophageal reflux disease), hepatic, or renal disorder).\n10. Participant has a presence or relevant history of any of the following medical conditions: organic brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain tumor or other medical conditions associated with seizures or convulsions).\n11. Diagnosis of hypertension or arrhythmia.\n12. Clinically relevant abnormal heart rate (resting supine heart rate \\>100 bpm) or blood pressure (resting supine systolic blood pressure (SBP) above 140 mmHg or diastolic blood pressure (DBP) above 90 mmHg) at screening. Screening supine SBP, DBP and heart rate for evaluation will be the average of 3 readings obtained after at least 5 minutes rest. Participants with abnormal vital signs which are out of range and deemed clinically significant by the Investigator at Day 1, following triplicate readings.\n13. Presence of clinically significant ECG abnormalities at the Screening visit, as defined by medical judgement.\n14. QT interval corrected for heart rate using Fridericia's formula (QTcF) \\>450 msec at Screening, following triplicate ECG readings.\n15. Hypothyroidism and\u002For current abnormal thyroid function tests. In case of uncertain or questionable screening thyroid function test results, the TSH test may be repeated once during screening. The TSH test must be reviewed to ensure that it is within normal limits before randomizing a participant into the study.\n16. Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at Screening. In case of uncertain or questionable results, tests performed during Screening may be repeated once to confirm eligibility or judged to be clinically irrelevant.\n17. Other eligibility considerations (i.e., participant personal circumstances, behavior, and\u002For any current problem that might interfere with participation or that is incompatible with establishment of rapport or safe exposure to psilocin), as judged by the Investigator.\n18. History or clinical evidence of any disease and\u002For existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion (ADME) of the study drug.\n19. Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study as outlined in this Protocol, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study.\n20. Participant is not fluent in English. Participants must be fluent in English because the consent form as well as all assessments are written and will be administered\u002Fcommunicated in English.\n21. Aspartate aminotransferase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT) or total bilirubin levels ≥1.5 x the upper limit of normal (ULN) at Screening. These laboratory evaluations may be repeated once at the discretion of the Investigator. If the repeat test is within the reference range, the participant may be included if the Investigator considers that the previous finding will not introduce additional risk factors.\n22. Positive urine test for drugs of abuse or alcohol breath test at Screening or Day 1. A positive test for cannabinoids (e.g., marijuana) at Screening may not exclude a participant if after discussion with and evaluation by the Investigator, the participant agrees not to use any marijuana or other cannabinoid products during the study, and if allowed to participate, the participant must test negative for cannabinoids on Day 1.\n23. Participant who consumes excessive amounts of caffeine (e.g., coffee, tea, caffeinated sodas) or (methyl) xanthines (e.g., chocolate) based on the Investigator's determination and discretion.\n24. The participant has participated in a clinical study and has received a medication or a new chemical entity within 3 months prior to dosing of current study medication.\n25. Known sensitivity to psilocybin, psilocin and\u002For any excipients present in the formulation.\n26. Participant is taking or has taken any drugs known to inhibit monoamine oxidase within 28 days prior to study drug administration.\n27. Participant is taking or has taken OTC doses of 5-hydroxytryptophan or St John's Wort within 28 days prior to study drug administration.\n28. Strenuous exercise within 48 hours prior to each visit, and while at the study site.\n29. Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 3 months after final dosing.\n30. Participants of childbearing potential who are pregnant, breastfeeding or planning to conceive. This is an FDA requirement.","21 Years",{"count":558,"type":21},30,[63],"The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomized, controlled study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using EEG\u002FEMG and multimodal MRI measures after administration of one oral dose of psilocybin, accompanied either with standard \"psychological support\" only; or with standard support plus Mindfulness-based Cognitive Therapy (MBCT).",[27,562],"Depression - Major Depressive Disorder",[564,565,566,567,568],"Psychedelic","functional MRI","Mindfulness-based Cognitive Therapy","Psilocybin","microstructural neuroplasticity","2026-06-24",{"date":571,"type":42},"2026-06-25",{"date":473,"type":21},{"date":574,"type":21},"2029-12",{"name":576,"class":49},"Anthony P King",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":585,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":591,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":80},"100552800","improving-sleep-in-veterans-with-the-polytrauma-clinical-triad-100552800","NCT06477796","Improving Sleep in Veterans With the Polytrauma Clinical Triad","A Sleep Intervention to Improve Quality of Life and Symptom Management in Veterans With the Polytrauma Clinical Triad","LIONv2","Inclusion Criteria:\n\n* Veteran\n* English speaking with phone and internet access\n* Current self-reported sleep disturbances\n* Clinical stable for current pharmacologic or behavioral health treatments for depression, anxiety, sleep and pain\n* Documented history of TBI\n\nExclusion Criteria:\n\n* Decisional impairment and\u002For dementia\n* Current usage of a lightbox or negative ion generator\n* Shift work\n* History of macular degeneration and\u002For bipolar disorder\n* Evidence for suicidal ideation\n* Cancer diagnosis within the past 6 months\n* Surgery within the past 6 months\n* Substance abuse within the past 6-12 months\n* Significant impairing post-stroke residual hemiparesis","89 Years",{"count":587,"type":21},96,[24],"The \"polytrauma clinical triad\" (PCT), a highly disabling constellation of factors, is defined by the coexistence of traumatic brain injury, post-traumatic stress disorder, and chronic pain. Veterans with the PCT are medically complex, often refractory to conventional therapies, and suffer from additional related chronic sequela. Notably, sleep disturbances and cognitive impairment, which the investigators hypothesize are significant contributing factors to these functional impairments and an impediment toward rehabilitation. Thus, the investigators' research aims to intervene \"at the level of sleep\", and by improving sleep, improve these interconnected, disabling, and difficult to treat enduring complexities associated with the PCT - ultimately to improve Veteran quality of life, functional independence, and restorative function. The investigators predict that the proposed intervention, morning bright light therapy, which is cost-effective, rapidly deployable and home-based, will be effective in improving sleep and overall PCT symptom management, thereby, resulting in a measurable and impactful improvement in quality of life.",[198,231,97],[592,593,29],"polytrauma clinical triad","TBI",{"date":540,"type":42},{"date":596,"type":42},"2025-05-01",{"date":598,"type":21},"2028-09-29",{"name":135,"class":105},{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":114,"enrollmentInfo":607,"targetDuration":4,"studyType":22,"phases":609,"briefSummary":610,"conditions":611,"keywords":613,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":80},"100545753","phase-2-psilocybin-assisted-cognitive-processing-therapy-for-chronic-ptsd-100545753","NCT06386003","Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD","Psilocybin-Assisted Massed Cognitive Processing Therapy for Chronic Posttraumatic Stress Disorder: An Open-label Trial","Inclusion Criteria:\n\n1. Meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a duration of 6 months or longer assessed by study psychiatrist;\n2. Have a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score of 50 or higher, indicating moderate to severe PTSD symptoms;\n3. Are willing to refrain from taking any psychiatric medications during the study period.\n\nExclusion Criteria:\n\n1. Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control;\n2. Have a history of or a current primary diagnosis of psychotic disorder, schizophrenia, delusional disorder, borderline personality disorder, schizoaffective disorder, bipolar disorder or, dissociative identity disorder;\n3. Have evidence or history of coronary artery disease or cerebral or peripheral vascular disease, hepatic disease with abnormal liver enzymes, or any other medical disorder judged by the investigator to significantly increase the risk of psilocybin administration;\n4. Have hypertension using the standard criteria of the American Heart Association (values of 140\u002F90 or higher assessed on three separate occasions;\n5. History of seizure disorder;\n6. Uncontrolled insulin-dependent diabetes;\n7. Recent stroke, intracranial or subarachnoid hemorrhage (\\\u003C 1 year from signing of informed consent form \\[ICF\\]), recent myocardial infarction (\\\u003C 1 year from signing of ICF), clinically significant arrhythmia (\\\u003C 1 year from signing of ICF);\n8. Have liver disease with the exception of asymptomatic subjects with Hepatitis C who have previously undergone evaluation and successful treatment;\n9. Lifetime history of substance-induced psychosis;\n10. Lifetime history of substance use disorder with a hallucinogen;\n11. History of alcohol use disorder in the past 3 months.",{"count":608,"type":21},15,[63],"This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).",[27,29,612],"Chronic PTSD",[27,567,614],"Cognitive Processing Therapy","2026-06-22",{"date":617,"type":42},"2026-06-26",{"date":619,"type":21},"2026-06",{"date":621,"type":21},"2027-01",{"name":623,"class":49},"Unity Health Toronto",{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":628,"acronym":629,"eligibilityCriteria":630,"healthyVolunteers":58,"sex":16,"minAge":17,"maxAge":114,"enrollmentInfo":631,"targetDuration":4,"studyType":22,"phases":632,"briefSummary":633,"conditions":634,"keywords":4,"overallStatus":281,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":636,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":80},"100644304","phase-1-effects-of-stimulant-medications-in-ptsd-100644304","NCT07664631","Effects of Stimulant Medications in PTSD","SMP","Inclusion Criteria:\n\n* Age 18 - 65 years old\n* BMI 19-30 kg\u002Fm2\n* English fluency\n\nExclusion Criteria:\n\n* Individuals with current moderate or severe substance use disorder, no past stimulant or cocaine use disorder\n* Individuals with current acute or high risk of suicide or suicide attempt in past 6 months\n* Individuals with current psychotic or bipolar disorder\n* Individuals with past schizophrenia, schizoaffective disorder, psychotic bipolar disorder, stimulant or cocaine use disorder\n* Individuals with chronic (non-PRN) treatment with antipsychotic drug (except PRN quetiapine 25mg PO qHS) or D2 antagonist\n* Individuals with medications with significant PD or PK interactions\n* Individuals with current treatment with a stimulant medication\n* Individuals with court or legally mandated treatment\n* Individuals with unstable or untreated medical disorder that would increase the risk of serious side effects of study drug (unstable hypertension, tachycardia, cardiac arrhythmia, recent MI or stroke, clinically significant neuropsychiatric or neurological disorder)\n* Members of a vulnerable population\n* High blood pressure (\\>140\u002F90)\n* Women who are pregnant, breastfeeding, or planning to become pregnant",{"count":89,"type":21},[149],"While there have been advances in understanding post-traumatic stress disorder (PTSD) as a disorder and its biological features, unfortunately only one out of five traumatized persons with PTSD reach remission after cycling through evidence-based and\u002For FDA-approved medications. This is especially unfortunate given that people with PTSD are often from vulnerable populations, or those whose professions entail personal sacrifice. It is clear that new serotonergic antidepressants and atypical antipsychotics will not be sufficient to fix this gap, and new mechanisms of action need to be tested. In the current proposal, the investigators test the hypothesis that mixed amphetamine salts (brand name Adderall), FDA-approved for treating attention deficit hyperactivity disorder (ADHD), can improve PTSD outcomes.",[635,29,27],"Adderall",{"date":569,"type":42},{"date":638,"type":21},"2026-09-15",{"date":640,"type":21},"2027-09-15",{"name":642,"class":49},"University of Chicago"]