[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"posttraumatic-stress-disorder-ptsd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:posttraumatic-stress-disorder-ptsd":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,48,72,105,132,159,184,213,241,266,291,318,343,369,392,414,439,482,525,551,575,595,623,651,685],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100651732","phase-2-mdma-at-for-ptsd-in-young-adults-with-childhood-trauma-100651732",false,"NCT07765693","MDMA-AT for PTSD in Young Adults With Childhood Trauma","MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder in Young Adults With Childhood Trauma: An Open-Label Pilot Study","Inclusion Criteria:\n\nDemographic and Participant Information\n\n* Between the ages of 18-26 years old upon signing the written consent form\n* Proficient in speaking and reading English.\n* Capable of providing informed consent.\n* Is able to swallow pills.\n* Willing and able to be contacted by phone throughout the study\n* Resides in the United States\n* Meets DSM-5 criteria for PTSD with sufficient severity assessed at study screening\n* History of index Criterion A trauma that occurred in childhood\n* Must agree to inform the research team within 48 hours of any emerging or new medical conditions and\u002For procedures\n* Must provide an emergency contact\n* Has someone to drive them home after each MDMA-AT session (or agrees to take a taxi\u002Frideshare while accompanied by a close other)\n* Agree not to drive for 24 hours after each MDMA-AT session\n* Agree to return to place of residence immediately after each MDMA-AT session, and stay there until the next morning\n* Has a trusted close other who is at least 18 years of age that agrees to stay with them throughout the night until the morning after each MDMA-AT session, and is willing to attend the ICF meeting and co-sign the ICF\n* Agree to not participate in any other interventional clinical trials from baseline to the primary study endpoint\n* Is willing and able to refrain from taking any psychiatric medications during the study period.\n* Agrees to abstain from other medications (e.g., over the counter, PRN medications, etc) unless approval from PI has been obtained\n\nIf able to become pregnant:\n\n* Must have a negative pregnancy screen during study screening and on the morning of each MDMA-AT session;\n* Must agree to use adequate birth control for the duration of participation\n* Has a primary care provider (PCP)\n* Has a regular outpatient mental health treater (e.g., psychiatrist, psychologist) that will resume care for the participant following completion or termination of study participation\n\nExclusion Criteria:\n\n* Recently attempted suicide or engaged in high risk self-injury or is otherwise assessed to be at imminent risk of suicide by study staff\n* In the opinion of the PI, would present a serious risk to others as established through study screening measures or clinical observations.\n* Meets DSM-5 criteria for any current substance use disorder, other than alcohol, cannabis, or nicotine use disorder\n* For cannabis use and alcohol use disorders without physiological dependence, must agree to be abstinent from alcohol and cannabis for one week prior to and following each MDMA-AT session.\n* Meets DSM-5 criteria for current cannabis or alcohol use disorder with physiological dependence, or physiological dependence cannot be determined\n* Meets other DSM-5 criteria for serious mental illness, as assessed by the DART or through clinical interviews or observations\n* Has a current restrictive eating disorder with current low body-mass index, or any eating disorder with active purging, currently, or in the 3 months prior to enrollment\n* Diagnosed major neurodevelopmental or neurological disorder.\n* Scaled score on the Test of Premorbid Functioning that is suggestive of possible cognitive impairment.\n* Has used MDMA in the month prior to enrollment\n* Has used MDMA excessively in the past\n* Has participated in a previous MDMA-AT for PTSD clinical trial\n* Has hypersensitivity to any ingredient of the Investigational Product\n* Requires ongoing concomitant therapy with a psychiatric drug, excluding gabapentin.\n* Is currently receiving trauma-focused psychotherapy and unwilling or unable to put treatment on hold for the duration of active study participation\n* Has received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.\n* Has received ketamine infusions and\u002For ketamine-assisted therapy in the 8 weeks prior to enrolment\n* Requires the use of opiates for pain management\n* Currently on methadone maintenance treatment\n* Has symptomatic liver disease or significant liver enzyme elevation\n* Weighs less than 48 kg (105 lbs)\n* History of concussion with loss of consciousness ≥ 24 hours or traumatic brain injury\n* History of hyponatremia or hyperthermia.\n* Any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate.\n* Uncontrolled hypertension\n* History of arrythmia (e.g., atrial or ventricular arrhythmia) at any time, other than occasional premature atrial contractions (PACs) or premature ventricular contractions (PVCs) in the absence of ischemic heart disease, within 12 months of screening.\n* History of tachycardia or cardiac disorder.\n* Has Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.\n* marked Baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\>450 milliseconds (ms) in males and \\>460 ms in females corrected by Fridericia's formula). For transgender or non- binary participants, QTc interval will be evaluated based on sex assigned at birth, unless the participant has been on hormonal treatment for five or more years.\n* History of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).\n* Requires use of concomitant medications that prolong the QT\u002FQTc interval\n* Standard MRI contraindications\n* Is pregnant or nursing, planning to become pregnant during the course of the study, or is able to become pregnant and not practicing an effective means of birth control.\n* In the opinion of the PI, participant's current place of residence is unstable\n* Is currently engaged in compensation litigation whereby financial gain would be achieved from prolonged psychiatric symptoms\n* Requires a legally authorized representative to provide informed consent\n* In the opinion of the study PI, is not able to adhere to the requirements for procedures, attendance and timing of visits, and observe limits regarding study staff time and support\n* Is participating in another interventional clinical trial at any point from study screening to the primary study endpoint (i.e., post-treatment visit)\n* Does not reside in the US\n* Substantial colorblindness sufficient to impede performance on the fMRI tasks","ALL","18 Years","26 Years",{"count":21,"type":22},15,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study is testing a new, emerging treatment for young adults (ages 18-26) with Posttraumatic Stress Disorder (PTSD). The treatment is combining the substance, MDMA, with up to three psychotherapy sessions, also known as MDMA-Assisted Therapy (MDMA-AT).\n\nThe main questions it aims to answer are:\n\n* Is the treatment safe and feasible to administer?\n* Does the treatment improve PTSD symptoms?\n\nParticipants will be asked to:\n\n* Complete screening procedures, including a medical and psychiatric evaluation to ensure safe participation\n* Attend up to three preparatory talk therapy sessions prior to the first MDMA-AT dosing session\n* Attend three integration talk therapy sessions after each MDMA-AT dosing session\n* Attend up to three total MDMA-AT dosing sessions\n* Complete assessments from baseline to 38-weeks post-baseline\n* Complete a fMRI scan at baseline and at 18-weeks post-treatment\n* Complete self-report measures and ecological momentary assessments (EMAs) across the study period",[28],"Posttraumatic Stress Disorder (PTSD)",[30,31,32,33,34],"Young adults","Ages 18-26","MDMA","Posttraumatic Stress Disorder","PTSD","NOT_YET_RECRUITING","2026-08-18",{"date":38,"type":39},"2026-08-20","ACTUAL",{"date":41,"type":22},"2026-10-31",{"date":43,"type":22},"2028-12-01",{"name":45,"class":46},"Jenna M. Traynor","OTHER",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":47},"100622338","metacognitive-therapy-compared-to-cognitive-behavioral-therapy-100622338","NCT07382323","Metacognitive Therapy Compared to Cognitive-behavioral Therapy","Transdiagnostic Metacognitive Therapy Compared to Disorder-specific Cognitive-behavioral Therapy for Anxiety Disorders: a Qualitative Study","Inclusion Criteria:\n\n* Age 18 years or older,\n* A principal diagnosis of generalized anxiety disorder, social anxiety disorder, or posttraumatic stress disorder,\n* No change in dose during the last six weeks if on pharmacological treatment, and\n* Ability to read and speak Swedish.\n\nExclusion Criteria:\n\n* A current diagnosis of psychotic disorder, bipolar disorder, neurocognitive disorder, or moderate to severe substance use disorder,\n* Acute suicide risk, or\n* Concurrent psychological treatment.",{"count":56,"type":22},30,[58],"NA","This is a qualitative study of participants who have taken part in a randomized controlled trial comparing transdiagnostic metacognitive therapy and disorder-specific cognitive-behavioral therapy for anxiety disorders. The purpose of the study is to explore participant perceptions of the respective treatment models to facilitate implementation and dissemination of the treatments.",[61,62,28],"Generalized Anxiety Disorder","Social Anxiety Disorder","RECRUITING","2026-08-17",{"date":36,"type":39},{"date":67,"type":39},"2026-01-28",{"date":69,"type":22},"2026-12",{"name":71,"class":46},"Karolinska Institutet",{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":104},"100498884","phase-4-methylphenidate-for-the-treatment-of-ptsd-with-associated-neurocognitive-complaints-100498884","NCT05776056","Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints","Randomized Placebo-Controlled Trial of Methylphenidate for the Treatment of Post-Traumatic Stress Disorder With Associated Neurocognitive Complaints","IMPACT","Inclusion Criteria:\n\n1. Any gender Veteran of the US military\n2. Independent decision-making capacity to sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) (i.e., no surrogate consent)\n3. Diagnosis of PTSD defined by DSM-5 symptom count on Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)\n4. CAPS-5 past month total score greater than or equal to 26\n5. Subjective neurocognitive impairment, defined as a total score of greater than or equal to 25 (1 standard deviation below the mean) on the NeuroQoL Cognitive Function 8-item self-report form\n\nExclusion Criteria:\n\n1. Diagnosis of DSM-5-defined bipolar I, schizophrenia spectrum or other psychotic disorders (by MINI)\n2. Presence of severe psychotic symptoms such that, based on the clinical judgement of the investigator or treatment provider, treatment with an antipsychotic is required\n3. Diagnosis of moderate or severe substance use disorder (except for caffeine and nicotine) during the preceding 2 months. Patients who utilize alcohol or cannabis but do not meet criteria for moderate or severe disorder are permitted at the discretion of the investigator. Participants must agree to abstain from illicit drugs, including cannabis products containing Tetrahydrocannabinol (THC) even when legal by state law\n4. History of severe TBI as defined by the Ohio State University TBI Identification Method\n5. Diagnosis of dementia or related progressive neurocognitive disorder, based on clinical records\n6. Increased risk of suicide that necessitates inpatient treatment or treatment excluded by the protocol; and\u002For intensity of suicidal ideation (Type 4 or Type 5) or any suicidal behavior in the past 2 months on Columbia Suicide Severity Rating Scale (C-SSRS)\n7. Pregnancy or lactation, or anticipated pregnancy at any point during study participation. Participants of child-bearing potential must have negative pregnancy test at study entry and must agree to adhere to a medically acceptable method of birth control (e.g., oral, implantable, injectable, or transdermal hormone-based contraceptives; intrauterine device; double-barrier method)\n8. Use of any investigational drug, MPH formulation, antipsychotics, mood stabilizers, monoamine oxidase inhibitors, stimulants, atomoxetine, or bupropion within 2 weeks of baseline\n9. Treatment with evidence-based trauma-focused therapy for PTSD within 2 weeks of baseline (if participant is receiving therapy, he\u002Fshe must complete treatment prior to entering study). Supportive psychotherapy may be continued during the study\n10. A clinically significant acute or uncontrolled chronic medical\u002Fsurgical illness that would contraindicate use of MPH, or a known terminal illness\n11. Prior allergic reaction to any MPH formulation\n12. Litigating for compensation for a psychiatric disorder outside the Veterans benefits compensation and pension process\n13. Current enrollment in another interventional trial for PTSD","65 Years",{"count":82,"type":22},70,[84],"PHASE4","Posttraumatic stress disorder (PTSD) is frequently accompanied by difficulty concentrating, poor memory, and inability to keep up with tasks, which negatively impacts a person's ability to function at work and in relationships. Currently available treatments do not fully relieve all symptoms. A published research report showed positive evidence that the stimulant medication methylphenidate was beneficial in treating these problems. This study will evaluate the ability of methylphenidate to treat PTSD and associated neurocognitive complaints in Veterans. An innovative feature is the study's N-of-1 design. In this design, every participant will move back and forth every 4-5 weeks between treatment with methylphenidate and treatment with placebo, in random order and under double-blind conditions, over a 20-week period. The investigators will compare the aggregated change in PTSD and neurocognitive symptoms between periods of treatment with methylphenidate versus placebo. Results will help clinicians to better choose the best treatment for Veterans living with PTSD.",[28],[34,33,88,89,90,91,92,93,94],"ADHD","Neurocognitive","Stimulant","Veteran","Traumatic Brain Injury","TBI","Methylphenidate",{"date":96,"type":39},"2026-08-19",{"date":98,"type":39},"2024-02-05",{"date":100,"type":22},"2027-09-30",{"name":102,"class":103},"VA Office of Research and Development","FED",3,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":47},"100652032","eeg-and-actigraphy-biomarkers-of-written-exposure-therapy-for-posttraumatic-stress-disorder-100652032","NCT07766798","EEG and Actigraphy Biomarkers of Written Exposure Therapy for Posttraumatic Stress Disorder","Trauma Recovery Via EEG and Actigraphy Tracking (TREAT): Biomarkers of Written Exposure Therapy in PTSD","TREAT","Inclusion Criteria:\n\n1. Age between 18 and 65\n2. History of trauma, with current elevated PTSD symptoms\n3. Ability to understand and sign informed consent\n4. Ability to read and write in English\n5. Stable psychotropic medications for at least six weeks prior to enrollment\n\nExclusion Criteria:\n\n1. Metal in the head\u002Fneck\n2. Current unstable medical conditions\n3. Head injury with prolonged loss of consciousness (over 30 minutes) within the past 10 years\n4. History of major neurological illness\n5. History of seizures\n6. History of central nervous system (CNS) tumors\n7. History of stroke\n8. History of cerebral aneurysm\n9. Currently receiving trauma-focused therapy\n10. Current benzodiazepine use\n11. Currently receiving non-pharmacological treatment e.g. transcranial magnetic stimulation (TMS) or electroconvulsive therapy (ECT)\n12. Current moderate or severe substance use disorder\n13. Lifetime Bipolar I or primary psychotic illness\n14. Pregnancy",{"count":114,"type":22},200,[58],"Posttraumatic stress disorder, or PTSD, can affect emotional health, sleep, daily functioning, and quality of life. Written Exposure Therapy is a brief trauma-focused psychotherapy in which participants complete structured writing exercises about a traumatic experience. However, it is not yet clear which changes in brain activity and sleep occur over the course of treatment or whether these measures can help predict who is most likely to benefit.\n\nThis study will enroll approximately 200 adults with PTSD. Participants will be randomly assigned to either Written Exposure Therapy or a neutral writing condition and will complete five weekly writing sessions. The study will collect electroencephalography, or EEG, recordings and actigraphy-based sleep and activity measures at scheduled time points before treatment, during the five-week intervention period, and after treatment. Participants will also complete clinical assessments of PTSD symptoms and related outcomes.\n\nThe primary goals are to identify EEG and sleep-related biomarkers associated with improvement in PTSD symptoms, determine how early these biomarkers change during treatment, and evaluate whether baseline measures can help predict individual treatment response.",[28],[119,120,121,122,123],"Written Exposure Therapy","Electroencephalography","Actigraphy","Treatment Response","Biomarkers","2026-08-10",{"date":64,"type":39},{"date":127,"type":22},"2026-09-01",{"date":129,"type":22},"2031-09-30",{"name":131,"class":46},"Mclean Hospital",{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":47},"100651133","phase-2-the-many-roads-to-trauma-recovery-a-clinical-trial-comparing-empirically-supported-treatments-for-veterans-with-co-morbid-posttraumatic-stress-and-substance-use-disorder-symptoms-100651133","NCT07756723","The Many Roads to Trauma Recovery: A Clinical Trial Comparing Empirically Supported Treatments for Veterans With Co-Morbid Posttraumatic Stress and Substance Use Disorder Symptoms","Inclusion Criteria:\n\n* PTSD diagnosis\n* Enrolled in VA healthcare\n* Attending residential programming at CVAMC\n* Current substance use difficulty based on screening questions\n\nExclusion Criteria:\n\n* Non-English speaking\n* Inability to complete study procedures\n* Lack competency to provide consent\n* Acute intoxication of a substance\n* Active psychotic symptoms at the study visit\n* Suicidal or homicidal ideation with intent and planning\n* Pacemaker or other cardiovascular implants.",{"count":139,"type":22},50,[25,141],"PHASE3","Veterans with co-morbid posttraumatic stress disorder (PTSD) and substance use disorders (SUDs) are at substantial risk of developing hypertension and cardiovascular diseases that often lead to premature death, with some evidence that they may die over 10 years earlier than their counterparts. As such, determining ways to improve their health outcomes is vital. Heart Rate Variability Biofeedback (HRVB) may be one way to restore autonomic balance and teach veterans with PTSD \u002F SUDs how to respond differently to their symptoms. Multiple studies have found that HRVB not only improves autonomic nervous system (ANS) regulation \u002F flexibility among veterans with PTSD, but also reduces PTSD symptoms. Additionally, there is evidence that HRVB reduces cravings and SUD symptoms. Currently it is proposed that the improvement in the PTSD and SUD symptoms are due to a combination of improving ANS regulation and veterans utilizing the HRVB techniques as coping strategies for their symptoms. Yet, none of these studies examined how HRVB versus other active interventions differentially effected symptoms and physiological outcomes. It may be useful to examine HRVB to other active interventions . The current project proposes to alleviate this gap by examining the effects of HRVB to one a active control condition (i.e., Present Centered Psychotherapy; PCT) among 50-residential veterans engaging in PTSD residential programming. Veterans will be recruited from residential programs at the Coatesville VAMC and screened for probable PTSD and an active (i.e., past year) SUD. If eligible, they will attend a brief visit that will include being randomized, engaging in a diagnostic interview, a battery of questionnaires related to PTSD \u002F SUDs, attached to physiology equipment, and then complete 3 tasks (i.e., baseline task, emotion induction, and HRVB or Self-Compassion Break). Upon task completion, all veterans will be screened for risk and begin one of the conditions. Similar research procedures will be conducted after their final session. This study would provide evidence for the real-world effectiveness of HRVB compared to a control condition among one of the highest risk populations treated at the VA, which may provide invaluable insight into active mind-body treatments for veterans with PTSD \u002F SUD.",[28,144],"Substance Use Disorder (SUD)",[34,146,147,148,149],"SUD","Veterans","HRV","Biofeedback","2026-08-07",{"date":152,"type":39},"2026-08-11",{"date":154,"type":22},"2026-08",{"date":156,"type":22},"2030-08",{"name":158,"class":103},"Coatesville VA Medical Center",{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":180,"leadSponsor":182,"locationsCount":47},"100610469","cognitive-rehabilitation-for-treatment-of-anger-in-veterans-with-tbi-and-ptsd-100610469","NCT07227987","Cognitive Rehabilitation for Treatment of Anger in Veterans With TBI and PTSD","Cognitive Rehabilitation for Treatment of Anger in Veterans With TBI (Traumatic Brain Injury) and PTSD (Post-traumatic Stress Disorder)","CALM","Inclusion Criteria:\n\nInclusion Criteria for Veterans\n\n* U.S. Veteran who served in one of the military branches (Army, Navy, Marines, Air Force, or Coast Guard) since 9\u002F11\u002F01\n* Meets criteria for TBI\n* Meets criteria for PTSD or subthreshold PTSD\n* Reports anger problems began after their head injury\n* Reports current problems with cognitive function\n* At least 18 years old\n* Fluent and literate in English\n* Able to provide voluntary, informed consent to participate.\n* Smartphone Use: Has an iPhone (iPhone 11 or higher with iOS 17 or higher) or Android (Android 8.0 or higher) smartphone.\n\nInclusion Criteria for Family members or Friends:\n\n* Over age 18;\n* Family member\u002Ffriend of Veteran who served in one of the military branches (Army, Navy, Marines, Air Force, National Guard) post-9\u002F11 and who meets TBI and PTSD inclusion criteria. (Veterans select this trusted family member or friend to serve as a support person for the study).\n* Fluent and literate in English\n* Able to provide voluntary, informed consent to participate.\n\nExclusion Criteria:\n\n-Does not have a trusted support person, e.g., spouse, family member, or friend for enrollment.",{"count":168,"type":22},100,[58],"This randomized clinical trial will enroll 100 Veteran-family\u002Ffriend dyads to test the efficacy of CALM in treating anger in TBI and PTSD. The investigators hypothesize that compared to an active control group, Veterans randomized to the CALM group will demonstrate:\n\n* Significantly larger decreases in anger dysregulation, impulsivity, and executive dysfunction.\n* Significantly larger improvements in social and adaptive functioning including less aggression.\n* Significantly larger reduction in PTSD symptoms and suicidal ideation.\n\nThe study targets Veterans who experience difficulties with anger and impulsivity due to TBI and PTSD. These issues are common, with up to 38% of Veterans with TBI also having PTSD. These conditions often make it challenging for Veterans to control their emotions and interact successfully in social and work settings. Our research will test the CALM (Cognitive Applications for Life Management) mobile app, which helps Veterans manage their goals, remember important tasks, and improve their attention. Initial tests of CALM have shown it can reduce levels of anger and related issues in Veterans. The investigators will conduct a study with 100 pairings of Veterans and a family member or friend. These pairs will be randomly assigned to one of two groups: one using the CALM mobile platform and the other receiving brain health education. Both groups will use their assigned intervention for three months and will receive support through videoconference calls at the beginning, middle, and end of the program.",[172,28],"Traumatic Brain Injury (TBI)",[172,174,175,147],"Posttraumatic stress Disorder (PTSD)","Mobile app","2026-08-04",{"date":178,"type":39},"2026-08-06",{"date":176,"type":39},{"date":181,"type":22},"2028-12-31",{"name":183,"class":46},"Duke University",{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":47},"100648255","treatment-of-fibromyalgia-and-ptsd-with-live-and-inactive-vagus-nerve-stimulation-with-pepc-100648255","NCT07718984","Treatment of Fibromyalgia and PTSD With Live and Inactive Vagus Nerve Stimulation With PEPC","SWIFT-RELIEVE : Simultaneous Treatment of Widespread Pain In Fibromyalgia and PTSD: Randomized Evaluation of Live vs. Inactive Electrical VNS With PE-PC","SWIFT-RELIEVE","Inclusion Criteria:\n\n1. Subjects must be any era Veterans reporting FM and PTSD symptoms (PTSD Checklist for DSM-5 (PCL-5) ≥ 28; FM confirmed with ACR Diagnostic Criteria and pain score at least 4\u002F10 for 3 months \\[94\\]\n2. Subjects must speak English\n3. If subjects are taking psychotropic medication, 2-weeks on stable dose prior to enrollment and agreement to maintain current medications until after the \\[4-month follow-up visit\\]\n\nExclusion Criteria:\n\n1. Subjects must not have other primary clinical issues that would interfere with FM or PTSD treatment such as recent stroke or severe heart disease\n2. Subjects must not have a level of suicide risk that requires intervention as determined by item 9 on PHQ-9 with follow-up risk assessment by study staff\n3. Subjects must not have severe cognitive impairment that interferes with PE-PC (unable to retain information in acute interaction)\n4. Subjects must not have unmanaged psychosis or bipolar disorder\n5. Subjects must not have moderate to severe substance use disorder in the past 8 weeks\n6. Subjects must not be currently receiving talk therapy for trauma-related symptoms or FM\n7. Subjects must not be currently pregnant or lactating given risk of pre-term labor and interference of oxytocin with VNS effects",{"count":193,"type":22},180,[58],"Fibromyalgia (FM) pain and PTSD are highly prevalent and comorbid with associated increased risk of negative physical and mental health outcomes, including higher risk for opioid use and suicide. This project is designed to determine the effects of a 4 week trial of a device for pain management \\[transauricular vagus nerve stimulation (taVNS)\\] on pain interference and intensity \\[Pain, Enjoyment, and Activity General Scale (PEG)\\] and PTSD. The investigators will also examine how this impacts the Veterans by examining heart rate variability (HRV) as a stress response related biomarker. The investigators plan to randomize 180 Veterans (estimate up to 360 enrolled) with co-morbid FM and PTSD across pain integrated care and PTSD sites in this prospective study and compare: 1) active taVNS for pain + Prolonged Exposure in Primary Care (PE-PC) and 2) sham taVNS + PE-PC. Study includes 4 weeks of randomized treatment and 4 weeks of voluntary open label treatment. Veterans are assessed (self report \\& interview measures, heart rate variability by wearable device) at Intake, Baseline\u002FPost Run-In, Week 2, Week 4, Week 8 and 4 month follow-up. The investigators plan to retain data after the study for potential future use in research.",[197,28],"Fibromyalgia (FM)",[199,200,201,202,203,204],"fibromyalgia","post-traumatic stress disorder","pain","heart rate variability","vagus nerve stimulation","treatment","2026-07-23",{"date":207,"type":39},"2026-07-27",{"date":209,"type":22},"2027-01-01",{"date":211,"type":22},"2030-12-31",{"name":102,"class":103},{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":219,"minAge":18,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":223,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":47},"100597565","cognitive-processing-therapy-cpt-for-perinatal-posttraumatic-stress-disorder-ptsd-100597565","NCT07060144","Cognitive Processing Therapy (CPT) for Perinatal Posttraumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n* Female, ages 18-46, Pregnant (\\\u003C 25 weeks), able to read and write in English, History of at least 1 criterion A trauma, Primary diagnosis of PTSD (confirmed by SCID), Psychotropic medications must be stable with no changes ≥ 2 weeks (≥ 6 weeks for fluoxetine), and no medication changes can be made during the course of therapy\n\nExclusion Criteria:\n\n* Not currently pregnant, Diagnosis of bipolar disorder, psychotic disorders, Suicidal ideation with plan or intent, Substance use disorder, Regular benzodiazepine use (\\> 4x weekly)","FEMALE","46 Years",{"count":222,"type":22},60,[58],"Pregnant women with a primary diagnosis of posttraumatic stress disorder (PTSD) (PTSD Checklist for DSM-5 (PCL-5) score \\> 33) will be randomized to receive conventional cognitive processing therapy (CPT) (60-min session once\u002Fweek for 12 weeks) or massed CPT (mCPT) (an intensive schedule of 12 60-min sessions over 5 days, approximately 2-3 sessions per day) via telemedicine, for treatment of PTSD. The research aims will be three-fold: (1) Evaluate the relative efficacy and tolerability of CPT vs. mCPT for treatment of perinatal PTSD and depression; (2) Determine the effect of CPT upon maternal-infant attachment and interaction; (3) Collect pilot data of obstetric and neonatal outcomes among those receiving the two CPT delivery schedules.",[28,226],"Pregnancy",[34,228,229,230,231],"pregnancy","cognitive processing therapy","psychotherapy","trauma","2026-06-15",{"date":234,"type":39},"2026-06-16",{"date":236,"type":39},"2025-08-01",{"date":238,"type":22},"2027-10",{"name":240,"class":46},"University of Texas at Austin",{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":23,"phases":250,"briefSummary":251,"conditions":252,"keywords":253,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":265},"100609907","integrated-health-care-for-ptsd-100609907","NCT07220681","Integrated Health Care for PTSD","A Hybrid I Evaluation of Integrative Health Care for PTSD","Inclusion Criteria:\n\n* clinical diagnosis\n* eligibility for Cognitive Processing Therapy (CPT) at a participating VA site\n* able to consent to study activities\n\nExclusion Criteria:\n\n* current, active engagement in one of the included approaches (per clinician judgment)\n* medical conditions that contraindicate engaging in the experimental interventions",{"count":249,"type":22},300,[58],"The goal of this clinical trial is to determine whether which types of integrative care, meaning a combination of psychotherapy and mind-body interventions, lead to the most changes in functioning among Veterans with posttraumatic stress disorder (PTSD). The main aims are:\n\n1. To evaluate the impact of integrative care approaches on functional outcomes among Veterans with PTSD.\n2. To examine factors relevant to the implementation of integrated treatments for PTSD from the perspective of patients, providers and administrators in the VA Healthcare System.\n\nParticipants will:\n\n1. Complete assessments at the beginning of the study and 12- and 24-weeks later.\n2. Engage in 12 weeks of integrated care, with the type being randomly assigned.",[28],[34,254,147,255],"complementary and integrative health","implementation","2026-06-10",{"date":258,"type":39},"2026-06-12",{"date":260,"type":39},"2026-04-23",{"date":262,"type":22},"2029-09-30",{"name":264,"class":46},"Veterans Medical Research Foundation",5,{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":47},"100604216","efficacy-of-an-emdr-app-for-ptsd-and-sud-100604216","NCT07146633","Efficacy of an EMDR App for PTSD and SUD","Efficacy and Feasibility of Autonomous Eye Movement Desensitization and Reprocessing (A-EMDR) for Patients With Posttraumatic Stress Disorder (PTSD) and Substance Use Disorders","Inclusion Criteria:\n\n* Aged 18-years old or older\n* Fluent in English\n* Diagnosed with PTSD by the PTSD Checklist for DSM-5 (PCL-5 past month version score \\>32)\n* Diagnosed with past-year substance use disorder other than caffeine by structured clinical interview for DSM-5 (SCID-5)\n* Agrees not to participate in other treatments during the study duration (e.g., mindfulness, yoga, biofeedback, self-hypnosis or tai chi) except individuals who have been already on continuous therapies for at least three months\n\nExclusion Criteria:\n\n* Diagnosis of a severe or unstable mental illness that precludes safe participation in the study by a healthcare practitioner such as acute psychosis or mania diagnosed by a healthcare practitioner\n* Current suicidality risk as indicated during the conduct of the Columbia Suicide Severity Rating Scale (C-SSRS) (21) with concurrence after a study physician's evaluation if the response to C-SSRS questions 1 or 2 is \"yes\"",{"count":274,"type":22},24,[58],"The current proposal is aimed to confirm the efficacy of this novel therapeutic method (autonomous eye movement desensitization and reprocessing; A-EMDR) in a patient group (PTSD and SUD), and to assess the feasibility of the application within this group. While there is no basis to assume lower efficacy of the treatment with this population, confirming that hypothesis is an important and helpful step before a full-performance research study can be initiated. Furthermore, this study proposal will provide additional information regarding the feasibility for this population, which will allow for a more tailored approach in future study.",[28,278],"Substance Use Disorders",[280,34,281],"EMDR","substance dependence","2026-05-20",{"date":284,"type":39},"2026-05-22",{"date":286,"type":39},"2026-01-20",{"date":288,"type":22},"2027-01-30",{"name":290,"class":46},"Centre for Addiction and Mental Health",{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":298,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":300,"phases":4,"briefSummary":301,"conditions":302,"keywords":305,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":47},"100639204","validation-of-the-cidi-50-against-the-scid-5-for-lifetime-mental-disorders-100639204","NCT07604753","Validation of the CIDI 5.0 Against the SCID-5 for Lifetime Mental Disorders","Validity of the World Health Organization CIDI 5.0 for Assessing Lifetime Prevalence of Mental Disorders: A Clinical Reappraisal Study Using the SCID-5","Inclusion Criteria:\n\n* All household members aged 18 years old and over are randomly sampled from the Census and Statistics Department List of Quarters\n* Live in the address sampled from the Census and Statistics Department List of Quarters\n* Reside in Hong Kong for at least six months in the past year\n* Able to read and communicate in Chinese or English\n* Without linguistic or cognitive difficulties\n\nExclusion Criteria:\n\n* Domestic workers",true,{"count":249,"type":22},"OBSERVATIONAL","The World Health Organization Composite International Diagnostic Interview (CIDI) is a fully structured diagnostic tool designed for lay interviewers to assess the prevalence of mental and substance use disorders. Earlier versions, such as the CIDI 3.0, demonstrated acceptable individual-level concordance with clinical assessments based on DSM-IV criteria (Haro et al. 2006). The latest iteration (CIDI 5.0) has been updated to operationalize DSM-5 criteria.\n\nRecent evidence from a large-scale, community-based national study in Qatar suggests that under DSM-5 criteria (Khaled et al. 2024), after recalibration, the CIDI 5.0 maintains high specificity (91.9% for MDD, 94.7% for GAD, and 85.5% for PTSD). Sensitivity suggested CIDI diagnoses aligned closely with clinical \"gold standard\" diagnoses (51.5% for MDD, 50.7% for GAD, and 77.3% for PTSD). Despite the evidence from Qatar, there remains a lack of evidence regarding the validity of the CIDI 5.0 in population-based studies.\n\nTherefore, this study aims to evaluate the diagnostic validity of the CIDI 5.0 for Lifetime MDD, GAD, and PTSD, using the Structured Clinical Interview for DSM-5 (SCID-5) as the definitive clinical gold standard.",[303,304,28],"Major Depressive Disorder (MDD)","Generalized Anxiety Disorder (GAD)",[306,307,308,309],"CIDI","Lifetime prevalence","Mental disorders","Clinical validation","2026-05-19",{"date":284,"type":39},{"date":313,"type":39},"2025-05-14",{"date":315,"type":22},"2028-01",{"name":317,"class":46},"The University of Hong Kong",{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":17,"minAge":325,"maxAge":18,"enrollmentInfo":326,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":329,"conditions":330,"keywords":332,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":47},"100634290","early-phase-1-predictors--mechanisms-of-adolescent-ptsd-100634290","NCT07537764","Predictors & Mechanisms of Adolescent PTSD","Identifying Biobehavioral Predictors and Targeting Mechanisms of Intervention in Adolescent Posttraumatic Stress Disorder","Adolescent Inclusion Criteria:\n\n1. Adolescent of any sex, race, or ethnicity; between the ages of 14 and 18 years old.\n2. Accompaniment by a caregiver willing to participate. Note: Adolescents aged 18 years old are able to provide their own consent though still require caregiver participation to be eligible for study participation.\n3. Ability to comprehend English. Rationale: Public census data indicates that the overwhelming majority of youth in the local community are English-speaking (\\>98%), inclusive of multi-lingual households.\n4. Endorsement of exposure to one or more potentially traumatic event(s), as defined by DSM-5 Criterion A event, that the adolescent remembers and is able to verbalize.\n5. A total score ≥15 on the Child and Adolescent Trauma Screen (CATS) or report at least one clinically significant symptom on Intrusion\u002FRe-experiencing, Avoidance, and Hyperarousal symptom domains, as defined by DSM-5 PTSD criteria, and one area of impairment.\n\nAdolescent Exclusion Criteria:\n\n1. Previous diagnosis indicating intellectual disability or pervasive developmental disorder that would preclude participant from understanding study procedures.\n2. Active psychosis, bipolar disorder, or a comorbid condition that requires a higher level of immediate care (e.g., anorexia nervosa, alcohol withdrawal).\n3. Active suicide risk with ideation, plan and intent and\u002For recent (past 6 months) hospitalization for suicidality. These individuals will be referred directly for immediate services and treatment. All participants who endorse suicidal ideation will be engaged in safety planning as part of the study protocol.\n4. Individuals on psychotropic medications must be stabilized on the medication for at least four weeks prior to study start date.\n5. Individuals currently engaged in trauma-focused, exposure-based treatment.\n\nCaregiver Inclusion Criteria:\n\n1. Caregiver, parent, or legal guardian of an adolescent between the ages of 14 and 18 years old.\n2. Ability to comprehend English.\n\nCaregiver Exclusion Criteria:\n\n1\\. Previous diagnosis indicating intellectual disability or pervasive developmental disorder that would preclude participant from understanding study procedures.","14 Years",{"count":193,"type":22},[328],"EARLY_PHASE1","This study examines how adolescents with trauma-related symptoms respond to stress and strong emotions. The study assesses brain activity, physiological responses, and behavior during experimental tasks that involve responding to potential threats, regulating emotions, and repeatedly imagining details of a personally experienced stressful or traumatic event using a script-driven imagery task.\n\nThe study evaluates whether repeated imaginal exposure is associated with changes in anxiety and physiological responses across sessions, and whether baseline patterns of threat reactivity and emotion regulation are associated with individual differences in response to the exposure task. Outcomes include self-reported anxiety, subjective distress ratings, and psychophysiological indices such as heart rate, skin conductance, and electromyographic activity.\n\nThe goal of this research is to improve understanding of biobehavioral processes related to trauma exposure in adolescents and to identify potential predictors of response to exposure-based intervention components relevant to posttraumatic stress disorder (PTSD).",[28,331],"Trauma Exposure",[333,331],"Adolescent PTSD","2026-05-07",{"date":336,"type":39},"2026-05-08",{"date":338,"type":22},"2026-09",{"date":340,"type":22},"2031-03",{"name":342,"class":46},"Medical University of South Carolina",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":349,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":352,"conditions":353,"keywords":355,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":47},"100640452","extended-group-written-exposure-therapy-for-comorbid-ptsd-and-bpd-traits-100640452","NCT07576387","Extended Group Written Exposure Therapy for Comorbid PTSD and BPD (Traits)","Inclusion Criteria:\n\n* Reading and writing proficiency in English\n* Access to an electronic device to attend virtual group meetings\n* Age 18-65\n* Previous diagnosis of Posttraumatic Stress Disorder (PTSD) and Borderline Personality Disorder (BPD)\u002FBPD traits\n* Completion of a DBT skills group via St. Joe's Community Psychiatry Clinic\n\nExclusion Criteria:\n\n* Diagnosis of an active severe substance use disorder or psychotic disorder\n* Untreated active psychotic symptoms, mania, or hypomania\n* Has attempted suicide in the 2 months prior to treatment beginning\n* Has engaged in high-risk self-harm (e.g., cutting, burning, asphyxiation) in the 2 months prior to beginning treatment\n* Has completed Cognitive Processing Therapy or another active PTSD treatment (i.e., prolonged exposure) in the past year",{"count":350,"type":22},63,[58],"The goal of this open label trial is to evaluate the effectiveness of virtual group extended Written Exposure Therapy (GE-WET) in reducing Post-Traumatic Stress Disorder (PTSD) symptoms in patients with comorbid PTSD and Borderline Personality Disorder (BPD) or BPD traits. GE-WET involves attending weekly 2-hour group WET sessions for the duration of 10 weeks, in which they write about their trauma experience using specific instructions.\n\nThis study will be conducted at St. Joseph's Healthcare Hamilton's Community Psychiatry Clinic with clients wait listed for PTSD treatment (ages 18- 65, any gender, co-morbid PTSD and BPD\u002FBPD traits).\n\nThe main questions this study aims to answer are:\n\nDoes GE-WET reduce PTSD symptoms (based on PCL-5 measures) in this population (outpatient clients ages 18-65 of any gender, with a diagnosis of PTSD and BPD or BPD traits)?\n\nDoes GE-WET result in reduced drop-out rates for this population, compared to that of other evidence-based treatment for PTSD?\n\nWhat are participants subjective experience of GE-WET?",[28,354],"Borderline Personality Disorder (BPD)",[356,357,358,359,360],"borderline personality disorder","posttraumatic stress disorder","written exposure therapy","group therapy","virtual","2026-05-04",{"date":336,"type":39},{"date":364,"type":22},"2026-06",{"date":366,"type":22},"2028-12",{"name":368,"class":46},"St. Joseph's Healthcare Hamilton",{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":375,"targetDuration":4,"studyType":23,"phases":377,"briefSummary":378,"conditions":379,"keywords":380,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":47},"100636409","two-week-intensive-outpatient-trauma-treatment-100636409","NCT07565311","Two-week Intensive Outpatient Trauma Treatment.","Inclusion Criteria:\n\n* PTSD\n* 18-65 years\n* Able to give written informed consent.\n\nExclusion Criteria:\n\n* Active substance abuse\n* psychotic or bipolar disorder\n* organic brain disorder\n* IQ\\\u003C 70\n* Currently in a life-threating situation.\n* Serious suicide risk.",{"count":376,"type":22},42,[58],"The objective of the study is to obtain knowledge about the treatment of patients who are offered intensive trauma treatment at Nydalen DPS (NDPS) and Søndre Oslo DPS (SODPS). The treatment takes place on an outpatient basis over two weeks. Up to 42 patients will be recruited. The efficacy of treatment will be investigated using validated self-report forms, which measure PTSD symptoms (PCL-5 and ITQ) and quality of life\u002Ffunction (WHO-5, and WSAS). The measurements will be done before the treatment and one and twelve weeks after treatment.In-depth interviews will also be conducted with up to 30 patients to investigate the outcome and any need for adjustments with focus on patients with minority backgrounds, men and patients with limited benefit. The study uses a mixed methods design, where quantitative measures and information from qualitative interviews are combined to map participants' experience, benefits and feasibility.",[28],[381,382,280,383],"Intensive trauma treatment","qualitative study","Prolonged exposure","2026-04-27",{"date":361,"type":39},{"date":387,"type":39},"2026-01-26",{"date":389,"type":22},"2027-12-31",{"name":391,"class":46},"Oslo University Hospital",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":23,"phases":399,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":47},"100633407","personalized-repetitive-transcranial-magnetic-stimulation-prtms-for-treatment-of-post-traumatic-stress-disorder-ptsd-100633407","NCT07526285","Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) for Treatment of Post-Traumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n* Reserve or former member of the military (veteran status)\n* Age 18 years or older\n* Primary diagnosis of post-traumatic stress disorder (PTSD) confirmed by the - Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)\n* Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) score ≥ 33, indicating clinically significant PTSD symptoms\n* Proficient in English (spoken and written) to ensure understanding of study procedures and informed consent\n\nExclusion Criteria:\n\n* History of open-skull traumatic brain injury\n* Clinically significant seizure disorder or history of manic episodes\n* Neurological conditions associated with increased risk (e.g., increased intracranial pressure, brain lesions, stroke, cerebral aneurysm)\n* Electroencephalogram (EEG) abnormalities suggesting elevated seizure risk\n* Repetitive transcranial magnetic stimulation (rTMS) within 3 months prior to screening\n* Current use of antipsychotic or anticonvulsant medications\n* Presence of intracranial implants or non-removable metal in or near the head (excluding the mouth)\n* Clinically significant or unstable medical conditions, including active suicidal ideation\n* Uncontrolled medical illness (e.g., thyroid, hepatic, cardiac, pulmonary, or renal disease)\n* Initiation of PTSD-specific treatment within the past 4 weeks (participants on a stable regimen may be eligible)\n* Pregnancy (for women of childbearing potential)\n* Any condition that, in the opinion of the investigator, may interfere with study participation or completion",{"count":168,"type":22},[58],"This study is testing a personalized form of brain stimulation called PrTMS as a treatment for post-traumatic stress disorder (PTSD) in military service members and veterans. Unlike standard approaches, this treatment uses a simple brainwave test (EEG) to tailor the therapy to each individual. Participants will be randomly assigned to receive either active treatment or a comparison (sham) treatment over 6 weeks. Researchers will track changes in PTSD symptoms, mood, sleep, and overall well-being, including using wearable devices to measure things like sleep and heart rate. The goal is to see whether this personalized approach can provide greater and longer-lasting relief for individuals living with PTSD.",[28],[403,33,147,404],"Transcranial Magnetic Stimulation","Precision Medicine","2026-04-10",{"date":407,"type":39},"2026-04-13",{"date":409,"type":22},"2026-08-01",{"date":411,"type":22},"2029-01-31",{"name":413,"class":46},"Massachusetts General Hospital",{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":23,"phases":423,"briefSummary":424,"conditions":425,"keywords":427,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":438,"locationsCount":47},"100588169","transdiagnostic-metacognitive-therapy-compared-to-disorder-specific-cognitive-behavioral-therapy-for-anxiety-disorders-100588169","NCT06937892","Transdiagnostic Metacognitive Therapy Compared to Disorder-Specific Cognitive-Behavioral Therapy for Anxiety Disorders","Transdiagnostic Metacognitive Therapy Compared to Disorder-Specific Cognitive-Behavioral Therapy for Anxiety Disorders: A Randomized Controlled Superiority Trial","Inclusion Criteria:\n\n* 18 years of age or older\n* A principal (most interfering and\u002For severe) diagnosis of GAD, SAD or PTSD\n* If on pharmacological treatment, no change in dose during the last six weeks\n* Ability to read and speak Swedish\n\nExclusion Criteria:\n\n* A current diagnosis of psychotic disorder, bipolar disorder, neurocognitive disorder, or moderate to severe substance use disorder\n* Acute risk of suicide\n* Simultaneous psychological treatment",{"count":422,"type":22},86,[58],"Background\n\nAnxiety disorders are the most prevalent psychiatric disorders around the world.\n\nEffective treatment consists of pharmacotherapy or psychological treatment based on cognitive-behavioral therapy (CBT) and these treatment options are recommended in clinical guidelines, with CBT as the first-line treatment for anxiety disorders. However, only 50% of patients with anxiety disorders achieve remission status following CBT and 20% of patients drop out of CBT.\n\nMetacognitive therapy (MCT) represents an alternative treatment approach to CBT. The theoretical model of MCT emphasizes the role of dysfunctional metacognitions (rather than cognitions, as in CBT), particularly negative metacognitions, in the development and maintenance of anxiety disorders and other psychiatric disorders. Metacognitions refer to cognitions about cognition, for example, a belief such as \"When I start worrying, I cannot stop\". Several meta-analyses indicate that MCT may be superior to CBT for various psychiatric disorders. However, more studies with larger samples are required to draw firm conclusions about the effectiveness of MCT.\n\nAn alternative approach to disorder-specific treatment is transdiagnostic treatment; that is, the application of a single, generic protocol for several disorders. There are advantages of transdiagnostic treatments in comparison to disorder-specific treatments in terms of therapist learnability (i.e., easier to learn one protocol than several) and dissemination into routine care. Despite the MCT model being described as applicable to a range of psychiatric disorders and MCT as a potentially transdiagnostic approach, at present there is only one sufficiently large study that compared transdiagnostic MCT (tMCT) to disorder-specific CBT.\n\nPurpose and aims\n\nThe purpose of the present project is to investigate the effectiveness of tMCT compared to disorder-specific CBT in patients with anxiety disorders in psychiatric care and evaluate the cost-effectiveness. Aim 1 is to compare the short- and long-term effects of tMCT and CBT, from pre- to post-assessment and from post-assessment to 6- and 12-month follow-up assessments. Aim 2 is to examine possible mediators of change (metacognitions and cognitions). Aim 3 is to compare the cost-effectiveness of tMCT to CBT.\n\nDesign and setting\n\nThe project has a prospective, pragmatic, two-arm parallel-group randomized controlled superiority trial design and is conducted in psychiatric services in Stockholm, Sweden. Treatment is conducted in an individual format and face-to-face.\n\nRandomization and blinding\n\nEach participant is stratified individually on principal diagnosis prior to randomization and then randomly allocated with a 1:1 ratio to tMCT or CBT. A list of random numbers is generated for each diagnosis for each psychiatric unit by an individual independent of the project. Researchers, therapists, participants, and independent assessors are blinded to the allocation sequence. Assessors are also blinded to treatment condition at post-treatment assessment. Researchers are blinded to treatment allocation in the analysis phase at all assessment points.\n\nTherapist training and supervision\n\nTherapists are licensed psychologists or psychotherapists with prior training in CBT and employed in psychiatric services in Stockholm, Sweden. Only therapists who can show competence in MCT and CBT, respectively, are allowed to treat participants in the project.\n\nProcedure\n\nPatients are consecutively assessed for eligibility by project therapists. As part of routine clinical care, patients are assessed for principal and comorbid diagnoses. Patients meeting criteria for GAD, SAD, or PTSD are assessed whether they meet other inclusion but not exclusion criteria for participation in the project. Patients provide written informed consent to therapists. At pre-treatment, participants complete outcome measures. Participants are then randomly assigned to tMCT or CBT. Following the last session, and at 6-month and 12-month follow-up assessments, participants complete the same measures as at pre-treatment. In addition, at post-treatment principal and comorbid diagnoses are assessed by independent assessors.\n\nData analysis\n\nMultilevel modeling is used to estimate between-group effects on outcome measures from pre- to post-assessment (following treatment completion; primary endpoint), and from post-assessment to 6- and 12-month follow-up assessments. To be comparable across diagnoses, scores on the primary outcome of disorder-specific measures are standardized by calculating z-scores. Missing data are estimated using maximum likelihood estimation. Data from all randomized participants are used in the multilevel models, following the principle of intention-to-treat.\n\nA detailed study protocol has been submitted for publication.",[304,426,28],"Social Anxiety Disorder (SAD)",[428,429,430,431],"Metacognitive therapy","Cognitive-behavioral therapy","Transdiagnostic treatment","Anxiety disorders","2026-03-23",{"date":434,"type":39},"2026-03-27",{"date":436,"type":39},"2025-08-27",{"date":366,"type":22},{"name":71,"class":46},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":17,"minAge":446,"maxAge":18,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":450,"conditions":451,"keywords":462,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":47},"100630104","comparative-effectiveness-of-sparcs-and-unified-protocol-for-youth-with-chronic-medical-conditions-and-trauma-related-distress-100630104","NCT07483333","Comparative Effectiveness of SPARCS and Unified Protocol for Youth With Chronic Medical Conditions and Trauma-Related Distress","Supporting Purposeful Interventions & Resilience In Trauma (SPIRIT) Program: Implementing Trauma-Specific Screening and Stratified Interventions for Youth With a Chronic Medical Condition","Inclusion Criteria:\n\n* Youth (aged 8-18 years) who received a SPIRIT program psychological trauma screening and were deemed clinically appropriate for SPIRIT group therapy. Clinically appropriate means the youth can historically engage in a group setting (e.g., school, camp, therapy group) without significant disruption to the group process or other participants.\n* Youth and parent\u002Flegal guardian are willing and able to provide informed consent\u002Fassent for randomization.\n* Youth and parent\u002Flegal guardian are fluent in English or Spanish.\n* Youth is not currently engaged in individual therapy at the time of enrollment (per patient\u002Fparent report).\n\nExclusion Criteria:\n\n* Wards of the state or DCFS youth in care.\n* Youth with reported or observed symptoms that would significantly impair group therapy engagement, including but not limited to: intellectual disability, moderate-to-severe autism spectrum disorder, active suicidal ideation, uncontrolled psychosis, or other acute psychiatric symptoms that could disrupt the group process.\n* Regular use of alcohol or other substances that interfere with participation or disrupt the group process.\n* Youth requiring immediate higher-level psychiatric care (e.g., intensive outpatient programming, partial hospitalization, inpatient psychiatric admission, or residential treatment) at the time of first randomization.","8 Years",{"count":448,"type":22},400,[58],"The goal of this clinical trial is to compare the effectiveness of trauma-focused therapies for improving mental health symptoms and daily functioning in youth with chronic medical conditions who have experienced psychological trauma and trauma-related distress. The study evaluates two evidence-based cognitive-behavioral therapies - Structured Psychotherapy for Adolescents Responding to Chronic Stress (SPARCS) and the Unified Protocol (UP) - delivered in group and individual formats to determine which approach, or combination of approaches, best reduces trauma symptoms and supports coping and adjustment. The study will also help researchers understand how to best support youth who continue to experience distress after an initial round of therapy.\n\nThe main questions it aims to answer are:\n\n* Does SPARCS group therapy or UP group therapy lead to greater improvements in trauma symptoms and functional impairment?\n* For youth who do not show enough improvement after group therapy, does adding SPARCS or UP individual therapy lead to better outcomes?\n* Which sequence of group and individual therapies leads to the greatest improvements in trauma symptoms and functioning?\n\nResearchers will compare two evidence-based therapies currently offered at Ann \\& Robert H. Lurie Children's Hospital of Chicago. Youth will first be randomly assigned to receive either SPARCS or UP in a group format. After completing group therapy, youth who still need additional support will be randomly assigned again to receive individual or family therapy using SPARCS or UP. This stepwise approach will help identify which sequence of therapies leads to the best overall outcomes for youth.\n\nParticipants will:\n\n* Take part in group therapy sessions using either SPARCS or UP\n* For those needing additional support after group therapy, participate in individual SPARCS or UP therapy\n* Complete brief assessments of mental health and daily functioning at enrollment, and every 12 weeks thereafter for 48 weeks, as part of their regular care through Ann \\& Robert H. Lurie Children's Supporting Purposeful Interventions \\& Resilience in Trauma (SPIRIT) program",[331,452,453,454,455,456,457,458,459,460,461],"Trauma","Trauma and Stressor Related Disorder","Mental Health Functioning","Chronic Medical Conditions","Chronic Medical Condition","Chronic Medical Illness","Posttraumatic Stress Disorder PTSD","Posttraumatic Stress Disorders","Posttraumatic Stress Symptoms","Posttraumatic Stress",[463,357,464,465,466,467,468,469,470,471,472],"pediatric trauma","chronic medical conditions","pediatrics","trauma symptoms","trauma and stressor related disorder","trauma informed care","Sequential, Multiple Assignment Randomized Trial","Supporting Purposeful Interventions and Resilience in Trauma","Unified Protocol","Structured Psychotherapy for Adolescents Responding to Chronic Stress","2026-03-16",{"date":475,"type":39},"2026-03-19",{"date":477,"type":22},"2026-07",{"date":479,"type":22},"2029-09-29",{"name":481,"class":46},"Anthony Vesco",{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":17,"minAge":489,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":300,"phases":4,"briefSummary":492,"conditions":493,"keywords":513,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":47},"100577917","lhc-cidi-5-in-hong-kong-100577917","NCT06804525","LHC-CIDI-5 in Hong Kong","Use of Life History Calendars to Enhance Measurement of Lifetime Experience With Mental Disorders in Hong Kong.","Inclusion Criteria:\n\n* All household members aged 25 years old and over are randomly sampled from the Census and Statistics Department List of Quarters\n* Live in the address sampled from the Census and Statistics Department List of Quarters\n* Reside in Hong Kong for at least six months in the past year\n* Able to read and communicate in Chinese or English\n* Without linguistic or cognitive difficulties\n\nExclusion Criteria:\n\n* Domestic workers","25 Years",{"count":491,"type":22},2500,"The World Health Organization Composite International Diagnostic Interview-5th (CIDI-5) is a standardized diagnostic tool used to assess the prevalence of mental and substance use disorders over varying time frames (30 days, 12 months, and lifetime) based on the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) and International Classification of Diseases 10th edition (ICD-10). However, retrospective measurements like the CIDI-5 are susceptible to recall bias, especially for the lifetime experience, which can hinder the reporting accuracy with mental disorders.\n\nTo mitigate this issue, the life history calendar (LHC) was introduced as an aid to assist respondents in recalling the timing of life events, enhancing the ability of the CIDI-5 to measure the lifetime prevalence of mental disorders. The LHC is a grid structure with columns representing time units and rows representing life domains under study.\n\nIn a study conducted in Nepal, combining the CIDI-5 with the LHC resulted in a significant increase in the detection of mental disorders compared to using the CIDI-5 alone. This approach did not lead to an increase in false positives after clinical validation.\n\nThis experiment aims to adapt a Hong Kong version of the LHC based on the Nepalese model and evaluate the effectiveness of the LHC-assisted CIDI-5 (LHC-CIDI-5) compared to the CIDI-5 alone in assessing mental disorders.",[494,303,495,496,497,498,499,500,501,502,503,504,505,304,506,507,508,509,28,510,511,512,144],"Major Depressive Episode (MDE)","Persistent Depressive Disorder (PDD)","Suicidal Ideation","Suicidal Plan","Suicidal Attempt","Suicidal Gesture","Nonsuicidal Self-Injury","Manic Episode","Hypomanic","Bipolar I Disorder","Bipolar Sub Disorder","Bipolar II Disorder","Intermittent Explosive Disorder (IED)","Panic Attack","Panic Disorder","Obsessive-Compulsive Disorder (OCD)","PCL-SC PTSD","PCL-5 PTSD","Alcohol Use Disorder (AUD)",[514,306,515,516,307,308],"Life History Calendar","Recall bias","Retrospective reporting","2026-03-09",{"date":519,"type":39},"2026-03-10",{"date":521,"type":39},"2025-01-18",{"date":523,"type":22},"2027-04",{"name":317,"class":46},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":547,"leadSponsor":549,"locationsCount":47},"100611254","augmenting-massed-cognitive-processing-therapy-cpt-to-prevent-suicide-risk-among-patients-with-ptsd-100611254","NCT07238192","Augmenting Massed Cognitive Processing Therapy (CPT) to Prevent Suicide Risk Among Patients With PTSD","mCPT+CRP","Inclusion Criteria:\n\n1. Active duty service member or veteran aged 18 or older eligible for military medical care.\n2. Able to read, write, and speak English.\n3. Meeting diagnostic criteria for PTSD or subthreshold PTSD (i.e., meeting diagnostic threshold for 3 of 4 symptom criteria within the past month) on the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).\n4. Active suicidal ideation within the past week as assessed by scoring ≥ 1 on Scale for Suicidal Ideation (SSI) item 4 (i.e., active suicidal ideation within the past month) or report an interrupted, aborted, or actual suicide attempt within the preceding month on the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R).\n5. Regular use of an iPhone or Android smartphone.\n\nExclusion Criteria:\n\n1. Inability to comprehend and complete the consent and baseline screening questionnaires.\n2. Current suicide or homicide risk meriting crisis intervention.\n3. Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate clinical attention based on interviewer assessment and clinical judgement.\n4. Currently engaged in evidence-based psychotherapy for PTSD (e.g., Cognitive Processing Therapy, Prolonged Exposure Therapy, Written Exposure Therapy).",{"count":533,"type":22},190,[58],"The purpose of this research is to see if Crisis Response Planning (CRP), a brief strategy designed to help people cope effectively with emotional crises, combined with Cognitive Processing Therapy (CPT), a talk treatment for posttraumatic stress disorder (PTSD), will reduce suicidal thoughts and behaviors.",[28,496,537],"Suicide Attempt",[34,539,540,541,542],"Cognitive Processing Therapy","military","suicide","Crisis Response Planning","2026-02-23",{"date":545,"type":39},"2026-02-24",{"date":67,"type":39},{"date":548,"type":22},"2028-08-31",{"name":550,"class":46},"Ohio State University",{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":558,"targetDuration":4,"studyType":23,"phases":559,"briefSummary":560,"conditions":561,"keywords":563,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":573,"locationsCount":47},"100618112","to-investigate-the-change-of-brain-and-autonomic-function-from-different-protocols-of-repeated-transcranial-magnetic-stimulation-therapy-for-patients-with-post-traumatic-stress-disorder-comorbid-major-depressive-disorder-100618112","NCT07327385","To Investigate the Change of Brain and Autonomic Function From Different Protocols of Repeated Transcranial Magnetic Stimulation Therapy for Patients With Post-traumatic Stress Disorder Comorbid Major Depressive Disorder","The Pathophysiological Mechanisms and Novel Treatments Linking Stress and Mental Health Conditions -To Investigate the Change of Brain and Autonomic Function From Different Protocols of Repeated Transcranial Magnetic Stimulation Therapy for Patients With Post-traumatic Stress Disorder Comorbid Major Depressive Disorder: a Randomized, Double-blind, Crossover Study","Inclusion Criteria:\n\n1. Adults aged 18 to 65 years.\n2. Clinical diagnosis of posttraumatic stress disorder (PTSD) according to DSM-5 criteria, confirmed by a board-certified psychiatrist.\n3. Presence of comorbid major depressive disorder with stable clinical condition.\n4. PTSD symptom severity defined as: PTSD Checklist for DSM-5, Chinese version (C-PCL-5) total score ≥ 31.\n5. Depressive symptom severity defined as: Patient Health Questionnaire-9 (PHQ-9) total score ≥ 10.\n6. Stable psychiatric medication regimen for at least 4 weeks prior to enrollment, or medication-free.\n7. Ability to understand the study procedures and provide written informed consent.\n8. Normal or corrected-to-normal vision and hearing.\n9. Ability to comply with study procedures and visit schedule.\n\nExclusion Criteria:\n\n1. Lifetime diagnosis of schizophrenia spectrum disorders, bipolar disorder, or pervasive developmental disorders.\n2. Alcohol or substance use disorder (excluding caffeine and nicotine) within the past 6 months.\n3. Ongoing trauma-focused psychotherapy during the study period.\n4. Prior exposure to repetitive TMS treatment exceeding five sessions.\n5. Current or recent (within the past year) suicidal ideation or behavior, defined as: PHQ-9 item 9 score ≥ 1, confirmed by clinical psychiatric evaluation.\n6. Self-injurious behavior requiring medical attention within the past 3 months.\n7. History of epilepsy, seizure disorder, or family history of epilepsy.\n8. Significant neurological disorders, severe traumatic brain injury, or history of brain surgery.\n9. Presence of implanted metallic or electronic medical devices (e.g., pacemakers, cochlear implants, neurostimulators).\n10. Uncontrolled major medical illnesses or severe cardiovascular disease.\n11. Pregnancy or breastfeeding.\n12. Skin lesions or infections at the stimulation site.\n13. Use of medications known to significantly lower seizure threshold (e.g., tricyclic antidepressants or certain analgesics).\n14. Any condition deemed by the investigator to render the participant unsuitable for rTMS.",{"count":139,"type":22},[58],"This study aims to investigate the immediate neurophysiological and autonomic effects of two noninvasive brain stimulation protocols-prolonged intermittent theta-burst stimulation (prolonged iTBS) and high-frequency repetitive transcranial magnetic stimulation (HF-rTMS)-in patients with posttraumatic stress disorder (PTSD) comorbid with major depressive disorder (MDD). Using a randomized, double-blind, sham-controlled crossover design, changes in prefrontal cortical activity measured by functional near-infrared spectroscopy (fNIRS) and autonomic nervous system function measured by heart rate variability (HRV) will be assessed before and immediately after a single stimulation session.",[28,562],"Depression - Major Depressive Disorder",[34,564,565,566],"functional near-infrared spectroscopy","Heart Rate Variability; HRV","rTMS","2026-02-11",{"date":569,"type":39},"2026-02-17",{"date":571,"type":22},"2026-02-09",{"date":181,"type":22},{"name":574,"class":46},"Tri-Service General Hospital",{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":582,"targetDuration":4,"studyType":23,"phases":584,"briefSummary":585,"conditions":586,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":593,"locationsCount":47},"100617329","phase-2-ayahuasca-esketamine-and-ptsd-100617329","NCT07317206","Ayahuasca, Esketamine and PTSD","Effects of Single Dose of Ayahuasca or Esketamine on Posttraumatic Stress Disorder: a Randomized, Double-blinded Study","Inclusion Criteria:\n\n* posttraumatic stress disorder\n\nExclusion Criteria:\n\n* psychiatric and other medical comorbidities",{"count":583,"type":22},10,[25],"Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine in patients with posttraumatic stress disorder.",[28],"2025-12-19",{"date":589,"type":39},"2026-01-05",{"date":591,"type":39},"2025-12-20",{"date":477,"type":22},{"name":594,"class":46},"University of Sao Paulo",{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":298,"sex":17,"minAge":18,"maxAge":603,"enrollmentInfo":604,"targetDuration":4,"studyType":23,"phases":606,"briefSummary":608,"conditions":609,"keywords":610,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":47},"100564569","phase-1-inflammatory-challenge-and-fear-100564569","NCT06630884","Inflammatory Challenge and Fear","Inflammatory Challenge and Fear Extinction: A Model to Enhance Understanding of Posttraumatic Stress Disorder","LIFE","Inclusion Criteria:\n\nAll Subjects:\n\n1. Aged 18-60 years old\n2. Trauma Exposed\n3. Current PTSD\u002FNo history of PTSD\n\nExclusion Criteria:\n\n1. Contraindications to typhoid vaccine\n2. Conditions associated with inflammation\n3. Pregnancy or plans to become pregnant in next three months","60 Years",{"count":605,"type":22},288,[607],"PHASE1","The goal of this study is to learn if short-term changes in the immune system alter how we process information and experience fear. The main questions it aims to answer are:\n\nDo people who receive typhoid vaccine respond differently than those who receive a placebo saline vaccine? Do people who receive typhoid vaccine experience changes in how they think and feel?\n\nParticipants will:\n\nAttend four appointments at the San Francisco VA Health Care System;\n\nReceive typhoid vaccine or placebo at one of the visits;\n\nHave their physiological responding measured while listening to sounds;\n\nComplete questionnaires and psychological tests.",[28],[34,611,612,613],"posttraumatic stress","inflammation","fear","2025-12-10",{"date":616,"type":39},"2025-12-15",{"date":618,"type":39},"2025-03-28",{"date":620,"type":22},"2028-11",{"name":622,"class":46},"University of California, San Francisco",{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":630,"enrollmentInfo":631,"targetDuration":4,"studyType":23,"phases":633,"briefSummary":634,"conditions":635,"keywords":637,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":47},"100565356","integrated-treatment-for-opioid-use-disorder-and-ptsd-100565356","NCT06641115","Integrated Treatment for Opioid Use Disorder and PTSD","Integrated Treatment for Co-Occurring Opioid Use Disorder and Posttraumatic Stress Disorder","Inclusion Criteria:\n\n* Any gender; any race or ethnicity; aged 18-70 years old.\n* English-speaking\n* Meet DSM-5 diagnostic criteria for OUD.\n* Meet DSM-5 diagnostic criteria for PTSD and have some memory of their index traumatic event.\n* Must be maintained on a stable dose of medication for OUD for at least 1 month.\n* Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 1 month before study initiation.\n\nExclusion Criteria:\n\n* Participants presenting with psychiatric contraindications (e.g., unmanaged psychosis or mania, or bipolar) will be excluded and referred clinically.\n* Participants considered an immediate suicide risk, with current suicidal ideation and a plan of intent, or displaying other high-risk behaviors (i.e., MOUD refusal, risky fentanyl use, etc.), as determined by the PI and study team. These individuals will complete a safety plan and be referred for treatment.\n* Participants meeting DSM-5 criteria for a concurrent, non-opioid, substance use disorder and who report that the other substance is their primary substance of use. These participants will be referred clinically for treatment.\n* Participants enrolled in ongoing evidence-based psychotherapy for substance use disorders or PTSD outside of medications for OUD and standard psychotherapy groups in treatment programs.\n* Medical problems requiring immediate and intensive treatment, such as unstable or symptomatic end stage liver disease.","70 Years",{"count":632,"type":22},76,[58],"This study will test a therapy intervention, HOPE, for individuals with opioid use disorder and posttraumatic stress disorder. Interested individuals will need to be taking medications for opioid use disorder (e.g., suboxone, naltrexone, methadone). Interested participants will complete a 10-12 week therapy, and be asked to complete surveys.",[636,28],"Opioid Use Disorder",[638,639,640,34,641,642],"Mental Health","Psychiatry","Substance Use","Opioid Use","Therapy","2025-11-21",{"date":645,"type":39},"2025-11-28",{"date":647,"type":39},"2025-03-01",{"date":649,"type":22},"2027-08",{"name":342,"class":46},{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":657,"eligibilityCriteria":658,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":659,"targetDuration":4,"studyType":23,"phases":661,"briefSummary":662,"conditions":663,"keywords":667,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":47},"100590547","project-comet-massed-prolonged-exposure-for-ptsd-and-sud-100590547","NCT06968832","Project COMET: Massed Prolonged Exposure for PTSD and SUD","Project COMET: Hybrid Effectiveness-Implementation Trial of Massed PTSD Treatment in a Community Substance Use Program","PROJECT COMET","Inclusion Criteria:\n\n* Age 18+\n* Enrolled in SUD treatment at Gateway Community Services\n* Meet DSM-5 criteria for a SUD (Tobacco Use Disorder alone not sufficient for inclusion)\n* Meet DSM-5 criteria for PTSD\n* Able to give informed consent\n\nExclusion Criteria:\n\n* severe cognitive impairment\n* current suicidal or homicidal intent requiring immediate treatment\n* current unstable psychotic or manic symptoms not attributable to SUD",{"count":660,"type":22},168,[58],"The goal of this clinical trial is to learn if Massed Prolonged Exposure Therapy (M-PE) can improve PTSD symptoms and reduce substance use in adults receiving intensive outpatient (IOP) treatment for substance use disorder (SUD). The main questions it aims to answer are:\n\n* Does M-PE reduce PTSD symptoms more effectively than trauma treatment as usual (TAU)?\n* Does M-PE reduce the number of days participants use substances?\n* How do patient-centered outcomes (such as depression, suicidal thoughts, and quality of life) differ between M-PE and trauma TAU?\n* Researchers will compare M-PE to treatment as usual to see if M-PE leads to better mental health and substance use outcomes and lower dropout rates.\n\nParticipants will:\n\n* Attend multiple therapy sessions per week (M-PE) or receive usual care\n* Complete assessments at baseline, during treatment, end-of-treatment, 1-month, 3-month, and 6-month follow-up\n* Share feedback through surveys and interviews about their experience in the program",[28,664,665,666],"Substance Use Disorders (SUD)","Comorbidity","Trauma and Stressor Related Disorders",[28,144,668,669,670,671,672,673,674,675],"PTSD\u002FSUD Comorbidity","Prolonged Exposure Therapy (PE)","Massed Prolonged Exposure (M-PE)","Randomized Clinical Trial (RCT)","Treatment as Usual (TAU)","Integrated PTSD and SUD Treatment","Implementation Science","Trauma-Focused Treatment","2025-10-23",{"date":678,"type":39},"2025-10-27",{"date":680,"type":39},"2025-09-02",{"date":682,"type":22},"2029-06-30",{"name":684,"class":46},"Rutgers, The State University of New Jersey",{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":4,"eligibilityCriteria":691,"healthyVolunteers":298,"sex":17,"minAge":18,"maxAge":692,"enrollmentInfo":693,"targetDuration":4,"studyType":23,"phases":695,"briefSummary":696,"conditions":697,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":699,"lastUpdatePostDateStruct":700,"startDateStruct":702,"completionDateStruct":704,"leadSponsor":705,"locationsCount":47},"100599080","a-neurosensory-account-of-anxiety-and-stress-study-2-100599080","NCT07079839","A Neurosensory Account of Anxiety and Stress (Study 2)","Threat-related Sensory Cortical (SC) Disinhibition and SPA Pathology in Posttraumatic Stress Disorder (PTSD) (Aim 3; Expts. 2&3)","Inclusion Criteria:\n\n* Right-handed\n* With normal or corrected-to-normal vision and normal olfaction\n* Between the ages of 18 and 50 years\n* Meeting the tACS screening criteria (see List I below; e.g., lack of a serious head injury or loss of consciousness)\n* Patients: Diagnosis of PTSD\n* Patients: If taking psychotropic medications, medication stability in the past 2 months\n* If having mild substance use disorder (for patients) or occasional substance use, abstention from use 48 hours before the experiment.\n\nExclusion Criteria:\n\n* A history of diagnosis for a major medical illness (e.g., cancer, metabolic syndrome, cardiovascular disease, inflammatory disorders) or a neurological disorder (e.g., seizure, stroke, Parkinson's disease).\n* Patients: Concurrent Axis I diagnosis (depression, anxiety, and mild substance use disorder are allowed given their high comorbidity with PTSD).\n* Healthy controls: A history of diagnosis for a Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Axis I disorder or current use of psychoactive medications.\n* Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior that poses an immediate danger to self or others.\n* History of head trauma with unconsciousness (\\> 5 minutes)\n* Report that they regularly drink 3 or more alcoholic beverages a day.\n* Report that they are unable to abstain from substance use (including alcohol, nicotine, cannabis, amphetamines, narcotics, solvents, cocaine, hallucinogens, tranquilizers, barbiturates, etc.) or sleep medication for 48 hours before being scanned.\n* Are on calcium channel blockers (e.g., verapamil, nifedipine) or alpha-blockers (e.g., prazosin, terazosin) and are unable to stop these medications for a 48-hour period prior to scanning (to exclude the impact of these medications on the interpretation of fMRI\u002FEEG).\n* Failed Urine Drug Screening Test: A rapid urine screening test that utilizes monoclonal antibodies to detect elevated levels of specific drugs (including alcohol, amphetamines, benzodiazepines, barbiturates, cocaine, marijuana, opiates, etc.) in urine (iCup)\n* Pregnancy based on urine test. The safety of magnetic resonance (MR) systems has not been established for fetuses\n* Having electrically, magnetically, or mechanically activated implants (e.g., cardiac pacemakers), because the electromagnetic fields produced by the MR system may interfere with the operation of these devices.","50 Years",{"count":694,"type":22},160,[58],"This study will take a basic neuroscience approach to investigate pathological mechanisms underlying PTSD. Additionally, the study aims to identify how Transcranial Alternating Current Stimulation (tACS) brain stimulation can modulate and correct neural networks and related emotions of anxious arousal and hypervigilance, with the goal of assessing tACS brain stimulation technology as a novel intervention for symptoms of anxiety.",[698,28],"Threat-related Sensory Cortical (SC) Disinhibition","2025-09-05",{"date":701,"type":39},"2025-09-12",{"date":703,"type":39},"2025-07-03",{"date":477,"type":22},{"name":706,"class":46},"The University of Texas Health Science Center, Houston"]