[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"moral-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:moral-injury":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,47,73,99,122,148,175,203,233],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100647577","comparing-two-moral-injury-treatments-100647577",false,"NCT07710521","Comparing Two Moral Injury Treatments","Comparing Two Moral Injury Treatments: Acceptance and Commitment Therapy for Moral Injury and Present Centered Therapy for Moral Injury","Inclusion Criteria:\n\n1. Eligible for VHA care\n2. Age 18-89\n3. Has been deployed to a warzone\n4. Has experienced moral injury from a morally injurious event in war that is impacting psychosocial functioning\n5. Willing to be randomized to either of the two conditions (ACT-MI or PCT-MI)\n\nExclusion Criteria:\n\n1. Inability to provide informed consent (operationalized as inability to answer 7 questions about the study and research participants' rights)\n2. Inability to complete study measures (e.g., due to significant acute intoxication\u002Fwithdrawal symptoms, mania, psychosis, aggression, catatonia, cognitive impairment)\n3. Imminent suicide risk\n4. Participation in another interventional mental health research study\n5. Membership in a vulnerable population (e.g., cognitively impaired)\n6. Current participation in an EBP for a condition related to moral injury\n7. Past participation in ACT (based on medical record review and Veteran self-report)","ALL","18 Years","89 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"NA","Purpose of this study: The purpose of this study is to evaluate the effectiveness of two psychological treatments for moral injury: Acceptance and Commitment Therapy for Moral Injury and Present Centered Therapy for Moral Injury. The main questions it aims to answer are:\n\n1. Determine the efficacy of ACT-MI for building functional recovery among 180 warzone deployed Veterans.\n2. Identify barriers and facilitators to implementing ACT-MI in VA mental health clinics or a national telehealth hub in preparation for future dissemination efforts.\n\nParticipants will be asked to:\n\n* Complete a two to two and a half hour initial assessment session online using videoconferencing. Participants will be asked to complete surveys and questionnaires.\n* Be randomized to either ACT-MI or PCT-MI\n* Meet with the study clinicians for 15 virtual outpatient sessions (12-group and 3-individual sessions).\n* Complete a post-treatment assessment session offered online using videoconferencing within one week of treatment completion to complete surveys and questionnaires.\n* Complete one- and three-month follow-up assessments offered online using videoconferencing to complete surveys and questionnaires.",[27],"Moral Injury",[29,30,31,32,33],"moral injury","acceptance and commitment therapy for moral injury (ACT-MI)","present centered therapy for moral injury (PCT-MI)","Veteran","psychosocial functioning","NOT_YET_RECRUITING","2026-07-13",{"date":37,"type":38},"2026-07-17","ACTUAL",{"date":40,"type":21},"2026-08",{"date":42,"type":21},"2030-09",{"name":44,"class":45},"VA Eastern Colorado Health Care System","FED",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":46},"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":55,"type":21},60,[57],"PHASE2","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 .",[60,27,61],"Post Traumatic Stress Disorder","MDMA ('Ecstasy')","RECRUITING","2026-07-07",{"date":65,"type":38},"2026-07-08",{"date":67,"type":38},"2023-06-01",{"date":69,"type":21},"2028-12-01",{"name":71,"class":72},"HaEmek Medical Center, Israel","OTHER",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":46},"100643275","moral-injury-study-among-healthcare-professionals-in-psychiatric-facilities-in-the-paca-region-100643275","NCT07631741","Moral Injury Study Among Healthcare Professionals in Psychiatric Facilities in the PACA Region","A Mixed Epidemiological Study of Moral Injury Among Healthcare Professionals in Psychiatric Facilities in the PACA Region","MI-PSY","Inclusion Criteria:\n\n* Healthcare Professionals working on Psychiatric Facilities in the PACA Region\n\nExclusion Criteria:\n\n* Absence of consent",true,{"count":83,"type":21},2688,"OBSERVATIONAL","Healthcare professionals working in psychiatric settings face demanding working conditions characterized by high rates of burnout and specific constraints, such as the deprivation of patients' liberty. \\*Moral Injury\\* (MI), a relatively recent concept, extends beyond burnout by focusing on the distress arising from ethical conflicts and the dissonance between professional values and the realities of clinical practice. Although the concept has begun to emerge from a theoretical perspective, particularly in the United States, it remains largely unknown in France and has yet to be investigated in psychiatric settings at the international level.\n\nThe hypothesis is that MI plays a central role in healthcare professionals' psychological distress and contributes to the major recruitment and retention crisis affecting public psychiatric institutions. This crisis is reflected, for example, in a 40% vacancy rate for hospital physician positions in public facilities, with particularly acute shortages in child and adolescent psychiatry. The demographic crisis in child and adolescent psychiatry is unprecedented, marked by a 30% decline in the workforce over the past decade and projections suggesting a further 50% reduction within the next ten years. At the same time, mental health disorders among adolescents-particularly suicide attempts among girls-have increased substantially since the COVID-19 pandemic.\n\nThis study aims to explore the organizational, individual, and systemic factors associated with Moral Injury in order to better understand and prevent this form of professional suffering.",[27],[27,88,89,90],"Burnout","Healthcare Professionals","Psychiatry","2026-07-06",{"date":63,"type":38},{"date":94,"type":21},"2026-07",{"date":96,"type":21},"2027-01",{"name":98,"class":72},"Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":81,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":121,"locationsCount":46},"100587277","moral-injury-in-french-healthcare-workers-100587277","NCT06926296","Moral Injury in French Healthcare Workers","MI-PRO","Inclusion Criteria:\n\n* Healthcare workers\n\nExclusion Criteria:\n\n* Absence of consent",{"count":107,"type":21},3073,[24],"Healthcare professionals are facing an escalating crisis, with burnout rates ranging between 40% and 60% and a growing intention to leave the profession, affecting one in five physicians and one in four nurses in the coming years. While current interventions focused on individual resilience, such as mindfulness, peer support, and workload management, have been promoted as solutions, they have failed to bring about systemic improvements. This raises the question of whether other factors, such as Moral Injury, play a key role in this crisis. Moral Injury is an emerging concept that highlights the profound misalignment between healthcare workers' professional values and the reality of their practice, often exacerbated by organizational and economic constraints.\n\nThe objective of this study is to describe the manifestations of Moral Injury among healthcare professionals in France. By establishing the first large-scale assessment of Moral Injury among healthcare professionals in France, this study aims to identify key organizational and personal risk factors contributing to this phenomenon. The use of Structural Equation Modeling will help build a robust theoretical model that clarifies the underlying mechanisms of Moral Injury and its interactions with broader health issues. The findings will support the development of targeted interventions focused on systemic organizational changes to improve healthcare workers' well-being and guide public health policies.",[27],[112,88,113,114,115,116],"Moral injury","Depression","Anxiety","Healthcare workers","Health services research",{"date":63,"type":38},{"date":119,"type":38},"2025-11-19",{"date":96,"type":21},{"name":98,"class":72},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":81,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":4},"100646723","professional-contributions-and-social-value-in-high-acuity-medical-care-settings-100646723","NCT07686666","Professional Contributions and Social Value in High-Acuity Medical Care Settings","An Exploratory Study on Professional Contributions and Social Value in High-Acuity Medical Care Settings","Inclusion Criteria:\n\n* Adults aged 18 years or older who are able to understand the study information and provide informed consent or agreement to participate.\n* Healthcare professionals working in hospital-based high-acuity clinical areas, such as emergency departments, trauma and critical care, intensive care units, respiratory care units, and related settings. Eligible participants may include physicians, nurses, allied health professionals, case managers, registry or data management personnel, and administrative staff involved in these areas.\n* Patients who have received care in high-acuity medical care settings.\n* Important family members or main caregivers who have accompanied, cared for, or supported decision-making for patients in high-acuity medical care settings.\n* Public-sector or emergency response personnel involved in emergency care, rescue, health, or social service systems related to high-acuity medical care.\n\nFor the first phase, healthcare professionals may be invited to complete questionnaires and\u002For participate in qualitative interviews. Patients, important family caregivers, and other relevant stakeholders may be invited to participate in qualitative interviews. For the second phase, eligible stakeholder groups may be invited to complete an anonymous online survey.\n\nExclusion Criteria:\n\n* Individuals who decline to participate after receiving the study explanation.\n* Individuals who do not meet the inclusion criteria.\n* Individuals who are unable to understand the study information or complete the study procedures.",{"count":130,"type":21},1350,"This study will explore experiences in high-acuity medical care settings, such as emergency, trauma, intensive care, and related clinical areas. These settings often involve heavy workloads, complex care decisions, teamwork, and communication among many people.\n\nThe study will invite healthcare professionals, patients, important family caregivers, and other related people to share their experiences. Participants may complete questionnaires, take part in interviews, or complete a later online survey. The study will ask about work experiences, care experiences, communication, support needs, teamwork, and the value of professional contributions in these settings.\n\nThe goal of this study is to better understand important but less visible contributions in high-acuity medical care, such as teaching, coordination, communication, and support. The findings may help identify areas that can be considered in future research, hospital improvement, workforce development, and policy discussion.",[133,27],"Professional Burnout",[135,136,137,138,139],"High-acuity medical care","Social value","SROI","Healthcare workforce","Workforce retention","2026-06-29",{"date":63,"type":38},{"date":143,"type":21},"2026-06-25",{"date":145,"type":21},"2030-12-31",{"name":147,"class":72},"Kaohsiung Medical University Chung-Ho Memorial Hospital",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":81,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":46},"100410556","general-psychological-distress-ptsd-and-co-morbidities-in-healthcare-workers-consequent-to-occupational-trauma-100410556","NCT04626050","General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to Occupational Trauma","A Brief Phased Two-Step Intervention for Treating General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to Occupational Trauma","Inclusion Criteria:\n\n* Any healthcare worker providing medical care or support who has experienced occupational-related trauma\n* English-speaking\n* Age \\>18\n* Medically stable\n* Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments\n* If on psychotropic medication stable for prior 60 days\n\nFor phase II additional inclusion criteria:\n\n\\- Current diagnosis of PTSD\n\nExclusion Criteria:\n\n* Current significant unstable medical illness precluding regular session attendance or assessment completion\n* Participants who in the investigator's judgment pose a current homicidal, suicidal, or other risk\n* Lifetime or current diagnosis of schizophrenia or other psychotic disorder\n* Participation in a clinical trial or concurrent evidence-based treatment for psychiatric conditions or PTSD during the previous 3 months.",{"count":156,"type":21},120,[24],"It is expected that large numbers of healthcare workers experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. The purpose of this study is to find interventions which are helpful in treating psychological distress in healthcare workers adversely affected by occupational-related trauma.\n\nThere are two phases of the study. All participants will take part in Phase I, which consists of 4 sessions over a two-week period of either a narrative writing intervention or a medical music intervention. Participants will be randomly assigned to the narrative writing intervention or medical music intervention.\n\nAfter Phase I, participants will be re-assessed. Healthcare workers who meet criteria for PTSD will be given the option to participate in Phase II of the study, in which they will be offered a choice between one of two evidence-based treatments for PTSD: Interpersonal Therapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minute sessions scheduled twice weekly. Participants will be allowed to choose a preferred treatment in Phase II. After Phase II participants will complete a final assessment concluding the study. All interventions will be offered using distance technology.",[160,27],"Post-traumatic Stress Disorder",[162,27,163,164,165],"PTSD","Psychological Distress","Healthcare Workers","Occupational Trauma","2026-06-17",{"date":168,"type":38},"2026-06-22",{"date":170,"type":38},"2022-01-20",{"date":172,"type":21},"2028-04",{"name":174,"class":72},"Weill Medical College of Cornell University",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":189,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100638809","mental-health-clinician--chaplain-collaboration-100638809","NCT07579143","Mental Health Clinician \u002F Chaplain Collaboration","Mental Health Clinician \u002F Chaplain Collaboration (MC3): A Pilot Study","MC3","Inclusion Criteria:\n\n* age 18 to 80 years\n* plan to follow-up with a VA mental health clinician for PTSD or SUD treatment within the next three months (therefore allowing for collaboration)\n* positive screen using the 6-item Moral Injury Distress Scale (MIDS) screener. A positive MIDS screen will be defined as being bothered at least moderately by exposure to at least one potentially morally injurious event (witnessing, omission, commission).\n\nExclusion Criteria:\n\n* diagnosis of schizophrenia, bipolar disorder, borderline personality disorder, or severe neurocognitive disorder (e.g., dementia, severe TBI). Veterans with borderline personality disorder will be eligible for participation in this study following DBT completion.\n* Planning to start or current participation in a moral injury treatment group or evidence-based psychotherapy (e.g., Prolonged Exposure or Cognitive Processing Therapy).","80 Years",{"count":185,"type":21},20,[24],"The goal of this clinical trial is to learn if the intervention can be delivered by VA chaplains and if it is acceptable for veterans who have symptoms of moral injury (guilt, shame, isolation) and are receiving VA mental health treatment. The main questions it aims to answer are:\n\nCan the study team enroll veterans for this intervention and complete data collection? Will veterans complete the intervention?\n\nThere is no comparison group.\n\nParticipants will will complete a baseline and 6-month interview and participate in up to 12 intervention sessions with a VA chaplain. The intervention will focus on facilitating forgiveness and community connection.",[27],[190,191,192],"feasibility","acceptability","single arm trial","2026-05-06",{"date":195,"type":38},"2026-05-11",{"date":197,"type":38},"2025-04-14",{"date":199,"type":21},"2026-06",{"name":201,"class":45},"Central Arkansas Veterans Healthcare System",2,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":210,"targetDuration":212,"studyType":84,"phases":4,"briefSummary":213,"conditions":214,"keywords":217,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":229,"leadSponsor":231,"locationsCount":46},"100629348","integrative-bilateral-cervical-sympathetic-blocks-for-trauma-related-symptoms-in-special-operations-veterans-a-prospective-case-series-100629348","NCT07473505","Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospective Case Series","Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospective Case Series.","Inclusion Criteria:\n\n* 18 years or older\n* PTSD (PCL Score of 33 or greater at baseline screening)\n* Willing and able to provide informed consent and complete study procedures\n* Fluent in English\n* Special Operations Forces Veteran\n\nExclusion Criteria:\n\n* Recent Sympathetic Block: Receipt of any cervical sympathetic block (including stellate ganglion block \\[SGB\\], dual sympathetic ganglion block \\[DSGB\\], or bilateral SGB\u002FBCSB), whether unilateral or bilateral, within the past 6 months.\n* Concurrent interventional clinical trial participation: Currently enrolled in another interventional clinical trial or receiving any experimental treatment targeting PTSD, TBI, or autonomic dysfunction during the study period\n* Acute Psychiatric Instability: Currently experiencing acute psychiatric crisis requiring inpatient care, active suicidal or homicidal intent, or untreated mania, psychosis, or severe dissociation\n* Medical Contraindications to BCSB: Any known anatomical abnormalities, bleeding disorders, allergy to local anesthetics, pregnancy, or comorbidities that represent a contraindication to receiving a cervical sympathetic block, per the treating physician's judgment.\n* Language or communication barriers: Inability to read, speak, or understand English sufficiently to complete informed consent and study assessments\n* Low PTSD Symptom Severity at Baseline: PCL-5 Score \\\u003C 33 at screening, indicating subclinical or minimal PTSD symptoms (Rationale: to ensure measurable clinical benefit and reduce floor effects)",{"count":211,"type":21},75,"270 Days","This study prospectively evaluates the effects of Integrative Bilateral Cervical Sympathetic Block (BCSB) on trauma-related symptoms in Special Operations Veterans, comparing outcomes in those receiving BCSB alone versus BCSB combined with structured integrative therapy. Using standardized FDA-approved dosing, validated symptom measures, and strict safety criteria, the study aims to determine whether this dual-level autonomic intervention improves PTSD-related and TBI-related symptoms, and whether pairing the procedure with therapy enhances durability and overall clinical benefit.",[162,215,27,114,216],"Trauma-related Mental Health Symptoms","Traumatic Brain Injury",[218,219,162,220,60,221,222,114,27,216,223,224],"Bilateral Cervical Sympathetic Blocks","Stellate Ganglion Block","Combat Veterans","Special Operations Forces Veterans","Trauma Related Symptoms","Integrative Therapy","Mental Health","2026-03-17",{"date":227,"type":38},"2026-03-20",{"date":227,"type":21},{"date":230,"type":21},"2027-07-01",{"name":232,"class":72},"Reset Medical and Wellness Center",{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":240,"minAge":4,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":46},"100546388","phase-3-examining-34-methylenedioxymethamphetamine-mdma-effects-on-psychological-relational-and-hyperarousal-related-neural-reactivity-mechanisms-in-veterans-with-ptsd-and-moral-injury-100546388","NCT06394284","Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury","IISPT2: Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and MI","Inclusion Criteria:\n\n* 1\\. Were assigned male sex at birth and currently identify as a male (e.g. are not transgender nor taking hormone replacement therapy) 2. Are veterans of the Israeli military 3. Are at least 18 years old. 4. Are fluent in speaking and reading Hebrew 5. Are able to swallow pills. 6. Agree to have EEG (three times) and salivary monitoring (during experimental sessions) at multiple occasions throughout the study.\n\n  7\\. Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug therapy sessions.\n\n  8\\. 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 unwell or unreachable.\n\n  8\\. Must agree to inform the investigators within 48 hours of any medical conditions and procedures.\n\n  9\\. Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to experimental sessions, not enroll 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\nMedical History\n\n10\\. At Screening, meet diagnostic criteria (Diagnostic Statisticians Manual, 5th version, DSM-5) for current military-based PTSD with a symptom duration of 6 months or longer with a history of at least one attempt at psychiatric or psychological treatment.\n\n11\\. At Screening, have a PCL-5 total score of 33 or greater and at Screening\u002FBaseline a confirmed diagnosis of PTSD per CAPS-5 and a total severity score of 28 or greater.\n\n12\\. Have a body weight of at least 45 kilograms. Participants with a body weight of 45 to 48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg\u002Fm2.\n\n13\\. Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n\\- Medical Conditions\n\n1. Alanine transaminase (ALT) \\[or aspartate transaminase (AST)\\]higher than 2 x upper limit of normal (ULN).\n2. Total bilirubin higher than 1.5 x ULN (isolated bilirubin higher than; 1.5 x ULN is acceptable if total bilirubin is fractionated and direct bilirubin less than; 35%).\n3. Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n\n   • Note: Stable chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B (e.g., the presence of hepatitis B surface antigen or positive hepatitis C antibody test result without evidence of active infection at screening or within 3 months prior to starting study intervention) is acceptable if the participant otherwise meets entry criteria.\n4. Have a recent history of clinically significant hyponatremia or hyperthermia.\n5. Have a marked baseline QTcF (QT interval corrected for heart rate ) interval higher than 450 ms demonstrated on repeated ECG (electrocardiogram) assessments. Participants whose QTcF exceeds this value during screening may be initially enrolled if a pre-study concomitant medication is suspected to be prolonging the QT-interval. ECGs should be repeated after initial enrollment and tapering off the pre-study concomitant medication to ensure the participant meets eligibility criteria prior to enrolment confirmation and to IMP dosing.\n\n   • Note: The QTcF is the QT interval corrected for heart rate according to Fridericia's formula. It is either machine-read or manually over-read.\n6. Have a 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 myocardial infarction, cerebrovascular accident, heart failure, severe coronary artery disease, or aneurysm.\n\n   * Participants with other mild, stable chronic medical problems may be enrolled if the study clinician and Sponsor Investigator (S-I) agree the condition would not significantly increase the risk of MDMA administration or be likely to produce significant symptoms during the study that could interfere with study participation or be confused with side effects of MDMA.\n   * Examples of stable medical conditions that could be allowed include but are not limited to human immunodeficiency virus (HIV) infection, gastroesophageal reflux disease (GERD), hypothyroidism (if taking adequate and stable thyroid replacement medication), glaucoma (if approval for study participation is received from an ophthalmologist). Any medical disorder judged by the investigator to significantly increase the risk of harm from MDMA exposure by any mechanism would require exclusion.\n7. Have a diagnosis of uncontrolled hypertension, defined as repeated blood pressure readings of ≥140 mmHg systolic or ≥90 mmHg diastolic. The diagnosis may be confirmed by repeated clinic measurements or home blood pressure monitoring if clinically indicated.\n\n   • Participants with well-controlled hypertension that has been successfully treated with anti-hypertensive medicines may be enrolled if they pass a risk assessment and potentially additional screening to rule out underlying cardiovascular disease.\n8. Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.\n9. Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.\n10. 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\n    • Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have been successfully treated with ablation and have not had recurrent arrhythmia for at least one year off all antiarrhythmic drugs, as confirmed by a cardiologist.\n11. Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).\n\n    Psychiatric Conditions (for MDMA-AT and somatic-based arms)\n12. Have engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment, including Electroconvulsive Therapy (ECT), and ketamine-assisted therapy.\n13. Are likely, in the investigator's opinion and via observation during the Preparatory Period, to be re-exposed to their index trauma or other significant trauma during the study.\n14. Have a current moderate (not in early remission in the 3 months prior to enrollment and meets at least 5 of 11 diagnostic criteria per DSM-5) or severe alcohol or cannabis use disorder within the 12 months prior to enrollment (meets at least 6 of 11 diagnostic criteria per DSM-5).\n\n    • May have current mild alcohol or cannabis use disorder (meets 3 of 11 diagnostic criteria per DSM-5) or moderate alcohol or cannabis use disorder in early remission for the 3 months prior to enrollment (meets 4 or 5 of 11 diagnostic criteria per DSM-5).\n15. Have an active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment.\n16. Any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to Columbia Suicide Severity Rating Scale (C-SSRS), and clinical judgment of the investigator will be excluded; however, history of suicide attempts is not an exclusion. Any participant who is likely to require hospitalization related to suicidal ideation and behavior, in the judgment of the investigator, will not be enrolled. Any participant presenting with the following on the Baseline\u002FScreening C-SSRS will be excluded:\n\n    * Suicidal ideation score of 4 or greater within the last month of the assessment at a frequency of once a week or more.\n    * Suicidal ideation score of 5 within the last 6 months of the assessment.\n    * Any suicidal behavior, including suicide attempts or preparatory acts, within the last 6 months of the assessment. Participants with non-suicidal self-injurious behavior may be included if approved by the study clinician.\n\n    Prior\u002FConcomitant Therapy\n17. Unable or unwilling to safely taper-off prohibited psychiatric medication with exceptions described in section on Concomitant Medications in study protocol or require use of prohibited medications during experimental sessions.\n18. Require use of concomitant medications that could prolong the QT interval during Experimental Sessions.\n19. Have used Ecstasy (unregulated 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.\n\n    Prior\u002FConcurrent Clinical Study Experience\n20. 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.\n\n    Diagnostic Assessments\n21. Have current Personality Disorders assessed via psychiatric assessment (by consultant psychiatrist).\n22. Have a current eating disorder with compensatory behaviors\n23. Have current major depressive disorder with psychotic features\n24. Have a history of, or a current primary psychotic disorder, bipolar affective disorder type 1 or dissociative identity disorder.\n\n    Other Exclusions\n25. 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.\n26. Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders.\n27. Lack social support or lack a stable living situation.\n28. Previous participation in a MAPS-sponsored MDMA clinical trial.\n29. Employees (and their immediate family members) of MAPS, MAPS Public Benefit Corporation, or MAPS Europe B.V; or individuals in a personal relationship with the site investigator.\n30. Have any current problem which, in the opinion of the sponsor-investigator or study clinician, might interfere with study participation.\n\nSecurity Criteria\n\nThe current study dealing with intensive treatment of military veterans suffering from PTSD, requires an environment of physical and emotional security for the patients. Safety is critical in the success of the treatment. Since October 7, 2023, we have been in a continuous state of war, which we do not know when it will end. Therefore, we are required at this time to define what security is as a criterion for conducting research at this time, and in relation to the normative reality in the world and in the State of Israel in particular. Therefore:\n\n1. The research will be carried out in Jerusalem and long sessions will not take place when there is a high risk of rocket attack or sirens during the previous day\u002Fnight.\n2. The participants in the study will be military veterans who do not participate or have taken an operational part in the war in the three months prior to the start of their participation in the study.\n3. The participants in the study do not have first degree relatives or a partner who are actively serving in a war zone at the time of their participation in the study.\n4. The participants live in a permanent and safe place and are not expected to change their place of residence during their participation in the study.","MALE",{"count":55,"type":21},[243],"PHASE3","Despite being exposed to a high level of potentially traumatic experiences due to exposure to combat, military veterans have poor response rates to traditional PTSD treatments, in some reports, just 1\u002F3 of veterans recover using traditional treatments. In recent years 3,4-methylenedioxymethamphetamine (MDMA), a psychedelic drug has demonstrated a significant treatment potential for severe and treatment resistant PTSD though not specifically in a veteran population. Additionally, even in groups where participants receive a placebo, the effect of the psychedelic treatment formulation, intensive, focused and respectful structure, appears to have promising effects. Indeed, in the current psychedelic literature, the setting and mind with which participant approach psychedelic therapy, significantly contributes to the treatment effect.\n\nThe current study proposes to address the major gaps in the theoretical literature by examining the proposed mechanisms by which MDMA enhances the \"window of tolerance\" for PTSD therapy, specifically in those with comorbid symptoms of moral injury; namely by reducing hyperarousal and enhancing connection (to self and others) and whether MDMA assisted therapy is more successful in reducing PTSD in veterans compared to a matched somatic experiential PTSD treatment, Somatic Experiental Acceptance Intensive Trauma-based therapy, (SEA-IT) which builds upon the promising placebo results, enhancing them with somatic and acceptance based treatment protocols.",[246,27],"PTSD, Post Traumatic Stress Disorder",[248,162,27,249,250,251],"MDMA","Oxytocin","veterans","Hyperarousal","2024-04-30",{"date":254,"type":38},"2024-05-01",{"date":256,"type":38},"2024-02-18",{"date":258,"type":21},"2028-12-31",{"name":260,"class":72},"Herzog Hospital"]