[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stress-disorders-post-traumatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stress-disorders-post-traumatic":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,38,0,25,[9,52,80,112,142,175,201,224,250,273,292,316,349,371,402,427,454,481,502,523,550,576,620,646,678],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":4},"100639928","postnatal-debriefing-after-adverse-obstetric-events-100639928",false,"NCT07579273","Postnatal Debriefing After Adverse Obstetric Events","Effect of a Structured Postnatal Debriefing on Psychological Outcomes and Birth Experience in Women After Adverse or Unexpected Obstetric Events","DBIRTH","Inclusion Criteria:\n\n* Women aged 18 years or older.\n* Women who have experienced an adverse or unexpected obstetric event during labor or the immediate postpartum period.\n* Admitted to the maternity unit of Hospital del Mar and clinically stable within the first 24 hours postpartum.\n* Able to understand and communicate in Spanish, Catalan, or English.\n* Willing to participate and able to provide written informed consent.\n* Access to an email account for follow-up assessments.\n\nExclusion Criteria:\n\n* Inability to communicate verbally.\n* Maternal-neonatal separation due to social reasons.\n* Unstable or severe psychiatric condition.\n* Immediate perinatal loss (intrapartum fetal death or early neonatal death).\n* Admission to intensive care within the first 24 hours postpartum.","FEMALE","18 Years",{"count":21,"type":22},142,"ESTIMATED","INTERVENTIONAL",[25],"NA","Adverse or unexpected obstetric events can negatively affect women's psychological well-being and childbirth experience, increasing the risk of postpartum traumatic stress. However, structured postnatal debriefing is not routinely implemented in clinical practice, and evidence regarding its effectiveness remains limited.\n\nThis study aims to evaluate the effect of a structured postnatal debriefing conducted within the first 24 hours after childbirth in women who have experienced an adverse or unexpected obstetric event.\n\nThis quasi-experimental pretest-posttest study will include two consecutive groups: a control group receiving usual postpartum care during the pre-implementation phase and an intervention group receiving structured postnatal debriefing during the implementation phase.\n\nThe primary outcome is childbirth-related trauma at 6 weeks postpartum. Secondary outcomes include birth satisfaction, early post-traumatic stress symptoms, satisfaction with information and emotional support received after childbirth, and clinical maternal and neonatal outcomes.\n\nThis study will provide evidence on whether structured postnatal debriefing improves psychological outcomes and contributes to more patient-centered obstetric care.",[28,29,30,31],"Stress Disorders, Post-Traumatic","Psychological Trauma","Obstetric Labor Complications","Postpartum Period",[33,34,35,36,37,38,39],"Traumatic Birth","Birth Experience","Postpartum PTSD","Postnatal Debriefing","Obstetric Debriefing","Patient-Centered Care","Maternal Mental Health","NOT_YET_RECRUITING","2026-06-22",{"date":43,"type":44},"2026-06-25","ACTUAL",{"date":46,"type":22},"2026-10",{"date":48,"type":22},"2029-01",{"name":50,"class":51},"Parc de Salut Mar","OTHER",{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100644226","pre-pilot-wings-mhealth-to-improve-moud-uptake-in-women-experiencing-intimate-partner-violence-and-ptsd-100644226","NCT07665502","Pre-Pilot WINGS+++: mHealth to Improve MOUD Uptake in Women Experiencing Intimate Partner Violence and PTSD","Pre-Pilot WINGS +++ An Effectiveness Trial of Syndemic Mhealth Intervention to Increase MOUD Uptake Among Women Impacted by Intimate Partner Violence and PTSD","Inclusion Criteria:\n\n* Identify as a woman (cis-gender or transgender)\n* Aged 18 or older\n* Report use of non-prescribed opioids in the past 30 days\n* Score positive for risk of opioid use disorder or other substance use disorder on the Drug Abuse Screening Test (DAST) with a cut-off score of 6 or higher\n* Report experiencing any severe psychological abuse or any physical or sexual abuse by a female or male intimate partner in the past year\n\nExclusion Criteria:\n\n* Evidence of significant psychiatric or cognitive impairment that would limit effective participation, as confirmed during informed consent\n* Inability to speak and understand English sufficiently to participate in assessments or intervention sessions",{"count":60,"type":22},7,[25],"The goal of this pre-pilot for the clinical trial is to develop a mobile health (mHealth) program called WINGS+++ can help women with opioid use disorder or other substance use disorders who have experienced intimate partner violence. The pre-pilot study will take place in Orange County, New York with n=7 women. .\n\nThe main questions it aims to answer are:\n\n1. Does WINGS+++ lower non-prescription opioid and other drug use in women?\n2. Does WINGS+++ help connect women to treatment for substance use, intimate partner violence, and post-traumatic stress disorder (PTSD)?\n\nResearchers will compare WINGS+++ to standard care to see if WINGS+++ works better to lower drug use and link women to helpful services.\n\nWINGS+++ is a 3-session program on a mobile device that:\n\n* Screens for intimate partner violence, PTSD, and substance use\n* Offers brief support and referrals based on each woman's needs and preferences\n* Connects women to a peer navigator who helps link them to services\n\nParticipants will:\n\n* Take part in only the WINGS+++ program for the pre-pilot\n* Answer survey questions about drug use, intimate partner violence, and PTSD symptoms\n* Provide biological samples (such as urine or hair) to check for drug use\n* Share information about the services they have used",[64,65,66,28,67,68,69],"Opioid-Related Disorders","Substance-Related Disorders","Intimate Partner Violence (IPV)","Domestic Violence","Medication for Opioid Use Disorder (MOUD)","Post Traumatic Stress Disorder PTSD","2026-06-18",{"date":72,"type":44},"2026-06-24",{"date":74,"type":22},"2026-06-15",{"date":76,"type":22},"2027-08-31",{"name":78,"class":51},"Dawn A. Goddard-Eckrich",2,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":19,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100641098","early-intervention-to-prevent-development-of-ptsd-in-burn-survivors-and-their-caregivers-100641098","NCT07656545","Early Intervention to Prevent Development of PTSD in Burn Survivors and Their Caregivers","Inclusion Criteria:\n\n* Alert, oriented, \\& not withdrawing from substance at time of screening\n* Can read and write in English\n* Hospitalized within 10 days of burn injury\n* Anticipated discharge \\\u003C=4 weeks\n* Have an email, mailing address, and at least 1 smart device for telehealth sessions\n* PTSD risk score of 2 or greater (patient-only)\n* Willing to attend therapy sessions with a loved one\n\nExclusion Criteria:\n\n* Currently incarcerated or in police custody\n* \\> 10 days post-burn\n* Lifetime diagnosis of primary psychosis or intellectual disability\n* Ongoing reported domestic violence in the dyad\n* Unstable bipolar disorder, severe substance use disorder, or acute suicidality with imminent intent that does not remit within 10 days of burn-injury\n* Inflammation Confounds (patient-only) of BMI \\> 40, metabolic syndrome, admission A1C of \\>= 6.5%\n* Currently receiving couples therapy",true,"ALL",{"count":89,"type":22},44,[25],"The purpose of this clinical trial is to adapt and test a brief patient-caregiver early intervention designed to reduce posttraumatic stress symptoms in hospitalized burn patients and their caregivers. This intervention is a brief, 4-session cognitive-behavioral intervention designed for burn patients and their loved one to complete together, during and after hospitalization. The intervention targets relational communication and functioning through reduction of invalidating, negative statements and avoidant coping by teaching patients and their loved ones to engage in adaptive natural disclosures, supportive responses, and approach coping after the burn trauma. The intervention uses evidence-based psychotherapy techniques, including psychoeducation, motivational interviewing, and skills coaching. The clinical trial will occur in two sequential phases. In the first phase of the study (case series), the intervention will be provided to two burn patient-caregiver dyads (four adults) to pilot test the intervention, seek patient and provider feedback, and refine the intervention. All four adults will receive the intervention. In the second phase of the study, the randomized controlled trial (RCT) phase, investigators will enroll 20 more burn patient-caregiver dyads (40 more adults) who will be randomly assigned (like the flip of a coin) at the dyad level to receive the intervention or a burn survivor-only minimally enhanced usual care psychoeducation control condition (mEUC). The goals of the RCT phase are to study whether the intervention is acceptable to patients, feasible to conduct, and whether the intervention improves burn survivor-caregiver healthy relationship communication about difficult events and treatment outcomes compared to mEUC.",[93,94,95,96,97,98,99,28,100,101,102],"Posttraumatic Stress Disorder","Burns","Traumatic Injury","Acute Stress Disorder","Trauma and Stressor Related Disorders","Trauma and Stress Related Disorders","Stress Disorder","Stress Disorders, Traumatic","Stress Disorders, Traumatic, Acute","Relationship, Social","2026-06-14",{"date":70,"type":44},{"date":106,"type":22},"2026-08-01",{"date":108,"type":22},"2029-02-28",{"name":110,"class":51},"University of Southern California",1,{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":86,"sex":87,"minAge":19,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":124,"conditions":125,"keywords":126,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":111},"100581604","phase-4-computational-assessment-of-gaba-receptor-modulation-in-ptsd-100581604","NCT06852469","Computational Assessment of GABA Receptor Modulation in PTSD","Individualized Computational Assessment of the Effects of GABA Receptor Modulation in Posttraumatic Stress Disorder","Inclusion Criteria:\n\nInclusion Criteria:\n\n1. Veteran;\n2. 18-65 years of age, inclusive;\n3. Participants must be willing to abstain from alcohol 24 hours prior to and 24 hours after the testing session;\n4. Participants must be able to participate and willing to give written informed consent and to comply with the study restrictions;\n\nAdditional Inclusion Criteria for PTSD Group:\n\n(a) Current diagnosis of PTSD based on CAPS-5.\n\nExclusion Criteria:\n\nExclusion Criteria:\n\n1. Has uncontrolled, clinically significant neurologic (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, which may impact the ability of the subject to participate or potentially confound the study results;\n2. Pregnancy (assessed by urine test at time of screening and prior to administration of study medication) or lactation;\n3. Lifetime history of a chronic psychotic disorder or bipolar disorder type I as assessed by MINI;\n4. Current moderate or severe substance use disorder as assessed by MINI;\n5. Positive urine toxicology (drugs of abuse as determined by a positive urine test) at screening and before drug administration. Subjects who screen positive for THC will be given an opportunity to be included in the event of a negative urine test 2 weeks later. THC is not infrequently used for medicinal purposes and, in California, is legal for recreational use. Subjects who are positive for THC will therefore not be excluded, but will be retested to ensure that THC is unlikely to be influencing results;\n6. Self-report or observable signs of drug or alcohol intoxication or withdrawal;\n7. Current benzodiazepine or opioid use; other psychotropic medications are allowed as long as they are at a stable dose for at least 2 weeks and do not exhibit an unsafe interaction with the study medication;\n8. Current or recent use of any medication deemed by the study physician (Dr. Howlett) to exhibit an unsafe interaction with lorazepam;\n9. Past intolerance (including allergic) to lorazepam or another benzodiazepine;\n10. Active suicidal ideation or otherwise considered at high suicidal risk by trained study staff using the C-SSRS;\n11. History of a traumatic brain injury (TBI) resulting in loss of consciousness for more than 30 minutes;\n12. Volunteers who do not have sufficient command of the English language, or who have any other impairment that would prevent them from reading and understanding the informed consent form(s) and completing the study procedures including clinical testing;\n13. Any other reason why, per study physician, the subject should not participate in this study, including concomitant disease or condition that could interfere with, or for which the study drug might interfere with, the conduct of the study, or that would, in the opinion of the study physician, pose an unacceptable risk to the subject in this study.\n\nAdditional Exclusion Criteria for HC Group:\n\n(a) Axis I disorder as assessed by MINI.\n\nAdditional Exclusion Criteria for fMRI Participants:\n\n1. Contraindication to magnetic resonance imaging.\n2. Not right-handed as assessed by Edinburgh Handedness Inventory.","65 Years",{"count":121,"type":22},150,[123],"PHASE4","A substantial majority of Veterans with posttraumatic stress disorder (PTSD) continue to suffer even with the best current medications. Progress in developing more effective medications is hampered by the substantial variability within Veterans with PTSD, meaning the most effective medication likely varies from individual to individual. New scientific tools to help identify distinct subgroups of Veterans with PTSD who are likely to respond to specific medications could help improve treatment in this population. Research has indicated that a specific subgroup of Veterans with PTSD with a high level of anxious arousal may benefit from medications which boost signaling of the neurotransmitter gamma-aminobutyric acid (GABA). This project aims to validate a clinical test to identify these individuals using new computational and neuroimaging methods combined with the medication lorazepam, a positive GABA modulator. The ultimate goal is to use these methods in future clinical trials of new medications to target the best treatments to individual Veterans with PTSD.",[28],[127,128,129,130,28],"Arousal","gamma-Aminobutyric Acid","Lorazepam","Neuroimaging","RECRUITING","2026-06-12",{"date":134,"type":44},"2026-06-16",{"date":136,"type":44},"2025-07-01",{"date":138,"type":22},"2029-06-30",{"name":140,"class":141},"VA Office of Research and Development","FED",{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":153,"conditions":154,"keywords":158,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":4},"100643199","serotonin-variants--gut-microbiota-in-mental-health-100643199","NCT07634458","Serotonin Variants & Gut Microbiota in Mental Health","Association Between Serotonin Pathway Genetic Variants and Tryptophan-Metabolizing Gut Microbiota in Adults With Mental Health Conditions: An Observational Pilot Study","Inclusion Criteria:\n\n1. Age: Adults aged 18 to 44 years.\n2. Residency: Current legal residents of the United States.\n3. Clinical Phenotype: Self-report of Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Post-Traumatic Stress Disorder (PTSD), or Panic Disorder.\n4. Medication Stability: If currently prescribed psychotropic medications (e.g., SSRIs, SNRIs, benzodiazepines), the dosage must remain stable with no changes in molecule or quantity for at least 3 months prior to enrollment.\n5. Language and Technology: Proficiency in English and access to a smartphone or computer for digital data entry.\n6. Financial Commitment: Explicit agreement to the \"Citizen Science\" model, including payment for discounted testing kits. Kit shipping (both directions) is prepaid by the study.\n\nExclusion Criteria:\n\n1. Use of systemic antibiotics, antifungals, or antivirals within the 8 weeks prior to specimen collection.\n2. Regular use of commercial probiotics or concentrated prebiotic supplements within 4 weeks of collection.\n3. Frequent use of osmotic or stimulant laxatives, or motility agents, within 4 weeks of collection.\n4. Chronic use (\\>3 times\u002Fweek) of NSAIDs, systemic corticosteroids, or high-dose Omega-3 supplementation (\\>2g\u002Fday) within 4 weeks of enrollment.\n5. Use of weight-loss medications or GLP-1 receptor agonists (e.g., semaglutide, liraglutide, tirzepatide) within the 3 months prior to enrollment.\n6. Confirmed diagnosis of Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis), Celiac Disease, or history of major gastric\u002Fintestinal resection.\n7. Current pregnancy or lactation.\n8. Presence of cognitive impairments that preclude the ability to provide informed consent.\n9. Individuals undergoing active cancer treatment.","44 Years",{"count":151,"type":22},30,"OBSERVATIONAL","This observational pilot study investigates whether a broad panel of genetic variants relevant to the serotonin pathway (including serotonergic system, methylation cycle, intestinal barrier integrity, and inflammatory response genes) are associated with distinct gut microbiome compositional and functional signatures in adults aged 18-44 years with self-reported mental health conditions (Major Depressive Disorder, Generalized Anxiety Disorder, PTSD, or Panic Disorder).\n\nThis is a decentralized, participant-funded (Citizen Science) study. Eligible participants provide at-home saliva (buccal swab) and stool samples. Genomic analysis is performed using the NeuroBiologix GenePro+ SNP Panel (Illumina Infinium Global Screening Array-24, \\~654,000 SNPs) via Gene By Gene, a CLIA\u002FCAP-accredited laboratory. Gut microbiome analysis is performed by Tiny Health using deep whole-genome shotgun metagenomics (≥20 million reads) on a NextGen Illumina Platform.\n\nThe study is non-interventional and hypothesis-generating, aiming to identify potential genotype-microbiome associations and estimate effect sizes to inform a future interventional trial. N=30 participants. Study Start: July 2026.",[155,156,28,157],"Major Depressive Disorder (MDD","Anxiety Disorder, Generalized","Panic Disorder",[159,160,161,162,163,164],"gut microbiome","serotonin","tryptophan metabolism","metagenomics","SNP genotyping","gut-brain axis","2026-06-08",{"date":167,"type":44},"2026-06-10",{"date":169,"type":22},"2026-07-01",{"date":171,"type":22},"2027-09",{"name":173,"class":174},"Neurobiologix","INDUSTRY",{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":111},"100558279","a-transdiagnostic-sleep-health-intervention-for-veterans-with-ptsd-100558279","NCT06549049","A Transdiagnostic Sleep Health Intervention for Veterans With PTSD","A Randomized, Controlled Trial of a Modified Sleep and Circadian Intervention for Veterans With PTSD: Advancing Psychosocial Rehabilitation Through Sleep Health","Inclusion Criteria:\n\n* U.S. Military Veteran aged 18 and above engaged in VA primary and\u002For mental health care\n* CAPS 5 PTSD diagnosis; or CAPS 5 score \\>=25 in the absence of full criteria\n* SCID Insomnia Disorder diagnosis, supported by ISI score \\>=10\n* CAPS-IV nightmare score \\>=4\n* Sleep-related functional impairment based on a WHODAS score \\>=32\n* Willingness to engage in 8-12 sessions of treatment to address their sleep disturbance\n\nExclusion Criteria:\n\n* Current cognitive problems, active psychosis or mania, or other mental\u002Fcognitive conditions such as moderate to severe neurodegenerative disease that would render the participant unable to connect to videoconferencing platform, engage in remote psychotherapy, or communicate using the required VA secure email platform\n* No access to reliable internet service connected to a computer, iPad or similar device (telephone not adequate)\n* Inability or unwillingness to use a VA-approved videoconferencing platform and VA secure email;\n* Current engagement in a sleep-focused psychotherapy, or plan to start a sleep-focused psychotherapy in the next 3 months. Sleep-focused psychotherapies include, but are not limited to, CBT-I, BBT-I, and IRT",{"count":183,"type":22},182,[25],"Sleep disturbance is a major problem in Veterans with posttraumatic stress disorder (PTSD). This study will test a version of a sleep treatment that's been shown to be effective in the general population, with some changes to tailor it to the needs of Veterans with PTSD and sleep disturbance.",[28,187],"Sleep Initiation and Maintenance Disorders",[189,190,191,192,193],"Insomnia","Posttraumatic stress disorder","Veterans","Nightmares","Psychotherapy","2026-06-04",{"date":165,"type":44},{"date":197,"type":22},"2026-09-01",{"date":199,"type":22},"2029-01-31",{"name":140,"class":141},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":213,"conditions":214,"keywords":217,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":79},"100423432","manage-emotions-to-reduce-aggression-mera-100423432","NCT04793776","Manage Emotions to Reduce Aggression (MERA)","Manage Emotions to Reduce Aggression - MERA: A Brief Aggression Treatment for Veterans With PTSD Symptoms","MERA","Inclusion Criteria:\n\n1. Male and female Veterans who deployed to combat zones since 9\u002F11.\n2. Currently meets criteria for full or subthreshold PTSD, determined by the Clinician-Administered PTSD Scale for DSM-5\n3. Engaged in at least 3 self-reported aggressive acts (e.g., yelling, throwing objects, hitting objects\u002Fpeople) in the last month, measured by the Overt Aggression Scale\n4. Impulsive aggression is his\u002Fher primary form of aggression, determined by the Impulsive Premeditated Aggression Scale\n5. Each Veteran must allow an independent aggression rater (live-in partner, family member, or roommate above 18 years of age)\\] verify the number of aggressive acts, using the Overt Aggression Scale.\n6. Agreement not to change psychotropic medications through the duration of the study.\n\nExclusion Criteria:\n\n1. Currently suicidal with intent of self-harm in the last week.\n2. Currently homicidal with plans to hurt a specific person.\n3. Unable to complete self-report measures.\n4. Meets diagnostic criteria for bipolar disorder or psychotic disorder.\n5. Had a psychotropic medication change within 4 weeks prior to the baseline assessment. Veterans receiving general mental health services or engaging in usual care will be allowed to participate.","64 Years",{"count":211,"type":22},204,[25],"PTSD is one of the most prevalent mental health conditions affecting Veterans who have served since 9\u002F11. Veterans with posttraumatic stress disorder (PTSD) report difficulty controlling impulsive aggression (IA). An inability to manage one's emotions (emotion dysregulation) is an underlying mechanism of IA. Reducing IA and increasing use of PTSD evidence-based psychotherapies are two critical missions for the Veterans Health Administration. The proposed research supports these missions by comparing a 3- session emotion regulation treatment (Manage Emotions to Reduce Aggression) to a control group in order to determine if MERA can reduce IA and prepare Veterans for PTSD treatment. By enhancing Veterans' abilities to cope with trauma-related emotions and feel equipped to initiate PTSD treatments, this research aims to help Veterans decrease IA and ultimately recover from PTSD.",[28,215,216],"Aggression","Emotion Regulation",[28,215,216,191,193],{"date":165,"type":44},{"date":220,"type":44},"2022-01-03",{"date":222,"type":22},"2026-12-30",{"name":140,"class":141},{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":234,"briefSummary":235,"conditions":236,"keywords":239,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":111},"100643453","preventive-narrative-exposure-intervention-for-ptsd-in-icu-patients-after-cardiopulmonary-bypass-cardiac-surgery-100643453","NCT07632131","Preventive Narrative Exposure Intervention for PTSD in ICU Patients After Cardiopulmonary Bypass Cardiac Surgery","Effects of Preventive Narrative Exposure Intervention on Posttraumatic Stress Disorder Among ICU Patients After Cardiopulmonary Bypass Cardiac Surgery: A Randomized Controlled Trial","ICU-pNET","Inclusion Criteria:\n\n1. Aged 18 years or older.\n2. Scheduled to undergo cardiac surgery with cardiopulmonary bypass, with planned postoperative admission to the cardiac surgical intensive care unit and an expected ICU stay of more than 24 hours.\n3. The participant is able to communicate effectively, and the participant and family members are willing to cooperate with the study.\n4. Conscious before the first postoperative intervention, negative for delirium as assessed by the Confusion Assessment Method for the Intensive Care Unit, and able to understand and complete the intervention and related assessments.\n\nExclusion Criteria:\n\n1. Experienced severe traumatic events within the past year, such as diagnosis of a major disease unrelated to the current cardiac condition in the participant or an immediate family member, or death of an immediate family member or significant other.\n2. Currently receiving treatment for mental disorders, including pharmacological treatment or psychotherapy for conditions such as depressive disorder, anxiety disorder, bipolar disorder, or schizophrenia spectrum disorders.\n3. History of a clearly diagnosed severe mental disorder, or mental abnormalities caused by organic brain disease.",{"count":233,"type":22},100,[25],"This clinical trial aims to evaluate whether an ICU-based preventive narrative exposure intervention can help prevent posttraumatic stress symptoms in adult patients after cardiac surgery with cardiopulmonary bypass.\n\nThe study will include adult patients who undergo cardiac surgery with cardiopulmonary bypass and are admitted to the cardiac surgical intensive care unit. Participants will be randomly assigned to either the intervention group or the control group.\n\nParticipants in the control group will receive routine care and routine psychological support. Participants in the intervention group will receive routine care plus an ICU-based preventive narrative exposure intervention supported by an ICU visitor book. The intervention includes preoperative education, review of ICU experiences, construction of a timeline, guided narration of stressful ICU-related events, and integration of the experience before discharge.\n\nThe ICU visitor book includes selected photos, family messages, and key recovery events. It is used to help patients better understand and organize their ICU experience.\n\nResearchers will compare the intervention group with the control group to see whether the intervention reduces posttraumatic stress symptoms. The primary outcome is posttraumatic stress symptoms at 1 month after discharge. Secondary outcomes include posttraumatic stress symptoms at 3 months after discharge, ICU memories, anxiety, depression, sleep quality, quality of life, and patient and family satisfaction with ICU care.\n\nThe findings may provide evidence for an early psychological nursing intervention to prevent posttraumatic stress disorder in ICU patients after cardiopulmonary bypass cardiac surgery.",[237,238,28],"Cardiopulmonary Bypass","Intensive Care Units",[237,240,241,28],"Intensive Care Unit","Narrative Exposure","2026-06-03",{"date":165,"type":44},{"date":245,"type":44},"2026-06-02",{"date":247,"type":22},"2027-04-30",{"name":249,"class":51},"First Affiliated Hospital of Fujian Medical University",{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":86,"sex":87,"minAge":19,"maxAge":119,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":111},"100252125","phase-2-role-of-sympathetic-overactivity-and-angiotensin-ii-in-ptsd-and-cv-100252125","NCT02560805","Role of Sympathetic Overactivity and Angiotensin II in PTSD and CV","Post-Traumatic Stress Disorder and Cardiovascular Disease Risk: Role of Sympathetic Overactivity and Angiotensin II","ANG-P","Inclusion Criteria:\n\n* veterans ages 18-65 years old with PTSD and without PTSD (controls) matched for age, gender, and race.\n\nExclusion Criteria:\n\n* pregnancy\n* hypertension\n* diabetes\n* heart or vascular disease\n* illicit drug use\n* excessive alcohol use (\\>2 drinks per day)\n* hyperlipidemia\n* autonomic dysfunction\n* current treatment with clonidine, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, or angiotensin II receptor blockers (ARBs)\n* treatment with monoamine oxidase (MAO) inhibitors within the last 14 days\n* any serious systemic disease\n* chronic kidney disease defined as estimated glomerular filtration rate (GFR) \\\u003C 60 cc\u002Fmin\n* hyperkalemia (serum potassium \\> 5 meq\u002FdL)\n* systolic blood pressure \\\u003C 100 mm Hg\n* diastolic blood pressure \\\u003C 60 mm Hg\n* heart rate \\\u003C 50 beats\u002Fmin\n* known hypersensitivity to ARBs or beta blockers",{"count":259,"type":22},134,[261],"PHASE2","The purpose of this study is to find out why patients with post-traumatic stress disorder (PTSD) have an increased risk for heart disease and high blood pressure later in life. A second purpose is to find out what causes PTSD patients to have high adrenaline levels during stress. This study will also test if a medicine called losartan improves high adrenaline levels in patients with PTSD and if a certain gene that has to do with high blood pressure might be associated with high adrenaline levels.",[28],"2026-05-14",{"date":266,"type":44},"2026-05-18",{"date":268,"type":44},"2015-10",{"date":270,"type":22},"2027-03-30",{"name":272,"class":51},"Emory University",{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":119,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":290,"locationsCount":111},"100504845","phase-4-mismatch-vs-standard-intervention-during-memory-reconsolidation-blockade-with-propranolol-effect-on-psychophysiological-reactivity-during-traumatic-imagery-100504845","NCT05853627","Mismatch vs. Standard Intervention During Memory Reconsolidation Blockade With Propranolol: Effect on Psychophysiological Reactivity During Traumatic Imagery","Inclusion Criteria:\n\n* Initial participants will be males or females 18-65 years old who have experienced a traumatic event that meets the DSM-5 PTSD A criterion, and whose PCL-5 score is \\>33 (to maximize the likelihood that they will meet our psychophysiological inclusion criterion). In order to be randomized, participants must further meet this psychophysiological inclusion criterion during baseline script-driven imagery testing Although we do not require a diagnosis of PTSD, because we have set a minimum psychophysiological inclusion criterion and a valid Criterion A traumatic event, our sample will include a substantial number, likely a majority, of PTSD participants.\n\nExclusion Criteria:\n\n1. Basal sitting or standing systolic blood pressure \\\u003C90\u002F60 mm Hg or basal HR \\\u003C50 BPM. Those participant-candidates excluded for this reason with such readings will be counseled and referred for further clinical consultation if symptomatic or if they wish to be referred even if asymptomatic.\n2. Medical condition that contraindicates PPNL, e.g., congestive heart failure, heart block, insulin- requiring diabetes, chronic bronchitis, emphysema, or asthma. Asthma attacks will only be exclusionary if they: a) occurred within the past ten years, b) occurred at any time in life if induced by a β-blocker, or c) are currently being treated\n3. Previous adverse reaction to, or non-compliance with, a β-blocker\n4. Current use of medication that may involve potentially dangerous or confounding interactions with PPNL, including anti- hypertensives, antiarrhythmics, and benzodiazepines. (Possible inhibition of CYP2D6 isoenzyme-dependent reactions will not be of concern in this study, because PPNL will only be administered once a week)\n5. Presence of drugs of abuse, including opiates, marijuana, cocaine, amphetamines, or alcohol at the initial assessment\n6. Pregnancy or breast feeding. Women of childbearing potential will have a pregnancy test at the initial assessment\n7. Presence of a contraindicating psychiatric condition, e.g., psychotic, bipolar, melancholic, or active substance use disorder; or suicidality (see below)\n8. Initiation of, or change in, psychotropic medication within the previous two months. For participants receiving stable doses of pharmacotherapy, they and their clinicians-prescribers will be asked not to alter the regimen during the proposed two-month study period (excluding the one-month follow-up) except in clinically urgent circumstances. If this becomes necessary, a decision will be made on a case-by-case basis about retaining the participant or terminating participation\n9. Current participation in any psychotherapy other than supportive. Participants will be asked not to initiate new psychotherapy during the proposed two-month study period (excluding the one-month follow-up) except in clinically urgent circumstances. If this becomes necessary, a decision will be made on a case-by-case basis about retaining the participant or terminating participation\n10. Inability to understand the study's procedures, risks, and side effects, or to otherwise give informed consent for participation\n11. Participant candidate does not understand English. This exclusion criterion is necessary because the procedures require a nuanced dialogue with English-speaking investigators.",{"count":280,"type":22},80,[123],"The proposed R21 project will attempt to further develop a novel intervention for posttraumatic stress symptoms inspired by the science of memory reconsolidation. Work in normal humans has shown that when a stable, consolidated memory is reactivated (i.e., retrieved) under appropriate conditions, it reverts to an unstable state, a process referred to herein as deconsolidation. In such a state, the memory is susceptible to the action of various \"amnestic\" agents that may inhibit its reconsolidation, thereby weakening it. The β-adrenergic blocker propranolol (PPNL) possesses such amnestic properties. More recent research has found that in order to initiate deconsolidation, there must be a prediction error, or mismatch, between what is expected and what occurs when the memory is reactivated.\n\nPrior placebo-controlled, randomized clinical trials (PBO-RCT) from our laboratory have found that when propranolol is administered concomitant with the reactivation of a psychologically traumatic memory, the memory is weakened, as revealed by subsequent lower physiological (heart rate, skin conductance, facial electromyogram) responding during script-driven mental imagery. Clinical applicability was evaluated in a PBO-RCT, in which PTSD participants receiving propranolol underwent six weekly sessions of 10-20 min of \"standard\" (STD) traumatic memory reactivation stimulated by reading a narrative. At post-treatment, these participants showed a greater reduction of PTSD symptoms compared to participants who had taken PBO. The goal of the proposed study is to test whether intentionally incorporating innovative mismatch (MM) into traumatic memory reactivation can improve upon physiological responding during script-driven mental imagery.\n\nParticipants will be randomized to one of 2 treatment arms: STD\u002FPPNL and MM\u002FPPNL. A baseline assessment will measure psychophysiological responsivity to script-driven mental imagery (target measure). PPNL will be administered 90-min prior to each of six weekly 10-20 min. traumatic memory reactivation sessions. In the MM condition, a different, unexpected mismatch (e.g., singing the narrative) will be incorporated into the reactivation. In the STD condition, the participant will read the narrative the same way each time. The focus of the R21 proposal will be to assess whether the MM\u002FPPNL group shows lower subsequent physiological responses than the STD\u002FPPNL group",[28],"2026-05-05",{"date":286,"type":44},"2026-05-06",{"date":288,"type":44},"2023-06-15",{"date":169,"type":22},{"name":291,"class":51},"Massachusetts General Hospital",{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":23,"phases":302,"briefSummary":303,"conditions":304,"keywords":306,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":111},"100353874","group-based-stabilization-and-skill-training-for-patients-with-lasting-posttraumatic-reactions-in-mental-health-care-100353874","NCT03887559","Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care","Adding a Group Based Stabilization and Skill Training Intervention for Patients With Long Lasting Posttraumatic Reactions Receiving Outpatient Treatment in Specialized Mental Health Care - A Randomized Controlled Trial","Inclusion Criteria:\n\n* Receiving treatment in ordinary out-patient clinics\n* Having been exposed to or witnessing to traumatic event(s) defined as \"one or several extremely threatening or horrific events or series of events or situations being of such a character which is likely to overwhelming distress in almost anyone in a similar situation\", measured by Stressful Life Events Screening Questionnaire\n* Presenting with posttraumatic reactions such as hyperarousal, avoidance, intrusions, emotional dysregulation or interpersonal difficulties.\n* Symptom duration for a minimum of six months.\n* Understand and speak Norwegian to an extent that is required to participate in a stabilization- and skill-training group.\n\nExclusion Criteria:\n\n* Active psychotic symptoms.\n* Substance or drug addiction or abuse.\n* High suicidal risk considered by the individual therapist.\n* Having participated in the course previously.","75 Years",{"count":301,"type":22},160,[25],"This study evaluates the addition of a group based stabilization and skill-training intervention to individual out-patient treatment for long lasting post-traumatic reactions. Half of the participants will receive the combined treatment while the other half will receive individual treatment as usual.",[28,305,97],"Mental Disorders",[193],"2026-04-24",{"date":309,"type":44},"2026-04-30",{"date":311,"type":44},"2019-03-25",{"date":313,"type":22},"2027-12",{"name":315,"class":51},"St. Olavs Hospital",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":327,"conditions":328,"keywords":334,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":111},"100634507","mocha-embedded-inpatient-mental-health-care-for-high-risk-perinatal-patients-100634507","NCT07540585","MOCHA: Embedded Inpatient Mental Health Care for High-Risk Perinatal Patients","MOCHA Protocol: Embedded Inpatient Mental Health Care for High-Risk Perinatal Patients","MOCHA","Inclusion Criteria:\n\n* 18 years old or older\n* Pregnant (or recently have given birth) at any gestational age\n* Must have experienced at least one adverse pregnancy outcome\n* Admitted for an extended inpatient stay\n* English speaking\n\nExclusion Criteria:\n\n* Under 18 years old\n* Not currently pregnant or past one year postpartum\n* Not experienced at least one adverse pregnancy outcome\n* Not admitted for an extended inpatient stay at RMT","100 Years",{"count":326,"type":22},50,"Pregnant and postpartum patients hospitalized for medical complications experience high rates of depression, anxiety, and trauma-related symptoms, yet access to timely psychiatric care during obstetric hospitalization is limited. Project MOCHA integrates early mental health screening, trauma-informed psychotherapy, and structured follow-up into routine inpatient maternity care for individuals at elevated clinical risk.\n\nThis single-arm implementation study examines the feasibility, acceptability, and fidelity of delivering a Collaborative Mental Health Care Program within a high-risk obstetric inpatient setting. The program includes brief inpatient psychotherapy, symptom monitoring, and post-discharge follow-up over three months. Preliminary changes in depression, anxiety, attention-deficit hyperactivity disorder, and posttraumatic stress symptoms will be assessed to inform future effectiveness trials and broader health system integration.",[329,28,330,331,332,333],"Anxiety Disorders","Pregnancy, High Risk","Depressive Disorder, Major","Pregnancy Complications","ADHD - Attention Deficit Disorder With Hyperactivity",[335,336,322,337,338,339],"Collaborative Mental Health Care Program","Inpatient high-risk pregnancy support","High-risk pregnancy mental health","Perinatal psychotherapy","Trauma-informed therapy","2026-04-18",{"date":342,"type":44},"2026-04-22",{"date":344,"type":22},"2026-06-01",{"date":346,"type":22},"2027-06-01",{"name":348,"class":51},"Indiana University",{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":86,"sex":87,"minAge":19,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":369,"locationsCount":111},"100539010","assessing-social-learning-and-course-delivery-timing-in-internet-delivered-cognitive-behaviour-therapy-for-public-safety-personnel-100539010","NCT06298279","Assessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel","A Randomized Factorial Trial of Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel: Examining the Impact of Content Delivery Method","Inclusion Criteria:\n\n* At least 18 years of age\n* Current or former public safety personnel (or public safety personnel trainee)\n* Residing in Canada at time of enrollment\n* Has regular access to the internet\n* Confirms intent to participate in study\n\nExclusion Criteria:\n\n* Not 18 years of age or older\n* Not a current or former public safety personnel (or public safety personnel trainee)\n* Not residing in Canada at time of enrollment\n* Does not have regular access to the internet",{"count":357,"type":22},164,[25],"This study is a randomized factorial trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet delivered cognitive behaviour therapy tailored for public safety personnel with tunneled of personalized course delivery and with or without the incorporation of social learning resources.",[361,362,28],"Depression","Anxiety","2026-04-09",{"date":365,"type":44},"2026-04-14",{"date":367,"type":44},"2024-03-12",{"date":247,"type":22},{"name":370,"class":51},"University of Regina",{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":119,"enrollmentInfo":378,"targetDuration":4,"studyType":23,"phases":380,"briefSummary":381,"conditions":382,"keywords":383,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":401},"100575339","a-study-of-a-novel-eeg-neurofeedback-system-for-ptsd-treatment-100575339","NCT06770998","A Study of a Novel EEG Neurofeedback System for PTSD Treatment","A Prospective Randomized Study of a Novel EEG Neurofeedback System for the Treatment of PTSD Using Machine Learning-Based Amygdala Biomarkers","Inclusion Criteria\n\nSubjects must meet the following inclusion criteria:\n\n1. Ages 18 to 65 (older limit to avoid those with potentially reduced brain plasticity due to age);\n2. Male, female, and gender-nonconforming subjects will be allowed. Sites will make efforts to enroll both male and female subjects in roughly equal proportions;\n3. Diagnosis of PTSD comorbidities will be confirmed by clinical chart review and structured interview with the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders (DIAMOND), a semi-structured diagnostic interview instrument for DSM-5 psychiatric disorders with good test-retest reliability (Tolin et al. 2018);\n4. Diagnosis of PTSD based on CAPS-5-R (scored as CAPS-5) total score with a minimum severity score of 26 at Baseline in the CAPS-5 score;\n5. 1-26 years from index trauma;\n6. Ability to give signed informed consent according to the judgment of the site investigator;\n7. Normal or corrected-to-normal vision of at least 20\u002F30 as per eye chart screening;\n8. Normal or corrected-to-normal hearing as per subject report and interview with study staff;\n9. Willingness and ability to adhere to the study schedule;\n10. Comorbid major depression will be allowed as long as the primary care is PTSD, because it is frequently comorbid with PTSD, and its inclusion will render our study results salient to the real-world clinical population;\\*\n11. Any psychotropic medication must have been at a stable dose for at least 4 weeks prior to screening;\n12. At the time of recruitment, patients must have no plan of changing their medication or psychotherapy during the study duration if applicable (subjects will only be dropped if significant psychotropic medication changes happen as a result of clinical instability that, in the opinion of the principal investigator (PI), would jeopardize their ability to learn or participate).\n\n    * Note: This is a clarification that comorbid depression is allowed and not an inclusion requirement.\n\nExclusion Criteria\n\nPotential subjects will be excluded for the following:\n\n1. Completed at least one adequate course of trauma-focused behavioral therapy in the past one (1) year without improvement in PTSD symptoms, as documented in medical records. (Subjects are ineligible if medical records do not show evidence of symptom improvement from the previous trauma focused therapy that had been conducted in the year prior to Screening); Non-response will be determined by clinical judgment and qualitative note content. If PCL-5 or CAPS-5 scores are available within 2 weeks prior to beginning treatment and within 2 weeks post-treatment, an improvement of \\\u003C10 points in PCL-5 and \\\u003C10 points in CAPS-5 will be used as a threshold indicating non-response in addition to clinical judgement.\n\n   • Note: This criterion is to avoid treatment resistant patients; such patients will be enrolled in future studies);\n2. Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I or II disorder, psychosis not otherwise specified, or delusional disorder;\n3. Any Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) Mood or anxiety disorder (in addition to those described in the previous exclusion) that is the primary focus of mental health treatment in the 6 months prior to screening, per the site investigator's clinical judgment;\n4. Intellectual disability (known full scale IQ\\\u003C70) per the site investigator's clinical judgment;\n5. DSM-5 diagnosis of moderate or severe substance use disorder within 3 months of screening;\n6. Prescribed benzodiazepine which cannot be stopped for the duration of the study (with a washout period of at least 2 weeks prior to the first Prism training session) or replaced with short-acting benzodiazepines taken only at night for sleeping;\n7. Any suicidal behavior in the last 6 months (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) prior to screening and during the screening period and or current (in the last 6 months) significant suicidality (defined as Level 4+ on the C-SSRS) or current significant homicidality;\n8. Within 3 months of beginning cognitive behavioral therapy (CBT) or any evidence-based PTSD psychotherapy, although continuing established maintenance supportive therapy will be permitted;\n9. Any significant neurological\u002Fneurosurgical history, including brain surgery, of penetrating, neurovascular, infectious, or other major brain injury, of epilepsy, or of other major neurological abnormality or known cognitive impairment;\n10. A history of moderate or severe traumatic brain injury (TBI) or history of gross structural damage on brain imaging;\n11. Any unstable medical condition per the investigator's clinical judgment;\n12. Any psychiatric hospitalization within the last 6 months;\n13. Enrollment in another interventional clinical study at screening or within 2 months prior to screening, or within the duration of this study;\n14. Pregnancy is allowed, but excluded if at week 20 or later in the pregnancy at Baseline because early labor in the late term of the pregnancy would require the subject to withdraw from the study.\n15. Acute symptoms of infection with SARS-CoV-2 (COVID-19) at time of screening or 2 months prior to screening as per interview and chart review;\n16. Under criminal investigation or pending legal charges with potential incarceration;\n17. Individuals who lack stable contact information (including lack of a telephone number);\n18. Subjects who anticipate working during the hours of midnight to 6 AM during the study;\n19. Subjects with narcolepsy;\n20. Subjects who have a Legally Authorized Representative;\n21. A positive result on the urine toxicology screen for any illegal substance besides marijuana. \\* \\* Note: If urine tests positive for any illegal substance, the results will not be included in the subject's medical record. However, these test results will remain part of the subject's confidential study record.",{"count":379,"type":22},250,[25],"The goal of this clinical trial is to learn if training with the Prism system can reduce PTSD symptoms in US military Veterans and civilians with PTSD. Prism is a form of neurofeedback training that uses EEG signals to promote self-regulation of brain function. The main question this study aims to answer is:\n\nDoes Prism training lead to decreased PTSD symptoms in US Veterans and civilians when used in addition to usual PTSD treatment?\n\nResearchers will compare Prism training to a sham training (a look-alike training that does not provide real feedback on brain activity) to see if Prism training decreases PTSD symptoms.\n\nParticipants will:\n\n* Complete two one-hour in-person training sessions a week for about 8 weeks (15 sessions)\n* Complete two booster training sessions one month and two months after finishing the main training course\n* Participate in three detailed interviews: one before training, a second after nine weeks of training, and a third one month after the last booster training session (about 20 weeks after the initial visit)",[28],[384,385,386,387,388,389,390,391],"EEG","trauma","neurofeedback","biofeedback","stress disorders, traumatic","trauma and stressor related disorders","military trauma","civilian trauma","2026-03-27",{"date":394,"type":44},"2026-04-01",{"date":396,"type":44},"2025-05-14",{"date":398,"type":22},"2027-08",{"name":400,"class":51},"Foundation for Atlanta Veterans Education and Research, Inc.",6,{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":23,"phases":411,"briefSummary":412,"conditions":413,"keywords":414,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":420,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":111},"100522875","enhancing-ptsd-treatment-outcomes-by-improving-patient-provider-communication-100522875","NCT06088303","Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication","AWARE","Inclusion Criteria:\n\n* Diagnosis of PTSD\n* Stable on psychiatric medications for at least 4 weeks\n\nExclusion Criteria:\n\n* Current unstable bipolar disorder\n* Current psychosis\n* Current active suicidal or homicidal ideation with intent or plan\n* Current severe substance use that warrants immediate medical attention\n* Current trauma-focused treatment\n* Significant cognitive impairment that would prevent engagement in assessments and therapy (e.g., advanced dementia, severe traumatic brain injury).",{"count":410,"type":22},54,[25],"The purpose of this clinical trial is to learn whether existing treatments for posttraumatic stress disorder (PTSD) can be improved. Two treatments for PTSD, cognitive processing therapy (CPT) and prolonged exposure (PE) will be studied. CPT and PE are effective treatments that are widely available, but interventions are needed to improve patient outcomes in these treatments. The investigators have developed an Adjunctive Writing intervention for Amplifying Response and Engagement (AWARE), which was designed using health communication strategies to enhance CPT and PE by improving communication between patients and therapists about patients' experiences in treatment. This research will investigate whether adding AWARE to CPT and PE will lead to better treatment outcomes compared to CPT and PE provided as usual without AWARE. AWARE includes a brief writing task asking patients about their experiences in treatment, as well as guided therapist responses to improve patient-therapist communication about patients' experiences in treatment. In the first phase of the study (case series phase), CPT or PE with AWARE will be provided to four adults with PTSD to pilot test adding AWARE to CPT and PE, seek patient and provider feedback, and refine AWARE. The first four participants who enroll will be part of the case series and will receive CPT or PE with AWARE. Then, in the second phase of the study, the randomized controlled trial (RCT) phase, the investigators will enroll 50 more adults with PTSD who will be randomly assigned (like flipping a coin) to receive CPT\u002FPE as usual or CPT\u002FPE with AWARE. It is expected that 25 participants will be randomized to CPT\u002FPE with AWARE and 25 participants will be randomized to receive CPT\u002FPE provided as usual. The goals of the RCT phase are to study whether AWARE is acceptable to patients, whether it is feasible to add AWARE to CPT and PE, and whether adding AWARE to CPT and PE improves patient-therapist communication and treatment outcomes compared to CPT\u002FPE as usual.",[28],[190,415,416,417,418,419],"Cognitive processing therapy","Prolonged exposure","Adjunctive writing for amplifying response and engagement","Health communication","Patient-provider communication",{"date":394,"type":44},{"date":422,"type":44},"2025-01-15",{"date":424,"type":22},"2028-12",{"name":426,"class":51},"Boston University",{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":23,"phases":436,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":452,"locationsCount":111},"100629180","parental-emdr-therapy-after-a-babys-stay-in-the-nicu-100629180","NCT07471321","Parental EMDR Therapy After a Baby's Stay in the NICU","Effectiveness of an EMDR Intervention in Reducing Trauma-Related Symptoms Among Parents Following Their Infant's Birth and Neonatal Intensive Care: A Randomized Controlled Trial","EMDR-NICU","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Presence of post-traumatic stress symptoms\n* Eligible to receive EMDR therapy according to clinical assessment\n* Ability to understand study procedures and provide informed consent\n* Sufficient proficiency in the Finnish language to complete study assessments and participate in therapy\n\nExclusion Criteria:\n\n* Acute psychiatric condition requiring immediate specialized treatment (e.g., acute psychosis or severe suicidal crisis).\n* Severe cognitive impairment or neurological condition that would prevent participation in psychotherapy or completion of study assessments.\n* Ongoing trauma-focused psychotherapy at the time of enrollment.\n* Any condition judged by the investigator to interfere with safe participation in the study.",{"count":280,"type":22},[25],"This randomized clinical trial evaluates the effectiveness of eye movement desensitization and reprocessing (EMDR) therapy in reducing symptoms of post-traumatic stress disorder (PTSD). Participants with PTSD symptoms will be randomly assigned in a 1:1 ratio to either immediate EMDR in addition to treatment as usual (EMDR+TAU) or delayed EMDR following an initial treatment-as-usual period (TAU+EMDR). Randomization will be stratified by sex.\n\nPTSD symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5) at baseline (T1), after the first treatment period (T2), and after the second treatment period (T3). The primary outcome is PTSD symptom severity measured by the PCL-5 at T2, comparing participants receiving EMDR+TAU with those receiving TAU alone during the first treatment period.\n\nSecondary outcomes include clinically meaningful improvement in PTSD symptoms, defined as a reduction of at least 10 points on the PCL-5, symptom change during the initial treatment-as-usual period, the effect of delayed EMDR, and the durability of the EMDR treatment effect over time.",[28],[440,29,441,442,443,444,445],"Post-Traumatic Stress Disorders","Eye Movement Desensitization and Reprocessing","Parents","Infant, Newborn","Intensive Care Units, Neonatal","Psychotherapy, Trauma Focused","2026-03-12",{"date":448,"type":44},"2026-03-13",{"date":450,"type":22},"2026-03",{"date":398,"type":22},{"name":453,"class":51},"Kuopio University Hospital",{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":23,"phases":463,"briefSummary":464,"conditions":465,"keywords":467,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":111},"100456099","phase-2-mdma-for-co-occurring-ptsd-and-oud-after-childbirth-100456099","NCT05219175","MDMA for Co-occurring PTSD and OUD After Childbirth","MDMA-Assisted Therapy 6 to 12 Months After Childbirth for People With Co-occurring Opioid Use and Post Traumatic Stress Disorders","Inclusion Criteria:\n\n* Potential participants are eligible to enroll in the protocol if they:\n\n  1. Are at least 18 years old.\n  2. Have opioid use disorder and are using daily oral methadone of 180 mg or less, or sublingual buprenorphine (or buprenorphine with naloxone in 4:1 ratio) of 24 mg or less. Assessed as stable for at least 3 months based upon review of the University of New Mexico Milagro and FOCUS program medical records or direct communication with the participant's buprenorphine or methadone prescriber.\n  3. Are fluent in speaking and reading English. This criteria is needed as the protocol requires two therapists that have specific training and it would be very difficult to identify two therapists fluent in another language\n  4. Are able to swallow pills.\n  5. Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments by an on-site Independent Rater for CAPS-5, and non-drug therapy sessions.\n  6. 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  7. Must agree to inform the investigators within 48 hours of any medical conditions and procedures.\n  8. If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session. Adequate birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e., condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Not able to become pregnant is defined as permanent sterilization or postmenopausal.\n  9. Agree to the lifestyle modifications described in Section 3.0 above:\n\n     Medical History\n  10. At Screening, meet DSM-5 criteria for current moderate to severe PTSD with a symptom duration of 6 months or longer.\n  11. At Screening, meet DSM-5 criteria for Opioid Use Disorder.\n  12. At Screening, have had PTSD symptoms for at least three months and at least moderate PTSD symptoms in the last month based on PCL-5 total score of 40 or greater.\n  13. May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease\n  14. May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.\n  15. At Baseline, have at least moderate PTSD per CAPS-5 and symptoms in the last month constituting a CAPS-5 Total Severity Score of 28 or greater\n  16. May have current mild alcohol or cannabis use disorder (meets 2 or 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 5 of 11 diagnostic criteria per DSM-5).\n  17. May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval by the study physician.\n  18. May have hypothyroidism if taking adequate and stable thyroid replacement medication.\n  19. May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist.\n\nExclusion Criteria (partial):\n\n* Potential participants are ineligible to enroll in the protocol if they:\n\n  1. Are not able to give adequate informed consent.\n  2. Prisoners will be excluded\n  3. Are likely, in the investigator's opinion and via observation during the Preparatory Period, to be re-exposed to their index trauma, lack social support, or lack a stable living situation.\n  4. Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation.\n  5. A 12 Lead EKG demonstrates QTc greater than 460 msec at time of screening for any potential participant or for the participants using methadone on an EKG obtained within 72 hours of each MDMA treatment session. An abnormal EKG may be repeated once to confirm the presence of QTc prolongation. 460 msec used as the upper acceptable limit as this study only includes women and the level of QTc that is considered abnormal is 10-20 msec longer for women.\n\n     Psychiatric History\n\n  7\\. Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment. 8. Have a history of or a current primary psychotic disorder, bipolar disorder 1 assessed via MINI and clinical interview or dissociative identity disorder assessed via structured clinical interview (SCID).\n\n  9\\. Have a current eating disorder with active purging assessed via MINI and clinical interview.\n\n  10\\. Have current major depressive disorder with psychotic features assessed via MINI.\n\n  11\\. Have a current moderate (not in early remission in the 3 months prior to enrollment based on meeting 4 or 5 of 11 diagnostic criteria per DSM-5) or severe alcohol or cannabis use disorder within the 6 months prior to enrollment (meets at least 6 of 11 diagnostic criteria per DSM-5).\n\n  12\\. Have an active illicit (other than cannabis or opioids) or prescription drug substance use disorder at any severity within 3 months prior to enrollment.\n\n  13\\. If there has been a diagnosis of moderate or severe cannabis use disorder within the last six months prior to enrollment, then the participant will need to have tapered off cannabis prior to the time of enrollment in the study and have either entered abstinence, limited cannabis use, or mild cannabis disorder. Mild cannabis use disorder or cannabis use alone are not exclusion criteria, however there can be no use in the 24 hours prior to the medication session.\n\n  14\\. Have current Personality Disorders Cluster A (paranoid, schizoid, schizotypal),) assessed via SCID-5-PD 15. Investigators will exclude potential participants with high risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, or lack of meaningful social support) 16. Any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to 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.\n\nMedical History\n\n17\\. 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\n19\\. 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\n20\\. Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.\n\n21\\. Have a history of arrhythmia, other than occasional premature atrial contractions (PACs) or PVCs in the absence of ischemic heart disease, within 12 months of screening.\n\n23\\. Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).\n\n24\\. Require use of concomitant medications that prolong the QT\u002FQTc interval during Experimental Sessions. Refer to Protocol Section \\_12\\_\\_\\_: Concomitant Medications.\n\n25\\. Have symptomatic liver disease or have significant liver enzyme elevations. 26. Have history of hyponatremia or hyperthermia. 27. Weigh less than 48 kilograms (kg). 29. Are pregnant or are able to become pregnant and are not practicing an effective means of birth control.",{"count":462,"type":22},15,[261],"This is an open-label study of the use of MDMA Assisted Therapy for postpartum people with co-occurring Post Traumatic Stress Disorder (PTSD) and Opioid Use Disorder (OUD). The study protocol has been adapted from the Phase 3 studies sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) for PTSD. Due to the high rate of concurrence of PTSD and OUD, people with OUD may experience great benefit from the treatment of their PTSD with MDMA-assisted therapy based on the phase 2 and 3 studies for PTSD. Use of MDMA-assisted therapy in this population has the potential to be of benefit for their OUD and maternal- infant attachment.\n\nThis study will serve to explore the feasibility and safety of offering MDMA-assisted therapy for treatment of PTSD in postpartum people with opioid use disorder. The CAPs 5 (PTSD) is the primary outcome, the Timeline Follow-Back (TLFB) for opioid use is the secondary outcome and other assessments of opioid use disorder, effects on maternal-infant attachment, social connectedness and other mental health outcomes are exploratory. The study will be conducted at the University of New Mexico Health Sciences Center located in Albuquerque New Mexico. In addition to northern New Mexico being an epicenter of the current opioid use disorder epidemic in the United States there is a long-standing history of multigenerational use of illicit opioids in many communities of northern New Mexico. There are high rates of opioid use disorder on pregnancy and accompanying Neonatal Opioid Use Withdrawal Syndrome (NOWS) in Albuquerque, Santa Fe, and surrounding communities.",[28,466],"Opioid Use Disorder",[468,466,469,470,471,472],"PTSD","Addiction","MDMA","Psychedelic Assisted Therapy","Maternal Infant Bonding",{"date":474,"type":44},"2026-03-16",{"date":476,"type":44},"2024-04-16",{"date":478,"type":22},"2027-11",{"name":480,"class":51},"University of New Mexico",{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":299,"enrollmentInfo":488,"targetDuration":4,"studyType":23,"phases":489,"briefSummary":490,"conditions":491,"keywords":492,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":111},"100479001","transcutaneous-vagal-nerve-stimulation-in-veterans-with-posttraumatic-stress-disorder-100479001","NCT05517304","Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder","VNS in PTSD","Inclusion Criteria:\n\n* Veterans between the ages of 18 and 75 will be included with a diagnosis of PTSD based on DSM-5 criteria\n\nExclusion Criteria:\n\nSubjects will be excluded with:\n\n* a history of mild traumatic brain injury (mTBI) based on VA Criteria\n* moderate or greater TBI\n* positive pregnancy test\n* meningitis or other neurological disorder\n* alcohol or substance abuse use disorder based on DSM-5 criteria within the past 12 months\n* current or lifetime history of schizophrenia, schizoaffective disorder, bipolar I disorder, anorexia nervosa or bulimia, based on DSM-5\n* active suicidal ideation with a plan\n* a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness that would preclude participation based on clinical judgment of the PI\n* active opiate or benzodiazepine treatment\n* history of structural abnormality on brain MRI or CT if one has been performed in the past",{"count":280,"type":22},[25],"This study effects the effects of transcutaneous cervical vagal nerve stimulation (tcVNS) or a sham control on brain, physiology, and PTSD symptoms in Veterans with posttraumatic stress disorder (PTSD). Veterans undergo brain imaging and physiological measures in conjunction with traumatic scripts before and after three months of twice daily treatment with tcVNS or sham stimulation at home.",[28],[28,468,493],"Vagus Nerve","2026-02-27",{"date":496,"type":44},"2026-03-03",{"date":498,"type":44},"2022-10-01",{"date":500,"type":22},"2027-11-10",{"name":140,"class":141},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":23,"phases":511,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":111},"100625395","impact-of-ercs-on-perceived-stress-in-patients-hospitalized-in-the-post-resuscitation-rehabilitation-service-100625395","NCT07422077","Impact of ERCS on Perceived Stress in Patients Hospitalized in the Post-resuscitation Rehabilitation Service","Impact of Energy Resonance by Skin Stimulation on Perceived Stress in Patients Hospitalized in the Post-resuscitation Rehabilitation Service","IRESC","Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Hospitalized adults in a Post-Intensive Care Rehabilitation Unit (SRPR)\n* Having given free and informed written consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* Persons deprived of their liberty by a judicial or administrative decision.\n* Persons who are subject to a legal protection measure or who are unable to express their consent.",{"count":5,"type":22},[25],"Surviving an intensive care unit hospitalization (ICU) can be the beginning of a long rehabilitation journey, hindered by symptoms of stress, PTSD, anxiety, and depression. In order to improve the care of these patients, it's essential to explore effective non-pharmacological approaches to reduce stress. Many non-drug techniques are being developed to alleviate the physical and psychological pain of patients.\n\nEnergy Resonance by Skin Stimulation (ERCS) is a noninvasive method of soothing and supporting the patient. This technique is based on the energetic principles of traditional Chinese medicine. It relies on a \"listening contact\" through the stimulation of cutaneous points to create resonance and transmit vibrational and wave messages in the tissues. ERCS has various applications, whether for the management of acute or chronic pain, emotional disorders such as fear, anxiety, and depression.\n\nOur study aims to assess the effects of ERCS on the perceived stress of patients hospitalized in the post-ICU rehabilitation service. By demonstrating its potential impact on both physical and psychological recovery, this research could support the integration of RESC into care protocols and open new perspectives for stress management in hospital settings",[28],"2026-02-18",{"date":516,"type":44},"2026-02-19",{"date":518,"type":44},"2025-12-08",{"date":520,"type":22},"2027-09-08",{"name":522,"class":51},"Hôpital Européen Marseille",{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":87,"minAge":530,"maxAge":299,"enrollmentInfo":531,"targetDuration":4,"studyType":23,"phases":533,"briefSummary":534,"conditions":535,"keywords":538,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":111},"100624815","phase-2-remotely-administered-tdcs-to-improve-cognitive-function-in-veterans-with-mtbi-and-ptsd-principal-investigator-100624815","NCT07414537","Remotely Administered tDCS to Improve Cognitive Function in Veterans With mTBI and PTSD Principal Investigator","Remotely Administered tDCS to Improve Cognitive Function in Veterans With mTBI and PTSD","Inclusion Criteria:\n\n* History of chronic mTBI as measured by Ohio State University Traumatic Brain Injury Identification Method\n* mTBI occurred \\> 5 years prior to study enrollment\n* History of PTSD with symptoms within the last month as confirmed PTSD Checklist (past month) score greater than or equal to 33,\n* Cognitive impairment as defined by telephone Montreal Cognitive Assessment \\\u003C 19\n* No history of reported or documented age-related or neurodegenerative condition\n* Access to internet for 1 hour per day\n* Willing and able to comply with all study related procedures and capable of independently reading and understanding study materials and providing informed consent.\n\nExclusion Criteria:\n\n* Skin lesions at the stimulation site that may increase conductance\n* Metallic objects in the face or head (e.g. braces, fillings, implants)\n* Pregnancy\u002Flactation or planning to become pregnant during study\n* History of other significant neurological disorders including seizure disorder, central nervous system tumors, stroke, cerebral aneurysm\n* History of primary psychotic disorder, bipolar I disorder, active substance use disorder (moderate or greater, measured by Drug Abuse Screening Test-10)\n* Active suicidal intent or plan, measured by Columbia-Suicide Severity Rating Scale\n* Other conditions or circumstances that, in the opinion of investigator team, have the potential to prevent completion and\u002For have a confounding effect on outcome assessments.\n* Unable to tolerate 2mA transcranial direct current stimulation (tDCS)","20 Years",{"count":532,"type":22},46,[261],"Traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) are common combat-related conditions that can result in impairments in cognition, including memory, attention and multi-tasking. There are few effective interventions to improve cognition in Veterans with cognitive impairment due to these conditions. Non-invasive brain stimulation techniques, like transcranial direct current stimulation (tDCS), can be used to stimulate activity in areas of the brain to optimize recovery and rehabilitation. In this study, the investigators are conducting a randomized controlled trial of tDCS to improve cognitive function in Veterans with cognitive impairment due to co-morbid TBI and PTSD. TDCS is remotely administered and paired with cognitive training.",[536,537,28],"Cognition","Brain Injuries",[539,540,541],"Cognitive impairment","Rehabilitation","Neuromodulation","2026-02-09",{"date":544,"type":44},"2026-02-17",{"date":546,"type":22},"2027-05-24",{"date":548,"type":22},"2030-11-30",{"name":140,"class":141},{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":23,"phases":559,"briefSummary":560,"conditions":561,"keywords":567,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":111},"100623481","act-for-veterans-with-ibd-and-mental-health-challenges-100623481","NCT07397195","ACT for Veterans With IBD and Mental Health Challenges","Using Acceptance and Commitment Training to Promote Rehabilitation and Engagement in Values-Centered Living in Veterans Adapting to Inflammatory Bowel Disease and Mental Health Challenges (RECLAIM)","RECLAIM","Inclusion Criteria:\n\n* Diagnosis of IBD as confirmed by the medical record\n* Current diagnosis of a depressive, anxiety, or trauma-related disorder\n\nExclusion Criteria:\n\n* Severe IBD symptoms that would prevent full participation in the study (i.e., hospitalized in the past 30 days, surgery in the past 30 days)\n* Significant cognitive impairment\n* Active suicidality\n* Uncontrolled psychosis or bipolar disorder",{"count":326,"type":22},[25],"Many Veterans with gastrointestinal disorders, such as inflammatory bowel disease (IBD), also have mental health conditions. IBD and mental health conditions can worsen one another through the brain-gut axis, leading to dramatic deficits in psychosocial functioning and quality of life (QOL). Yet, few Veterans with comorbid IBD and mental health conditions receive psychotherapy and no evidence-based psychotherapies have been tested in Veterans with these comorbidities. Adapting brief acceptance and commitment therapy (ACT) to the specific to the needs of these patients and embedding treatment into routine gastroenterology care may increase Veterans' access to efficient and effective rehabilitative care. This study aims to adapt and test an integrated, 1-Day ACT intervention tailored to the specific needs of Veterans with IBD and mental health conditions to improve psychosocial functioning and QOL.",[562,563,564,565,566,28],"Inflammatory Bowel Diseases","Crohn's Disease","Ulcerative Colitis","Depressive Disorder","Anxiety Disorder",[568,191,562,329,565,28],"Acceptance and Commitment Therapy","2026-02-02",{"date":542,"type":44},{"date":572,"type":22},"2028-01-01",{"date":574,"type":22},"2032-06-30",{"name":140,"class":141},{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":87,"minAge":4,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":586,"briefSummary":587,"conditions":588,"keywords":602,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":111},"100620350","enhancing-mental-and-physical-health-of-women-veterans-30-100620350","NCT07356479","Enhancing Mental and Physical Health of Women Veterans 3.0","Enhancing Mental and Physical Health of Women Through Engagement and Retention (EMPOWER) 3.0 (QUE 25-015)","EMPOWER","Inclusion Criteria:\n\n* This study is recruiting VA sites - not individual patients.\n* Prior to randomization, the study team will work with sites to ensure they have met the preconditions necessary to enroll in the study, which includes VISN, regional and\u002For facility level leadership support for participation.\n\nExclusion Criteria:\n\n* N\u002FA",{"count":585,"type":22},18,[25],"Women Veterans are the fastest growing segment of VA users, with most users in midlife. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. Furthermore, few VA improvement efforts have focused on women Veterans' health and health care in midlife. The EMPOWER QUERI 3.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 18 VA facilities from 4 regions.",[589,590,591,592,593,594,595,596,597,598,28,599,600,601],"Cardiovascular Diseases","Overweight","Obesity","Hypertension","Cholesterol","Diabetes Mellitus","Prediabetic State","Menopause","Cognitive Behavioral Therapy","Primary Health Care","Prevention","Implementation Science","Quality Improvement",[603,590,591,592,593,594,595,596,597,598,28,599,604,601,605,191,606,607,608,609,610,611],"Cardiovascular diseases","Implementation science","Women","Patient Participation","Patient Satisfaction","Patient Preference","Physicians, Primary Care","Physicians, Women","Health Behavior","2026-01-12",{"date":614,"type":44},"2026-01-21",{"date":616,"type":22},"2026-10-01",{"date":618,"type":22},"2031-09-30",{"name":140,"class":141},{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":4,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":119,"enrollmentInfo":627,"targetDuration":4,"studyType":23,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":111},"100552149","theories-of-working-memory-and-consolidationreconsolidation-in-the-process-of-resorption-of-post-traumatic-symptoms-100552149","NCT06469333","Theories of Working Memory and Consolidation\u002FRECOnsolidation in the Process of Resorption of Post-traumatic Symptoms.","Theories of Working Memory and Consolidation\u002FRECOnsolidation in the Process of Resorption of Certain Post-traumatic Symptoms: Interventional, Randomized Single-center Study","Inclusion Criteria:\n\n* Present symptoms of acute stress (score between 22 and 35 on the Impact Event Scale-Revised, IES-R) and\u002For PTSD (higher score or equal to 36 on the IES-R), but at least present moderate to high psychological distress (score equal to or greater than 8 on the Kessler Abbreviated Psychological Distress Scale, K6);\n* Being in need of psychotherapeutic follow-up but not having started it yet;\n* Be aged between 18 and 65 years inclusive;\n* Speak and write French (be able to understand information and complete questionnaires independently);\n* Have good vision (being able to follow the movement of a white point on a screen);\n* Have good hearing and tactile abilities (being able to perceive auditory and tactile tones);\n* Have a computer equipped with a webcam;\n* Be informed and sign informed consent.\n\nExclusion Criteria:\n\n* Be an adult protected under guardianship or curatorship;\n* Be a person subject to a judicial safeguard measure;\n* Present a lack of autonomy implying an impossibility in terms of administering questionnaires and filling out questionnaires;\n* Have a vision defect implying an impossibility of visual tracking of a white dot;\n* Present a hearing defect and\u002For tactile abilities implying an impossibility of perception;\n* Have a neurological condition constituting measurement biases (muscular dysfunctions, perceptual dysfunctions, etc.);\n* Suffer from psychotraumatic and dissociative disorders of complex type (respectively evaluated with regard to the anamestistic data of the patients and with a score greater than 25 on the dissociative experiences scale (Dissociative Experiences Scale, DES);\n* Do not present psychological distress (score less than 8 on the Kessler Abbreviated Psychological Distress Scale, K6) ;\n* Have a drug or alcohol dependence;\n* Benefit from ongoing psychotherapeutic monitoring;\n* Have already benefited from psychotherapeutic follow-up or have participated in studies in the last 6 months, both involving EMDR therapy.",{"count":121,"type":22},[25],"EMDR is a psychotherapeutic approach recommended by the World Health Organization (WHO) for the treatment of disorders such as post-traumatic stress disorder, anxiety, depression and, more generally, psychological distress. In all these disorders, intrusions are one of the symptoms leading to intense emotional distress. EMDR therapy, by making intrusions less emotional and less present in the mind (i.e. less vivid), would reduce psychological distress. This symptomatological reduction would be made possible by the therapist's application of alternating bilateral visual (rapid eye movements following a point from left to right), auditory (tones emitted alternately in the right ear and then in the left ear) and\u002For tactile (tapping with fingers on the left and right shoulders alternately) stimulations administered while the patient concentrates on his or her intrusive thoughts. Accordingly, the aim of this research is to investigate the efficacy of self-administration of Alternating Bilateral Stimulations (ABS), on the emotional intensity (emotionality) associated with negative intrusive thoughts (or intrusions).",[631,632,441,633,28,634,635,636],"Working Memory","Consolidation\u002FRecconsolidation Memory","Alterning Bilateral Stimulation","Intrusive Memories","Vividness","Emotivity","2025-11-20",{"date":639,"type":44},"2025-11-26",{"date":641,"type":44},"2024-09-06",{"date":643,"type":22},"2026-06",{"name":645,"class":51},"University of Lorraine",{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":4,"enrollmentInfo":653,"targetDuration":4,"studyType":23,"phases":655,"briefSummary":656,"conditions":657,"keywords":661,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":670,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":676,"locationsCount":111},"100407458","healthy-recovery-after-trauma-study-100407458","NCT04585685","Healthy Recovery After Trauma Study","HRT","Inclusion Criteria:\n\n* individuals with a history of sexual trauma meeting past-month diagnostic criteria for PTSD (meeting diagnostic status on the DIAMOND and score greater than or equal to 36 on the PCL-5) and\n* reporting current experiences of trauma-related mental contamination (greater than or equal to 10 on the PEMC).\n* 18 years of age or older\n* fluent in English\n* Patients on psychotropic medications will be included if they have been maintained on a stable dose for at least 4 weeks prior to beginning the study and are willing to maintain a stable dosage throughout the study period; this procedure allows for a broader range of participants and avoids having outcomes assessment confounded by the initiation of medication during treatment.\n* Finally, patients must be willing to refrain from additional trauma-related treatment for the duration of the study.\n\nExclusion Criteria:\n\n* We will exclude individuals diagnosed with psychological conditions that may be better addressed by alternative treatments; these conditions include\n* psychotic disorders\n* dissociative identity disorder\n* unmanaged (i.e., unmedicated or currently experiencing a manic\u002Fhypomanic episode) bipolar disorder\n* bulimia nervosa\n* anorexia nervosa\n* imminent risk of suicide (i.e., intent\u002Fplan)\n* severe substance use disorders.",{"count":654,"type":22},12,[25],"Mental contamination-an internal experience of dirtiness evoked in the absence of physical contact with an external source-has been linked to the development and maintenance of posttraumatic stress disorder (PTSD) following exposure to sexual abuse or assault (Adams et al., 2014; Badour et al., 2013; Brake et al., 2017). Mental contamination has been associated with greater PTSD severity (Rachman et al., 2015) and higher elevations in specific PTSD symptom clusters (particularly those of intrusive reexperiencing, negative cognitions\u002Fmood, and arousal\u002Freactivity; Brake et al., 2019; Fergus \\& Bardeen, 2016). Additionally, trauma-related mental contamination has been linked to a number of negative posttraumatic emotions such as shame, guilt, disgust, and anger (Fairbrother \\& Rachman, 2004; Radomsky \\& Elliott, 2009) Despite clear and consistent links between mental contamination and problematic posttraumatic outcomes following sexual trauma, there is a dearth of research investigating how existing or promising new interventions for PTSD impact mental contamination.\n\nCognitive Processing Therapy (CPT) is an efficacious and effective 12-session manualized cognitive-behavioral intervention for PTSD that is considered a gold-standard empirically-supported treatment for PTSD that is recommended by the American Psychological Association (APA, 2017). In addition to PTSD symptom improvement, CPT has also demonstrated benefit for improving feelings of shame and guilt, which are often seen among individuals with trauma-related mental contamination (Nishith et al., 2005; Resick et al., 2002, 2008). Cognitive reappraisal, a primary technique employed in CPT, involves challenging one's view of an emotionally-eliciting situation to alter its emotional impact (Gross \\& John, 2003). However, some investigators have suggested that cognitive reappraisal may be less effective in targeting moral emotions such as shame, guilt, and self-disgust that are based on an individual's standards and virtues (Finlay, 2015). Self-compassion (SC; i.e., self-directed care and kindness; forgiveness; and feelings of common humanity; Neff, 2003) has been proposed as an alternative method for addressing trauma-related shame and preliminary evidence suggests a 6-session self-compassion intervention may have benefit for reducing both PTSD symptoms and trauma-related shame (Au et al., 2017). Given the centrality of shame, guilt, and self-disgust to the experience of mental contamination, and the fact that mental contamination often arises in response to experiences involving moral violation or betrayal (Millar et al., 2016; Rachman, 2010), a SC intervention for PTSD may also offer promise as a standalone or adjunctive intervention for reducing trauma-related mental contamination. A test of these interventions for their impact on reducing trauma-related mental contamination is needed.\n\nThe current study will use Single Case Experimental Design to isolate and evaluate the effects of CPT and SC in reducing both PTSD symptoms and trauma-related mental contamination among individuals with PTSD resulting from sexual trauma.\n\nAims: 1) explore whether participants demonstrate reductions in mental contamination and PTSD symptoms in response to 12-sessions of CPT or 6-sessions of a SC intervention; 2) evaluate whether presentation of either treatment first yields differences in symptom reduction for PTSD and\u002For mental contamination symptoms; 3) evaluate whether the addition of the alternative module will enhance reductions in PTSD symptoms and mental contamination; 4) evaluate if such reductions are maintained during follow-up.\n\nVisual inspection analysis and statistical methods will be used to draw conclusions regarding the effects of the interventions on PTSD symptoms and mental contamination.",[28,658,659,660],"Shame","Guilt","Sexual Assault and Rape",[662,663,664,665,666,667,668],"post-traumatic stress disorder","mental contamination","cognitive processing therapy","self-compassion","shame","guilt","sexual trauma","2025-11-05",{"date":671,"type":44},"2025-11-10",{"date":673,"type":44},"2020-09-10",{"date":675,"type":22},"2026-11",{"name":677,"class":51},"Christal L Badour",{"id":679,"slug":680,"hasResults":12,"nctId":681,"briefTitle":682,"officialTitle":682,"acronym":4,"eligibilityCriteria":683,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":4,"enrollmentInfo":684,"targetDuration":4,"studyType":23,"phases":686,"briefSummary":687,"conditions":688,"keywords":690,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":692,"lastUpdatePostDateStruct":693,"startDateStruct":695,"completionDateStruct":697,"leadSponsor":699,"locationsCount":111},"100569095","a-mobile-health-intervention-to-improve-psychosocial-functioning-in-veterans-with-posttraumatic-stress-disorder-and-depression-symptoms-100569095","NCT06689787","A Mobile Health Intervention to Improve Psychosocial Functioning in Veterans With Posttraumatic Stress Disorder and Depression Symptoms","Inclusion Criteria:\n\n* Veteran\n* enrolled in VA care\n* fluent in English\n* able to provide informed consent\n* own a smartphone or willing to use a study-provided smartphone\n* have diagnoses of current posttraumatic stress disorder (PTSD) and major depressive disorder (MDD)\n* willing to not begin another form of Skills Training in Affective and Interpersonal Regulation (STAIR) during the study\n\nExclusion Criteria:\n\n* history of mania or psychosis\n* current suicidal ideation with plan and intent to harm self\n* acute intoxication from alcohol or other substances\n* current or past experience with any form of STAIR",{"count":685,"type":22},40,[25],"Posttraumatic stress disorder (PTSD) and depression are the two most common mental health conditions among Veterans. When Veterans experience both, there is a negative impact on their functioning, making it difficult to function at work or at home and socially with other people. Although talk therapies can result in improvements in functioning, they are difficult to access because there are limited clinicians who can provide them. As most US adults now own a smartphone, mobile apps are a way for Veterans to access content traditionally delivered through talk therapies at their own pace. This study will test a mobile app based on a trauma-informed talk therapy that has helped Veterans with PTSD and depression make large improvements in functioning, through learning skills to navigate emotions and relationships. Additionally, through answering brief surveys and enabling passive tracking on their smartphones, Veterans will see real-time information on their functioning and mental health and on potential benefits from using these skills.",[689,28,331],"Psychosocial Functioning",[191,691],"Mobile Applications","2025-10-27",{"date":694,"type":44},"2025-10-29",{"date":696,"type":22},"2027-04-01",{"date":698,"type":22},"2029-04-01",{"name":140,"class":141}]