[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-traumatic-stress\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-traumatic-stress":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,55,68,95],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":36,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100053319","cbt-i-vs-mbti-for-traumatic-brain-injury-tbi-related-insomnia-and-post-traumatic-stress-symptoms-100053319",false,"NCT05663034","CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms","CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms","Inclusion Criteria:\n\n1. Current or former member of the uniform services\n2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;\n3. Time duration since traumatic brain injury (TBI) injury \\>90 days\n4. Insomnia symptom duration \\>90 days\n5. Endorse insomnia symptoms (Insomnia Severity Index \\[ISI\\] score \\> 10)\n6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \\> -2)\n7. \\>18 years of age\n8. Access to and ability and to use computer.\n\nExclusion Criteria:\n\n1. History of neurological diseases other than TBI and not attributable to TBI\n2. Sleep apnea \\[apnea hypopnea index (AHI) \\>15; individuals with mild apnea (AHI \\> 5 and \\\u003C15) will be informed, but allowed to participate\\]. Participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea\u002Fhypopnea cutoff while using CPAP, are adherent to using the device (\\> 4 hours\u002Fnight 21\u002F30 consecutive days) and agree to continue using the device during study participation.\n3. Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.","ALL","18 Years",{"count":19,"type":20},360,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).",[26,27,28,29,30,31,32,33,34,35],"Traumatic Brain Injury","Insomnia","Depression","Post-traumatic Stress","Sleep","Memory Impairment","Cognitive Behavioral Therapy","Concussion, Brain","Head Injury","Brain Injury Traumatic Mild",[26,27,37,28,38,34,39,40,41],"Posttraumatic Stress Symptoms","Concussion","Brain Injury","Cognitive Behavioral Therapy for Insomnia","Mindfulness-based Treatment for Insomnia","RECRUITING","2026-07-10",{"date":45,"type":46},"2026-07-13","ACTUAL",{"date":48,"type":46},"2024-05-10",{"date":50,"type":20},"2027-06",{"name":52,"class":53},"Johns Hopkins University","OTHER",5,{"id":56,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":24,"conditions":59,"keywords":60,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":54},"100490200",{"count":19,"type":20},[23],[26,27,28,29,30,31,32,33,34,35],[26,27,37,28,38,34,39,40,41],"2026-05-26",{"date":63,"type":46},"2026-05-28",{"date":48,"type":46},{"date":66,"type":20},"2026-09",{"name":52,"class":53},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":92,"locationsCount":94},"100565023","phase-2-preventionreduction-of-asrs-and-ptsd-to-sustain-civilian-performance-with-sublingual-cyclobenzaprine-hcl-tnx-102-sl-100565023","NCT06636786","Prevention\u002FReduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)","Prevention\u002FReduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) - (Optimizing Acute Stress Reaction Interventions With TNX-102 SL - OASIS)","OASIS","Inclusion Criteria:\n\n1. ≥ 18 years and ≤ 55 years of age\n2. Presentation to ED within 72 hours of MVC\n3. Anticipated to be discharged home from the ED\n4. Stated willingness to comply with all study procedures and availability for the duration of the study\n5. Consent to receive unencrypted communications\n6. Has a smartphone with continuous service for ≥ 1 year\n7. Has a personal email address they regularly access\n8. Able to speak and read English\n9. Pain severity in the ED ≥ 4 (0-10 numeric rating scale)\n10. People who are not of childbearing potential (e.g., hysterectomy, bilateral oophorectomy, or confirmed postmenopausal for at least last 12 consecutive months)\n11. People with the capacity to conceive a pregnancy must agree to employ a highly effective form of birth control throughout the first 21 days of study participation (e.g., oral, injected, transdermal, or implanted hormonal methods of contraception for at least one full menstrual cycle prior to study drug administration; placement of an intrauterine device (IUD) or intrauterine system (IUS); or double barrier methods such as condoms and diaphragms)\n\nExclusion Criteria:\n\n1. Substantial comorbid injury (e.g., long bone fracture)\n2. People of childbearing potential who are pregnant, breastfeeding, planning to become pregnant, or not using a highly effective form of contraception (e.g., implants, intrauterine devices (IUDs), tubal ligation, hormonal birth control pills, patches, vaginal rings, or injections) during their participation\n3. Prisoner status\n4. Any chronic daily opioid use prior to MVC\n5. Active psychosis, suicidal ideation, or homicidal ideation\n6. Plans for hospital admission\n7. History of arrhythmias, heart block or conduction disturbances, congestive heart failure\n8. Currently in the acute recovery phase of myocardial infarction\n9. Hypersensitivity to cyclobenzaprine or the excipient in TNX-102 SL or placebo formulations\n10. History of urinary retention, angle-closure glaucoma, increased intraocular pressure, or hyperthyroidism (TSH \\\u003C lower limit of normal)\n11. Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation due to risk of potential fatal drug-drug interactions\n12. Current or planned use of the following prohibited concomitant medications during study participation: anticholinergic medications, guanethidine, selective serotonin reuptake inhibitors (SSRIs) , serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, MAO inhibitors, anticholinergic medications, guanethidine, potent cytochrome P450 subtype 3A4 inhibitor, St. John's wort, chronic use muscle relaxants or planned use after MCV or other prohibited concomitant medications listed in section 5.6. PI to assess individual cases where single dose of muscle relaxant is prescribed in ED for inclusion\n13. Any hepatic impairment or renal disease (defined as AST OR ALT \\> 3 times the upper limit of normal) or renal disease (defined as GFR ≤ 80 mL\u002Fmin)\n14. Lacking capacity to provide informed consent (receipt of sedative, hypnotic agent making the patient non-decisional for consent)\n15. Any other history or condition that would, in the site investigator's judgement, indicate that the patient would very likely be non-compliant with the study or unsuitable for the study (e.g., might interfere with the study, confound interpretation, or endanger patient)\n16. Elevated baseline blood pressure defined as systolic blood pressure ≥ 170 mmHg or diastolic blood pressure ≥ 100 mmHg and or elevated heart rate of ≥115\n17. Abnormal baseline ECG as defined as: QRS duration ≥ 120 ms; QTc \\> 460 ms; not in sinus rhythm; or 1st, 2nd, or 3rd degree heart block indicated\n18. Substance or alcohol use disorder, bipolar disorder, or schizophrenia\n19. History of severe or unexplained oral, or oropharyngeal swelling or edema","55 Years",{"count":78,"type":20},180,[80],"PHASE2","This study will examine the safety and efficacy of TNX-102 SL to reduce ASR symptoms and behavioral changes among patients presenting to the emergency department (ED) after motor vehicle collision (MVC). Specifically, the investigators will perform the Optimizing Acute Stress reaction Interventions with TNX-102 SL (OASIS) Trial, a double-blind placebo-controlled randomized clinical trial (RCT) to determine if TNX-102 SL initiated in the ED in the hours after MVC to high risk individuals, treats\u002Freduces acute stress reaction (ASR)\u002Facute stress disorder (ASD) symptoms (primary outcome), improves neurocognitive function, and prevents\u002Freduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 180 participants will be randomized, receive study drug in ED and be discharged with a 2-week drug supply. Prior to initial dose of study drug administration, and during the hours, days, and weeks after participants will receive serial longitudinal assessments of psychological and somatic symptoms, neurocognitive function, and adverse events.",[83,84,85,29],"Acute Stress Reaction","Acute Stress Disorder","Neurocognitive Function","2026-04-09",{"date":88,"type":46},"2026-04-13",{"date":90,"type":46},"2025-03-25",{"date":66,"type":20},{"name":93,"class":53},"University of North Carolina, Chapel Hill",9,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":106,"conditions":107,"keywords":117,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100621589","behavioral-health-collaborative-care-model-in-an-icu-recovery-clinic-100621589","NCT07372586","Behavioral Health Collaborative Care Model in an ICU Recovery Clinic","Integration of a Behavioral Health Collaborative Care Model Into an ICU Recovery Clinic","BeColM","Inclusion Criteria:\n\n\\- Attendance at the MUSC ICU Recovery Clinic within 180 days of discharge from the hospital\n\nExclusion Criteria:\n\n* ICU Admission was due to a primary addiction diagnosis (eg alcohol withdrawal or delirium tremens requiring ICU care)\n* Serious Mental Illness such as Schizophrenia, psychotic disorder, acute mania\n* Late Stage Dementia or Cognitive Impairment\n* Limited English or Spanish Proficiency\n* Lack of regular access to a computer, tablet or mobile device with internet access",{"count":104,"type":20},150,[23],"Survivors of critical illness are at high risk for mental health issues such as anxiety, depression, and PTSD. This single-site, randomized controlled trial at the Medical University of South Carolina will enroll 150 patients to compare outcomes between a behavioral health Collaborative Care Model (BH CoCM) and usual care (attention control). The intervention includes digital tools (Neuroflow), behavioral health coaching, and psychiatric support.",[108,109,110,111,112,113,114,115,116],"PICS","Anxiety","Depression - Major Depressive Disorder","Post-Traumatic Stress","PTSD","Critical Illness Recovery","Critical Illness","Collaborative Care","Behavioral Health Concerns",[118,119,108,120,121,112,122,123],"critical illness","post-ICU","anxiety","depression","collaborative care model","behavioral health","2026-03-11",{"date":126,"type":46},"2026-03-12",{"date":128,"type":46},"2026-01-30",{"date":130,"type":20},"2028-06-30",{"name":132,"class":53},"Medical University of South Carolina",1]