[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"posttraumatic-stress-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:posttraumatic-stress-disorder":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,57,0,25,[9,46,80,107,135,156,175,205,231,258,282,308,333,355,379,400,427,447,473,493,514,540,563,584,598],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100487272","reducing-psychological-barriers-to-prep-persistence-among-pregnant-and-postpartum-women-in-cape-town-south-africa-100487272",false,"NCT05624931","Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa","Inclusion Criteria:\n\n* For participants across all three aims are:\n\n  * Female sex\n  * Aged 15+\n  * Pregnant and presenting antenatal care at the Gugulethu MOU\n  * HIV-negative\n  * Recent PrEP initiation (\\\u003C1 month ago) or PrEP adherence challenges, either documented (\\>2 weeks late to pick up PrEP refill) or self-reported\n  * Moderate to severe symptoms of posttraumatic stress and\u002For depression (defined as a score of ≥31 on PTSD Checklist for DSM-5 (PCL-5) and\u002For a score of ≥13 on the Edinburgh Postnatal Depression Scale (EPDS). Cutoff scores may be adjusted by 3-5 points to facilitate recruitment.\n\nExclusion Criteria:\n\n* There are no exclusion criteria with respect to parity or gravidity.\n\n  * Participants who are unable to provide informed consent or assent in English or Xhosa\n  * Have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. Positive symptoms of active psychosis or mania will be assessed by the research assistants. They will be trained to identify delusions, hallucinations, disorganized or pressured speech, flight of ideas, and grandiosity as they speak to potential participants.\n  * Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.",true,"FEMALE","15 Years",{"count":20,"type":21},118,"ESTIMATED","INTERVENTIONAL",[24],"NA","Pregnant women in South Africa (SA) are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) use during pregnancy is both safe and effective in preventing HIV. However, posttraumatic stress (associated with intimate partner violence and\u002For other traumas) and depression negatively impact PrEP adherence among women in SA. Addressing posttraumatic stress and depression will likely improve PrEP adherence and persistence (i.e., sustained PrEP adherence over time) during pregnancy and breastfeeding, which are periods of dramatically increased HIV risk. The overarching goal of this proposal is to develop and test the feasibility and acceptability of a cognitive behavioral intervention that targets common underlying factors of posttraumatic stress and depression to improve PrEP adherence and persistence during pregnancy and the postpartum transition. The specific aims of the project are to (1) explore the mechanisms by which posttraumatic stress and depression impact PrEP adherence and persistence during pregnancy via qualitative interviews; (2) develop a brief PrEP adherence and persistence intervention (\\~4 sessions) that reduces the negative impact of psychological mechanisms common to posttraumatic stress and depression on PrEP use, and builds behavioral skills to improve self-care; and (3) evaluate the feasibility, acceptability, and signals of preliminary efficacy of the intervention, which will be integrated into antenatal care, in a pilot randomized controlled trial. All data will be collected in the Midwife Obstetrics Unit (MOU) in Gugulethu, a peri-urban settlement and former township community outside of Cape Town, SA.",[27,28,29,30],"Depression","Posttraumatic Stress Disorder","Pregnancy Related","Medication Adherence",[32],"HIV, pregnancy, PrEP","RECRUITING","2026-06-15",{"date":36,"type":37},"2026-06-16","ACTUAL",{"date":39,"type":37},"2025-04-17",{"date":41,"type":21},"2027-07-30",{"name":43,"class":44},"Boston University Charles River Campus","OTHER",2,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"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","ALL","18 Years",{"count":55,"type":21},44,[24],"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.",[28,59,60,61,62,63,64,65,66,67,68],"Burns","Traumatic Injury","Acute Stress Disorder","Trauma and Stressor Related Disorders","Trauma and Stress Related Disorders","Stress Disorder","Stress Disorders, Post-Traumatic","Stress Disorders, Traumatic","Stress Disorders, Traumatic, Acute","Relationship, Social","NOT_YET_RECRUITING","2026-06-14",{"date":72,"type":37},"2026-06-18",{"date":74,"type":21},"2026-08-01",{"date":76,"type":21},"2029-02-28",{"name":78,"class":44},"University of Southern California",1,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":79},"100576698","a-randomized-controlled-trial-of-a-web-based-moral-elevation-intervention-for-veterans-with-ptsd-100576698","NCT06788678","A Randomized Controlled Trial of a Web-Based Moral Elevation Intervention for Veterans With PTSD","Inclusion Criteria:\n\n* Enrolled in a VISN 17 health care system\n* English-speaking and able to provide written informed consent\n* Willingness to complete study procedures and be randomized\n* Internet access and an electronic device to complete the web-based sessions\n* Current diagnosis of PTSD based on the CAPS-5\n* History of PTSD diagnosis for at least 1 year\n\nExclusion Criteria:\n\n* History of severe traumatic brain injury indicated by medical record review and the Ohio State Traumatic Brain Injury Identification Method (OSU TBI-ID)\n* Current psychosis or mania as indicated by medical record review and the Mini International Neuropsychiatric Interview (MINI)\n* Current suicide risk based on the Beck Depression Inventory-II (BDI-II)\n* Currently enrolled and actively participating in a trauma-focused treatment including:\n\n  * Cognitive Processing Therapy\n  * Prolonged Exposure\n  * Eye Movement Desensitization Reprocessing",{"count":87,"type":21},250,[24],"Despite the availability of evidence-based treatments for PTSD, there are many challenges to successful trauma recovery for Veterans including difficulties starting and completing these treatments and gaps in fully addressing additional important treatment targets including lower social functioning and quality of life. Alternative, stand-alone treatment options that address a range of outcomes and can be easily accessed are needed to expand the reach of PTSD treatment to Veterans. One way to address this need is with a positive psychology intervention called MOVED, which has shown promise in a prior pilot study. MOVED is a web-based, self-guided intervention (8 sessions, 4 weeks) that uses moral elevation-feeling inspired by others' virtuous actions. This clinical trial will test if MOVED leads to decreased PTSD symptoms and increased social functioning and quality of life compared to a generic supportive treatment that does not focus on moral elevation. Results will help determine if MOVED is a useful alternative approach to target trauma recovery among Veterans with PTSD.",[28],[92,93,94,95,96],"PTSD","Web-Based Intervention","Veterans","Randomized Controlled Trial","Moral Elevation","2026-06-03",{"date":99,"type":37},"2026-06-05",{"date":101,"type":21},"2026-07-01",{"date":103,"type":21},"2029-09-30",{"name":105,"class":106},"VA Office of Research and Development","FED",{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":79},"100612167","self-help-cognitive-processing-therapy-cptwomen-veterans-network-woven-study-100612167","NCT07250061","Self-Help Cognitive Processing Therapy (CPT)\u002FWomen Veterans Network (WoVeN) Study","Augmenting Cognitive Processing Therapy With a Peer Led Support Intervention to Improve Well-Being: A Sustainable and Scalable Model for Enhancing PTSD Recovery in Vulnerable Populations","Inclusion Criteria:\n\n* Identifies as a woman\n* Has served in the United States military\n* A full or subthreshold (meets criteria for 2 out of 4 of the symptom clusters for PTSD) Post Traumatic Stress Disorder (PTSD) diagnosis\n* Able to read English well enough to complete study questionnaires\n\nExclusion Criteria:\n\n* Clinician judgment that the participant is not appropriate for self-help level of care for PTSD (i.e., recent psychiatric hospitalization, requires detox, volatile, active suicidality)\n* Current psychosis or unstable bipolar disorder (determined during baseline interview as described in screening and enrollment procedures)\n* Must not have participated in a WoVeN group within the last year\n* Must not be receiving an evidenced-based therapy for PTSD at the time of the screening",{"count":115,"type":21},100,[24],"Posttraumatic stress disorder (PTSD) can have significant impairment on aspects of mental well-being (MWB) including functioning, loneliness, physical health, and quality of life. There are several evidence-based treatments (EBPs) effective in treating PTSD such as Cognitive Processing Therapy (CPT) which is a specific type of cognitive behavioral therapy that has been proven effective in reducing symptoms of PTSD. However, there are several barriers (e.g., lack of providers, waitlists, costs, stigma, disabilities that complicate travel) that can prevent someone from engaging with these treatments. Recently, a self-help version of CPT was created to help address these barriers; but little research has been conducted to test its efficacy. Further, less is know about how a peer support program may augment improvements from participating in an EBP. The Women Veteran Network (WoVeN), a peer support program designed for women veterans, has a manualized 8-week program that directly targets MWB. It has been found to help foster belongingness and connectedness, particularly in those suffering from PTSD and depression.\n\nThe present study aims to establish the feasibility, acceptability and tolerability of a scalable, sustainable, and effective treatment option for trauma survivors with subthreshold or full PTSD. The overarching goal is to understand the effectiveness of a self-help version of an EBP (either alone or in combination with a peer support program) in reducing PTSD symptoms while also helping improve mental well-being, reduce barriers, and increase access to quality care within health disparity populations.",[28,27],[120,121,122,123,124,125],"Mental well being","Self help cognitive processing therapy","Peer support program","Quality of life","Loneliness","Women Veterans Network","2026-05-26",{"date":128,"type":37},"2026-05-27",{"date":130,"type":37},"2026-03-05",{"date":132,"type":21},"2028-03",{"name":134,"class":44},"Boston University",{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":79},"100538275","novel-telemedicine-delivered-prolonged-exposure-therapy-for-treating-ptsd-in-individuals-with-oud-100538275","NCT06288711","Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD","Inclusion Criteria:\n\n* \\>18 years old\n* Maintained on a stable methadone or buprenorphine dose for \\>1 month prior to the study\n* Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5\n* Participants receiving psychotropic medications must be maintained on a stable dose for \\>1 month prior to enrollment.\n\nExclusion Criteria:\n\n* Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview\n* Cognitive impairment as evidenced by scores \\\u003C22 on the Videoconference-based Mini Mental Status Examination (MMSE; Folstein, et al., 1975)\n* Enrolled in another ongoing evidence-based treatment for PTSD.\n* Pregnancy as verified by pregnancy test\n* No access to cellular service",{"count":142,"type":21},135,[24],"Among individuals with opioid use disorder (OUD), posttraumatic stress disorder (PTSD) presents a significant clinical challenge. The prevalence of PTSD is substantially higher in individuals with OUD than in the general population, with nearly 90% reporting lifetime trauma exposure and 33% meeting diagnostic criteria for PTSD. The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD.",[146,28],"Opioid Use Disorder","2026-05-13",{"date":149,"type":37},"2026-05-18",{"date":151,"type":37},"2024-06-03",{"date":153,"type":21},"2027-11-30",{"name":155,"class":44},"University of Vermont",{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":79},"100567583","prolonged-exposure-therapy-to-treat-posttraumatic-stress-disorder-in-pregnant-patients-100567583","NCT06670079","Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients","Inclusion Criteria:\n\n* Female\n* \\>18 years old\n* Gestational age ≤ 25 weeks\n* Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5\n* Participants receiving psychotropic medications must be maintained on a stable dose for \\>14 days prior to enrollment.\n\nExclusion Criteria:\n\n* Male\n* Under 18 years old\n* Gestational age \\> 25 weeks\n* No current diagnosis of PTSD\n* Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview\n* Enrolled in another ongoing evidence-based treatment for PTSD.",{"count":163,"type":21},30,[24],"The goal of this clinical trial is to learn if a treatment for adults with PTSD called prolonged exposure + incentives (PE+) works to treat pregnant patients. The main question it aims to answer is:\n\nDoes PE+ decrease PTSD symptoms?\n\nAll participants will receive PE+ to see if their PTSD symptoms at the end of the trial are less than at the beginning.\n\nParticipants will:\n\n* Receive individual PE+ therapy for 1 hour weekly for 12 weeks.\n* Receive financial incentives for attending each PE+ session.\n* Attend assessment visits every 4 weeks for the 12 weeks of the trial.\n* Allow research staff to collect some information about their labor and delivery from their medical records after their babies are born.",[28,167],"Pregnancy","2026-05-08",{"date":147,"type":37},{"date":171,"type":37},"2026-02-05",{"date":173,"type":21},"2027-07-22",{"name":155,"class":44},{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":191,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":79},"100489298","a-precision-medicine-approach-to-target-engagement-for-emotion-regulation-100489298","NCT05651295","A Precision Medicine Approach to Target Engagement for Emotion Regulation","Inclusion Criteria:\n\n* Elevated emotion dysregulation\n\nExclusion Criteria:\n\n* Lack of proficiency in English\n* No access to smartphone\n* Conditions requiring greater than outpatient care",{"count":182,"type":21},390,[24],"The proposed study is designed to first test whether teaching people personalized or standardized emotion regulation skills leads to greater decreases in daily negative emotion intensity. Second, using data from an initial sample, the investigators will prospectively assign an independent sample of participants to receive their predicted optimal or non-optimal skills to determine if it is feasible and efficacious to match participants to the most appropriate training condition. Results of these studies may identify the mechanisms by which emotion regulation interventions impact emotional functioning and allow for the development of personalized, evidence-based, and scalable emotion regulation interventions.",[186,27,187,188,189,28,190],"Emotional Regulation","Anxiety","Borderline Personality Disorder","Obsessive-Compulsive Disorder","Eating Disorders",[192,193,194,195],"cognitive-behavior therapy","mechanism","ecological momentary assessment","personalization","2026-05-07",{"date":198,"type":37},"2026-05-11",{"date":200,"type":37},"2023-09-29",{"date":202,"type":21},"2026-12-31",{"name":204,"class":44},"Matthew Southward, PhD",{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":220,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":229,"locationsCount":79},"100414125","emdr-treatment-in-ptsd-following-cardiac-events-100414125","NCT04672551","EMDR Treatment in PTSD Following Cardiac Events","EMDR_PTSD_MI","Inclusion Criteria:\n\n* Age between 18-70 years\n* Men or women\n* STEMI (irrespective of troponin, but ST-elevation) or non-STEMI (troponin positive) at the time of the cardiac event, as verified by the cardiologist\n* Diagnosis of PTSD caused by the cardiac event\n\nExclusion Criteria:\n\n* Psychotic disorder, bipolar disorder, substance abuse as measured with the Mini International Neuropsychiatric Interview (M.I.N.I)\n* Acute suicidal ideation as assessed with the M.I.N.I.\n* Non-selective beta blockers (e.g., propranolol) during the study period\n* Ongoing psychological\u002Fpsychiatric treatment outside of the trial during the study period\n* Visionary problems, e.g. strabismus, which does not allow adequate eye movements\n* Insufficient knowledge of the German language\n* Expected inability or willingness to follow the study protocol\n* Regular medication with benzodiazepine","70 Years",{"count":214,"type":21},60,[24],"Cardiac events can often result in debilitating and persistent psychological symptoms. A key question involves whether optimal treatment of cardiac-induced posttraumatic stress disorder (PTSD) reduces PTSD symptoms and thereby may offset the risk of recurrent or worsening cardiovascular disease. Cardiac-induced PTSD 1) is prevalent, 2) features symptoms unique to internal ongoing somatic threat, with fears and worries that can be distinguished from PTSD resulting from external causes, 3) is persistent, 4) is associated with negative physical and emotional consequences, and 5) has not been the subject of randomized-controlled treatment trials (RCT). There is preliminary evidence suggesting that patients with cardiac-disease induced PTSD might particularly profit from EMDR. Nevertheless, this possibility has not been tested in cardiac-induced PTSD. Currently, patients with cardiac-induced PTSD are not routinely offered trauma-focused therapies, with a lack of scientific evidence likely being one major reason for this omission. If our proposed RCT shows that EMDR can be an effective treatment for patients with ACS-induced PTSD, EMDR could be routinely implemented as first-line treatment. The RCT outcomes might inform larger trials to test whether poor prognosis in terms of major adverse cardiovascular events can be improved through EMDR in patients with cardiac-induced PTSD.",[28,218,219],"Myocardial Infarction","Eye Movement Desensitization and Reprocessing",[92,221,222,223],"MI","ACS","EMDR","2026-05-06",{"date":196,"type":37},{"date":227,"type":37},"2020-11-21",{"date":153,"type":21},{"name":230,"class":44},"University of Zurich",{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":257},"100562831","phase-2-ketamine-sgb-and-combination-treatment-for-tbi-associated-headache-or-ptsd-100562831","NCT06608277","Ketamine, SGB and Combination Treatment for TBI-associated Headache or PTSD","Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial Comparing Ketamine, Stellate Ganglion Blocks and Combination Treatment to Sham Therapies for Traumatic Brain Injury-Associated Headaches and Post-Traumatic Stress Disorder","Inclusion Criteria:\n\n1. Adults 18 years or older\n2. Stable doses of medications for \\> 2 weeks for TBI and\u002For PTSD\n3. For TBI-associated headache with or without PTSD: HIT-6 score of \\>\u002F=53. For PTSD with or without TBI-associated headache: PCL-5 score \\>\u002F=33 OR. For those with TBI and PTSD, and a HIT-6 score \\\u003C 53 and PCL-5 score of \\\u003C33, individuals with a HIT-6 score of 50-52 and a PCL-5 score of 31 or 32 will be included.\n4. Duration of chronic TBI or PTSD \\> 3 months\n\nExclusion Criteria:\n\n1. Ketamine infusion or SGB within the past 6 months\n2. Serious medical or psychiatric conditions other than TBI or PTSD that could affect cognition (e.g., dementia, Parkinson's Disease)\n3. Elevated intracranial pressure\n4. For TBI, prior history of headache that can explain the headache intensity (i.e., headache not attributable to TBI)\n5. Active psychosis or poorly controlled non-injury or PTSD-related psychiatric condition (e.g., bipolar disorder)\n6. Poorly controlled medical conditions that could be exacerbated by treatment (e.g., unstable angina)\n7. Pregnancy (women of childbearing age who can become pregnant will have to take a pregnancy test)\n8. Non-fluency in English (poor generalizability to military and veteran populations, instruments not validated for use or translated in many languages)",{"count":239,"type":21},175,[241],"PHASE2","Post-Traumatic Stress Disorder (PTSD) and traumatic brain injury (TBI) with associated headache are amongst the most common injuries sustained by our deployed forces in Iraq and Afghanistan, as well as in more recent conflicts in Eastern Europe and the Middle East. This study aims to determine whether a procedural intervention (stellate ganglion block (SGB)) or medication (ketamine), alone or in combination, can alleviate PTSD and TBI-associated headache. Determining efficacious treatments in a randomized, double-blind, placebo-controlled, multicenter study trial may improve quality of life in those with TBI and PTSD, and identifying factors associated with treatment outcome (personalized medicine) may enhance selection, thereby improving the risk: benefit and cost-effectiveness ratios.\n\nPrimary Objectives:\n\n1. To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for TBI-related headache;\n2. To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for PTSD;\n3. To determine the comparative effectiveness of SGB and ketamine infusion, and the effect of combination treatment on TBI-related headache and PTSD;\n4. Exploratory Aim 1: To determine the effects of SGB, ketamine infusion, and the combination on structural and functional MRI, biomarker levels and pain thresholds and tolerance;\n5. Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups.\n\nSecondary Objectives:\n\n1. Exploratory Aim 1: To determine the effects of SGB, ketamine infusion, and the combination on structural and functional MRI, biomarker levels and pain thresholds and tolerance (Biomedical levels and MRI not included at Northwestern University Site).\n2. Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups.",[244,28],"Posttraumatic Headache",[246,247],"Ketamine","Stellate Ganglion Block","2026-04-27",{"date":250,"type":37},"2026-05-01",{"date":252,"type":37},"2025-07-02",{"date":254,"type":21},"2028-04-30",{"name":256,"class":44},"Northwestern University",3,{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":267,"briefSummary":268,"conditions":269,"keywords":271,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":45},"100597218","improving-cognitive-rehabilitation-outcomes-100597218","NCT07055633","Improving Cognitive Rehabilitation Outcomes","Improving Cognitive Rehabilitation Outcomes for Veterans With mTBI+PTSD","Inclusion Criteria:\n\n* Post 9\u002F11 Veterans enrolled at VA San Diego or VA Portland\n* Ability to provide informed consent\n* Living independently\n* History of mTBI confirmed by OSU-TBI\n* Current diagnosis of PTSD confirmed by CAPS-5\n* Current cognitive concerns (\"Do you have concerns about your cognition, thinking, attention, or memory?\")\n* Current concern regarding depression and\u002For sleep disturbance; defined by a score of 5 on the PHQ-9 and\u002For 8 on the ISI, respectively (score of 2 or higher on ISI item 1, 2, or 3, reflecting at least \"moderate\" difficulty with falling asleep, staying asleep, or waking up too early in the morning)\n\nExclusion Criteria:\n\n* Current substance use disorder with \\\u003C30 days abstinence\n* History of primary psychotic disorder\n* History of moderate to severe TBI (loss of consciousness \\>30 minutes)\n* History of macular degeneration or bipolar disorder (both contraindicated for bright light therapy)\n* Not work night or swing shift schedules\n* Untreated obstructive sleep apnea either via self-report or a score 5 on the STOP-BANG\n* Current engagement in bright light therapy\n* Auditory or visual impairments precluding participation in assessments or treatments",{"count":266,"type":21},144,[24],"Posttraumatic stress disorder (PTSD) and mild TBI (mTBI) frequently co-occur in post-9\u002F11 Veterans, and together are associated with worse cognitive performance, mental health, everyday functioning, community integration, quality of life, and treatment response than either condition alone. Additional comorbidities, such as depression and sleep disturbance, are common and further exacerbate these problems. The investigators will investigate Compensatory Cognitive Training (CCT) and Morning Bright Light Therapy (MBLT) vs Negative Ion Generator (ION), to directly target cognition, depression, and sleep disturbance and to improve CCT-associated rehabilitation outcomes. The investigator's randomized controlled trial in 144 Veterans with mTBI+PTSD across two VA sites will compare cognition, functioning, and other secondary outcomes following CCT+MBLT vs. CCT+ION. This study addresses the significant gap in services and evidence-based treatments for Veterans with mTBI+PTSD.",[270,28],"Mild Traumatic Brain Injury",[272,273],"brain injury","posttraumatic stress disorder","2026-04-22",{"date":276,"type":37},"2026-04-24",{"date":278,"type":37},"2026-04-01",{"date":280,"type":21},"2030-09-30",{"name":105,"class":106},{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":293,"conditions":294,"keywords":296,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":45},"100512975","phase-2-integration-of-cognitive-processing-therapy-and-relapse-prevention-for-alcohol-use-disorder-and-ptsd-100512975","NCT05959434","Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD","Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and Co-Occurring PTSD: A Randomized Clinical Trial","CPT+RP","Inclusion Criteria:\n\n1. Any gender identity, any race or ethnicity, 18 years of age or older.\n2. Able to provide written informed consent.\n3. Ability to understand English.\n4. Meet DSM-5 diagnostic criteria for current (past month) moderate to severe alcohol use disorder ( \\>= 4 criteria).\n5. At least 3 to 4 heavy drinking days per week (4 or more drinks for a woman, 5 or more drinks for a man) in the last 30 days, or \\>14 drinks per week for females or \\> 21 drinks per week for males for at least 2 weeks in the last 30 days.\n6. Meet DSM-5 diagnostic criteria for current (past month) PTSD as assessed by the CAPS-5.\n7. Participants may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or anxiety disorders. The inclusion of participants with affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and anxiety disorders among patients with AUD and PTSD. Concurrent substance use disorders are acceptable provided alcohol is the participant's primary substance of choice.\n8. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.\n\nExclusion Criteria:\n\n1. Meeting DSM-5 criteria for a history of or current psychotic disorder or bipolar disorder, or imminent risk of suicidal or homicidal behavior. The intervention may be insufficient, and those participants will be referred clinically for a higher level of care.\n2. Participants on psychotropic medications which have been initiated during the past 4 weeks.\n3. Acute alcohol withdrawal as indicated by CIWA-Ar scores \\>8. Those participants will be referred clinically for medically supervised detoxification. They may be re-evaluated for eligibility after detoxification.\n4. Pregnancy or breastfeeding for women.\n5. Currently enrolled in evidence-based behavioral treatment for AUD or PTSD. Attendance at therapeutic activities (e.g., Alcoholics Anonymous) other than study sessions will be closely monitored using the Treatment Services Review.",{"count":291,"type":21},200,[241],"The goal of this clinical trial is to test the efficacy of a novel integrative cognitive-behavioral intervention in patients with posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD).\n\nSpecific Aim 1: Examine the efficacy of CPT-RP, as compared to RP alone, in reducing alcohol frequency (percent days drinking) and quantity (drinks per drinking day) as measured by the Timeline Follow-Back (TLFB).\n\nSpecific Aim 2: Examine the efficacy of CPT-RP, as compared to RP alone, in reducing PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5).\n\nSpecific Aim 3: Use ecological momentary assessment (EMA) to evaluate intervention effects on daily alcohol-related cognitions and behaviors through real-time associations with PTSD symptomatology and distress tolerance.\n\nResearchers will compare integrative CPT+RP with RP-alone to see if CPT+RP is more efficacious in reducing alcohol use and PTSD symptom severity.",[28,295],"Alcohol Use Disorder",[297,298,299,300],"trauma or PTSD","alcohol use","Cognitive Processing Therapy","Relapse Prevention",{"date":276,"type":37},{"date":303,"type":37},"2024-04-01",{"date":305,"type":21},"2028-07-31",{"name":307,"class":44},"Texas A&M University",{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":316,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":322,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":332},"100549495","multicenter-itbs-neuromodulation-for-ptsd-treatment-100549495","NCT06434766","Multicenter iTBS Neuromodulation for PTSD Treatment","A Multicenter Clinical Study on Transcranial Magnetic Stimulation of the Primary Motor Cortex for PTSD Treatment","TMCP","Inclusion Criteria:\n\n* Aged between 18 to 65 years old\n* Right handedness\n* Have a diagnosis of PTSD meeting DSM-5 criteria\n* CAPS-5 score\\>35\n* Under stable medication for at least four weeks\n* Capable of independently reading and understanding study materials and providing informed consent.\n\nExclusion Criteria:\n\n* Current (or past if appropriate) significant neurological or medical disorder, or lifetime history of 1) seizure disorder; 2) primary or secondary CNS tumors; 3) stroke; or 4) cerebral aneurysm.\n* Primary psychotic disorder, bipolar I disorder, major depressive disorder, or personality disorders\n* Lifetime history of attempted suicide or HAMD-17 suicide item (item 3) ≥ 3 points\n* Implanted device (deep brain stimulation) or metal in the brain; a pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos if choose to do fMRI\n* Previous experience of rTMS\n* Pregnancy\u002Flactation, or planning to become pregnant during the study\n* Current under psychological or other physical treatments","65 Years",{"count":318,"type":21},140,[24],"The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex (M1) as adjunct treatment for PTSD patients. The primary outcome measure includes changes in PTSD symptom severity, with secondary outcome measures focusing on negative moods improvements, quality of life and social\u002Foccupation functioning and functional connectivity of the brain.",[28],[323,92],"iTBS","2026-04-21",{"date":276,"type":37},{"date":327,"type":37},"2024-10-30",{"date":329,"type":21},"2027-06",{"name":331,"class":44},"Second Affiliated Hospital, School of Medicine, Zhejiang University",5,{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":16,"sex":52,"minAge":53,"maxAge":340,"enrollmentInfo":341,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":343,"conditions":344,"keywords":346,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":79},"100499201","brief-behavioral-treatment-for-insomnia-in-veterans-with-posttraumatic-stress-disorder-100499201","NCT05780177","Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder","BBTI & PTSD","Inclusion Criteria:\n\n* Individuals between the ages of 18-75 years who served in the military\n* Veterans who meet DSM-5 Criteria for Insomnia Disorder.\n* Veterans who meet DSM-5 Criteria for current PTSD\n* If currently taking insomnia, PTSD or other psychotropic medications, must be stable on these medications for at least one month and not make any changes to medications during the active treatment phase of the study.\n* If currently receiving any type of psychotherapy, must have received this treatment for at least one month and do not plan to discontinue treatment during the BBTI trial. Individuals planning to start a new type of psychotherapy will be required to wait one month prior to study enrollment. Individuals currently engaged or planning to engage in evidence-based treatments that are recognized by the VA as directly targeting insomnia or PTSD (i.e., Cognitive Behavioral Therapy for Insomnia, Cognitive Processing Therapy, or Prolonged Exposure Therapy) must complete treatment and wait one month prior to screening for the trial.\n* The investigators will not exclude individuals with TBI, given that prior studies have found that individuals with mild to severe TBI can benefit from behavioral interventions for insomnia.\n* The investigators will not exclude individuals with chronic pain, given that prior studies have found that these individuals can benefit from behavioral interventions for insomnia.\n* The investigators will not exclude individuals with treated sleep apnea or untreated sleep apnea or individuals that are high-risk for sleep apnea. Prior research has found that these individuals can benefit from behavioral interventions for insomnia. Recent research has also established that individuals with untreated mild, moderate or severe sleep apnea or those high-risk for sleep apnea are more likely to receive assessment and treatment for this condition after completing behavioral treatment for insomnia.\n\nExclusion Criteria:\n\n* Veterans with a lifetime history of psychotic disorder or manic episodes.\n* Veterans with moderate to severe alcohol or substance use disorder.\n* Veterans with recent homicidal behaviors. Veterans with suicidal ideation will not be excluded. However, Veterans with recent suicidal behaviors or hospitalization or those who report prominent suicidal ideation with intent or a plan will be excluded.\n* Veterans who are pregnant\n* Veterans who work night or rotating shifts\n* Veterans with unstable housing\n* Veterans with untreated medical conditions that are known to affect sleep (e.g., restless legs syndrome)\n* Veterans with uncontrolled seizure disorder. Sleep restriction is contraindicated for people with uncontrolled seizures due to the possibility of triggering a seizure.\n* Veterans who are unable to participate in video treatment sessions or complete online surveys.","75 Years",{"count":291,"type":21},[24],"This study will investigate treatments for insomnia in Veterans who have posttraumatic stress disorder (PTSD). The purpose of this study is to compare a brief behavioral treatment for insomnia (BBTI) to a treatment that helps promote relaxation (progressive muscle relaxation training or PMRT). The investigators will examine improvements in psychosocial functioning and insomnia severity. The investigators will also examine whether treatment gains last over time and whether suicidal ideation decreases following insomnia treatment.",[28,345],"Insomnia Disorder",[92,347],"Insomnia","2026-04-15",{"date":324,"type":37},{"date":351,"type":37},"2023-05-01",{"date":353,"type":21},"2027-04-30",{"name":105,"class":106},{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":16,"sex":52,"minAge":361,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":22,"phases":364,"briefSummary":365,"conditions":366,"keywords":369,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":79},"100478922","insomnia-treatment-and-cardiometabolic-health-in-older-adults-with-posttraumatic-stress-disorder-100478922","NCT05516277","Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder","Inclusion Criteria:\n\n* Community-dwelling Veterans aged 50 years and older\n* Received care from a Veterans Health Administration (VHA) facility in the prior year\n* Diagnosis of PTSD\n* Diagnosis of insomnia disorder\n* Lives within a 50-mile radius of the research offices at the VA Sepulveda Ambulatory Care Center\n\nExclusion Criteria:\n\n* Active substance use or in recovery with less than 90 days of sobriety\n* Too ill to engage in the study procedures (e.g., unable to attend the in-person meetings)\n* Unable to self-consent to participate\n* Unstable housing (as this will impact the research team's ability to retrieve costly and difficult to replace monitoring equipment)\n* Severe cardiovascular or respiratory disease (e.g., ventilatory failure, CHF)\n* Unstable medical or psychiatric disorders (which are a contraindication for behavioral treatment of insomnia)\n* Comorbid sleep disorders (i.e., central sleep apnea syndrome, diagnosed narcolepsy or circadian rhythm sleep-wake phase disorders) based on medical record review and baseline assessment data, or untreated, severe sleep disordered breathing (SDB) as assessed via WatchPAT or previous clinical evaluation (apnea-hypopnea index \\[AHI\\] ≥ 30; or AHI ≥ 15 plus Epworth Sleepiness Scale \\[ESS\\] score ≥ 10) that better explain sleep difficulties","50 Years",{"count":363,"type":21},167,[24],"This pilot pre-post trial will address a gap in knowledge related to addressing modifiable risk factors for cardiometabolic disease through treating residual insomnia, sleep difficulties that remain after successful treatment of another condition, in the context of PTSD in understudied older adults. This study provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by a non-medication sleep education and treatment program (Cognitive Behavioral Therapy for Insomnia, CBT-I) for sleep problems that remain after completing PTSD treatment in older adults with PTSD. The aims of this project are to evaluate 1) the added benefits of treating residual insomnia on sleep and PTSD symptoms; 2) the added benefits of treating residual insomnia following CPT on cardiometabolic risk biomarkers and quality of life; and 3) the durability of the sleep, PTSD, cardiometabolic and quality of life benefits of treating residual insomnia following CPT at 6-month follow-up in older adults with PTSD.",[28,347,367,368],"Cardiovascular Diseases","Metabolic Disease",[370],"Quality of Life","2026-04-10",{"date":348,"type":37},{"date":374,"type":37},"2023-04-01",{"date":376,"type":21},"2028-03-31",{"name":378,"class":44},"University of California, Los Angeles",{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":52,"minAge":385,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":79},"100499661","advancing-couple-and-family-alcohol-treatment-through-patient-oriented-research-and-mentorship-100499661","NCT05786157","Advancing Couple and Family Alcohol Treatment Through Patient-Oriented Research and Mentorship","Inclusion criteria\n\n1. Any gender identity; any race or ethnicity; ages 21 years or older.\n2. Must report ≥ 2 heavy drinking episodes in the past 30 days (i.e., 4 or more drinks for women, 5 or more for men in ≤ 2 hours) and consumed a quantity of alcohol that is equal to or greater than the standard dose administered for their weight in the laboratory (assessed via the TLFB).\n3. At least one instance of physical IPV in the current relationship reported by at least one partner within the couple (assessed by the CTS-2).\n4. Participants must agree not to drive or operate machinery for the remainder of the experimental visit day. Transportation will be provided if necessary.\n5. One or both partners in half the couples will be required to meet diagnostic criteria for PTSD or subthreshold PTSD (assessed by the CAPS-5).\n\nExclusion criteria:\n\n1. Possible drug use disorder (except caffeine or nicotine) as meeting DSM-5 diagnostic criteria via the QuickSCID; Recent recreational drug use (e.g., cannabis) is acceptable.\n2. Severe alcohol use disorder as meeting DSM-5 diagnostic criteria via the QuickSCID. Applies to those receiving alcohol administration only.\n3. Meeting DSM-5 criteria for a history of or current psychotic or bipolar disorders.\n4. Current suicidal or homicidal ideation and intent.\n5. History of or current psychiatric or medical condition for which alcohol administration is medically contraindicated.\n6. Body weight \\> 250 lbs (in order to rigorously control alcohol dosing). Applies to those receiving alcohol administration only.\n7. Use of medications such as lithium, methadone, alpha or beta blockers or cholinergic\u002F anticholinergic drugs likely to confound normative cardiovascular responding for the psychophysiological component of the project. Applies to those receiving alcohol administration only.\n8. Pregnancy or breastfeeding.\n9. Severe or unilateral partner violence in the past 6 months as measured by the CTS-2.","21 Years",{"count":318,"type":21},[24],"Intimate partner violence (IPV) is a serious public health problem that results in significant health and economic burdens including mortality, morbidity, and poor treatment outcomes. A well-developed field of research suggests that alcohol misuse and posttraumatic stress disorder (PTSD) can lead to IPV. Individuals with PTSD and\u002For problematic drinking behaviors are at risk for IPV because of several factors that are common symptoms of PTSD. Because individuals with PTSD often drink alcohol to \"self-medicate\" or cope with distressing PTSD symptoms, PTSD co-occurs with alcohol misuse and alcohol use disorder at extraordinarily high rates. However, few studies have examined the combined effects of alcohol misuse and PTSD on any form of violence.\n\nThis study will examine the effects of alcohol misuse and posttraumatic stress disorder (PTSD) on alcohol-related intimate partner violence (IPV). We will examine these associations among couples (N=70) in a controlled laboratory setting using validated, standardized methods in a 'real-world' settings using 28 days of ecological momentary assessment (EMA).",[295,28,390],"Couples","2026-04-02",{"date":393,"type":37},"2026-04-03",{"date":395,"type":37},"2024-03-01",{"date":397,"type":21},"2029-10-01",{"name":399,"class":44},"Medical University of South Carolina",{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":22,"phases":408,"briefSummary":410,"conditions":411,"keywords":413,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":79},"100429824","phase-3-repurposing-low-dose-clonidine-for-ptsd-in-veterans-100429824","NCT04877093","Repurposing Low-Dose Clonidine for PTSD in Veterans","Inclusion Criteria:\n\n* ≥18 years old\n* US military veteran\n* Currently has PTSD diagnosis as determined by clinical diagnosing or by the PI\n* Screening score on PCL5 minimum of 40 (per data from previous studies36-38, a PCL5 score of 40 is roughly equivalent to a CAPS score of 30)\n* Scores ≥10 on PCL5 items 1-5 (intrusion) or scores ≥10 on PCL5 items 15-20\n* From PCL5 questionnaire, must score the following minimum in each of the following categories:\n\n  * 1x score of 2 on Questions 1-5\n  * 1x score of 2 on Questions 6-7\n  * 2x score of 2 on Questions 8-14\n  * 2x score of 2 on Questions 15-20\n* Has score ≥3 on CAPS nightmare items B2 and E6\n* Speaks and understands English\n* Willing to come into the clinic as programmed\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* At Moderate or High risk of suicide based on \"past month\" column of the Columbia-Suicide Severity Rating Scale (CSSR-S) screen version - recent.\n* Has acute or unstable mental illness or any cognitive issues which the PI determines would interfere with engagement in the study (e.g., active schizophrenia, uncontrolled bipolar, history of neurocognitive impairment, history of moderate-severe traumatic brain injury)\n* Currently receiving exposure therapy\n* Recently enrolled (\\\u003C1 month) in other behavioral health therapies (exclusions made at the PI's discretion depending on therapy type and length since admission)\n* Urgent hypertension (BP above 160\u002F100) or symptomatic of hypertension (having a hypertensive emergency)\n* Blood pressure under 100\u002F60 or symptoms of low blood pressure (light headedness, dizziness, heart palpitations, or other symptoms as determined by clinician).\n* Any contraindications to taking clonidine such as:\n\n  * Known hypersensitivity to clonidine\n  * History of 2nd or 3rd degree atrioventricular block\n  * History of sinus bradycardia\n  * History of pheochromocytoma\n  * History of Raynaud's phenomenon\n  * Stage 5 Kidney disease\n  * Recent myocardial infarction (\\\u003C6 months)\n  * History of cerebrovascular disease or recent stoke (\\\u003C6 months)\n* Have used any of the following drugs in the past 30 days, unprescribed or not used as prescribed:\n\n  * Heroin\n  * Other opiates\u002Fanalgesics\n  * Barbiturates\n  * Other sedatives\u002F, hypnotics, or tranquilizers\n  * Cocaine\n  * Amphetamines\n  * Cannabis\n  * Hallucinogens\n  * Inhalants\n* Currently have any of the following diagnoses:\n\n  * Opioid use disorder\n  * Cocaine use disorder\n  * Alcohol use disorder\n  * Cannabis use disorder\n  * Sleep apnea diagnosis with verbal indication of non-adherence to treatment\n* Were prescribed clonidine within the last 6 months\n\n  * Any α2 agonist\n\n    * Catapres\u002FKapvay (clonidine)\n    * Aldomet (Methyldopa)\n    * Zanaflex (Tizanidine)\n    * Intuniv (Guanfacine)\n    * Lucemyra (Lofexidine)\n  * Any α1-adrenergic antagonist\n\n    * Prazosin\n    * Terazosin\n    * Doxazosin\n    * Silodosin\n    * Alfuzosin\n    * Tamsulosin\n  * Any opiate (e.g., buprenorphine, hydrocodone, oxycodone)\n  * Any antipsychotic medication\n\n    * Haldol (haloperidol)\n    * Loxitane (loxapine)\n    * Mellaril (thioridazine)\n    * Moban (molindone)\n    * Navane (thiothixene)\n    * Prolixin (fluphenazine)\n    * Serentil (mesoridazine)\n    * Stelazine (trifluoperazine)\n    * Trilafon (perphenazine)\n    * Thorazine (chlorpromazine)\n    * Abilify (aripiprazole)\n    * Clozaril (clozapine)\n    * Geodon (ziprasidone)\n    * Risperdal (risperidone)\n    * Seroquel (quetiapine)\n    * Zyprexa (olanzapine)\n  * Benzodiazepines\n  * Cyproheptadine\n* Based on PI or study team assessment is cognitively unable to engage in the study\n* Has a legal guardian",{"count":407,"type":21},32,[409],"PHASE3","Hypothesis: Veterans with PTSD prescribed clonidine will demonstrate improvements in PTSD symptoms, including daytime, nighttime, and sleep-related behaviors.",[92,28,412],"Sleep",[92,414,415,416,417],"veterans","military","sleep","adrenergic receptor","2026-03-25",{"date":420,"type":37},"2026-03-31",{"date":422,"type":37},"2023-06-01",{"date":424,"type":21},"2027-03-31",{"name":426,"class":44},"Wake Forest University Health Sciences",{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":52,"minAge":435,"maxAge":18,"enrollmentInfo":436,"targetDuration":4,"studyType":22,"phases":437,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":444,"leadSponsor":446,"locationsCount":79},"100403110","biomolecular-characteristics-of-reminder-focused-positive-psychiatry-100403110","NCT04529031","Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry","Clinical and Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry in Adolescent With Posttraumatic Stress Disorder","RFPP","Inclusion Criteria:\n\n* Boy\u002FGirl with documented PTSD,\n* aged 11- 15 years old,\n* able to read\u002Fwrite in English\n\nExclusion Criteria:\n\n* presence of intellectual disabilities,\n* presence of psychotic or self-injurious behavior,\n* presence of seizure disorder,\n* presence of language disorder,\n* presence of eye disorders,\n* presence of other neurodevelopmental disorders,\n* presence of diagnosis of substance use disorder.","11 Years",{"count":214,"type":21},[24],"Objective: Posttraumatic stress disorder (PTSD) is a prevalent neuropsychiatric disorder in children and is associated with increased neurovascular inflammation, suicidality, adulthood mental health disorder, and major adverse events. Reminder focused positive psychiatry (RFPP) has been shown as well tolerated feasible trauma focused intervention that is associated with improved core PTSD symptoms, decreased severity of reactivity to PTSD trauma reminders, and increased vascular function. This study evaluates the clinical and biomolecular characteristics of RFPP in adolescents with PTSD.\n\nResearch Design\u002FOverall Impact: After obtaining parents' informed consent and adolescent's assent, 60 adolescents aged 11-15 years old with PTSD, and free of known medical and other major psychiatric disorders will be recruited from the pool of eligible adolescents at Olive View UCLA Pediatrics Clinics (\\>3000 adolescents with PTSD). Eligible adolescents will be randomized to 1) RFPP group intervention, or 2) an attentional control condition (group process). Thirty subjects in each group will receive twice weekly telehealth intervention of either RFPP or group process, for 6 weeks, and undergo 4 blinded neuropsychiatric assessments at baseline, 3, 6, and 24 weeks. Parents will receive weekly interventions of either positive psychoeducation or group process, for 6 weeks and undergo baseline, 3, 6- and 24-weeks neuropsychiatric assessment. Vascular function, inflammatory biomarkers including CRP, homocysteine, and stress involved gene expression biomarkers (i.e. changes in gene expression of FKBP5, DDX6, B2M, LAIR1, RTN4, NUB1, and a multi-gene Conserved Transcriptional Response to Adversity score (CTRA) will be measured at baseline and 6-week. The primary and secondary endpoints are a) changes in PTSD core and reactivity to trauma reminder severity score in response to RFPP intervention, b) changes in wellbeing, biopsychosocial trait, vascular function, neuroinflammation and gene expression biomarkers in response to RFPP, and c) changes in parents' wellbeing and biopsychosocial trait as well as child-parent interactions.",[28],"2026-03-24",{"date":442,"type":37},"2026-03-27",{"date":278,"type":21},{"date":445,"type":21},"2028-12-28",{"name":378,"class":44},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":92,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":52,"minAge":454,"maxAge":316,"enrollmentInfo":455,"targetDuration":4,"studyType":22,"phases":456,"briefSummary":457,"conditions":458,"keywords":459,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":45},"100601042","exploring-efficacy-of-multi-mode-cognitive-processing-therapy-cpt-for-ptsd-100601042","NCT07105345","Exploring Efficacy of Multi-Mode Cognitive Processing Therapy (CPT) for PTSD","Efficacy of Multi-Modal Cognitive Processing Therapy for PTSD: A Longitudinal, Multicenter, Single-Blind RCT on Symptoms, Sleep, Anxiety, Depression, Remission, and Posttraumatic Growth","Inclusion Criteria:\n\n* Aged between 20 and 65 years\n* Diagnosed with PTSD according to DSM-5 criteria\n* Score ≥ 33 on the PTSD Checklist for DSM-5 (PCL-5)\n* Able to provide informed consent\n* Stable psychiatric medication regimen (if any) for at least 4 weeks prior to enrollment\n\nExclusion Criteria:\n\n* Diagnosed with schizophrenia, schizoaffective disorder, or bipolar I disorder\n* Current substance dependence or abuse within the past 6 months\n* Severe suicidal ideation or suicide attempt in the past 6 months\n* Cognitive impairment or neurological disorder affecting participation\n* Concurrent participation in other psychological treatment for PTSD","20 Years",{"count":214,"type":21},[24],"This study is a longitudinal, multicenter, single-blind, two-arm randomized controlled trial designed to evaluate the effectiveness of Multi-Modal Cognitive Processing Therapy (MMCPT) for individuals with posttraumatic stress disorder (PTSD). Participants will be randomly assigned to either the intervention group receiving MMCPT or a control group receiving treatment-as-usual (TAU). The intervention follows the standard CPT manual developed by Resick and consists of twelve weekly 90-minute individual sessions. The primary outcomes include PTSD symptom severity assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Checklist for DSM-5 (PCL-5). Secondary outcomes include sleep quality (actigraphy, PSQI), anxiety (STAI), depression (HDRS-17), remission rate, and posttraumatic growth (PTGI). Assessments will occur at baseline, mid-treatment, post-treatment, and at 3-, 6-, 9-, and 12-month follow-ups.",[28],[299,460,461,187,462,463,27],"Trauma-focused therapy","Sleep quality","RCT","Taiwan","2026-03-18",{"date":466,"type":37},"2026-03-20",{"date":468,"type":37},"2025-09-01",{"date":470,"type":21},"2027-12-31",{"name":472,"class":44},"Far Eastern Memorial Hospital",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":22,"phases":480,"briefSummary":481,"conditions":482,"keywords":483,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":492,"locationsCount":257},"100459826","family-involvement-in-treatment-for-ptsd-fit-ptsd-a-brief-feasible-method-for-enhancing-outcomes-retention-and-engagement-100459826","NCT05267665","Family Involvement in Treatment for PTSD (FIT-PTSD): A Brief, Feasible Method for Enhancing Outcomes, Retention, and Engagement","Inclusion Criteria:\n\nInclusion criteria for Veterans will include:\n\n* a current DSM-5 diagnosis of PTSD\n* Veteran status\n* willing to have a family member involved in the study\n* has recently begun or is currently initiating individual CPT or PE (completed no more than 3 sessions of the protocol at the time of the baseline assessment)\n\n  * If taking psychotropic medication, the Veteran must be on a stable dose for at least 30 days.\n\nInclusion criteria for family members will include:\n\n* age 18 or older, family member of the Veteran (significant other, parent, adult child, sibling, etc.)\n* currently having frequent contact with the Veteran (three or more times per week)\n\nExclusion Criteria:\n\nExclusion criteria for Veterans will include:\n\n* current engagement in couple\u002Ffamily treatment with the identified family member participant\n* current severe substance use disorder (mild\u002Fmoderate use disorders will not be excluded; any level of nicotine or caffeine use disorder accepted)\n* current psychosis or unstable bipolar disorder diagnosis\n* high suicidal risk\n* significant cognitive impairment\n\nExclusion criteria for family members will include:\n\n* same as listed for Veterans. Additionally\n* family members will NOT be permitted to participate if they meet criteria for current PTSD",{"count":291,"type":21},[24],"Although effective treatments for PTSD exist, high rates of treatment dropout and sub-optimal response rates remain common. Incorporating family members in treatment represents one avenue for improving outcomes and providing Veteran-centered care, and surveys of Veterans in outpatient VA PTSD care indicate that 80% desire family involvement. The VA has invested many years and millions of dollars on the dissemination of Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) for PTSD. A family-based intervention that complements these two first-line treatments would capitalize on existing treatment infrastructure while also potentially boosting outcomes and retention.\n\nPreliminary testing of the proposed Brief Family Intervention (BFI) resulted in 50% less dropout from CPT\u002FPE among Veterans whose family members received the BFI. There was also a large impact on PTSD symptoms at 16 weeks (d = 1.12) in favor of the BFI group. The goal of this study is to test the effectiveness of the BFI among a fully-powered sample. One hundred Veteran-family member dyads (n = 200) will be recruited. Veterans will be beginning a course of usual-care CPT or PE at one of two VA sites. Family members will be randomized to receive or not receive the BFI, a two-session psychoeducational and skills-based protocol. PTSD symptom severity and treatment retention will be the primary outcomes. Assessments will be conducted by independent evaluators at baseline, 6-, 12-, 18-, and 26-weeks. Veterans whose family members receive the BFI are expected to have lower dropout and a greater rate of change in their PTSD symptoms compared to Veterans whose family members do not receive the BFI. If the BFI is found to increase the effectiveness of and retention in CPT\u002FPE, it will be a highly appealing option for incorporating families into Veterans' PTSD care.",[28],[484,92,485,486],"Posttraumatic stress disorder","Veteran","Family treatment","2026-03-17",{"date":466,"type":37},{"date":490,"type":37},"2022-07-01",{"date":424,"type":21},{"name":105,"class":106},{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":22,"phases":501,"briefSummary":502,"conditions":503,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":79},"100532945","cih-stepped-care-for-co-occurring-chronic-pain-and-ptsd-100532945","NCT06219408","CIH Stepped Care for Co-occurring Chronic Pain and PTSD","A Pilot Randomized Controlled Trial of CIH Stepped Care for Co-occurring Chronic Pain and PTSD","Inclusion Criteria\n\nIn order to be eligible to participate in this study, clinic employees must meet all of the following criteria:\n\n1. Aged 18 years or older\n2. A clinic employee and\u002For trainee\n\nIn order to be eligible to participate in this study, patients must meet all of the following criteria:\n\n1. Aged 18 years or older\n2. English-speaking\n3. A patient at the clinic from which recruitment occurs\n4. Endorse chronic pain (defined as experiencing pain on more than half of the days of the past 3-months)\n5. Endorse at least moderate pain severity and interference (defined as at least an average of 4 on the PEG)\n6. Endorse at least 31 on the PCL-5, in combination with a Criterion A traumatic event. If we have difficulties in recruiting individuals who meet our PTSD diagnosis criteria, we will modify this criteria by removing the requirement of a Criterion A traumatic event, and require a destabilizing life event instead.\n\n4.2 Exclusion Criteria\n\nThere are no exclusion criteria for clinic employees.\n\nPatients who meet any of the following criteria will be excluded from participation in this study:\n\n1. In current treatment for chronic pain and\u002For PTSD at their respective clinic\n2. Past 2-week suicidal intention at screening\n3. Severe cognitive impairment preventing individual from participating",{"count":214,"type":21},[24],"The goal of this clinical trial is to evaluate the feasibility, acceptability, appropriateness, and retention of patient participants of a CIH Stepped Care approach for co-occurring chronic pain and PTSD vs. treatment as usual in two primary care settings (one rural and one urban).\n\nResearchers will compare CIH Stepped Care to treatment as usual.\n\nParticipants will complete assessments at baseline, 3-months, 6-months, and 9-months, and those in the CIH Stepped Care condition will participate in the intervention while also completed assessments every 2-weeks, which helps determine their treatment.\n\nWe hypothesize that, at 6-months, CIH Stepped Care will be feasible, acceptable, and appropriate (defined by an average of 4\u002F5 on each measure) to patients and clinic employees and result in at least 70% of individuals be retained in each condition (n=21 per condition).",[504,28],"Chronic Pain","2026-02-24",{"date":507,"type":37},"2026-02-27",{"date":509,"type":37},"2026-02-18",{"date":511,"type":21},"2027-08-30",{"name":513,"class":44},"University of Washington",{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":22,"phases":524,"briefSummary":525,"conditions":526,"keywords":528,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":79},"100464423","written-exposure-therapy-for-veterans-with-sud-and-ptsd-100464423","NCT05327504","Written Exposure Therapy for Veterans With SUD and PTSD","Written Exposure Therapy (WET) as a Brief Trauma Treatment for Veterans With Co-occurring Substance Use Disorders and PTSD","WET","Inclusion Criteria:\n\n* Veterans ages 18 years old or older;\n* Meets DSM-5 criteria for at least one substance use disorder (SUD);\n* Meets DSM-5 criteria for PTSD;\n* Approved for SUD treatment at VA Connecticut Healthcare System.\n\nExclusion Criteria:\n\n* Veterans who meet current criteria for schizophrenia, schizophrenia-type disorders, or unmedicated mania or bipolar disorder as determined by QuickSCID-5;\n* current suicidal or homicidal risks necessitating a higher level of care;\n* Veterans who have received an Evidence-Based Psychotherapy for PTSD protocol within the past 6 months;\n* Problems that would prevent a participant from completing the writing intervention or study assessments (e.g., illiteracy). To assess for literacy, participants will read parts of the consent out loud.",{"count":523,"type":21},170,[24],"The proposed project will evaluate the efficacy of written exposure therapy (WET) among Veterans engaged in substance use disorder (SUD) treatment, who present with co-occurring posttraumatic stress disorder (PTSD). While SUD treatment programs traditionally do not address PTSD, effective trauma treatments have been used successfully among those with substance use comorbidities. WET is a brief trauma-focused intervention shown to effectively treat PTSD. In a recent acceptability and feasibility pilot study among Veterans with co-occurring SUD and PTSD, results showed a decrease in PTSD symptoms among participants receiving WET. The goal of the present study is to improve outcomes for Veterans who present for SUD treatment with comorbid SUD\u002FPTSD.",[527,28],"Substance Use Disorders",[529,63,530,92,531],"Addiction","Substance Use Disorder","Comorbidity","2026-02-17",{"date":534,"type":37},"2026-02-19",{"date":536,"type":37},"2022-09-26",{"date":538,"type":21},"2027-06-30",{"name":105,"class":106},{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":340,"enrollmentInfo":547,"targetDuration":4,"studyType":22,"phases":549,"briefSummary":550,"conditions":551,"keywords":552,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":257},"100532277","trauma-bpe-prolonged-exposure-therapy-for-injured-individuals-admitted-to-a-level-i-trauma-center-100532277","NCT06210711","Trauma BPE Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center","Prevention of Posttraumatic Stress: A Randomized Controlled Trial of Brief Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center","Inclusion Criteria:\n\n* Between the ages of 18 and 75 years old.\n* Admitted to Baylor University Medical Center at Dallas (BUMC), Baylor Scott \\& White Medical Center at Temple (BSWMC), or Froedtert Hospital and the Medical College of Wisconsin (FH\u002FMCW) Level 1 Trauma Center\n\nExclusion Criteria:\n\n* Patients in police custody\n* Patients not fluent in English\n* Patients with severe cognitive impairment\n* Patients who are acutely suicidal\n* Patients with active psychosis",{"count":548,"type":21},300,[24],"The purpose of this research is to determine if a brief treatment method is effective for preventing posttraumatic stress disorder (PTSD) and a number of other concerns following injury.",[60,92,28],[92,553,484],"Traumatic injury","2026-02-09",{"date":556,"type":37},"2026-02-11",{"date":558,"type":37},"2024-02-28",{"date":560,"type":21},"2027-09",{"name":562,"class":44},"Baylor Research Institute",{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":16,"sex":52,"minAge":569,"maxAge":570,"enrollmentInfo":571,"targetDuration":4,"studyType":22,"phases":572,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":79},"100623464","increasing-treatment-access-in-trauma-exposed-children-developing-an-adapted-step-one-intervention-rct-100623464","NCT07396974","Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT)","Inclusion Criteria:\n\n* parent and child agree that the target event\u002Findex trauma occurred;\n* report of at least five symptoms of PTSD (1 from re-experiencing category or 1 from avoidance);\n* suicidal ideation does not exclude as long as there is no active plan\u002Fintent. Safety planning implemented and continued assessment for plan\u002Fintent;\n* children ages 7-12 and a legal guardian willing to participate;\n* can be fluent in English or Spanish;\n* at least 4 weeks since child's exposure to one or more potentially traumatic events;\n* trauma exposure occurred after child was 36 months old.\n\nExclusion Criteria:\n\n* Children with pervasive developmental disorders or Autism;\n* legal guardian or child with active psychosis;\n* any condition that may limit the legal guardian ability to understand CBT and the child's ability to follow instructions;\n* children who have unsupervised visitation with their perpetrator;\n* perpetrator (person that harmed child) is living in the home;\n* active substance use disorder;\n* child is currently receiving trauma-focused therapy;\n* legal guardian is actively suicidal will be excluded from participation;\n* children who have not been stable on psychotropic medication for 4 or more weeks, and\u002For for benzodiazepines\u002Fstimulants not stable for 2 or more weeks will not be eligible for the trial.","7 Years","14 Years",{"count":163,"type":21},[24],"One of the most common and widely disseminated trauma treatments is Trauma Focused Cognitive Behavioral Therapy (TF-CBT). TF-CBT is a therapist-led, structured and sequential intervention, with treatment organized around P.R.A.C.T.I.C.E. (Psychoeducation, Parent training, Relaxation, Affective Regulation, Cognitive Coping, Trauma Narrative, In-Vivo Exposure, Cognitive Reprocessing, and Enhancing Safety) components. Stepped Care Cognitive Behavioral Therapy for Children after Trauma (SC-CBT-CT) is an alternative delivery system that incorporates the best available evidence on the treatment of childhood Post-traumatic Stress Disorder (PTSD) within a stepped care model and utilizes task-shifting with caregiver involvement, which engages caregivers in actively helping their children. Stepped care approaches are characterized by a personalized approach to care in which a lower intensity (i.e., fewer number of sessions) intervention is initially provided before the child is reevaluated or ''stepped up'' for additional care should symptoms persist. The goal of this study is to assess a personalized modification of SC-CBT-CT for Latino families (pSC-CBT-CT). The hypothesis is that personalizing SC-CBT-CT will improve outcomes for Latino children.",[575,28],"Trauma","2026-02-02",{"date":554,"type":37},{"date":579,"type":21},"2026-09-01",{"date":581,"type":21},"2027-08-31",{"name":583,"class":44},"The University of Texas Health Science Center, Houston",{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":588,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":16,"sex":52,"minAge":569,"maxAge":570,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":591,"briefSummary":573,"conditions":592,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":595,"leadSponsor":597,"locationsCount":79},"100623461","increasing-treatment-access-in-trauma-exposed-children-developing-an-adapted-step-one-intervention-pilot-100623461","NCT07396935","Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (Pilot)",{"count":590,"type":21},7,[24],[575,28],{"date":554,"type":37},{"date":278,"type":21},{"date":596,"type":21},"2026-08-31",{"name":583,"class":44},{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":22,"phases":607,"briefSummary":608,"conditions":609,"keywords":611,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":79},"100504085","enhancing-psychotherapy-for-veterans-and-service-members-with-ptsd-and-anxiety-100504085","NCT05843695","Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety","Enhancing Intensive Transdiagnostic Cognitive Behavioral Therapy for Veterans With PTSD and Anxiety Disorders","Inclusion Criteria:\n\n* Veteran\u002FService Member at least 18 years old\n* Current diagnosis of at least one anxiety-based disorder: Posttraumatic Stress Disorder, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder, Other Specified Trauma- and Stressor-Related Disorder, Other Specified Anxiety Disorder, and Unspecified Anxiety Disorder (based on ADIS-5)\n* Moderate-to-poor life enjoyment and satisfaction as indicated by a score of 47 or lower on the QLES-Q-SF\n* Stable on psychotropic medication for 4 weeks before study participation\n* Willing to be randomized to treatment condition\n\nExclusion Criteria:\n\n* Active symptoms of mania or psychosis at baseline (based on ADIS-5)\n* Depression with active suicidal ideation and intent that would preclude treatment (based on ADIS-5 \\& BDI-II)\n* Moderate-to-severe cognitive impairment as indicated by the SLUMS (a score below 20)\n* Veterans\u002FService Members with comorbid substance\u002Falcohol use or dependence are study eligible but must agree to reduce and limit their use of substances during the active course of treatment, particularly during exposure exercises. If they do not agree to this, they will be excluded\n* Undergoing concurrent transdiagnostic CBT specifically targeting any of the above-mentioned disorders",{"count":606,"type":21},306,[24],"The goal of this clinical trial is to compare two different intensive formats of delivering cognitive-behavioral treatment for people with PTSD and anxiety disorders. The main questions it aims to answer are:\n\n* Is iTCBT delivered in individual and group formats more effective than TAU in improving anxiety symptoms and quality of life?\n* For treatment non-responders, is iTCBT-Enhanced more effective than TAU improving anxiety symptoms and quality of life?\n* Does iTCBT-Individual produce a larger improvement in anxiety and quality of life compared with iTCBT-Group?\n\nParticipants will undergo several assessments throughout the course of the study. Based on randomization, they will receive: (1) iTCBT in an individual format over a 2-week period, (2) iTCBT in a group format over a 2-day period, or (3) usual care. Those who do not show a response to treatment will receive 4 additional individual therapy sessions.",[28,610],"Anxiety Disorders",[92,187,94,612,613,614],"Service Members","Reservists","Treatment","2026-01-30",{"date":617,"type":37},"2026-02-03",{"date":619,"type":37},"2023-09-22",{"date":621,"type":21},"2027-03-30",{"name":623,"class":44},"Baylor College of Medicine"]