[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"United States Department of Defense\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100592189","a-hybrid-1-effectiveness-implementation-trial-of-partner-assisted-prolonged-exposure-for-ptsd-100592189",false,"NCT06990191","A Hybrid 1 Effectiveness-Implementation Trial of Partner-Assisted Prolonged Exposure for PTSD","COOPERATE","Inclusion Criteria:\n\n* Post-9\u002F11 Veteran Enrolled in VHA\n* 1 \\> mo stable medication\n* Committed relationship 6+ months\n* DSM-5-R PTSD Diagnosis\n\nExclusion Criteria:\n\n* Imminent suicidality\u002Fhomicidally\n* Mania, psychosis, or severe substance use disorder, past 3 mos\n* Severe cognitive impairment\n* Severe intimate partner violence in last 6 months\n* Fear of or intimidation by partner\n* Partner screens positive for PTSD","ALL","18 Years",{"count":19,"type":20},420,"ESTIMATED","INTERVENTIONAL",[23],"NA","PTSD occurs in up to 17% of post-9\u002F11 US Service Members and is associated with long-term functional impairment, family problems, unemployment, and suicidality. Trauma-focused therapies (TFTs), such as Prolonged Exposure (PE), result in significant relief for many. Yet, TFTs are not equally effective for everyone. An important minority (\\~40%) will retain their PTSD diagnoses after treatment, and many discontinue treatment prematurely, especially post-9\u002F11 Service Members. TFTs are also more effective in addressing symptoms than psychosocial functioning. More work is needed to improve the consistency and potency of TFTs. Partnering with significant others may provide a powerful method for helping individuals get more out of their PTSD treatment. Observational research shows that relationship factors can help patients initiate, stay in, and experience greater benefit from PTSD treatment. Veterans that were surveyed experienced greater treatment gains when they shared more about their treatment with loved ones and when loved ones accommodated less for PTSD symptoms. Despite the promise of partner-involved interventions, there is no couples approach to PTSD treatment that has demonstrated superior outcomes to individual-only treatment models (i.e., TFTs). To address this gap, the investigators have completed a series of partner-assisted PTSD treatment studies, leading up the current proposal (Partnered PE, PPE). The investigators found that treatment completion rates were better than routine clinical care, and the treatment led to large improvements in participants' functioning, PTSD symptoms, and romantic functioning. For this proposed study, the primary objective is to conduct a randomized controlled trial (Research Level 3; larger-scale clinical trial) to test the superiority of PPE to standard PE among post 9\u002F11 Veterans. The investigator's primary hypothesis is that PPE will lead to greater improvements in psychosocial functioning than standard PE. Secondary and tertiary aims examine posttreatment clinical outcomes (PTSD, depression) and intimate partner outcomes (relationship functioning, distress, caregiver burden, and psychosocial functioning), as well as examine strategies for PPE implementation. In exploratory aims, the investigators will examine the stability of group differences, treatment completion rates, the role military sexual trauma history, and treatment mechanisms.",[26],"Post Traumatic Stress Disorder",[28,29,30,31,32,33],"Trauma-focused therapies","Prolonged exposure","Veterans","Integrative Behavioral Couples Therapy","couples","PTSD","RECRUITING","2026-09-09",{"date":37,"type":38},"2026-09-11","ACTUAL",{"date":40,"type":38},"2025-05-16",{"date":42,"type":20},"2028-08-31",{"name":44,"class":45},"United States Department of Defense","FED",4,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":66,"locationsCount":46},"100589642","reducing-dropout-and-improving-outcomes-from-ptsd-therapy-when-to-switch-therapies-or-stay-the-course-100589642","NCT06957067","Reducing Dropout and Improving Outcomes From PTSD Therapy: When to Switch Therapies or Stay the Course","STEER","Inclusion Criteria:\n\n* Veterans interested in outpatient VA psychotherapy for PTSD\n* Meets DSM-5 criteria for PTSD\n* Be able to provide informed consent\n* Be willing to be randomized\n* Agree to not receive non-study psychotherapy for PTSD during study treatment (case management, supportive therapy\u002Fgroup, and concurrent substance use treatment are allowable)\n\nExclusion Criteria:\n\n* Severe cognitive impairment\n* Current suicidal or homicidal intent with a specific plan\n* Uncontrolled psychotic or manic symptoms\n* A psychiatric medication change in the past month\n* A severe SUD as diagnosed by the DSM-5",{"count":55,"type":20},280,[23],"Investigators' overall objective is to compare methods of identifying individuals who may be experiencing challenges in Cognitive Processing Therapy (CPT) and compare methods of intervening to optimize treatment retention and outcomes. Investigators' specific aims are:\n\n1. to determine whether the use of CPT skills versus collaboratively considering switching to Present Centered Therapy (PCT) is more effective in improving outcomes for individuals experiencing challenges with CPT. Outcomes include post-traumatic stress disorder (PTSD) severity \\[primary\\], depression, functioning, and treatment retention;\n2. to compare two approaches to identifying individuals in CPT in need of additional support during treatment;\n3. to study the barriers and facilitators of implementing these intervention strategies.\n\nFinally, exploratory aims will examine the stability of differences between treatment conditions, compare combinations of interventions tested, and examine moderators of intervention effects.",[26],[60,26,61,30],"Cognitive Processing Therapy","Trauma-focused treatments",{"date":37,"type":38},{"date":64,"type":38},"2025-03-17",{"date":42,"type":20},{"name":44,"class":45},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100422601","phase-2-epidural-stimulation-and-resistance-training-after-sci-100422601","NCT04782947","Epidural Stimulation and Resistance Training After SCI","Epidural Stimulation and Resistance Training for Overground Locomotion After Spinal Cord Injury","REST-SCI","Inclusion Criteria:\n\n1. All participants will be between 18-60 years old, male or female, with traumatic motor complete SCI and level of injury of T10 and above, as determined by EMG testing and International Standards for Neurological Classification of SCI (ISNCSCI) exam.\n2. Participants' knee extensors must respond to standard surface NMES procedures (frequency: 30 Hz; pulse duration:450 μs and amplitude of the current:200 mA) to ensure intact neural circuitry below the level of SCI.\n3. All participants will undergo ISNCSCI examination for neurological level and function and only those with American Spinal Injury Classification (AIS A and B; i.e. motor deficit below the level of injury) will be included.\n\nExclusion Criteria:\n\n1. Diagnosis of neurological injury other than SCI, including cauda equina or distal conus injuries resulting in limb or sacral areflexia;\n2. Unhealed fracture in either lower or upper extremities;\n3. Severe scoliosis, hip knee range of motion (ROM) or flexion knee contractures preventing positioning in an exoskeleton or plantarflexion contracture greater than 20 degrees.\n4. Untreated or uncontrolled hypertension defined as high resting blood pressure greater than 140\u002F90 mmHg and severe orthostatic hypotension (drop greater than 20 mmHg compared to resting supine blood pressure) or incapable to maintain a sitting or EAW standing posture;\n5. Other medical conditions including cardiovascular disease, uncontrolled type II DM, uncontrolled hypertension, and those on insulin, pressures sores stage 3 or greater, or symptomatic urinary tract infection;\n6. Unable to fit in the device for any reason;\n7. Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons;\n8. Implanted pacemakers and\u002For implanted defibrillator devices;\n9. DXA T-Score less than -2.5. Scans done will include total body, dual hips and knees. Total hip BMD T-scores \\\u003C -3.5 and knee BMD scores of less than 0.6 g\u002Fcm2 68-71;\n10. Functional upper and lower extremity ROM, strength, spasticity and skin integrity will also have assessed prior to enrollment in the program. The Modified Ashworth Scale will be used to ensure safety of the participants prior to engagement in the rehabilitation program. Participants with severe spasticity or limited ROM will be excluded from the trial. This is based on the Ekso® manufacturer's recommendations72;\n11. Untreatable severe spasticity judged to be contraindicated by the site Physician;\n12. Pressure ulcer of the trunk, pelvic area, or lower extremities of grade 3 or more;\n13. Psychopathology documentation in the medical record or history that may conflict with study objectives;\n14. Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study and\u002For increases the risk of infection.","60 Years",{"count":77,"type":20},20,[79,80],"PHASE2","PHASE3","Spinal cord injury (SCI) is a devastating health problem for tens of thousands of military personnel, Veterans and civilians annually. Many persons with SCI must use a wheelchair for their entire life. A new scientific breakthrough called \"lumbosacral epidural stimulation\" or \"ES\" can help people with SCI to stand, step and even walk again. At present, for ES to work, people must train with a specialized treadmill that requires several other qualified personnel to train them, which makes it hard for many people with SCI to benefit from this technology. On the other hand, there are wearable \"robot suits\" that can be used with ES, which would make it easier to use. Our research team has already used this \"ES Robot Suit\" for 3 months in one person with tetraplegia and showed remarkable improvements in motor control. Furthermore, the investigators are aiming to enhance overground motor recovery by adding 6 months of resistance training (RT). The addition of RT will likely to enhance muscle quality as indicated by increasing lean mass, peak torque and increase sensory flux to the central nervous system. Other additional benefits may include improvement in cardiovascular profile and bladder functions. The specific objectives of the current proposal are to compare the impact of EAW+ES following improving lower extremity muscle quality compared to those who will only undergo EAW+ ES without conducting RT on motor recovery, cardio-metabolic health and bladder control in persons with complete SCI. At the conclusion of the current proposal, the work will be readily available for translation into clinical setting to serve Veterans and Civilian survivors with SCI.",[83],"Spinal Cord Injuries",[85,86,87,88,89],"neuromodulation","epidural simulation","exoskeletal assisted walking","resistance training","rehabilitation","2025-12-31",{"date":92,"type":38},"2026-01-02",{"date":94,"type":38},"2021-02-03",{"date":96,"type":20},"2026-05-31",{"name":44,"class":45},1,""]