[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"VA Office of Research and Development\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":665},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,379,0,25,[9,45,68,103,131,163,190,215,244,276,298,322,348,380,401,427,450,475,498,525,548,567,591,617,639],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100646024","pns-to-improve-vascular-function-and-limb-health-in-veterans-100646024",false,"NCT07696988","PNS to Improve Vascular Function and Limb Health in Veterans","Peripheral Neural Stimulation to Improve Microvascular Function and Limb Health in Veterans With Diabetic Peripheral Neuropathy","Inclusion Criteria:\n\nInclusion Criteria - All Participants:\n\n* English-speaking\n* Veteran\n\nInclusion Criteria - Diabetic Peripheral Neuropathy (DPN) Participants:\n\n* Confirmed diagnosis of type 1 or type 2 diabetes mellitus for at least 5 years\n* Clinical signs and\u002For symptoms consistent with diabetic peripheral neuropathy Or confirmation of neuropathy via physical exam\n\nInclusion Criteria - Lower Limb Amputees:\n\n* Unilateral transtibial or transfemoral amputation\n* Medically stable for at least 3 months\n* For the designated subset of the limb-loss cohort (n = 6): implanted with C-FINEs on the sciatic and\u002For tibial nerves\n\nExclusion Criteria:\n\nExclusion Criteria - All Participants:\n\n* Severe neurological disorders impairing ambulation\n* Visual or hearing impairments interfering with study participation\n* Cardiovascular or respiratory conditions posing risk during participation\n* Cognitive or psychiatric conditions compromising informed consent\n* Participation in other clinical trials interfering with outcomes\n* Pregnancy\n* History of photosensitivity or known sensitivity to laser light\n\nAdditional Exclusion Criteria - Amputees:\n\n* Active skin breakdown or infection at residual limb\n* Significant phantom or residual limb pain interfering with study procedures\n* Bilateral lower-limb amputation",true,"ALL","18 Years",{"count":21,"type":22},42,"ESTIMATED","INTERVENTIONAL",[25],"NA","Establishing a sensitive, scalable physiological test for neurovascular reflex integrity and investigating whether targeted peripheral neural stimulation can enhance perfusion and vasodilatory responsiveness.",[28,29],"Lower Limb Amputees","Diabetes",[31,29],"lower extremity limb loss","NOT_YET_RECRUITING","2026-08-19",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":22},"2026-11-02",{"date":40,"type":22},"2030-05-30",{"name":42,"class":43},"VA Office of Research and Development","FED",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100614960","phase-3-testing-the-use-of-va-peer-specialists-to-prevent-veteran-suicide-100614960","NCT07286383","Testing the Use of VA Peer Specialists to Prevent Veteran Suicide","PREVAIL","Inclusion Criteria:\n\nThere are two Inclusion criteria:\n\n* Moderate to high suicide risk according to one of the following occurring in the prior 3 months:\n\n  * a completed Comprehensive Suicide Risk Evaluation (CSRE) indicating intermediate or high acute or chronic risk\n  * a high-risk suicide PRF\n  * a suicide attempt indicated on a Suicide Behavior or Overdose Report (SBOR)\n  * a suicide safety plan completed in the past 6 months\n\nAND\n\n* Current suicidal ideation according to the 9th item of the Patient health questionnaire (PHQ-9) \\> 0 at enrollment\n\n  * While a positive 9th item usually precedes the CSRE, because the CSRE could have been administered in the 3 months prior to enrollment, the purpose of requiring a positive 9th item is to ensure more recent suicidal ideation.\n  * It may be more difficult to show an intervention effect if the investigators enroll participants with no suicidal ideation at baseline.\n\nExclusion Criteria:\n\n* Inability to provide informed consent for any reason, including due to acute psychosis or mania, dementia, or active guardianship or durable power of attorney\n\n  * These criteria will be determined according to medical record review and, if clarification needed, consultation with a treating provider.\n  * The investigators will also screen for decision-making capacity using the Blessed Orientation, Memory, Concentration (BOMC) Test and a brief quiz about the study.\n  * This quiz will involve an iterative process of querying the participants' understanding of consent information with a 10-item true\u002Ffalse test and providing feedback until an acceptable level of understanding is achieved (must get 100% correct after 3 tries to enroll).\n* Current or planned receipt of residential or intensive outpatient treatment\n* Plan to transfer or terminate care in the next 3 months\n* Homicidal ideation in the past 6 months or violent behavior in the past 12 months",{"count":53,"type":22},306,[25],"This study examines a novel way to prevent suicide among Veterans with serious mental illness (SMI). It will assess the efficacy of PREVAIL-VA, a 3-month intervention of 12, one-on-one sessions between a Peer Specialist (PS) and a Veteran that involve semi-structured conversations focused on hope, belongingness, support, and safety. PSs are Veterans with SMI trained to use their own experience and recovery to help other Veterans with SMI. PSs have improved mental health outcomes in other research, but this study would be the first to test their efficacy for suicide prevention in VHA. The project will compare outcomes of Veterans at risk for suicide receiving usual care, to PREVAIL-VA. This work is responsive to national calls for Veterans with SMI to receive support that is evidence-based, improves recovery (not just symptoms), and is tailored to individual needs. If successful, PREVAIL-VA could be adopted by the 1400 Peer Specialists employed in VA, greatly increasing the delivery of evidence-based services to Veterans at risk for suicide.",[57],"Suicide Risk",[59,60],"suicide","peer support",{"date":35,"type":36},{"date":63,"type":22},"2026-09-01",{"date":65,"type":22},"2029-12-31",{"name":42,"class":43},3,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":44},"100455567","phase-3-basal-cell-carcinoma-chemoprevention-trial-100455567","NCT05212246","Basal Cell Carcinoma Chemoprevention Trial","CSP #2019 - Basal Cell Carcinoma Chemoprevention Trial (B3C)","B3C","Inclusion Criteria:\n\n* Veteran\n* 2 (or more) qualifying basal cell carcinoma (BCC) lesions in the prior 5 years, with at least one located on the face, neck, ears, or scalp. \"Qualifying lesions are those that meet the two inclusion criterion bullet points below, and none of the exclusion criteria listed in \"B.\"\n* Qualifying lesions not in a field of prior radiation therapy\n* Qualifying lesions not a recurrence after treatment, but the original lesion can qualify whether it recurred or not\n\nExclusion Criteria:\n\n* Actinic Keratosis (AK) or Keratinocyte Carcinoma (KC) field therapy on the face (5-FU cream, imiquimod (IMQ), diclofenac gel, chemical peel, or photodynamic therapy) for BCC treatment on the face in the last 2 months because it can cause inflammation that may interfere with the IMQ treatment. After 2 months, these patients can be included.\n* IMQ therapy on the face in the past year, although such therapy in the more distant past is not an exclusion\n* Suspicious skin lesions suggestive of any type of skin cancer present on the face at the initial exam conducted for the study must be removed and have another skin exam to confirm the facial skin cancer is cleared for 1 month prior to randomization so that the investigators can be confident that skin cancer lesions that arise during the trial are new\n* Currently receiving or received in the past two months: immune checkpoint inhibitor, hedgehog pathway inhibitor, or oral capecitabine\n* History of cutaneous T-cell lymphoma within the past year, but low-grade prostate cancer, patch stage CTCL, breast cancer, and history of solid hematologic cancer deemed to be in remission will be included\n* Genetic disorder associated with very high basal cell skin cancer risk (i.e., basal cell nevus syndrome, xeroderma pigmentosum) because prevention efforts with IMQ may have dramatically different efficacy in these patients compared to the general high-risk population\n* Solid organ or bone marrow transplant recipient such as renal, hepatic, or cardiac transplant because these patients are at increased risk of KC (much greater risk of squamous cell carcinoma (SCC) than basal cell carcinoma (BCC)) and the associated immunodeficiency may affect the effectiveness of IMQ\n* Radiation therapy to the face\n* Known allergy to IMQ or cream vehicle\n* Woman currently pregnant or breast feeding\n* Woman of childbearing potential unwilling to use birth control\n* Judged by investigator to have a very high mortality risk within a year due to co-morbid illness\n* Judged by investigator to be unlikely to comply with protocol requirements\n* Judged by investigator not to be competent to provide informed consent\n* Unable to communicate in English\n* Enrolled in another therapeutic interventional trial",{"count":77,"type":22},1630,[79],"PHASE3","This is an intent-to-treat, parallel design, multicenter randomized trial and the primary intervention is a double-blind comparison of Imiquimod (IMQ) vs. placebo cream for preventing basal cell carcinoma (BCC) of the skin on the face at one year and over 3 years after therapy. Participants will apply the IMQ or placebo cream to the face daily at bedtime for 12 weeks. This study will recruit 1630 Veterans at high risk of BCC from 17 VA medical centers.",[82],"Basal Cell Carcinoma",[82,84,85,86,87,88,89,90,91,92,93,94,95,96],"chemoprevention","imiquimod","facial skin cancer","skin cancer prevention","squamous cell carcinoma","keratinocyte carcinoma","actinic keratosis","quality of life","side effects","treatment compliance","automated text messaging","cost comparison and cost effectiveness","implementation science",{"date":35,"type":36},{"date":99,"type":22},"2026-09-21",{"date":101,"type":22},"2032-09-21",{"name":42,"class":43},{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":44},"100435227","proprioceptive-sensorimotor-integration-with-neural-interfaces-for-hand-prostheses-100435227","NCT04947462","Proprioceptive Sensorimotor Integration With Neural Interfaces for Hand Prostheses","PSI","Inclusion Criteria:\n\n* Veteran\n* Unilateral upper limb amputation above or below the elbow with fully healed and healthy surgical sites\n* Viable peripheral nerve function in the residual nerves serving the limb\n* Volitional activity of the residual muscles in the amputated limb or actuating movement of the limb\n* Medically fit to undergo general anesthesia\n* Fitted with a prosthesis by a certified prosthetic and orthotic specialist (CPO) and at least one month of experience using a prosthesis\n* Willingness and availability to follow the study protocol\n* Willingness to undergo psychological evaluation, if recommended by study surgeons or investigators, to determine that the participant is mentally competent and capable of completing the study-related activities\n\nExclusion Criteria:\n\n* Bilateral upper limb amputation, unless the amputation on the contralateral side only involves missing digits but does not qualify as a partial hand amputation\n* Inability to speak English\n* Medically unfit to undergo surgery\n* Pregnancy, or those who are of childbearing potential, unwilling to prevent pregnancy during the trial\n* Uncontrolled diabetes (Hemoglobin A1c (HgbA1c)\\>8.0%)\n* History of neuropathy and\u002For radiculopathy in the target limb\n* Active infection or open sores on the residual limb\n* History of frequent infection or sores with unknown cause\n* Inability to provide informed consent or follow experimental protocols\n* Severe pain that would prevent the participant from completing study-related activities\n* Poor surgical candidate",{"count":111,"type":22},8,[25],"The purpose of this study is to characterize proprioceptive sensations in the missing limb of upper limb amputees using nerve stimulation, and to develop advanced controllers for moving a prosthesis. Proprioceptive sensations are the sensations that tell individuals where their hand is in space, and if it is moving. The research team uses Functional Electrical Stimulation (FES), which involves applying small electric currents to the nerves. These signals are then transferred to the brain just like the information about the individual's intact hand used to be transferred to their brain. This study will test different placements for stimulation and determine which one(s) provide the individual with proprioceptive sensations. The investigators want to know what the participants feel and if the investigators can use proprioceptive sensation to give the participants information about limb movement and position.",[115],"Upper Limb Amputees",[117,118,119,120,121,122,123],"Proprioception","Prosthesis","Upper Extremity Limb Loss","Peripheral Nerve Stimulation","Embodiment","Sensorimotor","Neuroprostheses","RECRUITING",{"date":35,"type":36},{"date":127,"type":36},"2021-12-01",{"date":129,"type":22},"2030-05-31",{"name":42,"class":43},{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":17,"sex":18,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":23,"phases":142,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":44},"100263018","phase-4-sleep-apnea-in-elderly-100263018","NCT02703220","Sleep Apnea in Elderly","Pathophysiology-Guided Therapy for Sleep Apnea in the Elderly","Inclusion Criteria:\n\n* Adults with mild to moderate sleep apnea with Apnea-Hypopnea Index (AHI)\\>\u002F=5 to 20\u002Fhour with central, obstructive, mixed apneas and hypopneas\n* For the finasteride protocol elderly men with above criteria will be enrolled\n\nExclusion Criteria:\n\n* Patients with severe sleep apnea (Apnea-Hypopnea Index (AHI)\\>20\u002Fhour)\n* Patients with history of prostate cancer\n* Males with hypogonadism\n* History of cardiac disease, including myocardial infarction\n* Bypass surgery\n* Atrial and ventricular tachy-bradycardias\n* Systolic congestive heart failure and Cheyne-Stokes respiration\n* Current unstable angina\n* Stroke\n* Schizophrenia\n* Untreated hypothyroidism\n* Seizure disorder\n* Preexisting renal failure and liver disorders\n* Failure to give informed consent.\n* Patients with significant pulmonary diseases by history and abnormal pulmonary function testing, including moderate obstructive\u002Frestrictive lung\u002Fchest wall disorders with resting oxygen saturation of \\\u003C96% or on supplemental oxygen\n* Patients on certain medications including:\n\n  * study drugs\n  * sympathomimetics\u002Fparasympathomimetics or their respective blockers\n  * narcotics\n  * antidepressants\n  * anti-psychotic agents\n  * other central nervous system (CNS) altering medications\n  * current alcohol, tobacco or recreational drug use\n* Patients with Body mass index (BMI)\\>34 kilograms per square meter (kg\u002Fm2) will be excluded to avoid the effects of morbid obesity on pulmonary mechanics and ventilatory control\n* Elderly with unstable gait or mobility issues that may preclude safe participation\n* Individuals with allergy to finasteride or acetazolamide will be excluded from the specific protocol\n* Pregnant women","60 Years","89 Years",{"count":141,"type":22},100,[143],"PHASE4","Sleep-disordered breathing (SDB or sleep apnea) is very common among elderly Veterans and leads to increased morbidity and mortality in this population. The proposal aims to identity whether oxygen, finasteride and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in the elderly via different mechanisms. This proposal will enhance the investigators' understanding of the pathways that contribute to the development of sleep apnea in the elderly. The investigators expect that the results obtained from this study will positively impact the health of Veterans by identifying new treatment modalities for sleep apnea. A cumulative effect of the investigators' research will fulfill the long-term goal of improving the quality of life of elderly Veterans suffering from sleep apnea and its potential life-threatening complications.",[146,147],"Sleep Apnea","Elderly Adults",[149,150,151,152,153,154,155,156],"sleep apnea","chemoresponsiveness","cerebrovascular response","hyperoxia","acetazolamide","finasteride","apneic threshold","carbon-dioxide reserve",{"date":35,"type":36},{"date":159,"type":36},"2015-07-03",{"date":161,"type":22},"2027-12-31",{"name":42,"class":43},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":18,"minAge":169,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":173,"conditions":174,"keywords":177,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":44},"100609137","development-of-a-power-training-program-to-improve-mobility-in-older-veterans-100609137","NCT07210645","Development of a Power Training Program to Improve Mobility in Older Veterans","Inclusion Criteria:\n\nPilot Study Criteria:\n\n* Veteran\n* new enrollees of the Rocky Mountain Regional Gerofit Program\n* ability to function independently in a group setting\n\nExclusion Criteria:\n\n* inability to perform basic activities of daily living\n* oxygen dependency\n* unstable cardiac disease\n* moderate to severe cognitive impairment (Montreal cognitive assessment scores \\\u003C 24)\n* proliferative diabetic retinopathy\n* relative exclusions for participation in the in-person Gerofit exercise program including: open wounds, incontinence, and lack of transportation\n* inability to ambulate\n* progressive neurological diagnoses (e.g. Amyotrophic lateral sclerosis, Parkinson's disease, multiple sclerosis)\n* individuals with planned orthopedic surgeries in the next 3 months","65 Years",{"count":171,"type":22},30,[25],"The overall purpose of this study is to develop a power training intervention in partnership with Veterans participating in Gerofit and to evaluate the program's acceptability, feasibility, and preliminary participant outcomes (leg power, physical function and self-report participation).",[175,176],"Physical Deconditioning","Mobility Decline",[178,179,180,181],"power training","mobility","older adult","user-centered design","2026-08-18",{"date":184,"type":36},"2026-08-20",{"date":186,"type":22},"2027-04-01",{"date":188,"type":22},"2030-12-31",{"name":42,"class":43},{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":44},"100597586","phase-2-vascular-effects-of-sglt2i-in-non-diabetic-ckd-100597586","NCT07060417","Vascular Effects of SGLT2i in Non-diabetic CKD","The Effects of SGLT2 Inhibition on Vascular Health and Physical Function in Veterans With CKD","EMPA-CKD","Inclusion Criteria:\n\n* eGFR (estimated glomerular filtration rate) 20-59 mL\u002Fmin (milliliters per minute)\n* albuminuria \\\u003C300 mg\u002Fg (milligrams per gram)\n\nExclusion Criteria:\n\n* Type 1 or 2 diabetes mellitus\n* expected to start dialysis or receive kidney transplantation or die within 4 months\n* prior therapy with SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors) within the previous year\n* unable to participate in the physical function tests (hand grip, walk)\n* infections requiring intravenous antibiotic treatment\n* malignancy requiring systemic therapy\n* extremity skin ulceration requiring active therapy\n* history of Fournier's gangrene\n* severe hypoglycemia requiring external assistance within the past one year\n* known allergy to empagliflozin\n* pregnancy",{"count":199,"type":22},52,[201],"PHASE2","Empagliflozin, a sodium-glucose co-transporter 2 inhibitor (SGLT2i), is a novel diabetic medication that reduces the risk of progression of chronic kidney disease (CKD) and heart failure and improves exercise tolerance regardless of the diabetes status. One of the important ways that empagliflozin improves health may be through its benefits on blood vessels. The effects of empagliflozin on blood vessels and physical function have not been examined in patients with chronic kidney disease, and it is less clear if empagliflozin may be beneficial in patients with chronic kidney disease without heavy urinary protein leakage. The investigators will examine if empagliflozin can improve blood vessel function and exercise tolerance in Veterans with chronic kidney disease without heavy urinary protein leakage.",[204],"Non-diabetic Chronic Kidney Disease",[206,207,208],"CKD","SGLT2 inhibitor","endothelial function",{"date":184,"type":36},{"date":211,"type":22},"2026-10-01",{"date":213,"type":22},"2029-09-30",{"name":42,"class":43},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":231,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":111},"100474987","incremental-hemodialysis-for-veterans-in-the-first-year-of-dialysis-inchvets-100474987","NCT05465044","Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)","Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets): A Pragmatic, Multi-Center, Randomized Controlled Trial","INCHVETS","Inclusion Criteria:\n\n* Adult Veterans diagnosed with ESRD and who will soon need chronic dialysis initiation or have initiated hemodialysis (HD) not longer than 8 weeks of the target randomization day in one of the six VA centers\n* Meeting the incremental dialysis eligibility criteria in Table 4\\* under the IncHVets Study Protocol\n* Willingness to undergo the randomly assigned modality of 2x\u002Fweek vs. 3x\u002Fweek HD\n* Willingness to attend the baseline and quarterly study tests in the dialysis unit or via telehealth as determined by study staff, which will mostly be parallel to the routine dialysis clinic visits\n* Agreeable to receive monthly or more frequent reviews for and interviews, regardless of being assigned to the incremental or conventional dialysis group\n* As shown in Table 4 of the INCHVETS Study protocol under incremental dialysis criteria, eligible subjects must have a urine output \\>0.5 L\u002Fday (liters per day) and urea clearance (KRU) \\>3 ml\u002Fmin (milliliters per minute) and meet 5 or more of the 9 other incremental dialysis criteria, which are derived from the 2014 Incremental Dialysis Consensus paper (Kalantar-Zadeh et al. Twice-weekly and incremental hemodialysis treatment for initiation of kidney replacement therapy. Am J Kidney Dis. 2014 Aug;64(2):181-6. doi: 10.1053\u002Fj.ajkd.2014.04.019. PMID: 24840669 PMCID: PMC4111970)\n\nExclusion Criteria:\n\n* Having a terminal illness with a life expectancy less than 6 months such as stage 4 metastatic cancer or having signed for hospice with life expectancy less than 6 months\n* A serum potassium level \\>6.0 mEq\u002FL (milliequivalents per liter) during the 4 weeks prior to the study start",{"count":224,"type":22},252,[25],"In this pragmatic clinical trial, which will dovetail with Veterans' routine outpatient dialysis clinic visits in six VA medical centers, the investigators will study 252 Veterans with kidney disease who need to start dialysis treatment. If a Veteran is eligible for the study by making enough residual urine, he\u002Fshe will have a 50% chance to be offered the usual three-times-per-week dialysis vs. twice-per-week dialysis that is gradually increased to three-times per- week over one year. The investigators will compare health-related quality of life, how long residual kidney function lasts, and other measures including safety in these two groups. By conducting this study, the investigators hope to understand 1) whether starting dialysis with less frequency is safe, effective, and can help Veterans and their care-partners to better cope with dialysis, and 2) if incremental dialysis can result in major cost benefits to the VA health care system, thus allowing more patients to stay in VA dialysis clinics vs. being transferred to outside clinics.",[228,229,230],"Chronic Kidney Disease (CKD) Stage 5","Kidney Dysfunction Requiring Dialysis (KDRD)","Dialysis Dependency",[232,233,234,235,236,237],"chronic kidney disease (CKD)","Residual kidney function (RKF)","Uremia","End-stage Renal Disease (ESRD)","Hemodialysis","Dialysis adequacy",{"date":184,"type":36},{"date":240,"type":36},"2023-04-01",{"date":242,"type":22},"2027-09-30",{"name":42,"class":43},{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":254,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},"100635168","care-coordination-and-passive-mobile-data-monitoring-to-improve-mental-health-care-100635168","NCT07549178","Care Coordination and Passive Mobile Data Monitoring to Improve Mental Health Care","Care Coordination and Passive Mobile Data Monitoring to Engage Veterans and Improve Mental Health Care","CCM","Inclusion Criteria:\n\n* a medical record diagnosis of Serious Mental Illness (SMI)\n\n  * defined as schizophrenia, schizoaffective disorder, or bipolar disorder\n* receipt of care at the VA site during the prior 9 months\n* a Care Assessment Need (CAN) score over the 75th percentile, indicating high risk for hospitalization or death in the upcoming year\n* ownership of a smart phone\n\nExclusion Criteria:\n\n* none",{"count":253,"type":22},400,[25],"Providing care to individuals with serious mental illness can be challenging, requiring ongoing monitoring, treatment adjustments, and coordination of various medical and social services. Rates of emergency service and hospital use are high due to unexpected social, medical, and mental health crises. Stressors and poor adherence with treatment are common and can lead to rapid worsening in symptoms, job loss, homelessness, incarceration, or suicide. Clinician visits can be infrequent. Patient-clinician contact between visits is challenging and often nonexistent. As such, illness exacerbations usually occur with no clinician awareness in real time, leaving limited opportunity to provide services. Clinicians need interventions that are capable of monitoring and quickly detecting worsening behaviors and illness, to improve care coordination, outreach, and treatment. This project studies the effectiveness of enhanced care coordination using passive mobile data monitoring and support from peer specialists, with the goal of improving outcomes and reducing the need for acute care.",[257],"Severe Mental Illness",[259,260,261,262,263,264,265,266,267],"Mental Disorders, Severe","Veterans","Remote Sensing Technology","Mobile Applications","Patient Care Team","Continuity of Patient Care","Disease Management","Peer Coaching","Health Care Utilization","2026-08-17",{"date":33,"type":36},{"date":271,"type":36},"2026-08-10",{"date":273,"type":22},"2030-04-30",{"name":42,"class":43},2,{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":295,"leadSponsor":296,"locationsCount":297},"100631981","testing-an-adaptive-intervention-for-peer-supported-mobile-health-for-primary-care-veterans-with-psychological-distress-100631981","NCT07507747","Testing an Adaptive Intervention for Peer-Supported Mobile Health for Primary Care Veterans With Psychological Distress","Peer mHealth","Inclusion Criteria:\n\n* Veteran enrolled in primary care at one of 3 VA facilities (Philadelphia, PA; Ann Arbor, MI; and Bedford, MA)\n* clinically significant psychological distress on at least one DASS-21 subscale (Depression =\\> 10, Anxiety =\\> 8, Stress =\\> 13)\n\nExclusion Criteria:\n\n* symptoms that may preclude active engagement in the intervention such as gross cognitive impairment or current symptoms of mania or psychosis\n* suicide risk as measured by the P4 Suicide Assessment\n* plan to engage in psychotherapy during the intervention period\n* started or changed the dose of a psychotropic medication in the last two months\n* voice a preference to be directly referred to mental health specialty care",{"count":284,"type":22},384,[25],"Many Veterans experience psychological distress including depression, PTSD, anxiety and problems with sleep and anger. Services to address these problems need to be easy for Veterans to access. VA mobile health applications (mHealth apps) that teach skills to manage psychological distress are widely available. However, Veterans rarely use these apps enough to experience health benefits. Peer specialists are VA employees who are trained to use their lived experiences in mental health recovery to help other Veterans. Peers can provide support and accountability to Veterans as they use mHealth apps. Peers working in VA primary care settings are easily accessible to Veterans who receive VA services. This study aims to improve the health of Veterans by testing the effectiveness of peer-supported mHealth in reducing psychological distress. It will also test how much peer support Veterans need to improve their health with using mHealth apps.",[288],"Psychological Distress",[60,290,260,291,292],"mHealth","SMART design","psychological distress",{"date":33,"type":36},{"date":63,"type":22},{"date":273,"type":22},{"name":42,"class":43},5,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":306,"briefSummary":307,"conditions":308,"keywords":311,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":44},"100626074","empowerment-program-to-reduce-treatment-of-asymptomatic-bacteriuria-in-veterans-with-spinal-cord-injury-100626074","NCT07430904","Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury","Direct to Consumer Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury and Neurogenic Bladder","Inclusion Criteria:\n\n* Veterans with SCI\u002FD and neurogenic bladders who have been treated for at least one UTI in the past year\n* Have access to a telephone\n* Have not been involved in the development phase of the program\n\nExclusion Criteria:\n\n* Non-Veterans\n* Veterans without SCI\u002FD or neurogenic bladder\n* Patients with dementia who would not be able to provide consent or respond to interview prompts\n* Patients who do not receive primary care at the MEDVAMC\n* Veterans who participated in the development of the empowerment program",{"count":171,"type":22},[25],"Antimicrobial resistance is a major public health concern that worsens healthcare outcomes. Antibiotic resistant organisms occur more often in Veterans with spinal cord injury or disease (SCI\u002FD) given their frequent exposure to antibiotics, recurrent hospitalizations, and common use of urinary catheter devices. Veterans with SCI\u002FD are also at risk for overtreatment with antibiotics when they do not need them, particularly for over-diagnosed urinary tract infections. The investigators plan to create a patient empowerment program with input of Veterans with SCI\u002FD \\[and their providers\\] to help guide their decisions and next steps when they have a change in bladder symptoms. The program will give Veterans with SCI\u002FD the tools to speak up to their provider and advocate for themselves to avoid receiving unnecessary antibiotics. This program is highly innovative, as it puts Veterans with SCI\u002FD in charge of thoughtful antibiotic use, or antibiotic stewardship.",[309,310],"Spinal Cord Injury","Spinal Cord Disease",[312,313,314,309,310,315],"Asymptomatic Bacteriuria","Antimicrobial Stewardship","Veteran Healthcare","Neurogenic Bladder",{"date":33,"type":36},{"date":318,"type":22},"2027-08-02",{"date":320,"type":22},"2032-06-30",{"name":42,"class":43},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":169,"enrollmentInfo":330,"targetDuration":4,"studyType":23,"phases":332,"briefSummary":333,"conditions":334,"keywords":336,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":44},"100622824","improving-productive-community-integration-in-homeless-experienced-veterans-100622824","NCT07388641","Improving Productive Community Integration in Homeless-experienced Veterans","An Innovative Combined Psychosocial Intervention to Improve Productive Community Integration in Homeless-experienced Veterans","MI-CBT","Inclusion Criteria:\n\n* Veteran\n* fluent in English\n* history of homelessness and currently housed through VA HUD-VASH housing programs\n* expressed willingness to work on a school, work, or training goals\n\nExclusion Criteria:\n\n* no clinically significant medical, neurological, or physical condition that would interfere with providing informed consent or valid assessments\n* no visible sign of intoxication on the laboratory assessment visits",{"count":331,"type":22},106,[25],"The VA has been focused on reducing the number of homeless Veterans nationally. However, it has been very difficult to increase the level of productive activities--including work, school, and training--for homeless-experienced Veterans (HEVs), even when the VA provides substantial case management and support services in addition to housing. The overarching aim of this proposed treatment project is to validate an innovative psychosocial intervention (a combination of Motivational Interviewing and Cognitive Behavioral Therapy; MI-CBT) that is designed to enhance motivation and increase productive community integration in Veterans who have experienced homelessness. The efficacy of this new intervention will be evaluated in a randomized control trial that includes 24 weeks of active treatment, and a follow up assessment, compared with a control condition. The results of the proposed study will have clinical and functional impact for Veterans by helping HEVs to achieve fuller community integration.",[335],"Homeless Persons",[337,338,339,340,341],"motivation","motivational interviewing","psychosocial intervention","work","community integration",{"date":33,"type":36},{"date":344,"type":22},"2026-09-14",{"date":346,"type":22},"2031-09-14",{"name":42,"class":43},{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":358,"briefSummary":359,"conditions":360,"keywords":366,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":379,"locationsCount":67},"100585170","enhancing-veteran-clinical-collaboration-in-va-prrcs-100585170","NCT06898879","Enhancing Veteran-Clinical Collaboration in VA PRRCs","Enhancing Veteran-Clinical Collaboration in VA Psychosocial Rehabilitation and Recovery Centers","EVCC VPRRC","Inclusion Criteria:\n\n1. Be a Veteran currently receiving Psychosocial Rehabilitation and Recovery Center (PRRC), Mental Health Intensive Case Management (MHICM) and\u002For Behavioral Health Interdisciplinary Program (BHIP) services at VA San Diego, Los Angeles, or Albuquerque (e.g., seen in the clinic in the past month or based on clinic criteria)\n2. Meet Substance Abuse and Mental Health Services Administration (SAMHSA) criteria of serious mental illness; i.e., \"having (within the past year) a diagnosable mental, behavior, or emotional disorder that causes serious functional impairment that substantially interferes with or limits one or more major life activities,\" based on chart review and clinician consultation if needed\n3. Be fluent and literate in English\n4. Agree to have a subset of VA mental health treatment appointments audiotaped\n\nExclusion Criteria:\n\n1. Primary substance use or organic neurological disorder diagnosis determined by chart review\n2. Are determined by clinician and\u002For study staff to be at significant risk of exacerbation of symptoms, suicidal ideation, or other risk due to study participation\n3. Have a history and\u002For current risk of violence that clinicians and\u002For study staff determine to be too high risk to manage effectively in the study setting (e.g., poses a risk to Veterans or study staff)",{"count":357,"type":22},119,[25],"Over 60% of Veterans with serious mental illness have a service-connected disability that impairs their ability to work, go to school, and\u002For have successful personal lives. Although traditional treatments tend to focus on symptom remission, Veterans prioritize a range of treatment goals, including personal empowerment and gaining personally meaningful skills. Increasing Veteran-clinician collaboration can help effectively align care with each Veteran's goals and support an empowering therapeutic experience. This project will evaluate the effectiveness of a group-based intervention intended to increase Veterans' comfort, confidence, knowledge, and skills to collaborate with their treatment teams. Findings from this study will contribute important knowledge about this intervention's effectiveness and how to enhance its effectiveness, especially for Veterans from minoritized groups. If the decision-making intervention is effective, it would help Veterans with serious mental illness, and might also help Veterans with other chronic health conditions, like PTSD and chronic pain.",[361,362,363,364,365],"Schizophrenia","Schizoaffective Disorder","Delusional Disorder","Bipolar Disorder","Major Depressive Disorder",[367,368,369,370,371,372,373,374],"serious mental illness","psychosis","collaborative decision-making","shared decision-making","veterans","recovery","personal recovery","empowerment",{"date":33,"type":36},{"date":377,"type":36},"2026-08-12",{"date":213,"type":22},{"name":42,"class":43},{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":23,"phases":388,"briefSummary":389,"conditions":390,"keywords":392,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":399,"leadSponsor":400,"locationsCount":44},"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":387,"type":22},250,[25],"Despite the availability of evidence-based treatments for post-traumatic stress disorder (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.",[391],"Posttraumatic Stress Disorder",[393,394,260,395,396],"PTSD","Web-Based Intervention","Randomized Controlled Trial","Moral Elevation",{"date":33,"type":36},{"date":271,"type":36},{"date":213,"type":22},{"name":42,"class":43},{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":17,"sex":408,"minAge":409,"maxAge":410,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":417,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":44},"100558278","veteran-peer-navigators-to-promote-shared-decision-making-for-psa-screening-100558278","NCT06549036","Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening","Randomized Trial of Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening","Inclusion Criteria:\n\nVeteran patient participants:\n\n* Veteran\n* Male\n* Attending VANYHHS-Manhattan for routine primary care appointment\n\nProviders:\n\n* Primary care provider at VA New York Harbor Healthcare System (VANYHHS)\n* Caring for patients that fit inclusion criteria\n\nExclusion Criteria:\n\nVeteran Patients:\n\n* Patients seen within 9 months of other PSA tests\n* Patients seen within 180 days after primary diagnosis of urinary obstruction, prostatitis, hematuria, other disorder of prostate, unexplained weight loss, or lumbar back pain\n* Patients with a prior diagnosis of prostate cancer (ICD-10-CM C61)\n* Patients visiting their provider for any indication other than a well-visit appointment\n\nProviders:\n\n\\- Providers who do not treat adult male patients (e.g. OB\u002FGyns, pediatricians)","MALE","40 Years","69 Years",{"count":412,"type":22},228,[25],"The project will investigate the efficacy of a Veteran-peer-navigator-led decision coaching (PDC) program to promote Shared Decision Making (SDM) for prostate cancer screening among Veterans at the Veterans Health Administration (VA). Prostate cancer is commonly screen detected using PSA, a non-specific test which has led to modest population-level survival benefits at the cost of over-detection of low-risk disease. This trade off in outcomes is ideally addressed using SDM which can be challenging to implement in time constrained primary care office visits. The investigators propose the evaluation of a PDC intervention to promote SDM for PSA screening to improve both access and quality of care for Veterans. The investigators results will enhance understanding of the efficacy, cost-effectiveness, and sustainability of PDC interventions for SDM promotion across communication formats in the VA. Lessons learned through this proposal will not only improve quality of care for PSA screening but also will suggest a paradigm for dissemination of SDM across preventive services.",[416],"Prostate Cancer",[418,419,420],"prostate cancer","Prostate-Specific Antigen","shared decision making",{"date":33,"type":36},{"date":423,"type":22},"2026-10-05",{"date":425,"type":22},"2028-08-31",{"name":42,"class":43},{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":23,"phases":436,"briefSummary":437,"conditions":438,"keywords":440,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":44},"100551986","increasing-veterans-social-engagement-and-connectedness-100551986","NCT06467214","Increasing Veterans' Social Engagement and Connectedness","CONNECTED","Inclusion Criteria:\n\nEligible participants for Aim 1 \\& Aim 2\n\n1. Must be Veterans at the Roudebush Veterans Affairs Medical Center or its Community-Based Outpatient Clinics who had a primary care encounter in the prior 6 months and\n2. Veteran obtained a score 12, indicating social isolation, on the Lubben Social Isolation Scale (LSNS-6), a validated, 6-item social isolation measure, at the time of screening in Aim 1.\n\nExclusion Criteria:\n\nFor Aim 1 and Aim 2, the investigators will exclude Veterans with\n\n1. Active suicidal ideation needing immediate mental health treatment\n2. severe cognitive, hearing or speech impairment,\n3. current exacerbation of severe psychiatric symptoms (e.g., active psychosis), or\n4. severe illness that makes study participation not feasible.",{"count":435,"type":22},264,[25],"Social isolation is a negative social determinant of health that affects 1-in-5 adults in the U.S. and 43% of Veterans. Social isolation is estimated to cost the nation $6.7 billion annually in federal healthcare spending. Yet, social isolation has rarely been the direct focus of healthcare interventions. The proposed project is a randomized controlled trial that seeks to test the effectiveness of the Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention on social isolation among diverse Veteran groups in primary care clinics. Increasing Veterans' Social Engagement and Connectedness involves three key services delivered by peers via telehealth through individual and group sessions over 8 weeks: 1) peer support, which includes person-centered assessment for social isolation, 2) psychosocial interventions to address social isolation, and 3) navigation (i.e., connecting Veterans to social resources). Findings from this study will contribute to the VA's efforts to address social determinants of health among Veterans and to provide high quality, person-centered, and equitable care to all Veterans.",[439],"Social Isolation",[260,441,442,443],"Peer specialists","Loneliness","Navigation",{"date":33,"type":36},{"date":446,"type":36},"2024-10-04",{"date":448,"type":22},"2028-06-30",{"name":42,"class":43},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":23,"phases":458,"briefSummary":459,"conditions":460,"keywords":464,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":473,"locationsCount":474},"100528589","type-i-hybrid-effectiveness-implementation-trial-of-primary-care-brief-mindfulness-training-for-veterans-100528589","NCT06162741","Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans","Inclusion Criteria:\n\nTo be eligible, participants must be:\n\n* enrolled in VA primary care through the local VA site\n* report clinically significant psychological distress as measured in at least one of three areas:\n\n  * PTSD operationalized by 30 on the PCL-5 plus endorsing a criteria A stressor\n  * depression operationalized as 10 on the PHQ-9\n  * anxiety operationalized by 10 on the GAD-7\n\nExclusion Criteria:\n\nExclusion criteria are minimized to allow inclusion of any primary care patients with psychological distress that would normally receive treatment in primary care. Patients will be excluded if they demonstrate symptoms that would not allow them to actively participate in the interventions:\n\n* gross cognitive impairment\n* suicide attempt or desire to commit suicide in the last month\n\nTo allow the study to isolate the effects of the intervention and ensure patient treatment preferences are honored, patients will be excluded if they:\n\n* had a psychotherapy appointment outside of primary care within the last month and have future appointment scheduled\n* had a change in psychiatric medication outside of VHA primary care in the last 2 months\n* voice a preference to be directly referred to specialty mental health care\n\nVeterans with mild TBI, and alcohol\u002F substance use disorders will not be excluded because these problems commonly co-occur with psychological distress, and individuals with these conditions have previously benefited from mindfulness and problem-solving training. Patients who receive Primary Care Mental Health Integration (PCMHI) services will not be excluded as this is part of the usual primary care services that all Veterans receive.",{"count":457,"type":22},300,[25],"The VA wants to understand what type of integrative and whole health approaches are helpful for Veterans. The study is comparing two primary care based mental health treatments, a mindfulness class that teaches mindfulness meditation and a problem-solving class that teaches problem-solving skills and how to build resilience, for Veterans who are experiencing symptoms of anxiety, depression, and\u002For PTSD. The goal of the study is to understand if the classes reduce symptoms of anxiety, depression, and\u002For PTSD and increase overall functioning.",[461,462,463],"Post Traumatic Stress Disorder (PTSD)","Depression","Anxiety",[288,461,465,466,467,462,463,468],"Mindfulness","Primary Care","Brief Intervention","Problem-solving training",{"date":33,"type":36},{"date":471,"type":36},"2024-08-19",{"date":161,"type":22},{"name":42,"class":43},4,{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":169,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":483,"briefSummary":484,"conditions":485,"keywords":489,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":497,"locationsCount":44},"100513962","mechanisms-of-gulf-war-illness-100513962","NCT05972291","Mechanisms of Gulf War Illness","Inclusion Criteria:\n\n1. Veterans 18-65 years old with GWI and chronic GI symptoms (abdominal pain, diarrhea, bloating) that started during their deployment in the Persian Gulf\n2. Veterans 18-65 years old with GWI and chronic GI symptoms (abdominal pain, diarrhea, bloating)\n3. increased intestinal permeability on the lactulose\u002Fmannitol permeability test (ratio \\>0.07)\n4. able and willing to cooperate with the study\n\nExclusion Criteria:\n\n1. current participation in another research protocol or unable to give informed consent\n2. women with a positive urine pregnancy test or breastfeeding\n3. history of inflammatory bowel disease, lactose intolerance and\u002For celiac sprue\n4. \\+ hydrogen breath test for bacterial overgrowth\n5. \\+ anti-endomysial antibody titer\n6. use of NSAIDs 2 weeks before or during the study\n7. known allergy to glutamine or whey protein\n8. abdominal surgery except for removal of gallbladder, uterus, or appendix \\>6 months prior to entry into the study\n9. Abnormal serum BUN and\u002For creatinine\n10. Mannitol recovery out of the normal range of 5-25 U\u002Fg\n11. history of kidney disease\n12. allergies to monosodium glutamate\n13. current use of anti-seizure medications",{"count":482,"type":22},80,[25],"Many veterans with Gulf War Illness developed chronic gastrointestinal symptoms during their deployment to the Persian Gulf. The pathophysiologic mechanisms of these chronic gastrointestinal symptoms are not well understood but cause significant morbidity in veterans. Our proposed studies will provide an innovative and novel treatment trial for chronic gastrointestinal symptoms in veterans with Gulf War Illness that were deployed into war zones. Given that there are currently no specific treatments for these disorders, and that current symptomatic approaches are far from ideal, proof of principle of our trial would be an extremely important advance as it would not only have a beneficial impact on the health of many thousands of our veterans, but also it would substantially reduce the many negative economic effects of this ailment on the VA Health Care System.",[486,487,488],"Gulf War Illness","Irritable Bowel Syndrome","Gastrointestinal Symptoms",[490,491,492],"gastrointestinal","irritable bowel syndrome","glutamine",{"date":33,"type":36},{"date":495,"type":36},"2023-10-16",{"date":242,"type":22},{"name":42,"class":43},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":169,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":508,"briefSummary":509,"conditions":510,"keywords":512,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":524,"locationsCount":67},"100498884","phase-4-methylphenidate-for-the-treatment-of-ptsd-with-associated-neurocognitive-complaints-100498884","NCT05776056","Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints","Randomized Placebo-Controlled Trial of Methylphenidate for the Treatment of Post-Traumatic Stress Disorder With Associated Neurocognitive Complaints","IMPACT","Inclusion Criteria:\n\n1. Any gender Veteran of the US military\n2. Independent decision-making capacity to sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) (i.e., no surrogate consent)\n3. Diagnosis of PTSD defined by DSM-5 symptom count on Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)\n4. CAPS-5 past month total score greater than or equal to 26\n5. Subjective neurocognitive impairment, defined as a total score of greater than or equal to 25 (1 standard deviation below the mean) on the NeuroQoL Cognitive Function 8-item self-report form\n\nExclusion Criteria:\n\n1. Diagnosis of DSM-5-defined bipolar I, schizophrenia spectrum or other psychotic disorders (by MINI)\n2. Presence of severe psychotic symptoms such that, based on the clinical judgement of the investigator or treatment provider, treatment with an antipsychotic is required\n3. Diagnosis of moderate or severe substance use disorder (except for caffeine and nicotine) during the preceding 2 months. Patients who utilize alcohol or cannabis but do not meet criteria for moderate or severe disorder are permitted at the discretion of the investigator. Participants must agree to abstain from illicit drugs, including cannabis products containing Tetrahydrocannabinol (THC) even when legal by state law\n4. History of severe TBI as defined by the Ohio State University TBI Identification Method\n5. Diagnosis of dementia or related progressive neurocognitive disorder, based on clinical records\n6. Increased risk of suicide that necessitates inpatient treatment or treatment excluded by the protocol; and\u002For intensity of suicidal ideation (Type 4 or Type 5) or any suicidal behavior in the past 2 months on Columbia Suicide Severity Rating Scale (C-SSRS)\n7. Pregnancy or lactation, or anticipated pregnancy at any point during study participation. Participants of child-bearing potential must have negative pregnancy test at study entry and must agree to adhere to a medically acceptable method of birth control (e.g., oral, implantable, injectable, or transdermal hormone-based contraceptives; intrauterine device; double-barrier method)\n8. Use of any investigational drug, MPH formulation, antipsychotics, mood stabilizers, monoamine oxidase inhibitors, stimulants, atomoxetine, or bupropion within 2 weeks of baseline\n9. Treatment with evidence-based trauma-focused therapy for PTSD within 2 weeks of baseline (if participant is receiving therapy, he\u002Fshe must complete treatment prior to entering study). Supportive psychotherapy may be continued during the study\n10. A clinically significant acute or uncontrolled chronic medical\u002Fsurgical illness that would contraindicate use of MPH, or a known terminal illness\n11. Prior allergic reaction to any MPH formulation\n12. Litigating for compensation for a psychiatric disorder outside the Veterans benefits compensation and pension process\n13. Current enrollment in another interventional trial for PTSD",{"count":507,"type":22},70,[143],"Posttraumatic stress disorder (PTSD) is frequently accompanied by difficulty concentrating, poor memory, and inability to keep up with tasks, which negatively impacts a person's ability to function at work and in relationships. Currently available treatments do not fully relieve all symptoms. A published research report showed positive evidence that the stimulant medication methylphenidate was beneficial in treating these problems. This study will evaluate the ability of methylphenidate to treat PTSD and associated neurocognitive complaints in Veterans. An innovative feature is the study's N-of-1 design. In this design, every participant will move back and forth every 4-5 weeks between treatment with methylphenidate and treatment with placebo, in random order and under double-blind conditions, over a 20-week period. The investigators will compare the aggregated change in PTSD and neurocognitive symptoms between periods of treatment with methylphenidate versus placebo. Results will help clinicians to better choose the best treatment for Veterans living with PTSD.",[511],"Posttraumatic Stress Disorder (PTSD)",[393,391,513,514,515,516,517,518,519],"ADHD","Neurocognitive","Stimulant","Veteran","Traumatic Brain Injury","TBI","Methylphenidate",{"date":33,"type":36},{"date":522,"type":36},"2024-02-05",{"date":242,"type":22},{"name":42,"class":43},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":169,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":547,"locationsCount":44},"100467842","aat-for-alcohol-use-disorder-in-veterans-100467842","NCT05372029","AAT for Alcohol Use Disorder in Veterans","Enhancing Treatment Outcomes Among Veterans With Alcohol Use Disorder: Clinical and Neural Markers of Adjunctive Approach-avoidance Training","Inclusion Criteria:\n\n* fluent in English\n* primary diagnosis of AUD with no more than 90 days abstinence from alcohol\n* 4-week stability if taking psychotropic medications\n\nExclusion Criteria:\n\n* lifetime history of psychotic or bipolar disorder\n* neurodegenerative or neurodevelopmental disorders\n* history of moderate or severe traumatic brain injury or other known neurological condition\n* sensory deficits that would preclude completing tasks\n* suicidal or homicidal ideation within the past month necessitating urgent higher level care\n* concurrent individual psychotherapy or other treatment outside of standard DDRP programming\n* conditions unsafe for completing MRI scanning for those completing the scanning component only (e.g., metal in body)",{"count":533,"type":22},176,[25],"The proposed study will test a novel treatment for alcohol use disorders (AUD) to determine if it helps Veterans reduce their hazardous drinking and recover from alcohol-related functional impairments across social, occupational, and domestic domains. To do so, the investigators will evaluate clinical, cognitive, and neural effects of a computer-delivered Approach Avoidance Training (AAT) treatment - which changes implicit tendencies to approach alcohol-related cues - in conjunction with standard VA care. The project will support RR\\&D's mission to improve Veterans' participation in their lives and community by determining if this innovative alternative technique can improve recovery outcomes for Veterans with AUD and exploring how the intervention works.",[537],"Alcohol Use Disorder",[539,540,541,542],"alcohol","cognitive training","intervention","neuroimaging",{"date":33,"type":36},{"date":545,"type":36},"2023-02-03",{"date":242,"type":22},{"name":42,"class":43},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":23,"phases":557,"briefSummary":558,"conditions":559,"keywords":560,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":44},"100452010","facilitating-transition-to-recommended-ptsd-treatment-100452010","NCT05165940","Facilitating Transition to Recommended PTSD Treatment","Improving Care for Veterans by Understanding and Facilitating Transition to Recommended PTSD Treatment (CDA 21-194)","Inclusion Criteria:\n\n* Veteran\n* Diagnosed with PTSD as part of an intake assessment at the San Francisco Veterans Affairs Medical Center\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Cognitive impairment that precludes comprehension of study materials\n* Active psychosis",{"count":556,"type":22},40,[25],"Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) were widely disseminated as recommended posttraumatic stress disorder (PTSD) treatments. However, post-9\u002F11 Veterans with PTSD rarely initiate CPT or PE, especially as an initial treatment. Little research has explored the combinations and sequences of psychosocial and medication treatments that Veterans receive (\"treatment sequences\"). One common and understudied treatment sequence begins with stabilization treatment, which is designed to prepare Veterans for CPT or PE. There is a significant research gap in understanding how treatment sequence affects initiation of CPT or PE. The proposed research is an innovative, mixed-methods approach to assessing the impact of variability in treatment sequence, including stabilization treatment, on initiation of CPT or PE and applying this knowledge by developing a health services intervention that facilitates timely transition to CPT or PE. Research aims can improve PTSD treatment by increasing initiation of and reducing disparities in CPT\u002FPE.",[393],[393],{"date":182,"type":36},{"date":563,"type":22},"2026-12-01",{"date":565,"type":22},"2027-05-03",{"name":42,"class":43},{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":573,"eligibilityCriteria":574,"healthyVolunteers":17,"sex":18,"minAge":409,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":23,"phases":577,"briefSummary":578,"conditions":579,"keywords":581,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":590},"100391156","phase-4-pimavanserin-vs-quetiapine-for-treatment-of-parkinsons-psychosis-100391156","NCT04373317","Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis","CSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP)","C-SAPP","Inclusion Criteria:\n\n* Veteran\n* Diagnosis of Parkinson's Disease consistent with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria\n* Psychosis \\[with Neuropsychiatric Inventory (NPI) hallucinations (B) or delusions (A) score 4 or greater\\]\n* Stable dose of PD medications for at least 2 weeks\n* If on an acetylcholinesterase inhibitor (AChEI) initially prescribed at least 3 months prior and stable dose (no dose or medication change) for past month\n* Informed other must provide informed consent and agree to attend all study visits. The informed other must be at least 18 years of age and have regular contact with the patient (on average at least 4 days per week and at least 2 hours per day, or at least 3 days per week and at least 4 hours per day, that is with patient) via in-person, video, or telephone\n* English-speaking\n\nINFORMED OTHER\n\n* Age 18 years or older\n* Must have regular contact with the patient (on average at least 4 days per week, and at least 2 hours per day, or at least 3 days per week and at least 4 hours pr day, that is with patient) via in-person, video, or telephone\n* Agree to attend all study visits\n* Be able to provide informed consent\n* English-speaking\n\nExclusion Criteria:\n\n* Psychosis symptoms severe enough to preclude enrollment in a clinical trial and require prompt clinical care instead\n* Treatment with quetiapine \\>50 mg\u002Fday or pimavanserin in the past 3 months, or quetiapine 50 mg\u002Fday or another antipsychotic in the past week prior to study randomization\n* Deep brain stimulation (DBS) surgery within 3 months or has had stimulator adjustments in the previous 2 weeks\n* History of a psychotic disorder prior to PD, including bipolar disorder, schizophrenia, schizoaffective disorder, and major depressive disorder with psychotic features, if it is thought to be the cause of the current psychosis symptoms\n* Suspected atypical parkinsonian disorder or dementia with Lewy bodies (DLB)\n* Psychosis secondary to other toxic or metabolic disorder\n* History of long QT syndrome\n* Documented chart evidence indicating persistent hypoglycemia, hypokalemia, hypomagnesemia that would put patient at increased risk for QTc prolongation.\n* History of ventricular arrhythmias, except when treated with an implantable cardioverter defibrillator (ICD) or pacemaker, or untreated or unstable atrial fibrillation\u002Fflutter\n* Currently taking medications that are moderate or strong CYP3A4 inducers or strong CYP3A4 inhibitors\n* Concomitant use of drugs that prolong the QTc interval with a known risk of Torsades de Pointes\n* Comorbid medical condition determined too severe by Site Investigator to allow participation in clinical trial\n* Failure to tolerate quetiapine or pimavanserin previously\n* Severe cognitive impairment (MoCA score \\\u003C5)\n* Nursing home placement at screening or planned placement during the study, unless approved by study Co-Chairs. Approval will depend upon nursing facility agreement to receive, return, and administer medications or allow participant to self-administer study medications; appropriate IO availability; and transportation availability for study visits.\n* Currently enrolled in another therapeutic or interventional study\n* Pregnant, or a female of child-bearing potential who is unwilling to use a reliable form of contraception",{"count":576,"type":22},358,[143],"Patients with Parkinson's disease (PD) sometimes experience symptoms affecting their movement, such as slowness, tremor, stiffness, and balance or walking problems. Many patients also have other symptoms not related to movement, called non-motor symptoms, which may affect one's mood or emotions, memory or thinking, or cause one to see or hear things that aren't real (hallucinations) or believe things that aren't true (delusions). Hallucinations or delusions, together called psychosis, occur in up to 60% of PD patients at some point in time. Parkinson's disease psychosis can sometimes be associated with decreased quality of life, increased nursing home placement, increased rate of death, and greater caregiver burden. There are approximately 50,000 Veterans with Parkinson's disease receiving care in the VA, and up to 30,000 (60%) of them will experience psychosis at some point in time.\n\nQuetiapine is an antipsychotic drug approved by the Food and Drug Administration (FDA) that is the most commonly used medication to treat PD psychosis, but more studies are needed to determine if it works for this condition and is also well tolerated and safe. Pimavanserin is a newer antipsychotic drug approved by the Food and Drug Administration (FDA) specifically to treat PD psychosis, but more studies are needed to determine if it works and its safety.\n\nThe purpose of this research is to gather additional information on the safety and effectiveness of both Quetiapine and Pimavanserin. By doing this study, the investigators hope to learn which of these medications is the most effective course of treatment for people with PD psychosis.\n\nEnrollment is open to Veterans nationwide, see your VA provider about the possibility of being referred to one of the study's Hub sites. This can be done through contact from your provider to the study's NSC (Tamara Boney at 267-303-9829).",[580],"Parkinson's Disease Psychosis",[582,583],"Pimavanserin","Quetiapine",{"date":33,"type":36},{"date":586,"type":36},"2022-10-24",{"date":588,"type":22},"2028-08-24",{"name":42,"class":43},24,{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":23,"phases":600,"briefSummary":601,"conditions":602,"keywords":606,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":44},"100551039","developing-a-smartphone-application-to-support-veteran-opioid-use-disorder-treatment-100551039","NCT06454903","Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment","Developing a Smartphone Application to Support the Functional Needs of Veterans in Medication Treatment for Opioid Use Disorder","Inclusion Criteria:\n\n-For the Phase 3, Stage 1b RCT The investigators will be recruiting Veterans engaged in MOUD who also demonstrate deficits in psychosocial functioning (N = 40, n = 20 per condition).\n\nEligible Veterans in must have:\n\n* a current Opioid Use Disorder (OUD) diagnosis\n* active Medication treatment for OUD (MOUD) prescription for buprenorphine or methadone\n* have a Veterans Rand 12 (VR-12) Physical Component Scale (PCS) or Mental Component Scale (MCS) that is \\\u003C1SD below the normed mean for their respective sex-assigned-at-birth (Selim et al., 2008).\n\nExclusion Criteria:\n\nParticipants may not:\n\n* have untreated major psychiatric disorders (e.g., psychotic disorders)\n* current (i.e., past-month) suicidal\u002Fhomicidal ideation with intent (i.e., a positive C-SSRS)\n* cognitive\u002Fmedical impairments precluding meaningful participation (via clinician determination based on participant's behavior and\u002For chart review)",{"count":599,"type":22},75,[25],"Opioid Use Disorder (OUD) is a complex, chronic condition affecting nearly 70,000 Veterans who can experience significantly reduced quality of life (e.g., poorer social, occupational, and health-related functioning). VA clinics providing Medication treatment for OUD (MOUD); e.g., buprenorphine, methadone), the 1st-line treatment for OUD, often face challenges in also attempting to treat Veteran functional needs, which may require them to extend beyond their available resources to provide support. There is an urgent need for functionally impactful and accessible treatments for Veterans in MOUD.\n\nAcceptance and Commitment Therapy (ACT) is a well-suited framework to support the functioning of Veterans in MOUD with over 20 years of research support. However, the traditional practice ACT requires a trained clinician to provide weekly, hour-long therapy sessions (typically for 12-16 weeks) and may be too burdensome for MOUD clinics to use alongside standard care.\n\nFortunately, emerging research suggests that mobile health interventions (MHIs; e.g., smartphone apps) can overcome many of these pragmatic barriers. MHIs can efficiently deliver functionally-focused treatments focused on Veteran functioning in \"real-world\" settings, through minimally burdensome and accessible formats. Currently however, no MHI's targeting functioning exist for Veterans in MOUD.\n\nThe proposed study will address this gap by developing and evaluating an early prototype of a targeted smartphone app designed to enhance the functional outcomes of Veterans receiving MOUD called \"ACT to RECOVER\" (Acceptance and Commitment Therapy to Reach Empowerment through Commitment, Openness, and Valuing Experiences in Recovery).\n\nThe study will occur in 3 phases:\n\nPhase 1: Development. Develop content for ACT to RECOVER using Veteran (n=10) and provider feedback (n=10).\n\nPhase 2: Iterative Usability Assessment. Conduct field testing (3 rounds, n=4-5 per round) to refine ACT to RECOVER format, acceptability, and usability.\n\nPhase 3: Pilot ACT to RECOVER in a Stage 1b Randomized Controlled Trial (RCT). Conduct a pilot trial to compare ACT to RECOVER (n=20) to a smartphone-based symptom monitoring control group (n=20).\n\n* (3a) Evaluate the acceptability and feasibility of each condition's app and study procedures.\n* (3b) Explore changes in functional (e.g., values-based living, quality of life) and clinical outcomes (e.g., illicit opioid use) which will be key outcomes in future efficacy testing.",[603,604,605],"Opioid-Related Disorders","Psychosocial Functioning","Quality of Life",[603,604,605,262,607,608,609],"Smartphone Apps","Acceptance and Commitment Therapy","User-Centered Design","2026-08-13",{"date":268,"type":36},{"date":613,"type":36},"2025-04-02",{"date":615,"type":22},"2029-10-31",{"name":42,"class":43},{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":621,"acronym":4,"eligibilityCriteria":622,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":623,"enrollmentInfo":624,"targetDuration":4,"studyType":626,"phases":4,"briefSummary":627,"conditions":628,"keywords":630,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":634,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":638,"locationsCount":44},"100651914","a-comparison-between-ischial-containment-and-sub-ischial-prosthetic-sockets-to-determine-their-effects-on-secondary-health-conditions-100651914","NCT07768072","A Comparison Between Ischial-Containment and Sub-Ischial Prosthetic Sockets to Determine Their Effects on Secondary Health Conditions","Inclusion Criteria:\n\nFor all participants:\n\n* Ability to complete the experimental protocol without undue fatigue or health risks\n* Low Back Pain scale assessment (0-10) less than 4 (activities of daily living or quality of life not impacted)\n\nIn addition for persons with lower limb amputation:\n\n* Prosthesis user for a minimum of 2 years with their current socket design\n* Good fit with either an ischial containment (IC) or sub-ischial (SI) socket\n* Good skin integrity on their residual limb upon visual inspection\n* Does not require the use of assistive devices to walk\n\nExclusion Criteria:\n\n* Previously diagnosed with a spine condition (e.g., pinched nerve, bulging disc, etc.)\n* Previously diagnosed with an orthopedic or neuromuscular condition that may affect walking or balance (e.g., ankle fusion, Parkinson's disease, stroke, etc.)","70 Years",{"count":625,"type":22},45,"OBSERVATIONAL","Long-term above-knee prosthesis users are at an increased risk of developing secondary musculoskeletal conditions compared to the general able-bodied population. One secondary physical concern is low back pain (LBP), for which the development is not entirely understood, but in above-knee prosthesis users it is believed to relate to asymmetries and compensations that are typically demonstrated and required to stand and walk. Understanding spinal motion and compensations will enhance our knowledge of the factors contributing to LBP, and possibly lead to the development of new prosthetic and therapeutic interventions to prevent or alleviate LBP, thereby improving mobility and quality of life for prosthesis users.",[629],"Unilateral Transfemoral Amputation",[631,632,633],"transfemoral amputation","prosthetic socket design","low back pain",{"date":268,"type":36},{"date":636,"type":22},"2027-01-01",{"date":188,"type":22},{"name":42,"class":43},{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":645,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":647,"enrollmentInfo":648,"targetDuration":4,"studyType":23,"phases":650,"briefSummary":651,"conditions":652,"keywords":654,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":658,"startDateStruct":660,"completionDateStruct":662,"leadSponsor":664,"locationsCount":297},"100610334","phase-3-psilocybin-intervention-for-veterans-overcoming-treatment-resistant-depression-100610334","NCT07226232","Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression","A Multi-site Randomized Controlled Trial of Psilocybin for Treatment-Resistant Depression (TRD) in Veterans","PIVOT","Inclusion Criteria:\n\n* Veteran of the U.S. military who is English-speaking\n* Signed informed consent and HIPAA\n* Adults \\\u003C\u002F= 75 years of age\n* Meets DSM-5 criteria for current major depressive episode (MDE)\n* MADRS \\>\u002F= 20 at baseline\n* Failure to respond satisfactorily to \\>\u002F= 2 antidepressant treatments for \\>\u002F= 8 weeks, including \\>\u002F= 2 weeks at an adequate dose (\\>\u002F= 50% of the FDA-approved uppermost dose) for major depression. Augmentation with a medication for depression (e.g., neuroleptics, lithium, levothyroxine) is considered a separate course of treatment.\n* If applicable, concurrent \\& permitted antidepressants must be at stable doses for \\>\u002F= 4 weeks prior to baseline (see allowed \\& prohibited medication list)\n* Participants of child-bearing potential must have negative pregnancy test \\& agree to adhere to a medically acceptable method of birth control during the study\n* Has a responsible adult who will provide transportation to the participant's home or place of lodging on the days of psilocybin administration\n\nExclusion Criteria:\n\n* Lifetime bipolar, schizophrenia spectrum, or other psychotic disorders\n* First-degree relative with history of bipolar I, schizophrenia spectrum or other psychotic disorder\n* Presence of psychotic symptoms (e.g., MDE with psychotic symptoms)\n* Sedative-hypnotic, stimulant, inhalant and\u002For opioid use disorder within past 6 months (lifetime substance use disorder is allowed at the discretion of the LSI)\n* Severe alcohol and\u002For cannabis use disorder within the past 6 months (mild or moderate alcohol and\u002For cannabis use is allowed at the discretion of the LSI)\n* Lifetime hallucinogen persisting perception or hallucinogen use disorders\n* Use of psilocybin, ayahuasca, mescaline, lysergic acid diethylamide (LSD), dimethyltryptamine (DMT), 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), peyote, or 3,4-methylenedioxymethamphetamine (MDMA) within past XX months\n* Participant agrees to not use psychedelics (listed above) during the study, except as prescribed by the study protocol\n* Taking prohibited medication within 2 weeks of baseline (see allowed and prohibited concomitant medication list)\n* History of severe traumatic brain injury (TBI)\n* Diagnosis of dementia or related progressive neurocognitive disorder\n* Suicidal ideation\u002Fbehavior Type 4 or Type 5 intensity on C-SSRS within past 6 months of baseline\n* Psychiatric inpatient treatment within past 3 months of baseline\n* Treatment with electroconvulsive therapy, deep brain stimulation, vagus nerve stimulation, or transcranial magnetic stimulation within 3 months of baseline\n* Implanted central nervous system device\n* Treatment with evidence-based psychotherapy (EBP) for MDD or PTSD within 2 weeks prior to baseline. If receiving EBP therapy, he\u002Fshe must complete treatment at least 2 weeks prior to baseline. Other forms of non-EBP psychotherapy for MDD or PTSD are allowed to continue during the study period.\n* Pregnancy or lactation, or anticipated pregnancy or breastfeeding during the active treatment phase\n* History of myocardial infarction, congestive heart failure, diabetic ketoacidosis, brain cancer, stroke and\u002For severe cardiac disease\n* Clinically significant cardiac, pulmonary, renal, liver and\u002For other medical disease that, in the opinion of the investigator, may contraindicate the use of psilocybin, interfere with the interpretation of study results and\u002For constitute a health risk for the participant if they take part in the study\n* Seizure disorder, except for seizures due to fever or withdrawal from a substance\n* Clinically significant hypertension (\\>160\u002F95 mmHg), hypotension (\\\u003C90\u002F60 mmHg) tachycardia (\\>100 bpm at rest), QTc prolongation (\\>450 msec men; \\>470 msec women) or clinically significant arrhythmia on ECG\n* Clinically significant abnormal laboratory results on chemistry panel, liver function tests, complete blood count, and\u002For thyroid stimulating hormone\n* Positive urine drug screen for illicit drugs of abuse (except for THC) at screening or baseline\n* Prior allergic, adverse reaction or adverse experience to a psilocybin formulation\n* Litigating for disability income for a mental disorder outside the VA compensation and pension process","75 Years",{"count":649,"type":22},240,[79],"The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.",[653],"Major Depression",[655,656,371,657],"depression","psilocybin","post-traumatic stress disorder",{"date":659,"type":36},"2026-08-14",{"date":661,"type":36},"2026-08-03",{"date":663,"type":22},"2031-06-30",{"name":42,"class":43},""]