[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443132":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":43,"locations":52,"responsibleParty":70,"collaborators":74,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":34,"enrollmentInfo":86,"targetDuration":34,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":34,"overallStatus":55,"whyStopped":34,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Utah","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Brief mindfulness followed by brief mindfulness for non-responders","EXPERIMENTAL","1 session of brief mindfulness, plus standard of care. At the one-month post-surgical follow-up, non-responders will receive another single session of brief mindfulness. Responders will continue to receive standard of care.",[13],"Behavioral: Brief mindfulness",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard care followed by brief mindfulness for non-responders","Patients will attend a 2-hour preoperative class involving pain coping education and are offered prehabilitation services. At the one-month post-surgical follow-up, non-responders will receive one session of brief mindfulness. Responders will continue to receive standard of care.",[13,18],"Other: Standard care",{"label":20,"type":10,"description":21,"interventionNames":22},"Brief mindfulness followed by MORE for non-responders","1 session of brief mindfulness, plus standard of care. At the one-month post-surgical follow-up, non-responders will receive the 8 session MORE intervention. Responders will continue to receive standard of care.",[13,23],"Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)",{"label":25,"type":10,"description":26,"interventionNames":27},"Standard care followed by MORE for non-responders","Patients will attend a 2-hour preoperative class involving pain coping education and are offered prehabilitation services. At the one-month post-surgical follow-up, non-responders will receive the 8 session MORE intervention. Responders will continue to receive standard of care.",[23,18],[29,35,39],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BEHAVIORAL","Brief mindfulness","A 15-minute guided mindfulness practice that includes focused attention on breath and body sensations and open monitoring and acceptance of thoughts, emotions, and pain.",[20,9,15],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Mindfulness-Oriented Recovery Enhancement (MORE)","An 8-session intervention. Sessions involve: 1) mindfulness training to reduce pain and increase self-regulation over opioid use, 2) cognitive reappraisal to decrease psychological distress, and 3) savoring to augment natural reward processing, positive emotion, and esprit de corps.",[20,25],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"Standard care","Preoperative Standard Care. Patients will attend a 2-hour preoperative class involving pain coping education and are offered prehabilitation services. Postoperative standard care includes (1) pain medications to minimize opioid use, including acetaminophen, lyrica, meloxicam\u002Fnaproxen and celebrex, and (2) anticoagulants for 3-6 weeks postoperatively, as well as (3) ambulatory care with assistive devices 1-6 weeks after surgery. Patients see their surgeon postoperatively 2-6 weeks after surgery, 3-6 months, and yearly.",[25,15],[44,49],{"name":45,"role":46,"phone":47,"phoneExt":34,"email":48},"Rachel Mayhew","CONTACT","253.968.2911","rachel.j.mayhew.ctr@mail.mil",{"name":50,"role":46,"phone":34,"phoneExt":34,"email":51},"Tina Greenlee","tgreenlee@genevausa.org",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Brooke Army Medical Center","RECRUITING","Fort Sam Houston","Texas","78234","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-98.4417,29.45303,{"lat":65,"lon":64},[68],{"name":50,"role":46,"phone":34,"phoneExt":34,"email":69},"Ttgreenlee@genevausa.org",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Eric Garland","Distinguished Professor",[75],{"name":76,"class":6},"The Geneva Foundation","100443132","smart-embedded-intervention-for-military-postsurgical-engagement-readiness-100443132",false,"NCT05050409","SMART Embedded Intervention for Military Postsurgical Engagement Readiness","SEMPER","Inclusion Criteria:\n\n* Scheduled to undergo unilateral total TKA at one of the study sites\n* TRICARE beneficiary\n* Facility with the English language that is adequate to complete study procedures.\n\nExclusion Criteria:\n\n* Cognitive impairment preventing completion of study procedures,\n* Formal mindfulness training (e.g., MBSR, MBCT)\n* Severe, active suicidality\n* Contralateral TKA in the past 3 months or planned contralateral TKA during the study\n* Current cancer diagnoses.","ALL","18 Years",{"count":87,"type":88},500,"ESTIMATED","INTERVENTIONAL",[91],"NA","The overarching objective of this proposal is to conduct a multi-site Sequential Multiple Assignment Randomized Trial (SMART) across multiple Military Health System (MHS) sites to optimize the sequencing and integration of two intervention strategies in total knee arthoplasty (TKA) patients: a single-session mindfulness-based intervention (MBI) and an intensive 8-week MBI-Mindfulness-Oriented Recovery Enhancement (MORE) designed to simultaneously reduce prolonged pain and chronic opioid use by enhancing self-regulation. Aim 1: Evaluate the extent to which a brief preoperative MBI improves TKA patients' postoperative musculoskeletal health and reduces chronic opioid use. Aim 2: Evaluate the extent to which an intensive MBI (MORE) improves musculoskeletal health and reduces chronic opioid use among patients non-responsive to preoperative intervention. Aim 3: (A) Determine patient baseline characteristics that moderate MBI treatment responses. (B) Quantify the degree to which the impact of Phase 1 and 2 MBIs on musculoskeletal health and opioid dose are mediated by changes in mechanistic autonomic marker of self-regulation: heart-rate variability (HRV).",[94],"Knee Pain Chronic","2025-03-26",{"date":97,"type":98},"2025-03-27","ACTUAL",{"date":100,"type":98},"2022-05-01",{"date":102,"type":88},"2027-10",{"name":5,"class":6},1]