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SMART Embedded Intervention for Military Postsurgical Engagement Readiness

RecruitingNAAges 18 Years - anyAllUniversity of Utah
NCT05050409 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Scheduled to undergo unilateral total TKA at one of the study sites * TRICARE beneficiary * Facility with the English language that is adequate to complete study procedures. Exclusion Criteria: * Cognitive impairment preventing completion of study procedures, * Formal mindfulness training (e.g., MBSR, MBCT) * Severe, active suicidality * Contralateral TKA in the past 3 months or planned contralateral TKA during the study * Current cancer diagnoses.
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What it tests

  • Brief mindfulness
  • Mindfulness-Oriented Recovery Enhancement (MORE)
  • Standard care
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Where

1 site
Brooke Army Medical Center
Fort Sam Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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