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SMART Embedded Intervention for Military Postsurgical Engagement Readiness
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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).
What is being tested
- Brief mindfulness (behavioral)
- Mindfulness-Oriented Recovery Enhancement (MORE) (behavioral)
- Standard care (other)
Sponsor: University of Utah · Participants: 500 · Started: May 1, 2022
Contact the study team
- Rachel Mayhew · Phone: 253.968.2911
Official record on ClinicalTrials.gov — NCT05050409
Locations in the U.S.
| Texas | Brooke Army Medical Center, Fort Sam Houston |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.