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SMART Embedded Intervention for Military Postsurgical Engagement Readiness

SMART Embedded Intervention for Military Postsurgical Engagement Readiness

Recruiting
18 years and older
All
Phase N/A

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Overview

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).

Eligibility

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.

Study details
    Knee Pain Chronic

NCT05050409

University of Utah

28 January 2024

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