SMART Embedded Intervention for Military Postsurgical Engagement Readiness

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

500 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Utah

Lead sponsor

The Geneva Foundation

Collaborator