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
Sponsors and collaborators
University of Utah
Lead sponsor
The Geneva Foundation
Collaborator