NCT05050409

SMART Embedded Intervention for Military Postsurgical Engagement Readiness

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Knee Pain Chronic

Interventions

Type	Name	Description
BEHAVIORAL	Brief mindfulness	A 15-minute guided mindfulness practice that includes focused attention on breath and body sensations and open monitoring and acceptance of thoughts, emotions, and pain.
BEHAVIORAL	Mindfulness-Oriented Recovery Enhancement (MORE)	An 8-session intervention. Sessions involve: 1) mindfulness training to reduce pain and increase self-regulation over opioid use, 2) cognitive reappraisal to decrease psychological distress, and 3) savoring to augment natural reward processing, positive emotion, and esprit de corps.
OTHER	Standard care	Preoperative Standard Care. Patients will attend a 2-hour preoperative class involving pain coping education and are offered prehabilitation services. Postoperative standard care includes (1) pain medications to minimize opioid use, including acetaminophen, lyrica, meloxicam/naproxen and celebrex, and (2) anticoagulants for 3-6 weeks postoperatively, as well as (3) ambulatory care with assistive devices 1-6 weeks after surgery. Patients see their surgeon postoperatively 2-6 weeks after surgery, 3-6 months, and yearly.

Timeline

• Start date: 2022-05-01
• Primary completion: 2027-07-01
• Completion: 2027-10-01
• First posted: 2021-09-20
• Last updated: 2025-03-27

Locations

1 site across 1 country: United States