SMART Embedded Intervention for Military Postsurgical Engagement Readiness (SEMPER)

NCT05050409 NA RECRUITING

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).

Details

Lead sponsor	University of Utah
Phase	NA
Status	RECRUITING
Enrolment	500
Start date	2022-05-01
Completion	2027-10

Conditions

• Knee Pain Chronic

Interventions

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

Primary outcomes

• Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index — Baseline to 9 months
  Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index (min 0, max 240, with higher scores indicating worse osteoarthritis).

Countries

United States