SMART Embedded Intervention for Military Postsurgical Engagement Readiness (SEMPER)
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- STATUS
- Recruiting
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- End date
- Oct 26, 2025
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- participants needed
- 500
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- sponsor
- University of Utah
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
- 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
| Condition | Knee Pain Chronic |
|---|---|
| Treatment | Standard Care, Mindfulness-Oriented Recovery Enhancement (MORE), Brief Mindfulness |
| Clinical Study Identifier | NCT05050409 |
| Sponsor | University of Utah |
| Last Modified on | 4 October 2022 |
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