SMART Embedded Intervention for Military Postsurgical Engagement Readiness
RecruitingNot applicableNCT05050409
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- SMART Embedded Intervention for Military Postsurgical Engagement Readiness
- Conditions
- Interventions
- Behavioral: Brief mindfulness
- Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)
- Other: Standard care
- Sponsor
- University of Utah
- Collaborators
- The Geneva Foundation
- Start date
- 2022-05-01
- Primary completion
- 2027-07
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Current cancer diagnoses.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05050409