SMART Embedded Intervention for Military Postsurgical Engagement Readiness

Not Applicable

Recruiting

• Conditions: Knee Pain Chronic

• Registration Number: NCT05050409
• Lead Sponsor: University of Utah

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-20
• Study Start: 2022-05-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2027-07
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Defense and Veterans Pain Rating Scale	Baseline to 9 months	Defense and Veterans Pain Rating Scale, a numeric rating scale enhanced by word descriptors, color coding, and pictorial facial expressions matched to pain levels (0 to 10, higher scores indicating worse pain)
Opioid use	Baseline to 9 months	Opioid use will be assessed by triangulating EHR data from the pharmacy data transaction service (PDTS) with real-time self-reports using a smartphone-enabled daily diary and retrospective reports with the validated Timeline Followback procedure.
Opioid misuse	Baseline to 9 months	Current Opioid Misuse Measure (0 to 68, higher scores indicating higher opioid misuse)
Distress	Baseline to 9 months	Depression Anxiety and Stress Scale (range from 0 to 63, higher scores indicating worse distress)
Health-related quality of life	Baseline to 9 months	EuroQol EQ-5D (1 to 5, with higher scores indicating lower quality of life)

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States