SMART Embedded Intervention for Military Postsurgical Engagement Readiness

Overview

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).

Interventions

• 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,

Primary outcome measures

• Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index [Time frame: Baseline to 9 months]

Secondary outcome measures (5)

• Opioid use [Time frame: Baseline to 9 months]
• Distress [Time frame: Baseline to 9 months]
• Defense and Veterans Pain Rating Scale [Time frame: Baseline to 9 months]
• Opioid misuse [Time frame: Baseline to 9 months]
• Health-related quality of life [Time frame: Baseline to 9 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Brooke Army Medical Center — Fort Sam Houston

Identifiers

NCT: NCT05050409 · DOD02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗