SMART Embedded Intervention for Military Postsurgical Engagement Readiness (SEMPER)

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 Overview

• Status: Recruiting
• Conditions: Knee Pain Chronic
• Intervention / Treatment: Behavioral: Brief mindfulness; Other: Standard care; Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Mayhew; Phone Number: 253.968.2911; Email: rachel.j.mayhew.ctr@mail.mil
• Study Contact Backup: Name: Tina Greenlee; Email: tgreenlee@genevausa.org

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Recruiting
      • Brooke Army Medical Center
      • Contact: Tina Greenlee; Email: Ttgreenlee@genevausa.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief mindfulness followed by brief mindfulness for non-responders; 1 session of brief mindfulness, plus standard of care. At the one-month post-surgical follow-up, non-responders will receive another single session of brief mindfulness. Responders will continue to receive standard of care.	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.
Experimental: Standard care followed by brief mindfulness for non-responders; Patients will attend a 2-hour preoperative class involving pain coping education and are offered prehabilitation services. At the one-month post-surgical follow-up, non-responders will receive one session of brief mindfulness. Responders will continue to receive standard of care.	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.; 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, 3-6 months, and yearly.
Experimental: Brief mindfulness followed by MORE for non-responders; 1 session of brief mindfulness, plus standard of care. At the one-month post-surgical follow-up, non-responders will receive the 8 session MORE intervention. Responders will continue to receive standard of care.	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.
Experimental: Standard care followed by MORE for non-responders; Patients will attend a 2-hour preoperative class involving pain coping education and are offered prehabilitation services. At the one-month post-surgical follow-up, non-responders will receive the 8 session MORE intervention. Responders will continue to receive standard of care.	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, 3-6 months, and yearly.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index	Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index (min 0, max 240, with higher scores indicating worse osteoarthritis).	Baseline to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid use	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.	Baseline to 9 months
Distress	Depression Anxiety and Stress Scale (range from 0 to 63, higher scores indicating worse distress)	Baseline to 9 months
Defense and Veterans Pain Rating Scale	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)	Baseline to 9 months
Opioid misuse	Current Opioid Misuse Measure (0 to 68, higher scores indicating higher opioid misuse)	Baseline to 9 months
Health-related quality of life	EuroQol EQ-5D (1 to 5, with higher scores indicating lower quality of life)	Baseline to 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived ability to return to duty	3 questions assessing a service member's self-perceived ability to perform military related tasks (pass a required semi-annual physical fitness test, operate under full combat load, and % mission capability)	Baseline to 9 months
Pleasant body sensations	Pleasant sensation ratio as measured by Sensation Manikin, a measure comprised of a visual body map to demonstrate the location and distribution of sensations.	Baseline to 9 months
Self-transcendence	Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65)	Baseline to 9 months
Positive affect	Positive affect measured by numeric rating scale, with higher scores indicating higher positive affect (min 0, max 10)	Baseline to 9 months
Mindful reinterpretation of pain sensations	Mindful reinterpretation of pain sensations (min 0, max 54, with higher scores indicating greater mindful reappraisal of pain)	Baseline to 9 months
Heart rate variability	Change in HRV (mindfulness - resting baseline, higher values representing more HRV)	Baseline,1 month, 3 months
Trait mindfulness	Five Facet Mindfulness Questionnaire (min 39, max 195, higher scores indicating greater mindfulness)	Baseline to 9 months
Cognitive reappraisal	Reappraisal subscale of the Cognitive Emotion Regulation Questionnaire (min 4, max 20, higher scores indicating more reappraisal)	Baseline to 9 months
Savoring natural rewards	Brief savoring inventory (min 4, max 20, higher scores indicating more savoring)	Baseline to 9 months

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: The Geneva Foundation

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: DOD02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No