SMART Embedded Intervention for Military Postsurgical Engagement Readiness

NCT05050409 | Recruiting

• 1 other identifier: DOD02
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Pain Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Opioid use

  Baseline to 9 months

• Distress

  Baseline to 9 months

• Defense and Veterans Pain Rating Scale

  Baseline to 9 months

• Opioid misuse

  Baseline to 9 months

• Health-related quality of life

  Baseline to 9 months

Other Outcomes (9)

• Perceived ability to return to duty

  Baseline to 9 months

• Pleasant body sensations

  Baseline to 9 months

• Self-transcendence

  Baseline to 9 months

Study Arms (4)

Brief mindfulness followed by brief mindfulness for non-responders

EXPERIMENTAL

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

Standard care followed by brief mindfulness for non-responders

EXPERIMENTAL

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; Other: Standard care

Brief mindfulness followed by MORE for non-responders

EXPERIMENTAL

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; Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)

Standard care followed by MORE for non-responders

EXPERIMENTAL

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.

Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE); Other: Standard care

Interventions

Brief mindfulness BEHAVIORAL

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.

Brief mindfulness followed by MORE for non-responders; Brief mindfulness followed by brief mindfulness for non-responders; Standard care followed by brief mindfulness for non-responders

Mindfulness-Oriented Recovery Enhancement (MORE) BEHAVIORAL

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.

Brief mindfulness followed by MORE for non-responders; Standard care followed by MORE for non-responders

Standard care OTHER

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.

Standard care followed by MORE for non-responders; Standard care followed by brief mindfulness for non-responders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• The Geneva Foundation: collaborator

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Rachel Mayhew

CONTACT

253.968.2911; rachel.j.mayhew.ctr@mail.mil

Tina Greenlee

CONTACT

tgreenlee@genevausa.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Model Details: Our design is a sequential multiple randomization (SMART) study design with 2 treatment phases with a possibility of 2 randomizations per participant.

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 20, 2021
• Study Start: May 1, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

US (1)