SMART Embedded Intervention for Military Postsurgical Engagement Readiness

ConditionKnee Pain Chronic

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Utah

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

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.
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.
Standard care
Other intervention
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.

Treatment groups

500 Participants

are divided into 4 treatment groups

Group A: Brief mindfulness followed by brief mindfulness for non-respondersExperimental treatment 1 intervention

Group B: Standard care followed by brief mindfulness for non-respondersExperimental treatment 2 interventions

Group C: Brief mindfulness followed by MORE for non-respondersExperimental treatment 2 interventions

Group D: Standard care followed by MORE for non-respondersExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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).

Time frame

Baseline to 9 months

Secondary outcomes

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.

Time frame

Baseline to 9 months

Distress

Depression Anxiety and Stress Scale (range from 0 to 63, higher scores indicating worse distress)

Time frame

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)

Time frame

Baseline to 9 months

Opioid misuse

Current Opioid Misuse Measure (0 to 68, higher scores indicating higher opioid misuse)

Time frame

Baseline to 9 months

Other outcomes

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)

Time frame

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.

Time frame

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)

Time frame

Baseline to 9 months

Positive affect

Positive affect measured by numeric rating scale, with higher scores indicating higher positive affect (min 0, max 10)

Time frame

Baseline to 9 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

The Geneva Foundation

Collaborator

Source ClinicalTrials.gov

Apply now