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NCT Number: NCT05050409

SMART Embedded Intervention for Military Postsurgical Engagement Readiness

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).

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Key information

Conditions

Knee Pain Chronic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location status: Recruiting

Location contact

Tina Greenlee

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index

    Time frame: Baseline to 9 months

    Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index (min 0, max 240, with higher scores indicating worse osteoarthritis).

Secondary outcomes

  1. Opioid use

    Time frame: 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.

  2. Distress

    Time frame: Baseline to 9 months

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

  3. Defense and Veterans Pain Rating Scale

    Time frame: 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)

  4. Opioid misuse

    Time frame: Baseline to 9 months

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

  5. Health-related quality of life

    Time frame: Baseline to 9 months

    EuroQol EQ-5D (1 to 5, with higher scores indicating lower quality of life)

Other outcomes

  1. Perceived ability to return to duty

    Time frame: Baseline to 9 months

    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)

  2. Pleasant body sensations

    Time frame: Baseline to 9 months

    Pleasant sensation ratio as measured by Sensation Manikin, a measure comprised of a visual body map to demonstrate the location and distribution of sensations.

  3. Self-transcendence

    Time frame: Baseline to 9 months

    Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65)

  4. Positive affect

    Time frame: Baseline to 9 months

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

  5. Mindful reinterpretation of pain sensations

    Time frame: Baseline to 9 months

    Mindful reinterpretation of pain sensations (min 0, max 54, with higher scores indicating greater mindful reappraisal of pain)

  6. Heart rate variability

    Time frame: Baseline,1 month, 3 months

    Change in HRV (mindfulness - resting baseline, higher values representing more HRV)

  7. Trait mindfulness

    Time frame: Baseline to 9 months

    Five Facet Mindfulness Questionnaire (min 39, max 195, higher scores indicating greater mindfulness)

  8. Cognitive reappraisal

    Time frame: Baseline to 9 months

    Reappraisal subscale of the Cognitive Emotion Regulation Questionnaire (min 4, max 20, higher scores indicating more reappraisal)

  9. Savoring natural rewards

    Time frame: Baseline to 9 months

    Brief savoring inventory (min 4, max 20, higher scores indicating more savoring)

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Mayhew

CONTACT

[email protected]

253.968.2911

Tina Greenlee

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • The Geneva Foundation

Registry information

Acronym: SEMPER

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 20, 2021
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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