SMART Embedded Intervention for Military Postsurgical Engagement Readiness

Knee Pain Chronic Clinical Trial

— SEMPER  

Official title:

SMART Embedded Intervention for Military Postsurgical Engagement Readiness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050409
• Other study ID #: DOD02
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: October 2025

Study information

• Verified date: July 2022
• Source: University of Utah
• Contact: Rachel Mayhew
• Phone: 253.968.2911
• Email: rachel.j.mayhew.ctr[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Pain Chronic

Intervention

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.
• 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, 3-6 months, and yearly.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Geneva Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Positive affect	Positive affect measured by numeric rating scale, with higher scores indicating higher positive affect (min 0, max 10)	Baseline to 9 months
Other	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
Other	Heart rate variability	Change in HRV (mindfulness - resting baseline, higher values representing more HRV)	Baseline,1 month, 3 months
Other	Trait mindfulness	Five Facet Mindfulness Questionnaire (min 39, max 195, higher scores indicating greater mindfulness)	Baseline to 9 months
Other	Cognitive reappraisal	Reappraisal subscale of the Cognitive Emotion Regulation Questionnaire (min 4, max 20, higher scores indicating more reappraisal)	Baseline to 9 months
Other	Savoring natural rewards	Brief savoring inventory (min 4, max 20, higher scores indicating more savoring)	Baseline to 9 months
Primary	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	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
Secondary	Distress	Depression Anxiety and Stress Scale (range from 0 to 63, higher scores indicating worse distress)	Baseline to 9 months
Secondary	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
Secondary	Opioid misuse	Current Opioid Misuse Measure (0 to 68, higher scores indicating higher opioid misuse)	Baseline to 9 months
Secondary	Health-related quality of life	EuroQol EQ-5D (1 to 5, with higher scores indicating lower quality of life)	Baseline to 9 months