SMART Embedded Intervention for Military Postsurgical Engagement Readiness
- Conditions
- Knee Pain Chronic
- Interventions
- Behavioral: Brief mindfulnessOther: Standard careBehavioral: Mindfulness-Oriented Recovery Enhancement (MORE)
- Registration Number
- NCT05050409
- Lead Sponsor
- University of Utah
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Standard care followed by MORE for non-responders Standard care 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. Brief mindfulness followed by brief mindfulness for non-responders Brief mindfulness 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. Standard care followed by brief mindfulness for non-responders Standard care 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. Brief mindfulness followed by MORE for non-responders Mindfulness-Oriented Recovery Enhancement (MORE) 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. Standard care followed by brief mindfulness for non-responders Brief mindfulness 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. Brief mindfulness followed by MORE for non-responders Brief mindfulness 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. Standard care followed by MORE for non-responders Mindfulness-Oriented Recovery Enhancement (MORE) 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.
- Primary Outcome Measures
Name Time Method Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index Baseline to 9 months Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index (min 0, max 240, with higher scores indicating worse osteoarthritis).
- Secondary Outcome Measures
Name Time Method Defense and Veterans Pain Rating Scale 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)
Opioid use 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.
Opioid misuse Baseline to 9 months Current Opioid Misuse Measure (0 to 68, higher scores indicating higher opioid misuse)
Distress Baseline to 9 months Depression Anxiety and Stress Scale (range from 0 to 63, higher scores indicating worse distress)
Health-related quality of life Baseline to 9 months EuroQol EQ-5D (1 to 5, with higher scores indicating lower quality of life)
Trial Locations
- Locations (1)
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States