SMART Embedded Intervention for Military Postsurgical Engagement Readiness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Utah
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Brief mindfulness followed by brief mindfulness for non-responders
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.
Intervention: Brief mindfulness (Behavioral)
Standard care followed by brief mindfulness for non-responders
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.
Intervention: Brief mindfulness (Behavioral)
Standard care followed by brief mindfulness for non-responders
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.
Intervention: Standard care (Other)
Brief mindfulness followed by MORE for non-responders
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.
Intervention: Brief mindfulness (Behavioral)
Brief mindfulness followed by MORE for non-responders
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.
Intervention: Mindfulness-Oriented Recovery Enhancement (MORE) (Behavioral)
Standard care followed by MORE for non-responders
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.
Intervention: Mindfulness-Oriented Recovery Enhancement (MORE) (Behavioral)
Standard care followed by MORE for non-responders
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.
Intervention: Standard care (Other)
Outcomes
Primary Outcomes
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
- Defense and Veterans Pain Rating Scale(Baseline to 9 months)
- Opioid use(Baseline to 9 months)
- Opioid misuse(Baseline to 9 months)
- Distress(Baseline to 9 months)
- Health-related quality of life(Baseline to 9 months)
Investigators
Eric Garland
Distinguished Professor
University of Utah