SMART Embedded Intervention for Military Postsurgical Engagement Readiness (SEMPER)

Utah System of Higher Education (USHE)

Status: Enrolling

Conditions: Knee Pain Chronic

Treatments: Other: Standard care; Behavioral: Brief mindfulness; Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)

Study type: Interventional

Funder types: Other

Identifiers

NCT05050409

DOD02

Details and patient eligibility

About

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).

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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500 participants in 4 patient groups

Brief mindfulness followed by brief mindfulness for non-responders

Experimental group

Description:

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.

Treatment:

Behavioral: Brief mindfulness

Standard care followed by brief mindfulness for non-responders

Experimental group

Description:

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.

Treatment:

Other: Standard care

Behavioral: Brief mindfulness

Brief mindfulness followed by MORE for non-responders

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)

Behavioral: Brief mindfulness

Standard care followed by MORE for non-responders

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)

Other: Standard care