Clinical trial NCT05050409: SMART Embedded Intervention for Military Postsurgical Engagement Readiness
Official title: SMART Embedded Intervention for Military Postsurgical Engagement Readiness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Pain Chronic
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: The Geneva Foundation
First posted: 2021-09-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Our design is a sequential multiple randomization (SMART) study design with 2 treatment phases with a possibility of 2 randomizations per participant.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index
timeFrame: Baseline to 9 months
Secondary outcomes:
measure: Opioid use
timeFrame: Baseline to 9 months
measure: Distress
timeFrame: Baseline to 9 months
measure: Defense and Veterans Pain Rating Scale
timeFrame: Baseline to 9 months
measure: Opioid misuse
timeFrame: Baseline to 9 months
measure: Health-related quality of life
timeFrame: Baseline to 9 months
Other outcomes:
measure: Perceived ability to return to duty
timeFrame: Baseline to 9 months
measure: Pleasant body sensations
timeFrame: Baseline to 9 months
measure: Self-transcendence
timeFrame: Baseline to 9 months
measure: Positive affect
timeFrame: Baseline to 9 months
measure: Mindful reinterpretation of pain sensations
timeFrame: Baseline to 9 months
measure: Heart rate variability
timeFrame: Baseline,1 month, 3 months
measure: Trait mindfulness
timeFrame: Baseline to 9 months
measure: Cognitive reappraisal
timeFrame: Baseline to 9 months
measure: Savoring natural rewards
timeFrame: Baseline to 9 months
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
References: