NCT05050409 SMART Embedded Intervention for Military Postsurgical Engagement Readiness
| NCT ID | NCT05050409 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | Knee Pain Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2022-05-01 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05050409 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Pain Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05050409 currently recruiting?
Yes, NCT05050409 is actively recruiting participants. Contact the research team at rachel.j.mayhew.ctr@mail.mil for enrollment information.
Where is the NCT05050409 trial being conducted?
This trial is being conducted at Fort Sam Houston, United States.
Who is sponsoring the NCT05050409 clinical trial?
NCT05050409 is sponsored by University of Utah. The trial plans to enroll 500 participants.