SMART Embedded Intervention for Military Postsurgical Engagement Readiness

Status: Recruiting

Location: See location...

Intervention Type: Behavioral, Other

Study Type: Interventional

Study Phase: Not Applicable

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

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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.

Locations

United States

Texas

Brooke Army Medical Center

RECRUITING

Fort Sam Houston

Contact Information

Primary

Rachel Mayhew

rachel.j.mayhew.ctr@mail.mil

253.968.2911

Backup

Tina Greenlee

tgreenlee@genevausa.org

Time Frame

Start Date: 2022-05-01

Estimated Completion Date: 2027-10

Participants

Target number of participants: 500

Treatments

Experimental: 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.

Experimental: 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.

Experimental: 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.

Experimental: 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.

Related Therapeutic Areas

Chronic Pain

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