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| Name | Class |
|---|---|
| The Geneva Foundation | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief mindfulness followed by brief mindfulness for non-responders | Experimental | 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. |
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| Standard care followed by brief mindfulness for non-responders | Experimental | 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. |
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| Brief mindfulness followed by MORE for non-responders | Experimental | 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. |
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| Standard care followed by MORE for non-responders | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief mindfulness | Behavioral | A 15-minute guided mindfulness practice that includes focused attention on breath and body sensations and open monitoring and acceptance of thoughts, emotions, and pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index | Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index (min 0, max 240, with higher scores indicating worse osteoarthritis). | Baseline to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid use | Opioid use will be assessed by triangulating EHR data from the pharmacy data transaction service (PDTS) with real-time self-reports using a smartphone-enabled daily diary and retrospective reports with the validated Timeline Followback procedure. | Baseline to 9 months |
| Distress |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived ability to return to duty | 3 questions assessing a service member's self-perceived ability to perform military related tasks (pass a required semi-annual physical fitness test, operate under full combat load, and % mission capability) | Baseline to 9 months |
| Pleasant body sensations |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Mayhew | Contact | 253.968.2911 | rachel.j.mayhew.ctr@mail.mil | |
| Tina Greenlee | Contact | tgreenlee@genevausa.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | Recruiting | Fort Sam Houston | Texas | 78234 | United States |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Our design is a sequential multiple randomization (SMART) study design with 2 treatment phases with a possibility of 2 randomizations per participant.
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| Mindfulness-Oriented Recovery Enhancement (MORE) | Behavioral | An 8-session intervention. Sessions involve: 1) mindfulness training to reduce pain and increase self-regulation over opioid use, 2) cognitive reappraisal to decrease psychological distress, and 3) savoring to augment natural reward processing, positive emotion, and esprit de corps. |
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| Standard care | Other | Preoperative Standard Care. Patients will attend a 2-hour preoperative class involving pain coping education and are offered prehabilitation services. Postoperative standard care includes (1) pain medications to minimize opioid use, including acetaminophen, lyrica, meloxicam/naproxen and celebrex, and (2) anticoagulants for 3-6 weeks postoperatively, as well as (3) ambulatory care with assistive devices 1-6 weeks after surgery. Patients see their surgeon postoperatively 2-6 weeks after surgery, 3-6 months, and yearly. |
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Depression Anxiety and Stress Scale (range from 0 to 63, higher scores indicating worse distress) |
| Baseline to 9 months |
| Defense and Veterans Pain Rating Scale | Defense and Veterans Pain Rating Scale, a numeric rating scale enhanced by word descriptors, color coding, and pictorial facial expressions matched to pain levels (0 to 10, higher scores indicating worse pain) | Baseline to 9 months |
| Opioid misuse | Current Opioid Misuse Measure (0 to 68, higher scores indicating higher opioid misuse) | Baseline to 9 months |
| Health-related quality of life | EuroQol EQ-5D (1 to 5, with higher scores indicating lower quality of life) | Baseline to 9 months |
Pleasant sensation ratio as measured by Sensation Manikin, a measure comprised of a visual body map to demonstrate the location and distribution of sensations. |
| Baseline to 9 months |
| Self-transcendence | Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65) | Baseline to 9 months |
| Positive affect | Positive affect measured by numeric rating scale, with higher scores indicating higher positive affect (min 0, max 10) | Baseline to 9 months |
| Mindful reinterpretation of pain sensations | Mindful reinterpretation of pain sensations (min 0, max 54, with higher scores indicating greater mindful reappraisal of pain) | Baseline to 9 months |
| Heart rate variability | Change in HRV (mindfulness - resting baseline, higher values representing more HRV) | Baseline,1 month, 3 months |
| Trait mindfulness | Five Facet Mindfulness Questionnaire (min 39, max 195, higher scores indicating greater mindfulness) | Baseline to 9 months |
| Cognitive reappraisal | Reappraisal subscale of the Cognitive Emotion Regulation Questionnaire (min 4, max 20, higher scores indicating more reappraisal) | Baseline to 9 months |
| Savoring natural rewards | Brief savoring inventory (min 4, max 20, higher scores indicating more savoring) | Baseline to 9 months |