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Difficulty with participant enrollment and intervention engagement.
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While guideline-directed nonpharmacological strategies for chronic low back pain are well established, optimal chronic pain management for emergency department patients has yet to be defined. Mindfulness interventions can be used for management of chronic conditions, yet are understudied as a primary approach for patients with chronic pain discharged from the emergency department. Currently, there is limited evidence examining whether an individual telehealth mindfulness intervention is a feasible and acceptable for these patients. This study will develop, pilot, and evaluate the feasibility and effects of an 8-session (12-week) telehealth mindfulness intervention for patients with an acute exacerbation of chronic low back pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth Mindfulness Program | Experimental | Telehealth mindfulness sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth Mindfulness Program | Behavioral | Enrolled participants will participate in an individual (one-on-one) Telehealth-delivered (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight sessions lasting 75 minutes each (except the first session which lasts 90 minutes) over a 3-month period. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Recruitment | Proportion of eligible patients enrolled in study. | 3 months after discharge from emergency department |
| Feasibility - Retention | Proportion of enrolled participants who complete study. | 3 months after discharge from the emergency department. |
| Feasibility - Session attendance | Average number of sessions attended. | 3 months after discharge from the emergency department. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with treatment | Single item assessing satisfaction of overall results from telehealth mindfulness program. | Baseline and 3 months after discharge from the emergency department. |
| Patient Reported Outcomes Measurement Information System - Physical Function Short Form |
| Measure | Description | Time Frame |
|---|---|---|
| Five Facet Mindfulness Questionnaire - 15 | 15-item questionnaire assessing 5 facets of mindfulness (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience). Facet scores range from 3 to 15. A higher score indicates higher level of mindfulness, a better outcome. | Baseline and 3 months after discharge from the emergency department. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rogelio Coronado, PT, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Kristin Archer, PhD, DPT | Vanderbilt University Medical Center | Study Director |
| Sean Collins, MD | Vanderbilt University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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4-item physical function short form from the 29-item Patient Reported Outcomes Measurement Information System scale. Total raw scores range from 4 to 20. A higher score indicates higher physical function, a better outcome. |
| Baseline and 3 months after discharge from the emergency department. |
| Patient Reported Outcomes Measurement Information System - Pain Interference Short Form | 4-item pain interference short form from the 29-item Patient Reported Outcomes Measurement Information System scale. Total raw scores range from 4 to 20. A lower score indicates lower pain interference, a better outcome. | Baseline and 3 months after discharge from the emergency department. |
| Patient Reported Outcomes Measurement Information System - Pain Intensity | Single item from the 29-item Patient Reported Outcomes Measurement Information System scale assessing average pain intensity over the past 7 days rated on a 0 to 10 scale, with lower values indicates less pain, a better outcome. | Baseline and 3 months after discharge from the emergency department. |
| Self-reported opioid medication use | Average number of pills per day (name and dose specified) and covered to morphine equivalent dose. | Baseline and 3 months after discharge from the emergency department. |
| Self-reported return visits to the emergency department | Single item assessing return visits to emergency department. | 3 months after discharge from the emergency department. |
| Pain Catastrophizing Scale | 13-item questionnaire assessing thoughts and feeling when in pain. Total scores range from 0 to 52. A lower score indicates lower pain catastrophizing, a better outcome. | Baseline and 3 months after discharge from the emergency department. |
| Pain Self-Efficacy Questionnaire | 10-item questionnaire assessing confidence in ability to do certain things despite pain. Total scores range from 0 to 60. A higher score indicates higher pain self-efficacy, a better outcome. | Baseline and 3 months after discharge from the emergency department. |
| Patient Reported Outcomes Measurement Information System - Depression Short Form | 4-item depression short form from the 29-item Patient Reported Outcomes Measurement Information System scale. Total raw scores range from 4 to 20. A lower score indicates lower depression, a better outcome. | Baseline and 3 months after discharge from the emergency department. |
| Patient Reported Outcomes Measurement Information System - Anxiety Short Form | 4-item anxiety short form from the 29-item Patient Reported Outcomes Measurement Information System scale. Total raw scores range from 4 to 20. A lower score indicates lower anxiety, a better outcome. | Baseline and 3 months after discharge from the emergency department. |