Feasibility of Telehealth Mindfulness for Back Pain in the Emergency Department

Study Overview
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Brief Summary
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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

Official Title
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Feasibility and Acceptability of a Telehealth Mindfulness Intervention to Improve Outcomes of Patients With an Acute Exacerbation of Chronic Back Pain Presenting to the Emergency Department

Conditions
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Low Back Pain, Back Pain, Pain, Chronic Low-back Pain

Intervention / Treatment
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* Behavioral: Telehealth Mindfulness Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older; Presenting to the emergency department to address a chief complaint of an acute exacerbation of chronic low back pain; Meets NIH-supported definition of chronic low back pain (e.g., pain greater than 3 months that has resulted in pain on at least half the days in the past 6 months); and English-speaking due to feasibility of utilizing a telehealth mindfulness program developed in English Exclusion Criteria: Patients requiring hospitalization for a medical severe condition or comorbidity; Patients with a severe psychiatric or behavioral diagnosis or presenting symptoms, including psychosis, delirium, active suicidal ideation, or who screen positive on the Columbia Suicide Screening; Patients with a history of multiple substance use or abuse; Patients involved in litigation related to the chronic pain condition; and Patients who are unable to comply with the telehealth intervention (i.e., unable to provide stable home address or access telehealth link on a mobile device or computer).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth Mindfulness Program<br>Telehealth mindfulness sessions | Behavioral: Telehealth Mindfulness Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Telehealth, Mindfulness-based intervention