Feasibility of Telehealth Mindfulness for Back Pain in the Emergency Department

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

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

Study Overview

• Status: Terminated
• Conditions: Pain; Back Pain; Low Back Pain; Chronic Low-back Pain
• Intervention / Treatment: Behavioral: Telehealth Mindfulness Program

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 years or older;
2. Presenting to the emergency department to address a chief complaint of an acute exacerbation of chronic low back pain;
3. 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
4. English-speaking due to feasibility of utilizing a telehealth mindfulness program developed in English

Exclusion Criteria:

1. Patients requiring hospitalization for a medical severe condition or comorbidity;
2. 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;
3. Patients with a history of multiple substance use or abuse;
4. Patients involved in litigation related to the chronic pain condition; and
5. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Telehealth Mindfulness Program; Telehealth mindfulness sessions

Behavioral: Telehealth Mindfulness Program; 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.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Rogelio Coronado, PT, PhD, Vanderbilt University Medical Center; Study Director: Kristin Archer, PhD, DPT, Vanderbilt University Medical Center; Study Director: Sean Collins, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2021
• Primary Completion (ACTUAL): August 5, 2021
• Study Completion (ACTUAL): August 5, 2021

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (ACTUAL): March 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Mindfulness; Telehealth; Mindfulness-based intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Back Pain; Low Back Pain
• Other Study ID Numbers: 202543

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No