Clinical trial NCT04783532: Feasibility of Telehealth Mindfulness for Back Pain in the Emergency Department
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Low Back Pain
Back Pain
Pain
Chronic Low-back Pain
Keywords: Mindfulness
Telehealth
Mindfulness-based intervention
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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


Eligibility criteria: 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).

Primary outcomes:
measure: Feasibility - Recruitment
timeFrame: 3 months after discharge from emergency department
measure: Feasibility - Retention
timeFrame: 3 months after discharge from the emergency department.
measure: Feasibility - Session attendance
timeFrame: 3 months after discharge from the emergency department.
Secondary outcomes:
measure: Patient satisfaction with treatment
timeFrame: Baseline and 3 months after discharge from the emergency department.
measure: Patient Reported Outcomes Measurement Information System - Physical Function Short Form
timeFrame: Baseline and 3 months after discharge from the emergency department.
measure: Patient Reported Outcomes Measurement Information System - Pain Interference Short Form
timeFrame: Baseline and 3 months after discharge from the emergency department.
measure: Patient Reported Outcomes Measurement Information System - Pain Intensity
timeFrame: Baseline and 3 months after discharge from the emergency department.
measure: Self-reported opioid medication use
timeFrame: Baseline and 3 months after discharge from the emergency department.
measure: Self-reported return visits to the emergency department
timeFrame: 3 months after discharge from the emergency department.
Other outcomes:
measure: Five Facet Mindfulness Questionnaire - 15
timeFrame: Baseline and 3 months after discharge from the emergency department.
measure: Pain Catastrophizing Scale
timeFrame: Baseline and 3 months after discharge from the emergency department.
measure: Pain Self-Efficacy Questionnaire
timeFrame: Baseline and 3 months after discharge from the emergency department.
measure: Patient Reported Outcomes Measurement Information System - Depression Short Form
timeFrame: Baseline and 3 months after discharge from the emergency department.
measure: Patient Reported Outcomes Measurement Information System - Anxiety Short Form
timeFrame: Baseline and 3 months after discharge from the emergency department.
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Rogelio Coronado, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Kristin Archer, PhD, DPT
role: STUDY_DIRECTOR
affiliation: Vanderbilt University Medical Center
name: Sean Collins, MD
role: STUDY_DIRECTOR
References: