Feasibility of Telehealth Mindfulness for Back Pain in the Emergency Department

NCT04783532 | Terminated

• 1 other identifier: 202543
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Low Back Pain; Back Pain; Pain; Chronic Low-back Pain

Keywords

Mindfulness; Telehealth; Mindfulness-based intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Patient satisfaction with treatment

  Baseline and 3 months after discharge from the emergency department.

• Patient Reported Outcomes Measurement Information System - Physical Function Short Form

  Baseline and 3 months after discharge from the emergency department.

• Patient Reported Outcomes Measurement Information System - Pain Interference Short Form

  Baseline and 3 months after discharge from the emergency department.

• Patient Reported Outcomes Measurement Information System - Pain Intensity

  Baseline and 3 months after discharge from the emergency department.

• Self-reported opioid medication use

  Baseline and 3 months after discharge from the emergency department.

Other Outcomes (5)

• Five Facet Mindfulness Questionnaire - 15

  Baseline and 3 months after discharge from the emergency department.

• Pain Catastrophizing Scale

  Baseline and 3 months after discharge from the emergency department.

• Pain Self-Efficacy Questionnaire

  Baseline and 3 months after discharge from the emergency department.

Study Arms (1)

Telehealth Mindfulness Program

EXPERIMENTAL

Telehealth mindfulness sessions

Behavioral: Telehealth Mindfulness Program

Interventions

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.

Telehealth Mindfulness Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Low Back Pain; Back Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 5, 2021
• Study Start: March 5, 2021
• Primary Completion: August 5, 2021
• Study Completion: August 5, 2021
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

US (1)