Feasibility of Telehealth Mindfulness for Back Pain in the Emergency Department

August 26, 2022 updated by: Rogelio Coronado, Vanderbilt University Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility - Recruitment
Time Frame: 3 months after discharge from emergency department
Proportion of eligible patients enrolled in study.
3 months after discharge from emergency department
Feasibility - Retention
Time Frame: 3 months after discharge from the emergency department.
Proportion of enrolled participants who complete study.
3 months after discharge from the emergency department.
Feasibility - Session attendance
Time Frame: 3 months after discharge from the emergency department.
Average number of sessions attended.
3 months after discharge from the emergency department.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction with treatment
Time Frame: Baseline and 3 months after discharge from the emergency department.
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
Time Frame: Baseline and 3 months after discharge from the emergency department.
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
Time Frame: Baseline and 3 months after discharge from the emergency department.
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
Time Frame: Baseline and 3 months after discharge from the emergency department.
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
Time Frame: Baseline and 3 months after discharge from the emergency department.
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
Time Frame: 3 months after discharge from the emergency department.
Single item assessing return visits to emergency department.
3 months after discharge from the emergency department.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Five Facet Mindfulness Questionnaire - 15
Time Frame: Baseline and 3 months after discharge from the emergency department.
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
Time Frame: Baseline and 3 months after discharge from the emergency department.
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
Time Frame: Baseline and 3 months after discharge from the emergency department.
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
Time Frame: Baseline and 3 months after discharge from the emergency department.
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
Time Frame: Baseline and 3 months after discharge from the emergency department.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 5, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings