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Feasibility of Telehealth Mindfulness for Back Pain in the Emergency Department

Primary Purpose

Low Back Pain, Back Pain, Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth Mindfulness Program
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Back Pain focused on measuring Mindfulness, Telehealth, Mindfulness-based intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telehealth Mindfulness Program

Arm Description

Telehealth mindfulness sessions

Outcomes

Primary Outcome Measures

Feasibility - Recruitment
Proportion of eligible patients enrolled in study.
Feasibility - Retention
Proportion of enrolled participants who complete study.
Feasibility - Session attendance
Average number of sessions attended.

Secondary Outcome Measures

Patient satisfaction with treatment
Single item assessing satisfaction of overall results from telehealth mindfulness program.
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.
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.
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.
Self-reported opioid medication use
Average number of pills per day (name and dose specified) and covered to morphine equivalent dose.
Self-reported return visits to the emergency department
Single item assessing return visits to emergency department.

Full Information

First Posted
February 26, 2021
Last Updated
August 26, 2022
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04783532
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Difficulty with participant enrollment and intervention engagement.
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
August 5, 2021 (Actual)
Study Completion Date
August 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Back Pain, Pain, Chronic Low-back Pain
Keywords
Mindfulness, Telehealth, Mindfulness-based intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telehealth Mindfulness Program
Arm Type
Experimental
Arm Description
Telehealth mindfulness sessions
Intervention Type
Behavioral
Intervention Name(s)
Telehealth Mindfulness Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility - Recruitment
Description
Proportion of eligible patients enrolled in study.
Time Frame
3 months after discharge from emergency department
Title
Feasibility - Retention
Description
Proportion of enrolled participants who complete study.
Time Frame
3 months after discharge from the emergency department.
Title
Feasibility - Session attendance
Description
Average number of sessions attended.
Time Frame
3 months after discharge from the emergency department.
Secondary Outcome Measure Information:
Title
Patient satisfaction with treatment
Description
Single item assessing satisfaction of overall results from telehealth mindfulness program.
Time Frame
Baseline and 3 months after discharge from the emergency department.
Title
Patient Reported Outcomes Measurement Information System - Physical Function Short Form
Description
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.
Time Frame
Baseline and 3 months after discharge from the emergency department.
Title
Patient Reported Outcomes Measurement Information System - Pain Interference Short Form
Description
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.
Time Frame
Baseline and 3 months after discharge from the emergency department.
Title
Patient Reported Outcomes Measurement Information System - Pain Intensity
Description
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.
Time Frame
Baseline and 3 months after discharge from the emergency department.
Title
Self-reported opioid medication use
Description
Average number of pills per day (name and dose specified) and covered to morphine equivalent dose.
Time Frame
Baseline and 3 months after discharge from the emergency department.
Title
Self-reported return visits to the emergency department
Description
Single item assessing return visits to emergency department.
Time Frame
3 months after discharge from the emergency department.
Other Pre-specified Outcome Measures:
Title
Five Facet Mindfulness Questionnaire - 15
Description
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.
Time Frame
Baseline and 3 months after discharge from the emergency department.
Title
Pain Catastrophizing Scale
Description
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.
Time Frame
Baseline and 3 months after discharge from the emergency department.
Title
Pain Self-Efficacy Questionnaire
Description
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.
Time Frame
Baseline and 3 months after discharge from the emergency department.
Title
Patient Reported Outcomes Measurement Information System - Depression Short Form
Description
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.
Time Frame
Baseline and 3 months after discharge from the emergency department.
Title
Patient Reported Outcomes Measurement Information System - Anxiety Short Form
Description
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.
Time Frame
Baseline and 3 months after discharge from the emergency department.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rogelio Coronado, PT, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristin Archer, PhD, DPT
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sean Collins, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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Feasibility of Telehealth Mindfulness for Back Pain in the Emergency Department

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