Feasibility of Telehealth Mindfulness for Back Pain in the Emergency Department

Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04783532
• Other study ID #: 202543
• Status: Terminated
• Phase: N/A
• Start date: March 5, 2021
• Est. completion date: August 5, 2021

Study information

• Verified date: August 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 5, 2021
• Est. primary completion date: August 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Emergencies
• Low Back Pain
• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Primary	Feasibility - Recruitment	Proportion of eligible patients enrolled in study.	3 months after discharge from emergency department
Primary	Feasibility - Retention	Proportion of enrolled participants who complete study.	3 months after discharge from the emergency department.
Primary	Feasibility - Session attendance	Average number of sessions attended.	3 months after discharge from the emergency department.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Self-reported return visits to the emergency department	Single item assessing return visits to emergency department.	3 months after discharge from the emergency department.