Effective Self-Management of Chronic Pain With mHealth Neurofeedback

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to learn more about improving the quality of treatments for people who have chronic low back pain. Participants will complete interviews with Duke researchers at four different time points: the beginning of the study, at 3 months, at 6 months, and at 9 months. Participants will be asked to use a mobile app and a headset that are designed to train the brain to be more relaxed. Participants will use the mobile app for 10 minutes at a time, four times a week for three months. The study team will also check in with participants about app use six times throughout the study, via phone or video conference.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• Responding greater than 3 months to How long has low back pain been an ongoing problem for you?

• Responding 'at least half the days' to How often has low back pain been an ongoing problem for you over the past 6 months?

⁃ Investigators will follow recommendations to items and responses provided by the NIH Task Force on Research Standards for Chronic Low Back Pain, which specifically: recommended 2 questions to achieve the definition of chronic low back pain: (1) How long has back pain been an ongoing problem for you? (2) How often has low back pain been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1 and a response of 'at least half the days in the past 6 months' to question 2 would define chronic lower back pain.

Locations
United States
North Carolina
Duke University Medical Center, Department of Psychiatry
RECRUITING
Durham
Contact Information
Primary
Janequia Evans
DBHTL@duke.edu
919-681-1613
Backup
Betsy Serrano
DBHTL@duke.edu
919-681-1613
Time Frame
Start Date: 2023-10-02
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 150
Treatments
Experimental: Experimental Condition
Mobile Neurofeedback intervention arm
Placebo_comparator: Control Condition
Sham-control arm
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
Leads: Duke University

This content was sourced from clinicaltrials.gov