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Clinical Trial Summary

The purpose of this research study is to see if breathing and attention training (BAT) treatments improve pain symptoms and well-being in people who have chronic low back pain (cLBP). For this breathing intervention, you will be randomly assigned to either standard or focused BAT. The standard BAT includes instructions on deep breathing and relaxation. The focused BAT is similar to the standard BAT in most ways but includes extra instructions to help you focus and alter your breathing patterns.


Clinical Trial Description

The primary objective of the proposed pilot randomized controlled trial (RCT) is to examine the safety, feasibility, and acceptability of a 5-day breathing and attention training (BAT) in a sample of 30 adults with cLBP. The secondary objective is to explore preliminary clinical efficacy and potential mechanisms of the breathing interventions (focused-BAT and standard-BAT), by examining changes in clinical pain outcomes and potential pain-related psychological, physiological, and behavioral mediating variables. Both interventions will be delivered via an audio recording in order to standardize the interventions across participants and to enhance treatment fidelity. Results from this study will inform the successful design and implementation of a larger RCT and provide preliminary evidence regarding the potential efficacy of this breathing intervention for people with cLBP. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04740710
Study type Interventional
Source University of Florida
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 18, 2021
Completion date January 1, 2023

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