Actively Recruiting

Phase Not Applicable
Age: 50Years - 85Years
All Genders
NCT07415941

MBM and taVNS for Low Back Pain and Depressive Symptoms

Led by Florida State University · Updated on 2026-03-25

66

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This two-arm randomized controlled trial aims to test the preliminary effect of home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation on managing pain and depressive symptoms among community-dwelling older adults with chronic low back pain and depressive symptoms; and the effect of home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation on the host Brain-Gut Axis.

CONDITIONS

Official Title

MBM and taVNS for Low Back Pain and Depressive Symptoms

Who Can Participate

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 50 to 85 years old
  • Intact cognition with Mini-Mental State Exam score of 24 or higher
  • Moderate low back pain daily or almost daily for at least 3 months with a pain score of 3 or higher
  • Elevated depressive symptoms with Patient Health Questionnaire (PHQ-9) score between 5 and 19
  • Able to speak and read English
  • No intention to change pain medication during the trial
Not Eligible

You will not qualify if you...

  • Serious underlying illnesses like malignant neoplasms
  • Presence of other psychosis
  • Elevated suicide risk with Columbia-Suicide Severity Rating Scale score greater than 2
  • Functional limitations preventing meditation practice
  • Previous participation in meditation programs
  • Conditions prohibiting taVNS such as cardiovascular disorders, recent ear trauma, or metal implants above the neck
  • No access to the internet

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Florida State University

Tallahassee, Florida, United States, 32306

Actively Recruiting

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Research Team

J

Jie Chen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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