Actively Recruiting
Home-based Mindfulness-based Meditation and Transcutaneous Auricular Vagus Nerve Stimulation for Older Adults With Low Back Pain and Depressive Symptoms
Led by Florida State University · Updated on 2026-03-25
66
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of home-based mindfulness-based meditation (MBM) and transcutaneous auricular vagus nerve stimulation (taVNS) on managing pain and depressive symptoms in community-dwelling older adults with chronic low back pain and depressive symptoms. This randomized controlled trial also investigates how these interventions affect the brain-gut axis in this population. Participants are assigned to one of two groups: one group practices MBM daily for 20 minutes, five days a week, over eight weeks. The other group receives a single daily session, five days a week, consisting of 20 minutes of taVNS immediately followed by 20 minutes of MBM, totaling about 40 minutes per session over the same eight-week period. Throughout the study, participants undergo assessments at the start, two weeks, and eight weeks to measure changes in pain intensity, pain interference, depressive symptoms, pain self-efficacy, sensory testing results, pain modulation, co-occurring symptoms, brain responses to pain, and gut microbiota diversity. The study includes questionnaires, quantitative sensory testing, and microbiota analysis to monitor these outcomes and understand the intervention effects.
CONDITIONS
Brief Title
MBM and taVNS for Low Back Pain and Depressive Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 50 to 85 years old
- Intact cognition with Mini-Mental State Exam score of 24 or higher
- Experiencing moderate low back pain daily or almost every day for at least the past three months (score 3 or higher on numeric rating scale)
- Elevated depressive symptoms with PHQ-9 score between 5 and 19
- Able to speak and read English
- No intent to change pain medication during the trial
You will not qualify if you...
- Serious underlying illness such as malignant neoplasms
- Diagnosis of psychosis
- Elevated suicide risk with Columbia-Suicide Severity Rating Scale score over 2
- Functional limitations that prevent meditation practice
- Prior participation in a meditation program
- Conditions that prohibit taVNS including 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for baseline assessments
Duration - 8 weeks
Participants receive home-based mindfulness-based meditation (MBM) or transcutaneous auricular vagus nerve stimulation (taVNS) combined with MBM sessions to manage low back pain and depressive symptoms.
Daily sessions, five days per week at home
Duration - Up to 8 weeks post-treatment start
Participants complete assessments of pain, depressive symptoms, and sensory testing at 2 weeks and 8 weeks to evaluate treatment effects.
3 visits (baseline, 2 weeks, and 8 weeks) including assessments
Trial Site Locations
Total: 1 location
1
Florida State University
Tallahassee, Florida, United States, 32306
Actively Recruiting
Research Team
J
Jie Chen
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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