Recruiting

Mindfulness & Stimulation

Sponsor:

Florida State University

Code:

NCT07415941

Conditions

Chronic Low Back Pain

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

MBM

VNSM

Study Details

Brief summary:

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

Chronic Low Back Pain

Study ID

NCT07415941

Start date

Jan 30, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. aged 50 to 85 years old
2. intact cognition (examined by the Mini-Mental State Exam, ≥ 24)
3. experiencing moderate low back pain daily or almost every day at least the previous three months (≥3 out of 10 on numeric rating scale \[NRS\])
4. experiencing elevated depressive symptoms with the patient health questionnaire (PHQ-9) total score ranging between 5 to 19
5. able to speak and read English
6. not intent to change medication regimens for pain throughout the trial.

Exclusion Criteria:

1. serious underlying illness (e.g., malignant neoplasms),
2. other psychosis,
3. elevated suicide risk as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS) score > 2,
4. function limitation precluded the meditation practice,
5. participated meditation program before,
6. any other conditions/contraindications that prohibit the application of taVNS including but not limited to any current or past history of cardiovascular disorders, recent ear trauma, and metal implants above the level of the neck,
7. no access to the internet.

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Mindfulness-based meditation (MBM)

MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.

experimental: back-to-back taVNS and MBM

The VNSM includes a single daily session, five days per week, consisting of back-to-back 20-minute taVNS immediately followed by 20-minute MBM (total ≈ 40 minutes).

Interventions

MBM

MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.

VNSM

The VNSM consists of a single daily session, five days per week, comprising 20 minutes of taVNS immediately followed by 20 minutes of MBM (total ≈ 40 minutes) for 8 weeks.

Primary outcome measure

  • Change in pain intensity and interference [ Time Frame: Baseline and 2 weeks and 8 weeks ]
  • Change in depressive symptoms [ Time Frame: Baseline and 2 weeks and 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

Florida State University

Recruiting

Tallahassee, Florida, United States, 32306

Contacts

More Information

Sponsor

Florida State University

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

  • depressive symptoms
  • older adults
  • mindfulness
  • taVNS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida State University on 2026-03-25.