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Mindfulness Training During Accelerated TMS for Depression

RECRUITINGN/ASponsored by Medical University of South Carolina
Actively Recruiting
PhaseN/A
SponsorMedical University of South Carolina
Started2026-04-13
Est. completion2026-09-30
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →

NCT07369557

Summary

This NIH-funded single-arm pilot tests the feasibility, acceptability, and preliminary effects of embedding brief guided mindfulness practice (via the Waking Up smartphone app) into the inter-session intervals of clinically administered accelerated intermittent theta-burst stimulation (aiTBS) for major depressive disorder (MDD). Participants receive aiTBS as standard clinical care at MUSC; the research intervention is daily guided mindfulness practice during the aiTBS course. Outcomes include feasibility/acceptability, changes in state mindfulness and hedonic tone (Day 0 to Day 5), perceived ease of meditation, trait mindfulness at 4 and 12 weeks, and durability of antidepressant response (PHQ-9) at 4 and 12 weeks.

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
Inclusion Criteria:

* Clinical diagnosis of MDD and eligible for aiTBS at MUSC
* Already enrolled in aiTBS course at MUSC
* English proficiency
* Smartphone or willingness to use study-provided device

Exclusion Criteria:

* TMS contraindications (e.g., seizure history, implants, pregnancy)
* Concurrent neuromodulation (ECT, VNS)
* Psychotic disorder, bipolar disorder, active substance use disorder, high suicide risk
* Unable/unwilling to engage in mindfulness or complete questionnaires

Conditions1

Depression

Locations2 sites

IOP
Charleston, South Carolina, 29407
Danyal Smani, MD1 843 243 7306claytonolash@gmail.com
Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psychiatry
Charleston, South Carolina, 29407

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