Clinical Trial

Mindfulness Training During Accelerated TMS for Depression

Recruiting
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-06-18
Trial Details
NCT Number NCT07369557
Lead Sponsor Medical University of South Carolina
Collaborators: University of Wisconsin, Madison, National Institute on Drug Abuse (NIDA)
Conditions Depression
Enrollment 20 participants
Start Date 2026-04-13
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-17