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NCT07369557NARecruiting

Mindfulness Training During Accelerated TMS for Depression

Medical University of South Carolina

Start Date

4/13/2026

Completion Date

10/30/2026

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 Criteria

Age Range: 18 years to 80 years

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

Interventions

BEHAVIORAL

Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app

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Conditions

Depression

Locations

IOP

Charleston, South Carolina 29407

United States

Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psychiatry

Charleston, South Carolina 29407

United States