Not Yet RecruitingNot Applicable

Mindfulness Training During Accelerated TMS for Depression

United States20 participantsStarted 2026-04-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Feasibility of Guided Mindfulness Practice During aiTBS (Adherence Rate)

Timeframe: Day 0 to Day 5

Tolerability of Guided Mindfulness Practice During aiTBS (Adverse Events)

Timeframe: Day 0 to Day 5

Trial details

NCT IDNCT07369557

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Depression trials