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RECRUITING Not applicable ClinicalTrials.gov

Mindfulness Training During Accelerated TMS for Depression

Sponsor: Medical University of South Carolina • ClinicalTrials.gov ID: NCT07369557

Registry updated: 2026-10-06
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Description

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.

Interventions

  • Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app (Behavioral)
    5-15 minutes of mindfulness exercises during aiTBS inter-session intervals (9 total per day) for five consecutive treatment days; optional additional practices allowed. App analytics (with permission) and self-reports quantify engagement.

Eligibility criteria

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

Conditions

Depression

Locations

  • IOP — Charleston, South Carolina, United States
  • Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psychiatry — Charleston, South Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record