RecruitingNot ApplicableNCT07369557

Mindfulness Training During Accelerated TMS for Depression

MB-TBS: Mindfulness-Based Theta-Burst Stimulation-A Pilot Study Integrating Mindfulness Training Into Accelerated Neuromodulation Therapy for Depression


Sponsor

Medical University of South Carolina

Enrollment

20 participants

Start Date

Apr 13, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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

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Interventions

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

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.


Locations(2)

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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NCT07369557


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