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NCT07369557Recruiting

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

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
13 Jan 2026
Start date
Apr 2026
Primary completion date
Dec 2026
Lead sponsor
Medical University of South Carolina
Diseases
Depression
NCT number
NCT07369557

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From Apr 2026 to the primary completion date, Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent neuromodulation (ECT, VNS)

Other illness

  • TMS contraindications (e.g., seizure history, implants, pregnancy)
  • Psychotic disorder, bipolar disorder, active substance use disorder, high suicide risk

Other

  • Unable/unwilling to engage in mindfulness or complete questionnaires

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psychiatry
Coordinator of this site? Confirm its status
CharlestonUnited StatesNot yet recruiting
IOP
Coordinator of this site? Confirm its status
CharlestonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.