Mindfulness Training During Accelerated TMS for Depression
Recruiting · NCT07369557 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of South Carolina
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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
Where it is running
2 locations listed across 1 US state.
- IOP - Charleston, South Carolina, United States
- Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psychiatry - Charleston, South Carolina, United States