About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app
Treatment groups
Sponsors and collaborators
Medical University of South Carolina
Lead sponsor
University of Wisconsin, Madison
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator