Mindfulness Training During Accelerated TMS for Depression
Purpose
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.
Condition
- Depression
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Mindfulness Training during aiTBS |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Medical University of South Carolina
