Mindfulness Training During Accelerated TMS for Depression
Part of paid clinical trials in Charleston, South Carolina.
- Sponsor
- Medical University of South Carolina
- Study ID
- NCT07369557
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app — BEHAVIORAL5-15 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.
Study Details
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.
Key Dates
- Start date
- Apr 1, 2026
- Status verified
- Mar 2026
- Primary completion
- Sep 30, 2026
- Completion
- Oct 30, 2026
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Mindfulness Training during aiTBS
Primary Outcome Measure
Feasibility of Guided Mindfulness Practice During aiTBS (Adherence Rate) [ Time Frame: Day 0 to Day 5 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psychiatry | Charleston | South Carolina | 29407 | - |
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