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
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 — BEHAVIORAL
    5-15 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 13, 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 (2)

FacilityCityStateZIPSite coordinators
IOPCharlestonSouth Carolina29407
Danyal Smani, MD
[email protected]
1 843 243 7306
Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of PsychiatryCharlestonSouth Carolina29407-

Find similar trials in Charleston, SC

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
IOP· Charleston, SCMedical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psychiatry· Charleston, SC

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