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Mindfulness Training During Accelerated TMS for Depression

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 30, 2026 → Dec 30, 2026
See other at-risk trials from Medical University of South Carolina

Record History

  1. Primary completion pushed from Sep 30, 2026 to Dec 30, 2026 Completion pushed from Oct 30, 2026 to Apr 30, 2027 · Eligibility criteria expanded, about 8 words · Secondary endpoints: details revised at 2 of 6 entries Show 3 more changesShow less
    • Completion pushed from Oct 30, 2026 to Apr 30, 2027
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 2 of 6 entries
  2. Recruitment opened Study sites: 1 to 2 · Start date changed from estimate of Apr 1, 2026 to Apr 13, 2026v4 Show 2 more changesShow less
    • Study sites: 1 to 2
    • Start date changed from estimate of Apr 1, 2026 to Apr 13, 2026
  3. Interventions: Guided Mindfulness Practice (Healthy Minds app) (Behavioral) to Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app (Behavioral) Secondary endpoints: details revised at 1 of 6 entries · Study title shortened, about 1 wordv3 Show 2 more changesShow less
    • Secondary endpoints: details revised at 1 of 6 entries
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Feb 20, 2026 to Apr 1, 2026 Primary completion date: Jul 30, 2026 to Sep 30, 2026 · Completion date: Aug 30, 2026 to Oct 30, 2026v2 Show 2 more changesShow less
    • Primary completion date: Jul 30, 2026 to Sep 30, 2026
    • Completion date: Aug 30, 2026 to Oct 30, 2026
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07369557
Lead Sponsor Medical University of South Carolina
Collaborators: University of Wisconsin, Madison, National Institute on Drug Abuse (NIDA)
Conditions Depression
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov