Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-05-14 @ 7:20 PM
Study NCT ID:
NCT07369557
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness Training During Accelerated iTBS for Depression (MB-TBS)
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
MB-TBS: Mindfulness-Based Theta-Burst Stimulation-A Pilot Study Integrating Mindfulness Training Into Accelerated Neuromodulation Therapy for Depression
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This NIH-funded single-arm pilot tests the feasibility, acceptability, and preliminary effects of embedding brief guided mindfulness practice (via the Healthy Minds 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R25DA020537 | NIH | None | https://reporter.nih.gov/quic… | View |