Recruiting

aiTBS with Mindfulness

Sponsor:

Medical University of South Carolina

Code:

NCT07369557

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app

Study Details

Brief summary:

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.

Conditions

Depression

Study ID

NCT07369557

Start date

Apr 13, 2026

Status verified date

Mar, 2026

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mindfulness Training during aiTBS

Interventions

Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app

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.

Primary outcome measure

  • Feasibility of Guided Mindfulness Practice During aiTBS (Adherence Rate) [ Time Frame: Day 0 to Day 5 ]
  • Tolerability of Guided Mindfulness Practice During aiTBS (Adverse Events) [ Time Frame: Day 0 to Day 5 ]

Central Contacts and Locations

Locations

IOP

Recruiting

Charleston, South Carolina, United States, 29407

Contacts

Danyal Smani, MD

1 843 243 7306claytonolash@gmail.com

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jun 17, 2026

Last verified

Mar, 2026

Keywords

  • Major Depressive Disorder
  • Transcranial Magnetic Stimulation
  • Theta-Burst Stimulation
  • Mindfulness
  • Positive Affect
  • Hedonic Tone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-06-17.