Mindfulness During Accelerated TMS for Depression
Official title: MB-TBS: Mindfulness-Based Theta-Burst Stimulation-A Pilot Study Integrating Mindfulness Training Into Accelerated Neuromodulation Therapy for Depression
Run by Medical University of South Carolina · NCT07369557 · Data updated 2026-11-12
This pilot tests whether short guided mindfulness practice used during aiTBS treatment for major depressive disorder is feasible, acceptable, and shows early signals of benefit.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 2 sites (Charleston, South Carolina and 1 other locations) |
| Status | Recruiting |
| Started | April 13, 2026 |
| Main results expected | December 30, 2026 |
| Study ends | April 30, 2027 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT07369557 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a clinical diagnosis of major depressive disorder who are already enrolled in an aiTBS course at MUSC and can use a smartphone or provided device.
✕Probably not a fit
Patients who do not engage with mindfulness practice or have contraindications to TMS or neuromodulation may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-arm pilot study embeds brief guided mindfulness practice through the Waking Up app during the inter-session intervals of an accelerated intermittent theta-burst stimulation course for major depressive disorder. Feasibility and acceptability are measured alongside changes in state mindfulness, hedonic tone, ease of meditation, and trait mindfulness over 4 and 12 weeks. Antidepressant response durability is explored with PHQ-9 assessments at 4 and 12 weeks. The study uses a study-created web app linked to the commercially available mindfulness app to deliver daily practice during aiTBS at MUSC. Enrollment requires eligibility for aiTBS, English proficiency, and access to a smartphone or provided device.
Why it matters
Potential benefit: If successful, the approach could offer an accessible way to enhance mood and sustain response during a TMS treatment course.
How similar studies have gone: Prior studies in related areas suggest that mindfulness components can be compatible with neuromodulation and may improve mood, but this exact embedding during aiTBS is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Iop
Charleston, South Carolina, United States Recruiting -
Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psychiatry
Charleston, South Carolina, United States Not yet recruiting
Study contacts
- Principal investigator: Clayton Olash, MD — Medical University of South Carolina
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Smartphone-supported single-session psychotherapy for postpartum depression
A single online therapy session plus four weeks of app-based support is being tested to see if it reduces depressive symptoms in postpartum women compared with a waitlist.
-
Mindful Smartphone Use: A Mindfulness-Based Program for Teens with Sleep and Mood Challenges
This study tests Mindwire, a mindfulness-based program, to see if it helps teens with problematic phone use who also have depression or anxiety.
-
Tele-based wellbeing centres for women's mental health in Bangladesh
A randomized trial tests whether tele-counselling for depression and anxiety in Bangladeshi women is as effective as in-person counselling.
-
Remote monitoring for adults with depression using ThIA Suivi
This study tests whether adding the ThIA Suivi remote monitoring tool to usual psychiatric care helps adults with depression feel more improved after 3 months compared with standard care alone.
-
HBOT to see if it helps cognition and well‑being in first responders with prior brain injury
This study tests whether 40 hyperbaric oxygen therapy sessions can improve thinking skills and post-concussion symptoms in current or former first responders with a history of brain injury.
-
Focused ultrasound for mood and anxiety disorders
This study tests whether repeated low-intensity focused ultrasound using the ATTN201 device can help people with subsyndromal to moderate depression, anxiety, or OCD.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.