Mindfulness Training During Accelerated TMS for Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app.
- Who it may be relevant to
- Registry conditions: Depression. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MB-TBS: Mindfulness-Based Theta-Burst Stimulation-A Pilot Study Integrating Mindfulness Training Into Accelerated Neuromodulation Therapy for Depression
Overview
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.
Interventions
- Behavioral 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 measures
- 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]
Secondary outcome measures (6)
- Change in State Mindfulness (Toronto Mindfulness Scale Total Score) [Time frame: Day 0 to Day 5]
- Change in Hedonic Tone (Snaith-Hamilton Pleasure Scale Total Score) [Time frame: Day 0 to Day 5]
- Change in Perceived Ease of Meditation (0-10 Rating) [Time frame: Day 0 to Day 5]
- Change in Trait Mindfulness (CAMS-R Total Score) [Time frame: Baseline to Week 12 (with Week-4 assessment)]
- Durability of Antidepressant Response (Percent Change in PHQ-9) [Time frame: Baseline to Week 4]
- Meditation Engagement (App Analytics and Self-Report) [Time frame: Day 0 to Week 12]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- IOP — Charleston
- Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psy — Charleston
Identifiers
NCT: NCT07369557 · Pro00148491 · R25DA020537