NCT Number: NCT07369557
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
IOP, Charleston, South Carolina, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 0 to Day 5
Proportion of participants who complete all mandatory guided practice on each of the five aiTBS treatment days. Calculated as: number completing all five days ÷ total enrolled. Higher values indicate better feasibility.
Time frame: Day 0 to Day 5
Number and severity of meditation-related adverse events recorded via participant report and study staff observation. Higher values indicate worse tolerability.
Time frame: Day 0 to Day 5
Change in Toronto Mindfulness Scale (TMS) total score from baseline to Day 5. Higher scores indicate greater state mindfulness.
Time frame: Day 0 to Day 5
Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to Day 5. Lower scores indicate improved hedonic tone.
Time frame: Day 0 to Day 5
Change in meditation ease rating on a 0-10 numeric scale (0 = not at all easy; 10 = extremely easy). Higher scores indicate greater perceived ease.
Time frame: Baseline to Week 12 (with Week-4 assessment)
Change in Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) total score from baseline to Week 12. Higher scores indicate greater trait mindfulness.
Time frame: Baseline to Week 4
Percent change in PHQ-9 total score from baseline to Week 4. Lower scores indicate improvement
Time frame: Day 0 to Week 12
Engagement with the Waking Up app measured by total minutes practiced, number of Foundations completed, and cumulative meditation minutes. Higher values indicate greater engagement.
Medical University of South Carolina
Other
MB-TBS: Mindfulness-Based Theta-Burst Stimulation-A Pilot Study Integrating Mindfulness Training Into Accelerated Neuromodulation Therapy for Depression
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