MB-TBS: Mindfulness-Based Theta-Burst Stimulation-A Pilot Study Integrating Mindfulness Training Into Accelerated Neuromodulation Therapy for Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Tolerability of Guided Mindfulness Practice During aiTBS (Adverse Events)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Tolerability of Guided Mindfulness Practice During aiTBS (Adverse Events)
时间窗: 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.
Feasibility of Guided Mindfulness Practice During aiTBS (Adherence Rate)
时间窗: 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.
次要结局
- Change in State Mindfulness (Toronto Mindfulness Scale Total Score)(Day 0 to Day 5)
- Change in Hedonic Tone (Snaith-Hamilton Pleasure Scale Total Score)(Day 0 to Day 5)
- Change in Perceived Ease of Meditation (0-10 Rating)(Day 0 to Day 5)
- Change in Trait Mindfulness (CAMS-R Total Score)(Baseline to Week 12 (with Week-4 assessment))
- Durability of Antidepressant Response (Percent Change in PHQ-9)(Baseline to Week 4)
- Meditation Engagement (App Analytics and Self-Report)(Day 0 to Week 12)
研究者
Clayton Olash
Medical/Dental Resident
Medical University of South Carolina