Mindfulness Training During Accelerated TMS for Depression

Официальное название

MB-TBS: Mindfulness-Based Theta-Burst Stimulation-A Pilot Study Integrating Mindfulness Training Into Accelerated Neuromodulation Therapy for Depression

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (6)

• Change in State Mindfulness (Toronto Mindfulness Scale Total Score) [Срок оценки: Day 0 to Day 5]
• Change in Hedonic Tone (Snaith-Hamilton Pleasure Scale Total Score) [Срок оценки: Day 0 to Day 5]
• Change in Perceived Ease of Meditation (0-10 Rating) [Срок оценки: Day 0 to Day 5]
• Change in Trait Mindfulness (CAMS-R Total Score) [Срок оценки: Baseline to Week 12 (with Week-4 assessment)]
• Durability of Antidepressant Response (Percent Change in PHQ-9) [Срок оценки: Baseline to Week 4]
• Meditation Engagement (App Analytics and Self-Report) [Срок оценки: Day 0 to Week 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• IOP — Charleston
• Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psy — Charleston

Идентификаторы

NCT: NCT07369557 · Pro00148491 · R25DA020537

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗