Mindfulness Training During Accelerated TMS for Depression

Conditions studied

Depression

About this study

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 outcomes

• Feasibility of Guided Mindfulness Practice During aiTBS (Adherence Rate) (Day 0 to Day 5)
• Tolerability of Guided Mindfulness Practice During aiTBS (Adverse Events) (Day 0 to Day 5)

Eligibility information

Study locations

• IOP, Charleston, South Carolina 29407 United States
• Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psychiatry, Charleston, South Carolina 29407 United States