Mindfulness Training During Accelerated TMS for Depression

ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Medical University of South Carolina

Lead sponsor

University of Wisconsin, Madison

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator