Mindfulness Training During Accelerated iTBS for Depression (MB-TBS)

Medical University of South Carolina (MUSC)

Status

Begins enrollment this month

Conditions

Depression

Treatments

Behavioral: Guided Mindfulness Practice (Healthy Minds app)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07369557

R25DA020537 (U.S. NIH Grant/Contract)

Pro00148491

Details and patient eligibility

About

This NIH-funded single-arm pilot tests the feasibility, acceptability, and preliminary effects of embedding brief guided mindfulness practice (via the Healthy Minds 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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