Anxiety & Depression Association of America

Mindfulness Training During Accelerated TMS for Depression

Purpose

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.

Condition

Depression

Eligibility

Eligible Ages: Between 18 Years and 80 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Mindfulness Training during aiTBS		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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Medical University of South Carolina

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.