Mindfulness Training During Accelerated TMS for Depression

Medical University of South Carolina20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

IOP

Charleston, South Carolina, United States

RECRUITING

Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psychiatry

Charleston, South Carolina, United States

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Feasibility of Guided Mindfulness Practice During aiTBS (Adherence Rate)

Proportion of participants who complete all mandatory guided practice on each of the five aiTBS treatment days. Calculated as: number completing all five days ÷ total enrolled. Higher values indicate better feasibility.

Time frame: Day 0 to Day 5

Tolerability of Guided Mindfulness Practice During aiTBS (Adverse Events)

Number and severity of meditation-related adverse events recorded via participant report and study staff observation. Higher values indicate worse tolerability.

Time frame: Day 0 to Day 5

Secondary Outcomes

Change in State Mindfulness (Toronto Mindfulness Scale Total Score)

Change in Toronto Mindfulness Scale (TMS) total score from baseline to Day 5. Higher scores indicate greater state mindfulness.

Time frame: Day 0 to Day 5

Change in Hedonic Tone (Snaith-Hamilton Pleasure Scale Total Score)

Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to Day 5. Lower scores indicate improved hedonic tone.

Time frame: Day 0 to Day 5

Change in Perceived Ease of Meditation (0-10 Rating)

Change in meditation ease rating on a 0-10 numeric scale (0 = not at all easy; 10 = extremely easy). Higher scores indicate greater perceived ease.

Time frame: Day 0 to Day 5

Change in Trait Mindfulness (CAMS-R Total Score)

Change in Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) total score from baseline to Week 12. Higher scores indicate greater trait mindfulness.

Time frame: Baseline to Week 12 (with Week-4 assessment)

Durability of Antidepressant Response (Percent Change in PHQ-9)

Percent change in PHQ-9 total score from baseline to Week 4. Lower scores indicate improvement

Time frame: Baseline to Week 4

Meditation Engagement (App Analytics and Self-Report)

Engagement with the Waking Up app measured by total minutes practiced, number of Foundations completed, and cumulative meditation minutes. Higher values indicate greater engagement.

Time frame: Day 0 to Week 12