Depression
Conditions
Keywords
Major Depressive Disorder, Transcranial Magnetic Stimulation, Theta-Burst Stimulation, Mindfulness, Positive Affect, Hedonic Tone
Brief summary
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
BEHAVIORALGuided 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.
Sponsors
Medical University of South Carolina
University of Wisconsin, Madison
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Guided Mindfulness Practice During aiTBS (Adherence Rate) | Day 0 to Day 5 | 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. |
| Tolerability of Guided Mindfulness Practice During aiTBS (Adverse Events) | Day 0 to Day 5 | Number and severity of meditation-related adverse events recorded via participant report and study staff observation. Higher values indicate worse tolerability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in State Mindfulness (Toronto Mindfulness Scale Total Score) | Day 0 to Day 5 | Change in Toronto Mindfulness Scale (TMS) total score from baseline to Day 5. Higher scores indicate greater state mindfulness. |
| Change in Hedonic Tone (Snaith-Hamilton Pleasure Scale Total Score) | Day 0 to Day 5 | Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to Day 5. Lower scores indicate improved hedonic tone. |
| Change in Perceived Ease of Meditation (0-10 Rating) | Day 0 to Day 5 | 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. |
| Change in Trait Mindfulness (CAMS-R Total Score) | Baseline to Week 12 (with Week-4 assessment) | Change in Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) total score from baseline to Week 12. Higher scores indicate greater trait mindfulness. |
| Durability of Antidepressant Response (Percent Change in PHQ-9) | Baseline to Week 4 | Percent change in PHQ-9 total score from baseline to Week 4. Lower scores indicate improvement |
| Meditation Engagement (App Analytics and Self-Report) | Day 0 to Week 12 | Engagement with the Waking Up app measured by total minutes practiced, number of Foundations completed, and cumulative meditation minutes. Higher values indicate greater engagement. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORClayton Olash, MD
Medical University of South Carolina
Outcome results
None listed