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| ID | Type | Description | Link |
|---|---|---|---|
| R25DA020537 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Wisconsin, Madison | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Training during aiTBS | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 0 to Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 to Day 5 |
| Change in Hedonic Tone (Snaith-Hamilton Pleasure Scale Total Score) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clayton Olash, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IOP | Recruiting | Charleston | South Carolina | 29407 | United States |
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Within 12 months of study completion
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to Day 5. Lower scores indicate improved hedonic tone. |
| 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. | 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. | 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 | 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. | Day 0 to Week 12 |
| Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psychiatry | Not yet recruiting | Charleston | South Carolina | 29407 | United States |
| D001523 |
| Mental Disorders |