Mindfulness Training During Accelerated TMS for Depression
ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app
Behavioral5-15 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Mindfulness Training during aiTBSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 52
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 5Secondary outcomes
1
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 52
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 53
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 54
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
University of Wisconsin, Madison
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov