Mindfulness Training During Accelerated TMS for Depression

NCT07369557 | Not Yet Recruiting DMC

• 2 other identifiers: Pro00148491R25DA020537
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Major Depressive Disorder; Transcranial Magnetic Stimulation; Theta-Burst Stimulation; Mindfulness; Positive Affect; Hedonic Tone

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Change in State Mindfulness (Toronto Mindfulness Scale Total Score)

  Day 0 to Day 5

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

  Day 0 to Day 5

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

  Day 0 to Day 5

• Change in Trait Mindfulness (CAMS-R Total Score)

  Baseline to Week 12 (with Week-4 assessment)

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

  Baseline to Week 4

Study Arms (1)

Mindfulness Training during aiTBS

EXPERIMENTAL

Behavioral: Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app

Interventions

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.

Mindfulness Training during aiTBS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: collaborator
• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

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

Charleston, South Carolina, 29407, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Clayton Olash, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical/Dental Resident

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Within 12 months of study completion

Locations

US (1)