Mindfulness Training During Accelerated TMS for Depression

March 27, 2026 updated by: Clayton Olash, Medical University of South Carolina

MB-TBS: Mindfulness-Based Theta-Burst Stimulation-A Pilot Study Integrating Mindfulness Training Into Accelerated Neuromodulation Therapy for Depression

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness Training during aiTBS
Behavioral: Guided 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of Guided Mindfulness Practice During aiTBS (Adverse Events)
Time Frame: 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.
Day 0 to Day 5
Feasibility of Guided Mindfulness Practice During aiTBS (Adherence Rate)
Time Frame: 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.
Day 0 to Day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in State Mindfulness (Toronto Mindfulness Scale Total Score)
Time Frame: Day 0 to Day 5
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)
Time Frame: 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.
Day 0 to Day 5
Change in Perceived Ease of Meditation (0-10 Rating)
Time Frame: 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.
Day 0 to Day 5
Change in Trait Mindfulness (CAMS-R Total Score)
Time Frame: 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.
Baseline to Week 12 (with Week-4 assessment)
Durability of Antidepressant Response (Percent Change in PHQ-9)
Time Frame: Baseline to Week 4
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)
Time Frame: 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.
Day 0 to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute on Drug Abuse (NIDA)
University of Wisconsin, Madison

Investigators

  • Principal Investigator: Clayton Olash, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00148491
  • R25DA020537 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Within 12 months of study completion

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe