DepressionNCT07369557
Mindfulness Training During Accelerated TMS for Depression
A study testing Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app in people with Depression, run by Medical University of South Carolina at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Apr 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
IOP
Charleston, South Carolina, 29407
Danyal Smani, MD, 1 843 243 7306, claytonolash@gmail.com
- Not yet recruiting
Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psychiatry
Charleston, South Carolina, 29407
About this study
Official title: 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.
- Conditions
- Depression
- Being tested
- Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app
- Keywords
- Major Depressive Disorder, Transcranial Magnetic Stimulation, Theta-Burst Stimulation, Mindfulness, Positive Affect, Hedonic Tone
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Training during aiTBS | Experimental | Not described Receives: Behavioral: Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0 to Day 5
Secondary outcomes (6)
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.
Measured: Day 0 to Day 5
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Day 0 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start13 Apr 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Clayton Olash, Medical University of South Carolina
- Investigators
- Clayton Olash, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369557
- Sponsor's protocol ID
- Pro00148491
- Other IDs
- R25DA020537
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MB-TBS: Mindfulness-Based Theta-Burst Stimulation-A Pilot Study Integrating Mindfulness Training Into Accelerated Neuromodulation Therapy for Depression
- ClinicalTrials.gov ID
- NCT07369557
- Acronym / sponsor ID
- Pro00148491
- Conditions
- Depression
- Keywords
- Major Depressive Disorder, Transcranial Magnetic Stimulation, Theta-Burst Stimulation, Mindfulness, Positive Affect, Hedonic Tone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison, National Institute on Drug Abuse (NIDA)
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training during aiTBS | Experimental | Behavioral: Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app5-15 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. | Behavioural | Mindfulness Training during aiTBS |
Primary outcome
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.
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.
6 secondary outcomes
Change in State Mindfulness (Toronto Mindfulness Scale Total Score)
Time frame: Day 0 to Day 5
Change in Hedonic Tone (Snaith-Hamilton Pleasure Scale Total Score)
Time frame: Day 0 to Day 5
Change in Perceived Ease of Meditation (0-10 Rating)
Time frame: Day 0 to Day 5
Change in Trait Mindfulness (CAMS-R Total Score)
Time frame: Baseline to Week 12 (with Week-4 assessment)
Durability of Antidepressant Response (Percent Change in PHQ-9)
Time frame: Baseline to Week 4
Meditation Engagement (App Analytics and Self-Report)
Time frame: Day 0 to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clayton Olash, MD principal investigator
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app in people with Depression, run by Medical University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Guided Mindfulness Practice During aiTBS (Adherence Rate) (time frame: Day 0 to Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.