Mindfulness Training for Depression

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This NIH-funded single-arm pilot tests the feasibility, acceptability, and preliminary effects of embedding brief guided mindfulness practice (via the Healthy Minds 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.

Who Is on the Research Team?

CO

Clayton Olash, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals with major depressive disorder (MDD) who are already enrolled in an accelerated intermittent theta-burst stimulation (aiTBS) course at MUSC. Participants must have a smartphone or be willing to use one provided by the study.

Inclusion Criteria

I am proficient in English.
I am enrolled in the aiTBS course at MUSC.
I have a smartphone or am willing to use one provided by the study.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive accelerated intermittent theta-burst stimulation (aiTBS) with daily guided mindfulness practice via the Healthy Minds app

5 days
Daily sessions

Follow-up

Participants are monitored for changes in trait mindfulness and antidepressant response

12 weeks
Assessments at Week 4 and Week 12

What Are the Treatments Tested in This Trial?

Interventions

  • Guided Mindfulness Practice (Healthy Minds app)

Trial Overview

The trial tests the addition of guided mindfulness practice, using the Healthy Minds app, during aiTBS treatment sessions for depression. It aims to see if this combination is feasible and acceptable, and how it affects mood and mindfulness up to 12 weeks after treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Mindfulness Training during aiTBSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

University of Wisconsin, Madison

Collaborator

Trials
1,249
Recruited
3,255,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+