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Virtual Mindfulness Training for Depression

N/A
Recruiting
Led By Lu Shi, Ph.D.
Research Sponsored by Clemson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
be able to attend intervention sessions.
be over 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Awards & highlights

Study Summary

This trial will explore whether a low-cost, online Mindfulness Based Cognitive Therapy (MBCT) intervention is an effective method of preventing relapse of an episode of Major Depressive Disorder (MDD).

Who is the study for?
Adults over 18 with a past diagnosis of Major Depressive Disorder (MDD), living in upstate South Carolina or Prisma Health beneficiaries, who can attend virtual sessions and have at least a 6th-grade level of English literacy. Excluded are those with current psychosis, dementia, severe brain injury, active suicidality, harmful behaviors needing clinical management, prior MBCT treatment completion or attendance.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Mindfulness Based Cognitive Therapy (MBCT) delivered virtually as a low-cost option for preventing depression relapse. Participants will either receive this intervention or be placed on a waitlist (treatment as usual). The study aims to measure changes in depression severity and overall mental health.See study design
What are the potential side effects?
While MBCT typically has minimal side effects compared to medication-based treatments, participants may experience emotional discomfort when confronting difficult thoughts and feelings during mindfulness exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can attend all required treatment sessions.
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I am over 18 years old.
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I have been diagnosed with major depression before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Depression Severity
Change in Psychiatric Distress
Secondary outcome measures
Change in Adherence to Medication Assisted Treatment (MAT)
Mindfulness
Change in Frequency of major depressive disorder relapse episodes
+4 more
Other outcome measures
Change in Emotion regulation
Change in Savoring
Intervention fidelity

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MBCT InterventionExperimental Treatment1 Intervention
Eight weekly two-hour mindful MBCT intervention sessions led by a trained healthcare provider. Post-intervention, the experimental group will receive treatment as usual.
Group II: Wait List ControlActive Control1 Intervention
Participants will engage in treatment as usual during the baseline period. After the experimental group completes the MBCT intervention, the wait list control group will complete the MBCT intervention.

Find a Location

Who is running the clinical trial?

Prisma Health-UpstateOTHER
82 Previous Clinical Trials
42,846 Total Patients Enrolled
Clemson UniversityLead Sponsor
33 Previous Clinical Trials
5,801 Total Patients Enrolled
Lu Shi, Ph.D.Principal InvestigatorClemson University
2 Previous Clinical Trials
51 Total Patients Enrolled

Media Library

MBCT Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05347719 — N/A
Depression Research Study Groups: MBCT Intervention, Wait List Control
Depression Clinical Trial 2023: MBCT Intervention Highlights & Side Effects. Trial Name: NCT05347719 — N/A
MBCT Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05347719 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the paramount goals of this experiment?

"This clinical trial aims to reduce Psychiatric Distress by examining the impact of a certain intervention over an 8 week period. The secondary objectives are to measure Change in Extent of mindfulness self-practice, Posttraumatic stress and Mindfulness skills. To gain insight into these facets, participants will be asked multiple questions regarding their practice such as frequency and duration per session, while also having access to assessment tools like the PTSD Checklist - Civilian Version (PCL-C) and Five Facet Mindfulness Questionnaire (FFMQ)."

Answered by AI

Is it possible to still enroll in this research endeavor?

"According to the records hosted on clinicaltrials.gov, this specific medical study has ceased its recruitment efforts; it was initially posted in September of 2022 and last edited in mid-June of the same year. Despite that fact, 1296 other trials are currently recruiting participants."

Answered by AI

Who else is applying?

What site did they apply to?
Prisma Health
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Fear of always being like this.
PatientReceived 2+ prior treatments
~9 spots leftby May 2024