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NCT03571386 · ClinicalTrials.gov registry record
Mechanisms of Mindfulness-based Interventions
A clinical trial, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- 136
- Enrollment target
NCT03571386: Completed study, sponsored by Vanderbilt University Medical Center.
NCT03571386 is a clinical trial that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 136 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03571386 has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- 136 participants
- Enrollment target
Study Summary
Mindfulness-based Interventions (MBIs) are a family of standardized cognitive and behavioral therapies that focus on cultivating mindfulness-related skills for improving maladaptive cognitive, emotional, and behavioral processes. MBIs have been developed for a wide range of problems, disorders, and populations and are increasingly available in a variety of health settings. This mixed methods study proposes to investigate proposed neurobiological, physiological, psycho-social-behavioral, and cognitive mechanisms by which MBIs may improve health outcomes.
Primary Outcome
fMRI BOLD response to emotional word stimuli baseline to 12 weeks (post-MBCT). BOLD signal change (pre- to post-MBCT) is estimated from the contrast of emotional word vs neutral words, and extracted from voxels within the fronto-parietal and default mode areas at baseline and 12-weeks. Significant Voxel-wise BOLD activity is reported using z-scores from peak voxels. A mean score was calculated based on z-score and SD of 2 in the context of reporting fMRI BOLD data here. Z-scores is a statistical
Interventions
- BEHAVIORAL Mindfulness-based Stress Reduction (MBSR)
- BEHAVIORAL Mindfulness-based Cognitive Therapy (MBCT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2019-01-08 |
| Est. Completion | 2022-09-30 |
What the finished NCT03571386 record still lists
NCT03571386 is an observational study that tracks outcomes without assigning an intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Mindfulness-based Stress Reduction (MBSR) is the first listed.
NCT03571386 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03571386 about?
NCT03571386 is a clinical study titled "Mechanisms of Mindfulness-based Interventions". Mindfulness-based Interventions (MBIs) are a family of standardized cognitive and behavioral therapies that focus on cultivating mindfulness-related skills for improving maladaptive cognitive, emotional, and behavioral processes. MBIs have been developed for a wide range of problems, disorders, and ...
What is the current status of trial NCT03571386?
This trial is currently completed. The enrollment target is 136 participants. The study started on 2019-01-08. Estimated completion is 2022-09-30.
What interventions are being tested in trial NCT03571386?
The interventions under investigation include: Mindfulness-based Stress Reduction (MBSR) (BEHAVIORAL), Mindfulness-based Cognitive Therapy (MBCT) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03571386?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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