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NCT03922581 · ClinicalTrials.gov registry record · NA
Primary-Care Based Mindfulness Intervention
A NA study of Major Depressive Disorder and Post Traumatic Stress Disorder, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT03922581: Completed NA study of Major Depressive Disorder and Post Traumatic Stress Disorder, sponsored by Emory University.
NCT03922581 is a NA study of Major Depressive Disorder and Post Traumatic Stress Disorder that has completed, run by Emory University. The registered enrollment target is 80 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03922581, a NA study of Major Depressive Disorder and Post Traumatic Stress Disorder, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to pilot a primary-care based mindfulness intervention for chronically traumatized African Americans screening positive for posttraumatic stress disorder (PTSD) and major depressive disorder (MDD) in primary care clinics within an urban public hospital. The study will utilize a randomized controlled trial (RCT) design along with a multi-method psychological and physiological assessment approach to establish the feasibility and acceptability of a mindfulness-based cognitive therapy (MBCT) intervention for primary care versus wait-list control in African Americans with chronic trauma exposure and comorbid PTSD and MDD. Preliminary mechanisms of action associated with MBCT including emotion dysregulation and autonomic function will be evaluated. The data collection and 8-session group intervention will take place in primary care clinics within an urban public hospital serving primarily low-income, minority individuals (\>80% African American).
Primary Outcome
Retention rates were assessed using session attendance. Previous mindfulness-based stress reduction (MBSR) interventions among low-income minority populations have yielded completion rates of 53-80%. Based on 80% completion rates of MBSR in primary care and 75% completion rates of MBCT both in combat vet samples and the anticipated improved accessibility through primary care, it is expected that subjects in the intervention group will evidence at least 75% retention and follow-up rates.
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness-Based Cognitive Therapy
Study Locations (1)
Georgia
- Grady Health System - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2018-09-14 |
| Est. Completion | 2023-08-18 |
| Phase | NA |
What the finished NCT03922581 record still lists
NCT03922581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Mindfulness-Based Cognitive Therapy is the first listed.
NCT03922581 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT03922581 about?
NCT03922581 is a clinical study titled "Primary-Care Based Mindfulness Intervention". The purpose of this study is to pilot a primary-care based mindfulness intervention for chronically traumatized African Americans screening positive for posttraumatic stress disorder (PTSD) and major depressive disorder (MDD) in primary care clinics within an urban public hospital. The study will ut...
What is the current status of trial NCT03922581?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2018-09-14. Estimated completion is 2023-08-18.
What conditions does trial NCT03922581 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT03922581?
The interventions under investigation include: Mindfulness-Based Cognitive Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03922581?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03922581 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03922581's enrollment target sits among peer trials
80 143rd of 282 higher than 134 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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