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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 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.

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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).

Interventions

  • BEHAVIORAL Mindfulness-Based Cognitive Therapy

Study Locations (1)

Georgia

  • Grady Health System - Atlanta

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2018-09-14
Est. Completion 2023-08-18
Phase NA

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT03922581

The ClinicalTrials.gov registry entry for NCT03922581 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (79% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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