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Primary-Care Based Mindfulness Intervention
NCT03922581 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03922581
The ClinicalTrials.gov registry entry for NCT03922581 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,434 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03922581 reports 1 study location spanning 1 distinct geographic area — top geographies include Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03922581?
The interventions under investigation include: Mindfulness-Based Cognitive Therapy (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03922581?
This trial is sponsored by Emory University, which has 1,434 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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