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NCT03620721 · ClinicalTrials.gov registry record · NA
Effectiveness and Implementation of a Mindfulness Intervention for Depressive Symptoms Among Adults in a FQHC
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 245
- Enrollment target
NCT03620721 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 245 participants.
The verdict
NCT03620721, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 245 participants
- Enrollment target
Study Summary
The objective of this project is to examine the clinical effectiveness of a mindfulness intervention on reducing depressive symptoms among socio-economically disadvantaged, racial/ethnic minority adults and explore factors related to implementation in a Federally Qualified Health Center (FQHC). This research will be used to develop a generalizable model for delivery of streamlined mental health interventions in community based settings that will be broadly disseminated and scalable to other populations. Black and Hispanic adults are more likely than those who are White to receive depression treatment in primary care, where antidepressants are the most commonly offered treatment. However, Black and Hispanic adults are less likely than Whites to find antidepressants acceptable. A mindfulness depression intervention provided within primary care may be more accessible and acceptable for low-income, racial/ethnic minority individuals, a severely underserved population. The investigators will conduct a randomized controlled trial to test the clinical effectiveness of a mindfulness intervention (M-Body) on reducing depressive symptoms, compared to usual care, among low-income racial/ethnic minority adults in a FQHC. The M-Body intervention is based on Mindfulness Based Stress Reduction and has been tailored for the FQHC setting and patient population. Adults (N=254) with depressive symptoms will be recruited from a FQHC in the Chicago, IL area that serves majority racial/ethnic minority individuals (90%) living at or below the poverty line (74%). Half of the patients will be randomized to the M-Body intervention arm where they will receive 8-weeks of mindfulness training led by FQHC staff and the other half will be randomized to usual care. Information on factors relevant to implementation of the intervention in the FQHC will be obtained by convening a series of workgroups and individual interviews with FQHC staff, executive leadership and community stakeholders. Specific
Interventions
- BEHAVIORAL mindfulness
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2023-08-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03620721
The ClinicalTrials.gov registry entry for NCT03620721 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 245 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which mindfulness is the first listed.
NCT03620721 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03620721 about?
NCT03620721 is a clinical study titled "Effectiveness and Implementation of a Mindfulness Intervention for Depressive Symptoms Among Adults in a FQHC". The objective of this project is to examine the clinical effectiveness of a mindfulness intervention on reducing depressive symptoms among socio-economically disadvantaged, racial/ethnic minority adults and explore factors related to implementation in a Federally Qualified Health Center (FQHC). This...
What is the current status of trial NCT03620721?
This trial is currently completed. It is a NA study. The enrollment target is 245 participants. The study started on 2019-03-01. Estimated completion is 2023-08-30.
What interventions are being tested in trial NCT03620721?
The interventions under investigation include: mindfulness (BEHAVIORAL).
Who is sponsoring clinical trial NCT03620721?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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