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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: Completed NA study, sponsored by Northwestern University.
NCT03620721 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 245 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Inventory of Depressive Symptoms (IDS-C), 30 items rated on a 0-3 point scale, total scores range from 0-84
Interventions
- BEHAVIORAL mindfulness
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2023-08-30 |
| Phase | NA |
What the finished NCT03620721 record still lists
NCT03620721 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which mindfulness is the first listed.
NCT03620721 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03620721's enrollment target sits among peer trials
245 436th of 2000 higher than 1,563 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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