Abstract
Background: Mindfulness-based interventions have been shown to improve psychological outcomes including stress, anxiety, and depression in general population studies. However, effectiveness has not been sufficiently examined in racially and ethnically diverse community-based settings. We will evaluate the effectiveness and implementation of a mindfulness-based intervention on depressive symptoms among predominantly Black women at a Federally Qualified Health Center in a metropolitan city. Methods: In this 2-armed, stratified, individually randomized group-treated controlled trial, 274 English-speaking participants with depressive symptoms ages 18–65 years old will be randomly assigned to (1) eight weekly, 90-min group sessions of a mindfulness-based intervention (M-Body), or (2) enhanced usual care. Exclusion criteria include suicidal ideation in 30 days prior to enrollment and regular (>4x/week) meditation practice. Study metrics will be assessed at baseline and 2, 4, and 6 months after baseline, through clinical interviews, self-report surveys, and stress biomarker data including blood pressure, heart rate, and stress related biomarkers. The primary study outcome is depressive symptom score after 6 months. Discussion: If M-Body is found to be an effective intervention for adults with depressive symptoms, this accessible, scalable treatment will widely increase access to mental health treatment in underserved, racial/ethnic minority communities. Trial registration: ClinicalTrials.gov NCT03620721. Registered on 8 August 2018.
| Original language | English (US) |
|---|---|
| Article number | 115 |
| Journal | Trials |
| Volume | 24 |
| Issue number | 1 |
| DOIs | |
| State | Published - Dec 2023 |
Funding
Program officer: Michelle Doose, PhD Social and Behavioral Sciences Administrator (Program Official) Division of Clinical and Health Services Research [email protected] 310-402-4620 This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results The Principal Investigator oversees all aspects of the trial. She is responsible of execution of the study design, protocol, data collection and analysis plan, preparation of manuscripts, and presentations as well as other dissemination of results. The research staff, including the research coordinator and research assistants, are responsible for the day to day management of the study under supervision by the PI. They are responsible for recruitment, screening, enrollment and follow-up of participants, data management, adherence to the protocol, and maintaining study materials. They visit to the community health center(s) regularly. They coordinate meetings between the PI, co-investigators, and FQHC. The research coordinator is responsible, jointly with the PI, for coordination of all study activities including IRB approval, development of the manual of operations (MOO), training the research team, and coordinating meetings with the community health center stakeholders, co-investigators, and the Data Safety and Monitoring Board. S/he will also oversee recruitment, screening, and enrollment of participants; protocol adherence; REDCap database development; data management; quality monitoring; safety monitoring; prompt review; and reporting of adverse events. The study biostatistician and data analyst is responsible for maintenance of trial IT system, data management, randomization, data analysis, and reporting to the DSMB. The CHC collaborators include the medical director, director of behavioral health, director of research, and study interventionists. The CHC is responsible for identifying staff to participate in the training and deliver the intervention, referring potential participants to the study, and participating in quarterly stakeholder meetings to assess the process of implementation. The DSMB will be responsible for safeguarding the interests of study participants, assessing the safety and efficacy of study procedures, and for monitoring the overall conduct of the study. The DSMB is an independent group advisory to the Director of the National Institute for Minority Health and Disparities (NIMHD) and will be required to provide recommendations about starting, continuing, and stopping the study. In addition, the DSMB is asked to make recommendations, as appropriate, to the NIMHD. Research reported in this publication was supported by the National Institute on Minority Health and Health Disparities under award number 1R01MD012236-01A1. All project costs were financed by the National Institutes of Health. Total amount awarded was $2,127,268. The Asher Center for the Study and Treatment of Depressive Disorders provided funding to support the publication of this manuscript. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Keywords
- Community health
- Depression treatment
- Disparities
- Health equity
- Mindfulness
ASJC Scopus subject areas
- Medicine (miscellaneous)
- Pharmacology (medical)
