Comparative effectiveness of a mindfulness-based intervention (M-Body) on depressive symptoms: study protocol of a randomized controlled trial in a Federally Qualified Health Center (FQHC).
Inger Burnett-Zeigler, Elayne Zhou, Jennifer H Martinez, Katelyn Zumpf, Lynette Lartey, Judith T. Moskowitz, Katherine L Wisner, Thomas McDade, C Hendricks Brown, Jacqueline Gollan, Jody D Ciolino, Jacob M Schauer, Lucia C Petito
Trials February 17, 2023 DOI: 10.1186/s13063-022-07012-2 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial (study protocol) Peer reviewed |
|---|---|
| Sample size | 274 |
| Population | English-speaking adults aged 18-65 with depressive symptoms, predominantly Black women, recruited at a Federally Qualified Health Center in a metropolitan city |
| Interventions | Mindfulness-based intervention (M-Body) enhanced usual care |
| Duration | 8-week intervention; assessments at baseline and 2, 4, and 6 months after baseline |
| Topics | Meditation |
| Keywords | Community health Depression treatment Disparities Health equity |
| Registration | NCT03620721 |
| Key findings | The protocol outlines a two-armed, stratified, individually randomized group-treated controlled trial comparing eight weekly 90-minute group sessions of a mindfulness-based intervention (M-Body) with enhanced usual care among 274 adults with depressive symptoms. The authors propose that if M-Body is effective, it could increase access to mental health treatment in underserved racial and ethnic minority communities. |
Abstract
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. 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. 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. ClinicalTrials.gov NCT03620721. Registered on 8 August 2018.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cited by 4
- HIV Patients' Mindfulness Moderates How Death Anxiety and Depression Impact Life Quality. OMEGA - Journal of Death and Dying December 18, 2024
- Mindfulness research in Saudi Arabia: a scoping review of mental health applications in a non-WEIRD context Middle East Current Psychiatry April 22, 2026
- The Effects of Mindfulness Techniques on Anxiety, Depression, and Stress, with an Emphasis on Gratitude: A Systematic Review and Meta-Analysis Healthcare February 27, 2026
- Exploring Mechanisms, Methods, and Measurement in Mindfulness Research: A Scoping Review of Community-Based Interventions Mindfulness September 15, 2026
Cites 13
- Using Self-Report Assessment Methods to Explore Facets of Mindfulness Assessment January 27, 2006
- Mindfulness training as a clinical intervention: A conceptual and empirical review. Clinical Psychology Science and Practice 2003
- Standardised Mindfulness-Based Interventions in Healthcare: An Overview of Systematic Reviews and Meta-Analyses of RCTs PLoS One April 16, 2015
- Training Teachers to Deliver Mindfulness-Based Interventions: Learning from the UK Experience Mindfulness April 26, 2010
- The effects of mindfulness-based stress reduction on cardiac patients' blood pressure, perceived stress, and anger: a single-blind randomized controlled trial. Journal of the American Society of Hypertension : JASH October 2016
and 8 more in the library