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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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 languageEnglish (US)
Article number115
JournalTrials
Volume24
Issue number1
DOIs
StatePublished - Dec 2023

Keywords

  • Community health
  • Depression treatment
  • Disparities
  • Health equity
  • Mindfulness

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine (miscellaneous)

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