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)

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-minute 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.