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)

• Published in: Current controlled trials in cardiovascular medicine 2023-02, Vol.24 (1), p.115-115, Article 115
• Main Authors: Burnett-Zeigler, Inger, Zhou, Elayne, Martinez, Jennifer H, Zumpf, Katelyn, Lartey, Lynette, Moskowitz, Judith T, Wisner, Katherine L, McDade, Thomas, Brown, C Hendricks, Gollan, Jacqueline, Ciolino, Jody D, Schauer, Jacob M, Petito, Lucia C
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Black people; Clinical trials; Community health; Coping; Depression - diagnosis; Depression - psychology; Depression - therapy; Depression treatment; Disparities; Ethnicity; Female; Focus groups; Health equity; Humans; Intervention; Meditation; Mental depression; Mental disorders; Mental health; Middle Aged; Mindfulness; Mindfulness - methods; Minority & ethnic groups; Minority Groups; Race; Randomized Controlled Trials as Topic; Stress; Suicidal behavior; Surveys and Questionnaires; Treatment Outcome; Young Adult
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-022-07012-2

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.