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).
Study Goal
The researchers aimed to evaluate the effectiveness and implementation of a mindfulness-based intervention (M-Body) on depressive symptoms among predominantly Black women in a community-based setting.
Results Summary
The study will assess depressive symptom scores at 6 months post-intervention, comparing mindfulness-based group sessions to enhanced usual care, but results are not yet reported in the abstract.
Population
Predominantly Black women aged 18-65 with depressive symptoms, recruited from a Federally Qualified Health Center in a metropolitan city.
Effective Dosage
Eight weekly, 90-minute group sessions of mindfulness-based intervention (M-Body).
Duration
8 weeks (with follow-up assessments at 2, 4, and 6 months post-baseline).
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
mindfulness-based interventions | decrease | psychological outcomes including stress, anxiety, and depression | general population | - | have been shown to improve | #1 |
mindfulness-based intervention (M-Body) | neutral | depressive symptoms | predominantly Black women at a Federally Qualified Health Center | - | will evaluate the effectiveness | #2 |
mindfulness-based intervention (M-Body) | decrease | depressive symptoms | adults with depressive symptoms | - | If found to be an effective intervention | #3 |
mindfulness-based intervention (M-Body) | increase | access to mental health treatment | underserved, racial/ethnic minority communities | - | will widely increase access | #4 |
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.