Northwestern University Asher Center for the Study and Treatment of Depressive Disorders
Chicago, Illinois, 60611, United States
NCT Number: NCT03620721
The objective of this project is to examine the clinical effectiveness of a mindfulness intervention on reducing depressive symptoms among socio-economically disadvantaged, racial/ethnic minority adults and explore factors related to implementation in a Federally Qualified Health Center (FQHC). This research will be used to develop a generalizable model for delivery of streamlined mental health interventions in community based settings that will be broadly disseminated and scalable to other populations. Black and Hispanic adults are more likely than those who are White to receive depression treatment in primary care, where antidepressants are the most commonly offered treatment. However, Black and Hispanic adults are less likely than Whites to find antidepressants acceptable. A mindfulness depression intervention provided within primary care may be more accessible and acceptable for low-income, racial/ethnic minority individuals, a severely underserved population. The investigators will conduct a randomized controlled trial to test the clinical effectiveness of a mindfulness intervention (M-Body) on reducing depressive symptoms, compared to usual care, among low-income racial/ethnic minority adults in a FQHC. The M-Body intervention is based on Mindfulness Based Stress Reduction and has been tailored for the FQHC setting and patient population. Adults (N=254) with depressive symptoms will be recruited from a FQHC in the Chicago, IL area that serves majority racial/ethnic minority individuals (90%) living at or below the poverty line (74%). Half of the patients will be randomized to the M-Body intervention arm where they will receive 8-weeks of mindfulness training led by FQHC staff and the other half will be randomized to usual care. Information on factors relevant to implementation of the intervention in the FQHC will be obtained by convening a series of workgroups and individual interviews with FQHC staff, executive leadership and community stakeholders. Specific Aims: 1) Determine the effectiveness of M-Body on reducing depressive symptoms compared to enhanced usual care for racial/ethnic minority adults in a FQHC; 2) Explore potential mediators (stress related biomarkers, mindfulness) and moderators (age, personal, social, environmental stressors) of the intervention's effect; 3) Conduct a broad assessment of organizational and individual agency factors related to preparation and implementation of the M-Body intervention in a FQHC using a mixed methods approach.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60611, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
8-week mindfulness based group intervention
Time frame: 6 months
Inventory of Depressive Symptoms (IDS-C), 30 items rated on a 0-3 point scale, total scores range from 0-84
Time frame: 6 months
Generalized Anxiety Disorder (GAD-7), 7 items, rated on a 0-3 point scale
Time frame: 6 months
Anger Self-Report Questionnaire (ASRQ), 30 items rated on a 1-6 point scale
Time frame: 6 months
Perceived Stress Scale (PSS), 10 items rated on a 0-4 point scale
Time frame: 6 months
Five Facet Mindfulness Questionnaire (FFMQ), 14 items rated on a 1-5 point scale
Time frame: 6 months
Cognitive Emotion Regulation Questionnaire (CERQ), 36 items rated on a 1-5 point scale
Time frame: 6-months
Self Compassion Scale (SCS), 26 items rated on a 1-5 point scale
Time frame: 6 months
Difficulties in Emotion Regulation Scale (DERS), 36 items rated on a 1-5 point scale
Time frame: 6 months
Reflection and Rumination Questionnaire (RRQ), 24 items rated on a 1-5 point scale
Time frame: Baseline
Social Problems Questionnaire (SPQ), 33 items rated on a 0-3 point scale
Time frame: 6 months
PTSD Checklist for DSM-5 (PCL-5) with Life Events Checklist-5 (LEC-5), 20 items rated on a 0-4 point scale with an additional 17 items checklist
Time frame: Baseline
Spirituality Scale (SS), 8 items rated on a 1-6 point scale
Time frame: Baseline, 8, 16, and 24 weeks
Ranges of blood pressure measurements (mmHg)
Time frame: Baseline, 8, 16, and 24 weeks
Dried Blood Spot (DBS) samples will be assessed for inflammatory biomarkers (CRP, IL6, and IL8)
Time frame: Baseline and 8 weeks
Racial and Ethnic Microaggressions Scale (REMS), 28 items rated on a 0-5 point scale
Northwestern University
Other
Effectiveness and Implementation of a Mindfulness Intervention for Depressive Symptoms Among Low-income, Racial/Ethnic Minority Adults in a Federally Qualified Health Center
Acronym: M-Body
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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