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Completed

NCT Number: NCT03620721

Effectiveness and Implementation of a Mindfulness Intervention for Depressive Symptoms Among Adults in a FQHC

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Asher Center for the Study and Treatment of Depressive Disorders

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years old
  • mild to severe depressive symptoms (Patient Health Questionnaire-9, PHQ-9, total score ≥ 5)
  • English speaking

Exclusion criteria

  • PHQ-9 total score <5
  • past 30-day suicidal ideation
  • current, regular practice of meditation (≥ 4 per week)

Treatment and study plan

Mindfulness

Behavioral

8-week mindfulness based group intervention

Primary outcomes

  1. Depressive Symptoms

    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

Secondary outcomes

  1. Anxiety

    Time frame: 6 months

    Generalized Anxiety Disorder (GAD-7), 7 items, rated on a 0-3 point scale

  2. Anger

    Time frame: 6 months

    Anger Self-Report Questionnaire (ASRQ), 30 items rated on a 1-6 point scale

Other outcomes

  1. Self-reported Stress

    Time frame: 6 months

    Perceived Stress Scale (PSS), 10 items rated on a 0-4 point scale

  2. Mindfulness

    Time frame: 6 months

    Five Facet Mindfulness Questionnaire (FFMQ), 14 items rated on a 1-5 point scale

  3. Cognitive Reactivity

    Time frame: 6 months

    Cognitive Emotion Regulation Questionnaire (CERQ), 36 items rated on a 1-5 point scale

  4. Self-Compassion

    Time frame: 6-months

    Self Compassion Scale (SCS), 26 items rated on a 1-5 point scale

  5. Affective Dysregulation

    Time frame: 6 months

    Difficulties in Emotion Regulation Scale (DERS), 36 items rated on a 1-5 point scale

  6. Negative Thinking

    Time frame: 6 months

    Reflection and Rumination Questionnaire (RRQ), 24 items rated on a 1-5 point scale

  7. Social Functioning

    Time frame: Baseline

    Social Problems Questionnaire (SPQ), 33 items rated on a 0-3 point scale

  8. Traumatic Life Events

    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

  9. Spirituality

    Time frame: Baseline

    Spirituality Scale (SS), 8 items rated on a 1-6 point scale

  10. Blood Pressure

    Time frame: Baseline, 8, 16, and 24 weeks

    Ranges of blood pressure measurements (mmHg)

  11. Inflammatory Biomarkers

    Time frame: Baseline, 8, 16, and 24 weeks

    Dried Blood Spot (DBS) samples will be assessed for inflammatory biomarkers (CRP, IL6, and IL8)

  12. Race-Based Stress

    Time frame: Baseline and 8 weeks

    Racial and Ethnic Microaggressions Scale (REMS), 28 items rated on a 0-5 point scale

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2018
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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