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

NCT03620721 | Completed DMC

• 1 other identifier: STU00207126
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depressive Symptoms; Stress, Psychological; Stress, Physiological

Outcome Measures

Primary Outcomes (1)

• Depressive Symptoms

  Inventory of Depressive Symptoms (IDS-C), 30 items rated on a 0-3 point scale, total scores range from 0-84

  6 months

Secondary Outcomes (2)

• Anxiety

  6 months

• Anger

  6 months

Other Outcomes (12)

• Self-reported Stress

  6 months

• Mindfulness

  6 months

• Cognitive Reactivity

  6 months

Study Arms (2)

M-Body

EXPERIMENTAL

mindfulness group intervention

Behavioral: mindfulness

Usual Care

NO INTERVENTION

treatment as usual

Interventions

mindfulness BEHAVIORAL

8-week mindfulness based group intervention

M-Body

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

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

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Haidar A, Schauer J, Gurra M, Burnett-Zeigler I. The Impact of the COVID-19 Pandemic on Depression, Anxiety, and Stress among Black Women with Depressive Symptoms at a Federally Qualified Health Center. J Racial Ethn Health Disparities. 2025 Jun;12(3):1657-1664. doi: 10.1007/s40615-024-01998-y. Epub 2024 Apr 18.

  PMID: 38635151 DERIVED

• Burnett-Zeigler I, Zhou E, Martinez JH, Zumpf K, Lartey L, Moskowitz JT, Wisner KL, McDade T, Brown CH, Gollan J, Ciolino JD, Schauer JM, Petito LC. 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). Trials. 2023 Feb 17;24(1):115. doi: 10.1186/s13063-022-07012-2.

  PMID: 36803835 DERIVED

MeSH Terms

Conditions

Depression; Stress, Psychological

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assosciate Professor

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 8, 2018
• Study Start: March 1, 2019
• Primary Completion: July 31, 2023
• Study Completion: August 30, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)