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

Depressive Symptoms Clinical Trial

— M-Body  

Official title:

Effectiveness and Implementation of a Mindfulness Intervention for Depressive Symptoms Among Low-income, Racial/Ethnic Minority Adults in a Federally Qualified Health Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620721
• Other study ID #: STU00207126
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 30, 2023

Study information

• Verified date: December 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: August 30, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Stress, Physiological
• Stress, Psychological

Intervention

Behavioral:
• mindfulness
8-week mindfulness based group intervention

Locations

Country	Name	City	State
United States	Northwestern University Asher Center for the Study and Treatment of Depressive Disorders	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported Stress	Perceived Stress Scale (PSS), 10 items rated on a 0-4 point scale	6 months
Other	Mindfulness	Five Facet Mindfulness Questionnaire (FFMQ), 14 items rated on a 1-5 point scale	6 months
Other	Cognitive Reactivity	Cognitive Emotion Regulation Questionnaire (CERQ), 36 items rated on a 1-5 point scale	6 months
Other	Self-Compassion	Self Compassion Scale (SCS), 26 items rated on a 1-5 point scale	6-months
Other	Affective Dysregulation	Difficulties in Emotion Regulation Scale (DERS), 36 items rated on a 1-5 point scale	6 months
Other	Negative Thinking	Reflection and Rumination Questionnaire (RRQ), 24 items rated on a 1-5 point scale	6 months
Other	Social Functioning	Social Problems Questionnaire (SPQ), 33 items rated on a 0-3 point scale	Baseline
Other	Traumatic Life Events	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	6 months
Other	Spirituality	Spirituality Scale (SS), 8 items rated on a 1-6 point scale	Baseline
Other	Blood Pressure	Ranges of blood pressure measurements (mmHg)	Baseline, 8, 16, and 24 weeks
Other	Inflammatory Biomarkers	Dried Blood Spot (DBS) samples will be assessed for inflammatory biomarkers (CRP, IL6, and IL8)	Baseline, 8, 16, and 24 weeks
Other	Race-Based Stress	Racial and Ethnic Microaggressions Scale (REMS), 28 items rated on a 0-5 point scale	Baseline and 8 weeks
Primary	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	Anxiety	Generalized Anxiety Disorder (GAD-7), 7 items, rated on a 0-3 point scale	6 months
Secondary	Anger	Anger Self-Report Questionnaire (ASRQ), 30 items rated on a 1-6 point scale	6 months