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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03620721
Other study ID # STU00207126
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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