Effectiveness and Implementation of a Mindfulness Intervention for Depressive Symptoms Among Adults in a FQHC (M-Body)
Primary Purpose
Depressive Symptoms, Stress, Psychological, Stress, Physiological
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mindfulness
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Symptoms
Eligibility Criteria
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)
Sites / Locations
- Northwestern University Asher Center for the Study and Treatment of Depressive DisordersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
M-Body
Usual Care
Arm Description
mindfulness group intervention
treatment as usual
Outcomes
Primary Outcome Measures
Depressive Symptoms
Inventory of Depressive Symptoms (IDS-C), 30 items rated on a 0-3 point scale, total scores range from 0-84
Secondary Outcome Measures
Anxiety
Generalized Anxiety Disorder (GAD-7), 7 items, rated on a 0-3 point scale
Anger
Anger Self-Report Questionnaire (ASRQ), 30 items rated on a 1-6 point scale
Full Information
NCT ID
NCT03620721
First Posted
July 23, 2018
Last Updated
January 11, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT03620721
Brief Title
Effectiveness and Implementation of a Mindfulness Intervention for Depressive Symptoms Among Adults in a FQHC
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Stress, Psychological, Stress, Physiological
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
254 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
M-Body
Arm Type
Experimental
Arm Description
mindfulness group intervention
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
mindfulness
Intervention Description
8-week mindfulness based group intervention
Primary Outcome Measure Information:
Title
Depressive Symptoms
Description
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
Secondary Outcome Measure Information:
Title
Anxiety
Description
Generalized Anxiety Disorder (GAD-7), 7 items, rated on a 0-3 point scale
Time Frame
6 months
Title
Anger
Description
Anger Self-Report Questionnaire (ASRQ), 30 items rated on a 1-6 point scale
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Self-reported Stress
Description
Perceived Stress Scale (PSS), 10 items rated on a 0-4 point scale
Time Frame
6 months
Title
Mindfulness
Description
Five Facet Mindfulness Questionnaire (FFMQ), 14 items rated on a 1-5 point scale
Time Frame
6 months
Title
Cognitive Reactivity
Description
Cognitive Emotion Regulation Questionnaire (CERQ), 36 items rated on a 1-5 point scale
Time Frame
6 months
Title
Self-Compassion
Description
Self Compassion Scale (SCS), 26 items rated on a 1-5 point scale
Time Frame
6-months
Title
Affective Dysregulation
Description
Difficulties in Emotion Regulation Scale (DERS), 36 items rated on a 1-5 point scale
Time Frame
6 months
Title
Negative Thinking
Description
Reflection and Rumination Questionnaire (RRQ), 24 items rated on a 1-5 point scale
Time Frame
6 months
Title
Social Functioning
Description
Social Problems Questionnaire (SPQ), 33 items rated on a 0-3 point scale
Time Frame
Baseline
Title
Traumatic Life Events
Description
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
6 months
Title
Spirituality
Description
Spirituality Scale (SS), 8 items rated on a 1-6 point scale
Time Frame
Baseline
Title
Blood Pressure
Description
Ranges of blood pressure measurements (mmHg)
Time Frame
Baseline, 8, 16, and 24 weeks
Title
Inflammatory Biomarkers
Description
Dried Blood Spot (DBS) samples will be assessed for inflammatory biomarkers (CRP, IL6, and IL8)
Time Frame
Baseline, 8, 16, and 24 weeks
Title
Race-Based Stress
Description
Racial and Ethnic Microaggressions Scale (REMS), 28 items rated on a 0-5 point scale
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meghana Nallajerla
Phone
773-683-1275
Email
mbody@northwestern.edu
Facility Information:
Facility Name
Northwestern University Asher Center for the Study and Treatment of Depressive Disorders
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elayne Zhou
Phone
312-695-8441
Email
mbody@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Inger E. Burnett-Zeigler, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness and Implementation of a Mindfulness Intervention for Depressive Symptoms Among Adults in a FQHC
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