Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness and Implementation of a Mindfulness Intervention for Depressive Symptoms Among Adults in a FQHC (M-Body)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03620721
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
Inger Burnett-Zeigler, Northwestern University

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=330) 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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Stress, Psychological Stress, Physiological Behavioral: mindfulness Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : March 30, 2023

Arm Intervention/treatment
Experimental: M-Body
mindfulness group intervention
Behavioral: mindfulness
8-week mindfulness based group intervention

No Intervention: Usual Care
treatment as usual



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 or yoga (≥ 4 per week)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620721


Contacts
Layout table for location contacts
Contact: Lynette Lartey, MPH 3126956250 lynette.lartey@northwestern.edu
Contact: Victoria Wee, BA 3129262188 victoria.wee@northwestern.edu

Locations
Layout table for location information
United States, Illinois
Northwestern University Asher Center for the Study and Treatment of Depressive Disorders Recruiting
Chicago, Illinois, United States, 60611
Contact: Lynette Lartey, MPH    312-695-6250    lynette.lartey@northwestern.edu   
Contact: Victoria Wee, BA    312-926-2188    victoria.wee@northwestern.edu   
Principal Investigator: Inger E. Burnett-Zeigler, PhD         
Sponsors and Collaborators
Northwestern University

Layout table for additonal information
Responsible Party: Inger Burnett-Zeigler, Assosciate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03620721    
Other Study ID Numbers: STU00207126
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Stress, Psychological
Behavioral Symptoms