Depressive Symptoms, Stress, Physiological, Stress, Psychological
Conditions
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.
Interventions
BEHAVIORALmindfulness
8-week mindfulness based group intervention
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | 6 months | Inventory of Depressive Symptoms (IDS-C), 30 items rated on a 0-3 point scale, total scores range from 0-84 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | 6 months | Generalized Anxiety Disorder (GAD-7), 7 items, rated on a 0-3 point scale |
| Anger | 6 months | Anger Self-Report Questionnaire (ASRQ), 30 items rated on a 1-6 point scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-Compassion | 6-months | Self Compassion Scale (SCS), 26 items rated on a 1-5 point scale |
| Affective Dysregulation | 6 months | Difficulties in Emotion Regulation Scale (DERS), 36 items rated on a 1-5 point scale |
| Negative Thinking | 6 months | Reflection and Rumination Questionnaire (RRQ), 24 items rated on a 1-5 point scale |
| Social Functioning | Baseline | Social Problems Questionnaire (SPQ), 33 items rated on a 0-3 point scale |
| Self-reported Stress | 6 months | Perceived Stress Scale (PSS), 10 items rated on a 0-4 point scale |
| Spirituality | Baseline | Spirituality Scale (SS), 8 items rated on a 1-6 point scale |
| Blood Pressure | Baseline, 8, 16, and 24 weeks | Ranges of blood pressure measurements (mmHg) |
| Inflammatory Biomarkers | Baseline, 8, 16, and 24 weeks | Dried Blood Spot (DBS) samples will be assessed for inflammatory biomarkers (CRP, IL6, and IL8) |
| Race-Based Stress | Baseline and 8 weeks | Racial and Ethnic Microaggressions Scale (REMS), 28 items rated on a 0-5 point scale |
| Traumatic Life Events | 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 |
| Mindfulness | 6 months | Five Facet Mindfulness Questionnaire (FFMQ), 14 items rated on a 1-5 point scale |
| Cognitive Reactivity | 6 months | Cognitive Emotion Regulation Questionnaire (CERQ), 36 items rated on a 1-5 point scale |
Countries
United States
Outcome results
None listed