Clinical trial NCT03620721: Effectiveness and Implementation of a Mindfulness Intervention for Depressive Symptoms Among Adults in a FQHC
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
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Stress, Psychological
Stress, Physiological
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Depressive Symptoms
timeFrame: 6 months
Secondary outcomes:
measure: Anxiety
timeFrame: 6 months
measure: Anger
timeFrame: 6 months
Other outcomes:
measure: Self-reported Stress
timeFrame: 6 months
measure: Mindfulness
timeFrame: 6 months
measure: Cognitive Reactivity
timeFrame: 6 months
measure: Self-Compassion
timeFrame: 6-months
measure: Affective Dysregulation
timeFrame: 6 months
measure: Negative Thinking
timeFrame: 6 months
measure: Social Functioning
timeFrame: Baseline
measure: Traumatic Life Events
timeFrame: 6 months
measure: Spirituality
timeFrame: Baseline
measure: Blood Pressure
timeFrame: Baseline, 8, 16, and 24 weeks
measure: Inflammatory Biomarkers
timeFrame: Baseline, 8, 16, and 24 weeks
measure: Race-Based Stress
timeFrame: Baseline and 8 weeks
Locations:
city: Chicago
country: United States
facility: Northwestern University Asher Center for the Study and Treatment of Depressive Disorders
state: Illinois
Study officials:
References: