Depression, Anxiety Clinical Trial
Official title:
Harlem Strong Mental Health Coalition: A Multi-sector Community-Engaged Collaborative for System Transformation
Addressing health disparities, especially in the face of coronavirus pandemic, requires an integrated multi-sector equity-focused, community-based approach. This study will examine the impact of Harlem Strong Community Mental Health Collaborative, a community-wide multi-sectoral coalition in which a health insurer works with a network of community-based organizations, medical providers, and behavioral health providers to engage in a network-wide implementation planning process to: (1) problem-solve financing, access, and quality of care barriers, (2) support capacity building for mental health (MH) task-sharing for community health workers, (3) facilitate coordination and collaboration across MH/behavioral health, primary care, and a range of social services, including case management, housing supports, financial education, employment support, and other community resources to improve linkages to services, and (4) identify a set of common MH, social risk, and health metrics and strategies to integrate these metrics into data systems across the network for continuous quality improvement of the system. The long-term goal of our study is to develop sustainable model for task-sharing MH care that will be embedded in a coordinated comprehensive network of services, including primary care, behavioral/MH, social services, and other community resources.
Status | Recruiting |
Enrollment | 700 |
Est. completion date | August 31, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Black and Latino adults between 18 and 65 years - Harlem residents from low-income housing developments or receiving primary care services in Harlem - PHQ-4 Total Score =3, moderate risk for depression Exclusion Criteria: - Those with risk for depression or anxiety who screen positive for severe mental illness (e.g., psychosis, mania, substance abuse, and high suicide risk) using screening items from the Mini-International Neuropsychiatric Interview will be excluded from the study and referred to MH services at higher levels of care |
Country | Name | City | State |
---|---|---|---|
United States | Harlem Congregation for Community Improvement | New York | New York |
Lead Sponsor | Collaborator |
---|---|
City University of New York, School of Public Health | Harlem Congregation for Community Improvement, Inc., Healthfirst |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depression - PHQ-9 | Depression symptom severity is assessed using the Patient Health Questionnaire (PHQ-9), which includes nine items on a scale ranging from "0" (Not at all) to "3" (Nearly every day).
PHQ-9 scores range from 0 to 27, with higher scores indicating greater severity of depression. The scores are categorized into five levels: minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27). |
6-12 months | |
Primary | Anxiety - GAD-7 | Anxiety symptom severity is assessed using the General Anxiety Disorder (GAD-7) scale, which consists of seven items designed to screen and evaluate anxiety symptom severity on a scale ranging from "0" (Not at all) to "3" (Nearly every day).
GAD-7 scores range from 0 to 21, with higher scores indicating greater anxiety symptoms. Scores are classified into four levels: minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21). |
6-12 months | |
Primary | Housing Security | % of participants who experience housing insecurity.
Housing insecurity is defined by meeting criteria such as currently living in a shelter, having experienced eviction in the past, or facing challenges in paying for their rent or mortgage. |
6-12 months | |
Primary | Employment Security | % of participants who experience employment insecurity.
Employment insecurity is defined by meeting criteria such as currently not working, working only part-time or intermittently over the past few months, or not receiving payment for work they have performed. |
6-12 months | |
Primary | Food Security | % of participants who experience food insecurity.
Food insecurity is defined by meeting criteria such as not having enough to eat often or sometimes, and/or cannot afford to purchase enough food to meet their basic nutritional needs. |
6-12 months | |
Primary | Reach of Screening | Number of new consumers screened for depression using the Patient Health Questionnaire (PHQ-4) relative to the total number of low-income housing residents or patients seen at the sites will be used. | 0-24 months | |
Primary | Mental Health Service Linkage | % of successful MH linkages (connecting with MH navigator or MH referrals). | 0-24 months | |
Secondary | Program Adoption | % of delivering MH care components during the Supported Implementation when implementation support is provided (% of MH care components delivered - screening, assessment, education, referral). | 0-12 months | |
Secondary | Program Sustainment | % of delivering MH care components during the Sustainment Phases when study-funded implementation supports are withdrawn (% of MH care components delivered - screening, assessment, education, referral). | 24 months | |
Secondary | Implementation Barriers and Facilitators | The investigators will review the implementation data table before conducting qualitative interviews to construct the "implementation story (themes)" based on the implementation data which is extracted from clinical records/logs and training records. | 12, 24 months | |
Secondary | Provider Attitude towards Adopting Evidence-Based Practices (EBPAS) | The Evidence-based Practice Attitude Scale with 15 items is used to assess providers' attitudes including their requirements, appeal, openness, and divergence. Each item is scored from "0" (not at all) to "4" (to a very great extent), with higher scores indicating a more positive attitude towards adopting evidence-based practices. | 0, 6, 12, 24 months | |
Secondary | Partnerships with Coalition Members | Partnerships and Collaboration are assessed using a 20-item scale developed by investigators. The scale includes different subdomains such as collaboration, organizational capacity, sustainability, and responsive models.
Each item will be rated on a scale of "0" (Strongly Disagree) to "5" (Strongly Agree), with a higher score indicating greater partnership. |
0, 6, 12, 24 months |
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