Harlem Strong Mental Health Coalition

Depression, Anxiety Clinical Trial

Official title:

Harlem Strong Mental Health Coalition: A Multi-sector Community-Engaged Collaborative for System Transformation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05833555
• Other study ID #: U01OD033245
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: April 2023
• Source: City University of New York, School of Public Health
• Contact: Thinh T Vu, MSc
• Phone: 646-309-7981
• Email: thinh.vu[@]sph.cuny.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study examines the impact of Harlem Strong Community Mental Health Collaborative, a community-wide multi-sectoral coalition in which a health insurer works with community-based organizations and medical and behavioral health providers to (1) problem-solve financing, access, and quality of care barriers, (2) support capacity building for MH task-sharing for community health workers, (3) facilitate coordination and collaboration across MH/behavioral health, primary care, and social services, and (4) identify a set of common metrics and strategies for continuous system quality improvement. The research study will evaluate the impact using a Hybrid Implementation-Effectiveness design to assess the effects of the Harlem Strong Collaborative on implementation and consumer outcomes. The investigators will also describe implementation outcomes and key informant interviews to explore impact of community engagement, organization variables, and provider factors on model impact. The long-term goal of this study is to develop a sustainable model for task-sharing MH care that will be embedded in a coordinated comprehensive network of services.

The investigators will conduct a stepped-wedge clustered randomized control study evaluating the effectiveness of a MH task-sharing intervention, that involves randomization and sequenced exposure to three implementation conditions: (1) online education and resources (E&R) about MH task-sharing (screening, education, and referral), (2) community-engaged multisector collaborative care model (MCC), where a neighborhood-based coalition will support implementation of MH task-sharing, and (3) community crowdsourced technology solution to support implementation (MCC+Tech).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Mental Health Wellness
• Stress-related Problem

Intervention

Behavioral:
• MH task-sharing training
Providers will be trained to screen for MH, provide education, refer, and coordinate to range of social services. MH training typically consists of education and resources, such as one-time workshops and toolkits, provided with limited technical assistance.
• Supervision
Additionally, Community Health Workers (CHWs) will receive bi-weekly group supervision for the first 6-months, and monthly supervision for the remaining year on Zoom from a supervisor at Center for Innovation in Mental Health.
• Learning Collaborative
A learning collaborative with multidisciplinary teams from various healthcare organizations will support continuous quality improvement and develop develop structured approach to improve provision of care.

Other:
• Technology Intervention
To be determined by community crowdsourcing after the first phase of implementation of the multisector collaborative care for MH task-sharing.

Locations

Country	Name	City	State
United States	Harlem Congregation for Community Improvement	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
City University of New York, School of Public Health	Harlem Congregation for Community Improvement, Inc., Healthfirst

Country where clinical trial is conducted

United States, 

Outcome

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