---
title: Harlem Strong Mental Health Coalition
nct_id: NCT05833555
overall_status: RECRUITING
phase: NA
sponsor: City University of New York, School of Public Health
study_type: INTERVENTIONAL
primary_condition: Stress-related Problem
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05833555.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05833555"
ct_last_update_post_date: 2024-08-12
last_seen_at: "2026-05-12T07:32:40.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Harlem Strong Mental Health Coalition

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

**NCT ID:** [NCT05833555](https://clinicaltrials.gov/study/NCT05833555)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 700
- **Lead Sponsor:** City University of New York, School of Public Health
- **Collaborators:** Harlem Congregation for Community Improvement, Inc., Healthfirst
- **Conditions:** Stress-related Problem, Depression, Anxiety, Mental Health Wellness
- **Start Date:** 2023-04-05
- **Completion Date:** 2026-08-31
- **CT.gov Last Update:** 2024-08-12

## Brief 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.

## Detailed 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).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **Education and Resources** (ACTIVE_COMPARATOR) — Education and Resources (E\&R) involves online training through the E-Hub on delivery of basic MH task-shifting skills, such as screening, psychoeducation, and referral to MH care. A community directory along with training on community resources will be made available to all participants. Specifically, we will recommend that those identified to have common MH problems (PHQ-4≥3) are offered a single two-hour zoom-based group psychoeducation session about depression and anxiety, COVID-19 impact on MH, wellness and self-care skills, and directory of Harlem-based MH services and other community resources. Participants exhibiting higher level needs are referred to MH specialists.
- **Multisector Collaborative Care** (EXPERIMENTAL) — Multisector Collaborative Care (MCC) Model will consist of all resources offered in E\&R and additional trainings on skills related to working in a multisectoral team, care navigation, syndemic risks and coordination of services related to MH, social services, and health care.
- **Multisector Collaborative Care and Technology** (EXPERIMENTAL) — MCC sites will be randomized to receive an additional technology-based implementation tool to evaluate impact on implementation and consumer outcomes.

## Interventions

- **MH task-sharing training** (BEHAVIORAL) — 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** (BEHAVIORAL) — 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** (BEHAVIORAL) — 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.
- **Technology Intervention** (OTHER) — To be determined by community crowdsourcing after the first phase of implementation of the multisector collaborative care for MH task-sharing.

## Primary Outcomes

- **Depression - PHQ-9** _(time frame: 6-12 months)_ — 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).
- **Anxiety - GAD-7** _(time frame: 6-12 months)_ — 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).
- **Reach of Screening** _(time frame: 0-24 months)_ — 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.
- **Mental Health Service Linkage** _(time frame: 0-24 months)_ — % of successful MH linkages (connecting with MH navigator or MH referrals).

## Secondary Outcomes

- **Program Adoption** _(time frame: 0-12 months)_
- **Program Sustainment** _(time frame: 24 months)_
- **Implementation Barriers and Facilitators** _(time frame: 12, 24 months)_
- **Provider Attitude towards Adopting Evidence-Based Practices (EBPAS)** _(time frame: 0, 6, 12, 24 months)_
- **Partnerships with Coalition Members** _(time frame: 0, 6, 12, 24 months)_
- **Housing Security** _(time frame: 6-12 months)_
- **Employment Security** _(time frame: 6-12 months)_
- **Food Insecurity** _(time frame: 6-12 months)_

## Locations (2)

- CUNY Graduate School of Public Health and Health Policy, New York, New York, United States — _RECRUITING_
- Harlem Congregation for Community Improvement, New York, New York, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.cuny graduate school of public health and health policy|new york|new york|united states` — added _(2026-05-12)_
- `locations.harlem congregation for community improvement|new york|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05833555.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05833555*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*