Recruiting

Observational Study

Sponsor:

City University of New York, School of Public Health

Code:

NCT05833555

Conditions

Stress-related Problem

Depression, Anxiety

Mental Health Wellness

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

MH task-sharing training

Supervision

Learning Collaborative

Technology Intervention

Study Details

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.

Conditions

Stress-related Problem

Depression, Anxiety

Mental Health Wellness

Study ID

NCT05833555

Start date

Apr 5, 2023

Status verified date

May, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Education and Resources

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.

experimental: Multisector Collaborative Care

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.

experimental: Multisector Collaborative Care and Technology

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

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.

Technology Intervention

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

Primary outcome measure

  • Depression - PHQ-9 [ Time Frame: 6-12 months ]
  • Anxiety - GAD-7 [ Time Frame: 6-12 months ]
  • Reach of Screening [ Time Frame: 0-24 months ]
  • Mental Health Service Linkage [ Time Frame: 0-24 months ]

Central Contacts and Locations

Central contacts

Locations

CUNY Graduate School of Public Health and Health Policy

Recruiting

New York, New York, United States, 10025

Contacts

Harlem Congregation for Community Improvement

Recruiting

New York, New York, United States, 10025

Contacts

Malcolm Punter, Ed.D

212-281-4887mpunter@hcci.org

More Information

Sponsor

City University of New York, School of Public Health

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

  • Task-sharing
  • Implementation research
  • Collaborative care
  • Behavior Activation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by City University of New York, School of Public Health on 2026-05-20.