Community-Based Interventions for Mental Health

Recruiting at 1 trial location

Overseen By Malcolm Punter, Ed.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City University of New York, School of Public Health

Disqualifiers: Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve mental health care in the Harlem community by testing various collaborative approaches, including the Learning Collaborative and MH task-sharing training. It explores how different organizations can work together to make mental health services more accessible and effective. Participants receive training and resources on mental health care and may use technology tools to assess their impact on outcomes. Good candidates for the trial are Black and Latino adults living in Harlem with moderate depression or anxiety. As an unphased trial, this study offers participants the opportunity to contribute to innovative mental health solutions in their community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that different community organizations collaborate to improve access to mental health care. Studies examine how mental health services can integrate into regular health care and other community services.

Specific information about the safety of these collaborative care models is not yet available. However, they generally apply existing, safe mental health practices in innovative ways. The trial is labeled "Not Applicable" for its phase, indicating a focus on studying effectiveness rather than testing a new drug or treatment. This suggests the approach is not expected to pose significant safety risks to participants.

For the technology-enhanced model, specific safety data is also unavailable. The technology likely supports existing community and health services, which are usually well-tolerated. The focus remains on improving coordination and access, not introducing new treatments.

In summary, while specific safety data is missing, the interventions are expected to have minimal risk. Participants will engage with well-established mental health practices and community services. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these mental health interventions because they focus on empowering communities and integrating technology in innovative ways. The Education and Resources approach offers online training to equip community members with mental health skills, like screening and psychoeducation, alongside a directory of local resources. The Multisector Collaborative Care model goes a step further by adding training on teamwork and care coordination, which is crucial for addressing complex needs. Finally, the addition of technology tools in the Multisector Collaborative Care and Technology arm aims to enhance the effectiveness of these interventions, potentially improving both implementation and consumer outcomes. Unlike traditional mental health care that often relies on individual therapy sessions or medication, these interventions promote community-based support and collaborative care, which could make mental health resources more accessible and effective.

What evidence suggests that this trial's treatments could be effective for mental health?

This trial will evaluate different community-based interventions for mental health. One treatment arm, the Multisector Collaborative Care (MCC) Model, involves collaboration across various sectors to improve mental health care. Research has shown that such collaborations help coordinate care and make it easier for people to access necessary services. Another arm, Multisector Collaborative Care and Technology, will assess the impact of adding a technology-based implementation tool. Evidence suggests that using technology in these collaborations improves results by enhancing communication and tracking progress. Additionally, the Education and Resources arm focuses on sharing tasks among different roles, which has shown promise in making mental health care more accessible and effective. Overall, these methods aim to enhance mental health support by utilizing community resources and technology. ^{2 3 4 6 7}

Who Is on the Research Team?

Victoria K Ngo, PhD

Principal Investigator

City University of New York

Are You a Good Fit for This Trial?

This trial is for Black and Latino adults aged 18-65 living in Harlem, specifically those from low-income housing or receiving primary care locally. Participants should have a moderate risk for depression, indicated by a PHQ-4 Total Score of 3 or higher.

Inclusion Criteria

Harlem residents from low-income housing developments or receiving primary care services in Harlem

PHQ-4 Total Score ≥3, moderate risk for depression

I am a Black or Latino adult aged between 18 and 65.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

0-6 months

Education and Resources

Participants receive online training on MH task-shifting skills, including screening, psychoeducation, and referral to MH care.

6-12 months

Online sessions

Multisector Collaborative Care

Participants engage in a community-engaged multisector collaborative care model, including additional training on multisectoral team skills and care navigation.

6-12 months

Follow-up

Participants are monitored for implementation and consumer outcomes, including mental health service linkage and program sustainment.

12-24 months

What Are the Treatments Tested in This Trial?

Interventions

• Learning Collaborative
• MH task-sharing training
• Supervision
• Technology Intervention

Trial Overview

The study tests the Harlem Strong Community Mental Health Collaborative's approach to mental health. It involves problem-solving care barriers, training community workers in mental health tasks, coordinating healthcare with social services, and improving data systems for quality care.

How Is the Trial Designed?

Group I: Multisector Collaborative Care and Technology Experimental Treatment 4 Interventions

MCC sites will be randomized to receive an additional technology-based implementation tool to evaluate impact on implementation and consumer outcomes.

Group II: Multisector Collaborative Care Experimental Treatment 3 Interventions

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.

Group III: Education and Resources Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

City University of New York, School of Public Health

Lead Sponsor

Trials

27

Recruited

36,200+

Harlem Congregation for Community Improvement, Inc.

Collaborator

Trials

1

Recruited

700+

Healthfirst

Collaborator

Trials

3

Recruited

1,100+

Healthfirst

Collaborator

Trials

3

Recruited

1,100+

Published Research Related to This Trial

A participatory action research project involving mental health providers and consumers highlighted the importance of dialogue in creating a knowledge exchange process that supports recovery-oriented care.

The study identified significant interpersonal and intrapersonal tensions in the provider-consumer relationship, emphasizing the need for open communication to foster understanding and empowerment in mental health recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental health consumers and providers dialogue in an institutional setting: a participatory approach to promoting recovery-oriented care. Schwartz, R., Estein, O., Komaroff, J., et al.[2022]

The implementation of an app-augmented collaborative care model (CoCM) in a diverse patient population led to significantly more healthcare team contacts and quicker follow-up times compared to standard CoCM, indicating improved patient engagement in treatment.

Patients using the app showed similar clinical outcomes in depression improvement as those in standard CoCM, but with higher appointment compliance and fewer missed appointments, suggesting that technology can enhance the effectiveness and sustainability of behavioral health care in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the scalability of the collaborative care model for depression using mobile technology. Carleton, KE., Patel, UB., Stein, D., et al.[2021]

Interviews with staff from ten outpatient mental health teams in the US Department of Veterans Affairs revealed varying degrees of alignment with the Collaborative Care Model (CCM), which is designed to improve care for chronic health conditions.

Understanding the current care delivery practices in these settings is crucial for effectively implementing CCM-based outpatient mental health care in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Collaborative Care in Mental Health Teams: Qualitative Analysis to Guide Future Implementation. Miller, CJ., Sullivan, JL., Kim, B., et al.[2020]

The collaborative practice model (CPM) at the Cape Fear Clinic effectively integrated a Clinical Pharmacist Practitioner and psychologists to provide mental health care to low-income, uninsured patients, demonstrating its feasibility since 2004.

Despite the implementation of the CPM, a comparison of health measures before and after treatment did not show significant improvements, likely due to challenges in patient follow-up and retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel collaborative practice model for treatment of mental illness in indigent and uninsured patients. Buxton, JA., Chandler-Altendorf, A., Puente, AE.[2019]

The collaborative care model is an effective approach for managing mental illness and chronic conditions, but its implementation faces significant challenges in low- and middle-income countries (LMICs).

Strategies such as mobilizing community resources, advocacy, and strengthening healthcare systems can enhance the scalability and effectiveness of this model, as demonstrated in large-scale programs in Nepal and India.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative Care for Mental Health in Low- and Middle-Income Countries: A WHO Health Systems Framework Assessment of Three Programs. Acharya, B., Ekstrand, M., Rimal, P., et al.[2018]

The Stages of Implementation Completion (SIC) tool was successfully adapted to assess the effectiveness of Collaborative Care Management (CoCM) for treating depression in eight rural primary care clinics, highlighting its potential for broader application.

The SIC identified variations in implementation performance across different sites, which can inform targeted strategies to enhance the scale-up of CoCM, particularly for low-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scaling Implementation of Collaborative Care for Depression: Adaptation of the Stages of Implementation Completion (SIC). Saldana, L., Bennett, I., Powers, D., et al.[2023]

Collaborative care (CC) models significantly improve outcomes for patients with depression and anxiety, as demonstrated by over 80 randomized trials, making them a valuable approach in primary care settings.

CC for depression is not only effective but also cost-effective compared to many treatments for medical disorders, suggesting it could be a sustainable option for managing mental health in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closing the False Divide: Sustainable Approaches to Integrating Mental Health Services into Primary Care. Kroenke, K., Unutzer, J.[2022]

The paper emphasizes the need for effective intervention models in community mental health care, drawing on established practices from community medicine that utilize epidemiological concepts.

It highlights the importance of community diagnosis as a critical step in planning interventions, supported by a practical example demonstrating its application by mental health workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intervention technics in the community: community diagnosis]. Levav, I., Gofin, J.[2006]

In a study involving 1162 unique patients in a rural primary care clinic in Nepal, consulting psychiatrists made 214 recommendations for 192 patients, indicating that while most treatment plans were adequate, there were significant areas for improvement.

Common recommendations included revisiting mental health diagnoses and increasing focus on counseling and psychosocial support, highlighting the need for better training for non-specialists in mental health care and the importance of non-pharmacological interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment recommendations made by a consultant psychiatrist to improve the quality of care in a collaborative mental health intervention in rural Nepal. Rimal, P., Maru, D., Chwastiak, L., et al.[2020]

Innovations like task-sharing and a development model of mental healthcare, which have been successfully implemented in low- and middle-income countries, could help improve mental health services in resource-rich countries.

These approaches aim to enhance the efficacy, efficiency, and acceptability of mental health services, addressing current challenges faced in high-income settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Global mental health in high-income countries. Sashidharan, SP., White, R., Mezzina, R., et al.[2018]

A community mental health model using university students successfully identified and referred individuals with varying levels of depression in Kerala, India, with 11.29% reporting mild to severe depression and 6.9% experiencing suicidal thoughts.

The model demonstrated feasibility and acceptability, effectively coordinating care and creating referral pathways, with 27 individuals referred for high-intensity interventions and 135 for low-intensity support, indicating a promising approach to strengthen mental health resources in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Task sharing and stepped referral model for community mental health promotion in low- and middle-income countries (LMIC): insights from a feasibility study in India. Devassy, SM., Scaria, L., Cheguvera, N.[2022]

Community interventions that promote mental health and social equity have shown effectiveness across various areas, including collaborative care and school-based programs, emphasizing the importance of individual and interpersonal relationships in mental health outcomes.

Sustainable success of these interventions relies on ongoing resources, ethical partnerships, and policy reforms that support collaboration between healthcare and community sectors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Interventions to Promote Mental Health and Social Equity. Castillo, EG., Ijadi-Maghsoodi, R., Shadravan, S., et al.[2023]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39300414/

A multisector community-engaged collaborative for mental ...

This research study will evaluate the effectiveness of a multisectoral community-engaged collaborative for task-sharing mental health care.

2.

researchgate.net

researchgate.net/publication/384150654_A_multisector_community-engaged_collaborative_for_mental_health_integration_in_primary_care_and_housing_developments_Protocol_for_a_stepped-wedge_randomized_controlled_trial_the_Harlem_Strong_Program

A multisector community-engaged collaborative for mental ...

A multisector community-engaged collaborative for mental health integration in primary care and housing developments: Protocol for a stepped- ...

3.

reporter.nih.gov

reporter.nih.gov/project-details/10930700

Harlem Strong Mental Health Coalition

A multisector coalition to work together to implement an expanded model of community collaborative care for evidence-based mental health to Harlem residents.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05833555

NCT05833555 | Harlem Strong Mental Health Coalition

This study examines the impact of Harlem Strong Community Mental Health Collaborative, a community-wide multi-sectoral coalition in which a health insurer works ...

5.

aims.uw.edu

aims.uw.edu/evidence-base-for-cocm/

Evidence Base for Collaborative Care (CoCM) - AIMS Center

CoCM is also shown to be highly effective in treating co-morbid mental health and physical conditions such as cancer, diabetes, and HIV. Below are multiple ...

6.

bmcpublichealth.biomedcentral.com

bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-20026-6

A multisector community-engaged collaborative for mental ...

This research study will evaluate the effectiveness of a multisectoral community-engaged collaborative for task-sharing mental health care.

7.

nam.edu

nam.edu/perspectives/multi-sector-community-driven-partnerships-an-intentional-strategy-to-advance-health-equity/

Multi-Sector, Community-Driven Partnerships

This commentary summarizes the key takeaways from the webinar, highlighting the work of two multi-sector organizations in California and ...