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

Trial Summary

What is the purpose of this trial?

This trial studies a community program in Harlem that aims to improve mental health services by solving funding and access issues, training local health workers, and coordinating various health and social services. The program also uses common metrics to continuously improve care quality. The goal is to create a sustainable model for providing mental health care within a network of comprehensive services.

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.

What data supports the effectiveness of this treatment?

The Collaborative Care Model (CoCM), which is part of the treatment, has been shown to be effective for mental health conditions like depression, especially in primary care settings. Studies have demonstrated its potential to improve mental health care quality and address unmet needs, particularly in low-income and rural areas. ^{1 2 3 4 5}

Is the Community-Based Interventions for Mental Health treatment generally safe for humans?

The Collaborative Care Model (CCM), a component of the Community-Based Interventions for Mental Health, has been widely studied and shown to be safe and effective in improving mental health outcomes, particularly for depression and anxiety, without significant safety concerns reported. ^{1 3 6 7 8}

How does this community-based mental health treatment differ from other treatments?

This treatment is unique because it uses a community-based approach, involving university students and local health workers to identify and refer individuals with mental health issues, making it more accessible and cost-effective in low-resource settings compared to traditional clinical treatments. ^{5 9 10 11 12}

Research Team

Victoria K Ngo, PhD

Principal Investigator

City University of New York

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mental health consumers and providers dialogue in an institutional setting: a participatory approach to promoting recovery-oriented care. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Scaling Implementation of Collaborative Care for Depression: Adaptation of the Stages of Implementation Completion (SIC). [2023]

3. England 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. [2020]

4. England pubmed.ncbi.nlm.nih.gov

A novel collaborative practice model for treatment of mental illness in indigent and uninsured patients. [2019]

5. United States 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. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Enhancing the scalability of the collaborative care model for depression using mobile technology. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Closing the False Divide: Sustainable Approaches to Integrating Mental Health Services into Primary Care. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Assessing Collaborative Care in Mental Health Teams: Qualitative Analysis to Guide Future Implementation. [2020]

9. England 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. [2022]

10. Argentina pubmed.ncbi.nlm.nih.gov

[Intervention technics in the community: community diagnosis]. [2006]

11. United States pubmed.ncbi.nlm.nih.gov

Community Interventions to Promote Mental Health and Social Equity. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Global mental health in high-income countries. [2018]