Behavioral Health Care for Mental Health Disorders and HIV/AIDS

(EASE Trial)

Overseen By Susan Reif

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Reduced mental or physical capacity

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

Compensation: Varies

Number of Visits: 2

Duration: 6 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a comprehensive outpatient behavioral health care program can improve mental health, substance use, and overall well-being for people who identify as LGBTQ+ or are living with HIV. Participants will engage in six months of tailored therapy, including individual and group counseling, case management, and peer support. The researchers will assess whether this approach improves health outcomes across different age groups and health needs. Individuals may be a good fit if they identify as LGBTQ+ or have HIV, have used alcohol or drugs in the last 90 days, and live in Mecklenburg County or nearby areas. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance support for diverse communities.

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 focuses on behavioral health treatment and does not mention medication changes.

What prior data suggests that the EASE holistic behavioral health and wellness program is safe?

Research has shown that outpatient behavioral health care is generally safe and well-tolerated. This care often includes one-on-one and group therapy, assistance with managing daily tasks, and support from others with similar experiences. These services aim to help people with mental health challenges in a supportive setting.

Evidence suggests that these programs can improve mental health without significant risks. By focusing on managing mental health conditions and providing support, they lead to better overall health. Reports of serious negative effects from these programs are rare.

Because this study does not involve a new drug or surgery, it poses less risk than some other clinical trials. Participants in similar programs have experienced improvements in their mental health and quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this behavioral health care approach because it offers a holistic treatment option for people living with HIV and those in the LGBTQ+ community, focusing on mental health in addition to physical health. Unlike standard treatments that may primarily address HIV management or mental health separately, this comprehensive care model integrates individual and group therapy, case management, peer support, and education into a cohesive program. This integrative approach not only aims to improve mental health outcomes but also enhances overall well-being by fostering a supportive community and providing tailored resources for each individual.

What evidence suggests that the EASE holistic behavioral health and wellness program is effective for mental health disorders and HIV/AIDS?

Research shows that combining mental health care with HIV treatment can improve health outcomes for people with HIV. This trial includes a single intervention arm where participants will receive holistic behavioral health treatment tailored for people living with HIV and the LGBTQ+ community over a 6-month period. Studies have found that programs offering services like one-on-one and group therapy, care management assistance, and peer support can enhance mental health and reduce substance use. These services enable individuals to better manage their health. Evidence also shows that personalized mental health programs can boost overall health and well-being for people living with HIV and LGBTQ+ individuals. Early results suggest that this comprehensive care can enhance social support and mental health, especially when tailored to the needs of specific communities. ^{6 7 8 9 10}

Who Is on the Research Team?

Susan Reif, PhD, MSW

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults over 18 living with HIV or identifying as LGBTQ+ who have used alcohol or substances in the last 90 days and reside in Mecklenburg County or nearby. It's not suitable for those unable to consent due to mental or physical limitations.

Inclusion Criteria

HIV diagnosis or self-identified LGBTQ+

Any alcohol or illicit substance use in the last 90 days

Residing in Mecklenburg County or surrounding areas.

Exclusion Criteria

I cannot give consent due to mental or physical limitations.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 6 months of behavioral health treatment tailored to their needs, including individual counseling, group counseling, case management, peer support, and related education.

6 months

Regular visits as per individual treatment plan

Follow-up

Participants complete surveys to measure changes in health outcomes over time, including mental health, substance use, and social support.

6 months

2 visits (virtual) for survey completion

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive outpatient behavioral health care

Trial Overview The study tests a comprehensive behavioral health care program tailored for LGBTQ+ individuals and/or those living with HIV. It aims to improve mental health, substance use outcomes, and social support through personalized treatment over six months.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

There is one arm of the study and this involves participating in holistic behavioral health treatment for people living with HIV and the LGBTQ+ community for a 6 month period. Specific services include individual and group therapy, case management, peer support, and behavioral health education and awareness

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

Integrated services for individuals living with HIV/AIDS who also have psychiatric and substance abuse disorders are increasingly necessary due to the growing population with these co-morbidities.

The article highlights the HIV/AIDS Treatment Adherence, Health Outcomes and Cost Study, which emphasizes the importance of multifaceted service delivery systems that assess mental health and substance abuse, ultimately improving health outcomes and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The HIV/AIDS Treatment Adherence, Health Outcomes and Cost Study: conceptual foundations and overview. [2019]

The Behavioral Health Home (BHH) model, which integrates primary care into mental health services, was found to be highly acceptable and appropriate by both patients and providers, particularly for its team-based approach and universal health screening.

However, there were challenges in the acceptability and feasibility of certain components, like population health management, indicating that while some aspects of the BHH model are well-received, others need improvement to enhance patient engagement and overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and provider perception of appropriateness, acceptability, and feasibility of behavioral health home (BHH) core components based on program implementation in an urban, safety-net health system. Progovac, AM., Tepper, MC., Stephen Leff, H., et al.[2023]

Ambulatory care information systems can enhance holistic care for HIV-infected individuals by integrating the patient's perspective into their treatment plans.

These systems improve care coordination and knowledge sharing among healthcare providers, ensuring that patients receive timely and personalized care tailored to their specific needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of ambulatory care information systems in supporting the provision of holistic care for persons infected with the human immunodeficiency virus. Henry, SB., Costantino, M.[2019]

A four-week holistic wellness program for individuals with HIV/AIDS was successfully implemented in a residential treatment facility, incorporating activities like yoga, meditation, and Reiki to help manage symptoms and improve overall well-being.

Participant feedback and evaluations indicated that the program is feasible and could provide significant benefits, suggesting the need for larger studies to quantify these effects and support the integration of holistic approaches in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of a holistic wellness program for HIV/AIDS patients residing in a voluntary inpatient treatment program. Morgan, V.[2014]

Over a 4-year evaluation involving 534 adult clients, the Hope Health and Wellness Clinic demonstrated significant improvements in physical health markers such as LDL and total cholesterol, as well as self-reported measures of social connectedness and psychological distress.

Individuals with serious mental illness showed notable enhancements in both physical health and self-reported health outcomes, highlighting the effectiveness of integrated care that combines primary and behavioral health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Hope Health and Wellness Clinic: Outcomes of Individuals with Serious Mental Illness in a Bidirectional Integrated Care Clinic. Soberay, A., Tolle, LW., Kienitz, E., et al.[2021]

Implementing a case management unit significantly improved compliance rates for psychiatric follow-up care after hospital discharge, which is crucial for reducing hospital readmissions.

The quality improvement process by HIP Health Plan of New York highlights the effectiveness of structured follow-up care in enhancing behavioral health outcomes, providing valuable insights for other providers across the U.S.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving continuity of care: success of a behavioral health program. Reich, LH., Jaramillo, BM., Kaplan, LJ., et al.[2019]

The study evaluated a partial hospital-crisis stabilization program for 285 adults with severe mental illness, finding that participants experienced reduced symptoms and improved daily functioning after treatment.

The evaluation model demonstrated that clients who showed greater improvement required less financial resources for treatment, indicating a positive relationship between clinical effectiveness and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A model for evaluating intensive outpatient behavioral health care programs. Raskin, R., Novacek, J., Bahlinger, D., et al.[2015]

HIV testing and counselling staff in Uganda recognize the importance of mental health in managing HIV, viewing psychological health as inseparable from HIV treatment and medication adherence, based on interviews with 21 staff members.

Despite acknowledging the significance of mental health, staff face challenges in balancing time constraints with the need to provide adequate support, highlighting a need for more training in mental health assessment and intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Vital": HIV counselling and testing staff's views of addressing mental health with HIV in Uganda. Martin, F., Nalukenge, W., Lazarus, O., et al.[2021]

Patients with co-occurring disorders who received treatment in programs with integrated mental health services showed significantly greater improvements in psychological functioning and higher rates of mental health service utilization over six months.

Increased use of psychological services was linked to reduced heroin use, highlighting the importance of specialized dual diagnosis services in substance abuse treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of program services on treatment outcomes of patients with comorbid mental and substance use disorders. Grella, CE., Stein, JA.[2019]

The Harris County Community Behavioral Health Program successfully treated approximately 3,000 low-income, uninsured residents in Houston within its first 11 months, demonstrating effective integration of behavioral health services at a cost of about $268 per patient.

Patient outcomes improved, and provider satisfaction was high, indicating that the program not only expanded access to behavioral health services but also enhanced the quality of care delivered in community health centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating behavioral health and primary care: the Harris County Community Behavioral Health Program. Begley, CE., Hickey, JS., Ostermeyer, B., et al.[2021]

Interdisciplinary models of care for HIV, identified through a qualitative study of nine clinical sites funded by the Ryan White HIV/AIDS Program, emphasize patient-centered approaches that integrate various services in one location, improving treatment outcomes.

Key components of successful HIV care include diverse teams of providers, a stigma-reducing environment, comprehensive services, effective communication strategies like electronic health records, and a focus on quality, all supported by RWHAP funding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interdisciplinary HIV care in a changing healthcare environment in the USA. Ojikutu, B., Holman, J., Kunches, L., et al.[2014]

Housing Works provides a comprehensive program for HIV/AIDS clients that not only focuses on medical needs but also addresses personal and social needs, promoting overall well-being.

This holistic approach ensures that clients receive support in multiple areas of their lives, which can enhance their quality of life and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Special report: a role model for ASOs. Myriad needs addressed under one huge umbrella. Even legal services are provided. [2005]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6635049/

Mental health and HIV/AIDS: the need for an integrated ... Integration of mental health screening and care into all HIV testing and treatment settings would not only strengthen HIV prevention and care outcomes, but it ...

2. dhcs.ca.gov dhcs.ca.gov/Documents/Assessing-the-Continuum-of-Care-for-BH-Services-in-California.pdf

Assessing the Continuum of Care for Behavioral Health ... • Intensive Outpatient Programs (IOPs), which consist of a prearranged schedule of core services (e.g., individual counseling, group therapy ...

3. library.samhsa.gov library.samhsa.gov/sites/default/files/sma16-4999.pdf

The Case for Behavioral Health Screening in HIV Care ... Programs ensure that staff are well aware of the link between behavioral health and good health outcomes for people living with HIV and use this knowledge as ...

4. chcf.org chcf.org/wp-content/uploads/2024/12/CABHDataLandscape2024.pdf

California's Behavioral Health Data Landscape It provides an overview of how California currently measures behavioral health quality, outcomes, and equity and a look toward the future of ...

5. apa.org apa.org/health/behavioral-integration-fact-sheet

Behavioral Health Integration Fact Sheet Data to support the PCBH model · PCBH improves the patient/family experience of care (satisfaction with care) · PCBH improves patient outcomes (improves ...

6. samhsa.gov samhsa.gov/data/

SAMHSA Data SAMHSA collects data through multiple sources and surveys and provides access to public-use data files and documentation to support a better understanding of ...

7. jointcommission.org jointcommission.org/en-us/accreditation/behavioral-health-care-and-human-services

Behavioral Health Care & Human Services Behavioral health care and human services providers face ever-changing challenges that impact the quality and accessibility of care.

8. hcpf.colorado.gov hcpf.colorado.gov/bh-policies

Behavioral Health Policies, Standards, and Billing ... Assessments, which may include treatment history, results of screening and/or diagnostic tools, Mental Status Exam (MSE), and clinical impressions. Relevance to ...

9. michigan.gov michigan.gov/mdhhs/assistance-programs/medicaid/behavioral-health-home

Behavioral Health Home The Behavioral Health Home (BHH) will provide comprehensive care management and coordination services to Medicaid beneficiaries with a serious mental illness.

10. cms.gov cms.gov/files/document/mln909432-behavioral-health-integration-services.pdf

mln909432-behavioral-health-integration-services.pdf Use CPT codes 99492, 99493, and 99494, and HCPCS code G2214 to bill for monthly CoCM services. Studies show this BHI approach improves outcomes. What is CoCM?