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

Trial Summary

What is the purpose of this trial?

The goal of this treatment study is to learn about the mental health, substance use and physical health outcomes associated with participating in the EASE holistic behavioral health and wellness program for individuals identifying as LGBTQ+ and/or living with HIV. The main questions it aims to answer are: 1. Do important health outcomes, including substance use, mental health and social support related outcomes of individuals living with HIV and/or identifying as LGBTQ who participated in the holistic behavioral health and wellness program change after study participation? 2. Does a tailored approach to meet the specific needs of different subpopulations including 1) older (40+) PLWH and/or LGBTQ individuals with or at risk for additional health comorbidities and 2) PLWH and/or LGBTQ young adults (18-40) improve health outcomes including improvement in health and health behaviors . Participants will be asked to: * participate in 6 months of behavioral health treatment tailored to their needs, which may include individual counseling, group counseling, case management, peer support, and related education. * Complete surveys at the time of study entry and 6 months later to measure changes in health outcomes over time.

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 data supports the effectiveness of the treatment Comprehensive outpatient behavioral health care, Holistic Behavioral Health and Wellness Program, Comprehensive Outpatient Behavioral Health Care, EASE Program for mental health disorders and HIV/AIDS?

Research shows that integrated care programs, which combine primary and behavioral health services, lead to improvements in physical health, social connectedness, and psychological well-being for individuals with serious mental illness. Additionally, programs with on-site mental health services and specialized staff training have been linked to better psychological outcomes and reduced substance use in patients with co-occurring disorders. ^{1 2 3 4 5}

Is the Behavioral Health Care for Mental Health Disorders and HIV/AIDS treatment generally safe for humans?

The research on similar programs, like the holistic wellness program for HIV/AIDS patients, suggests that these treatments are feasible and potentially beneficial, but specific safety data is not detailed. The focus is on the feasibility and potential benefits rather than explicit safety outcomes. ^{1 5 6 7 8}

How is the Comprehensive Outpatient Behavioral Health Care treatment unique for mental health disorders and HIV/AIDS?

This treatment is unique because it offers a holistic approach, integrating mental health and substance abuse care with HIV/AIDS treatment, and includes activities like yoga, meditation, and therapeutic dance to address both physical and mental health needs. ^{6 9 10 11 12}

Research Team

Susan Reif, PhD, MSW

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

The Hope Health and Wellness Clinic: Outcomes of Individuals with Serious Mental Illness in a Bidirectional Integrated Care Clinic. [2021]

2. United States 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. [2023]

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

Improving continuity of care: success of a behavioral health program. [2019]

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

Impact of program services on treatment outcomes of patients with comorbid mental and substance use disorders. [2019]

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

Integrating behavioral health and primary care: the Harris County Community Behavioral Health Program. [2021]

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

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

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

A model for evaluating intensive outpatient behavioral health care programs. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Interdisciplinary HIV care in a changing healthcare environment in the USA. [2014]

9. United States 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. [2019]

10. England pubmed.ncbi.nlm.nih.gov

"Vital": HIV counselling and testing staff's views of addressing mental health with HIV in Uganda. [2021]

11. England pubmed.ncbi.nlm.nih.gov

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

12. United States 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]