200 Participants Needed

Behavioral Health Care for Mental Health Disorders and HIV/AIDS

(EASE Trial)

SR
Overseen BySusan Reif
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.15678

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.69101112

Research Team

SR

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.
See 1 more

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 OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Intervention ArmExperimental Treatment1 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

Find a Clinic Near You

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

References

The Hope Health and Wellness Clinic: Outcomes of Individuals with Serious Mental Illness in a Bidirectional Integrated Care Clinic. [2021]
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]
Improving continuity of care: success of a behavioral health program. [2019]
Impact of program services on treatment outcomes of patients with comorbid mental and substance use disorders. [2019]
Integrating behavioral health and primary care: the Harris County Community Behavioral Health Program. [2021]
The feasibility of a holistic wellness program for HIV/AIDS patients residing in a voluntary inpatient treatment program. [2014]
A model for evaluating intensive outpatient behavioral health care programs. [2015]
Interdisciplinary HIV care in a changing healthcare environment in the USA. [2014]
The role of ambulatory care information systems in supporting the provision of holistic care for persons infected with the human immunodeficiency virus. [2019]
"Vital": HIV counselling and testing staff's views of addressing mental health with HIV in Uganda. [2021]
The HIV/AIDS Treatment Adherence, Health Outcomes and Cost Study: conceptual foundations and overview. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Special report: a role model for ASOs. Myriad needs addressed under one huge umbrella. Even legal services are provided. [2005]