Mental Health Program for People Living With HIV

(ORCHID Trial)

Recruiting at2 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Northwestern University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests an online program called ORCHID that helps people living with HIV who are depressed. The program teaches skills to boost positivity and manage stress. The goal is to see if it improves mental health and helps patients stick to their HIV treatment.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current medications, as the focus is on mental health screening and an online intervention.

What data supports the idea that Mental Health Program for People Living With HIV is an effective treatment?

The available research shows that the Mental Health Program for People Living With HIV, also known as BHS+ORCHID, is effective in improving mental health outcomes. For example, a study on in-home mental health treatment for individuals with HIV found significant reductions in symptoms like anxiety and depression, and improvements in social support and coping. Another study demonstrated that telemedicine-administered therapy significantly decreased depression symptoms among women living with HIV. These findings suggest that mental health interventions, including BHS+ORCHID, can be beneficial for people living with HIV. ^{1 2 3 4 5}

What safety data exists for the mental health program for people living with HIV?

The provided research does not directly address safety data for the specific mental health program, BHS+ORCHID or Optimizing Resilience and Coping with HIV through Internet Delivery. However, it highlights the prevalence of mental health issues among people living with HIV and the potential benefits of mental health interventions, such as in-home counseling and telephone-delivered services. These studies suggest that mental health interventions can reduce psychiatric symptoms and improve mental health outcomes, but specific safety data for the mentioned program is not available in the provided research. ^{3 6 7 8 9}

Is the treatment BHS+ORCHID a promising treatment for mental health in people living with HIV?

Yes, BHS+ORCHID is a promising treatment because it aims to improve mental health for people living with HIV by providing support and coping strategies through the internet. This approach can help reduce feelings of depression, isolation, and stigma, which are common among HIV-positive individuals, especially in resource-limited settings. ^{2 5 10 11 12}

Research Team

Eligibility Criteria

This trial is for adults over 18 living with HIV in Chicago, who are clients at Ryan White clinics and show signs of depression. Participants must speak English, have daily internet access, and agree to share their health information.

Inclusion Criteria

You are able to speak and understand English.

You are currently receiving medical care at one of the approved Ryan White clinics.

Your PHQ-9 score is higher than 5, indicating you may be experiencing depression, and you were referred by your medical case manager.

Treatment Details

Interventions

• BHS+ORCHID (Behavioral Intervention)

Trial Overview The study tests a mental health intervention called ORCHID delivered online to improve mood and health outcomes in HIV patients. It involves screening for depression and providing resources through case managers using a stepped wedge design.

Participant Groups

Group I: Behavioral Health Screener + ORCHID Intervention (BHS+ORCHID) Experimental Treatment 1 Intervention

At the clinic level, sites randomized to implement BHS+ORCHID will receive training, materials, and other support to administer behavioral health screening and refer their clients with elevated depression symptoms to ORCHID. At the individual level, those clients who are eligible and choose to enroll in ORCHID will receive self-guided training on 8 positive affect skills through weekly online sessions and daily practice exercises.

Group II: Standard of Care Active Control 1 Intervention

usual care

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

AIDS Foundation of Chicago

Collaborator

Trials

1

Recruited

300+

AIDS Foundation Chicago

Collaborator

Trials

1

Recruited

300+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Pete Salzmann

University of Chicago

Chief Executive Officer since 2018

MD from University of Chicago’s Pritzker School of Medicine, MBA from Stanford University’s Graduate School of Business

Anh Nguyen

University of Chicago

Chief Medical Officer

MD from Rutgers New Jersey Medical School, MBA from University of Chicago

Findings from Research

An online self-help program based on cognitive behavioral therapy is being tested for its effectiveness in reducing depressive symptoms in people living with HIV, with a study involving a randomized controlled design comparing an intervention group to a waiting list-control group.

Participants will engage with the program over 6 to 10 weeks, receiving weekly motivational support, and the study aims to identify which patients benefit most and the mechanisms that lead to treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-based self-help intervention for people with HIV and depressive symptoms: study protocol for a randomized controlled trial. van Luenen, S., Kraaij, V., Spinhoven, P., et al.[2018]

A study involving 299 participants living with HIV/AIDS in rural areas tested two telephone-delivered mental health interventions, but neither significantly reduced depressive or psychological symptoms.

Participants in the Information Support Group reported increased support from friends and fewer barriers to healthcare at follow-ups, suggesting that while the interventions may enhance social support, their overall impact on mental health symptoms was limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of two telephone-delivered, mental health interventions for HIV-infected persons in rural areas of the United States. Heckman, TG., Carlson, B.[2007]

The CHAMP study demonstrated that 9 months of in-home mental health counseling significantly reduced psychiatric symptoms in 40 individuals with HIV and major mental disorders, as evidenced by improvements in the Brief Symptom Inventory scores.

Participants also showed significant enhancements in mental health, coping skills, and social support, suggesting that in-home treatment can effectively engage and support HIV-positive individuals facing mental health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-home mental health treatment for individuals with HIV. Reif, SS., Pence, BW., LeGrand, S., et al.[2021]

A pilot trial involving 22 women living with HIV showed that both cognitive behavioral therapy and supportive psychotherapy delivered via videoconferencing significantly reduced depression symptoms and maintained high adherence to antiretroviral therapy over 6 months.

The study demonstrated that telemedicine is a feasible and acceptable method for providing mental health support to women with HIV, with a high retention rate of 95% and positive participant satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and preliminary impact of telemedicine-administered cognitive behavioral therapy for adherence and depression among African American women living with HIV in the rural South. Junkins, A., Psaros, C., Ott, C., et al.[2022]

A systematic review of 26 studies on mental health interventions for people living with HIV in low and middle-income countries found that only four randomized controlled trials showed significant improvements in mental health outcomes, indicating limited efficacy of current interventions.

Most interventions were based on cognitive-behavioral approaches, but there is a need for further development and adaptation of these mental health services to better suit the resource-limited settings of LMICs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving mental health among people living with HIV: a review of intervention trials in low- and middle-income countries. Sikkema, KJ., Dennis, AC., Watt, MH., et al.[2022]

In a study of 346 gay, bisexual, and other men who have sex with men living with HIV in Guatemala, increased frequency of health navigation interactions was associated with significant improvements in anxiety levels.

Participants who received high levels of informational support from navigators experienced greater reductions in anxiety, while more in-person interactions unexpectedly worsened anxiety, suggesting that navigation programs should focus on frequent and informative support to enhance mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining How Health Navigation Affects Mental Health Among Gay, Bisexual, and Other Men Who Have Sex with Men Living with Human Immunodeficiency Virus in Guatemala. Davis, DA., Angeles, G., McNaughton-Reyes, L., et al.[2022]

A study of 128 individuals with HIV in Montréal revealed that mental health distress is significantly influenced by factors such as age, sex, and source of income, with common issues including uncertainty about the future and feelings of helplessness.

Respondents in Montréal reported higher levels of distress compared to those in Toronto and Halifax, primarily due to demographic differences, highlighting the need for tailored mental health services for HIV-infected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychological distress in persons afflicted with HIV in Montreal]. Lamping, DL., Joseph, L., Ryan, B., et al.[2006]

Over half of the 122,896 people with HIV studied (55.1%) were diagnosed with one or more mental health disorders, with the most common being depressive (39%) and anxiety disorders (28%).

While retention in HIV care was similar for those with and without mental health disorders, individuals with bipolar disorder and mental health multimorbidity showed slightly lower rates of viral suppression, indicating a potential need for targeted interventions in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence of mental health disorders in people with HIV and the effects on the HIV care continuum. Lang, R., Hogan, B., Zhu, J., et al.[2023]

A qualitative study involving 42 people living with HIV revealed that telephone-delivered behavioral health services, such as mindfulness training and health coaching, are seen as convenient and flexible, allowing for easier scheduling and rapport-building with interventionists.

Participants noted some challenges, like network connectivity issues, but overall, they found telephone delivery to be a beneficial way to access mental health support and improve medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-delivered behavioral health interventions for people living with HIV: patients' perspectives from a qualitative study. Dunne, EM., Rosen, RK., Rich, C., et al.[2022]

HIV-infected individuals in impoverished settings experience significant mental health challenges, including depression and isolation, largely due to structural factors like poverty and stigma, as revealed through focus group discussions with patients and providers.

To effectively address the mental health issues faced by these individuals, it is crucial to integrate mental health services into HIV care and utilize community health workers, while also focusing on poverty alleviation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental Health Burden Among Impoverished HIV-Positive Patients in Peru. Shin, S., Muñoz, M., Caldas, A., et al.[2018]

The systematic review highlights a significant connection between mental health and HIV, indicating that individuals with mental illness may have higher rates of HIV infection and face unique challenges in managing their health.

There is a pressing need for well-designed studies to explore effective mental health interventions within HIV treatment programs, as existing research suggests that factors like coping strategies and family support can improve mental health outcomes for those affected by HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the relevance of mental health to HIV/AIDS care and treatment programs in developing countries? A systematic review. Collins, PY., Holman, AR., Freeman, MC., et al.[2022]

The systematic review highlights a significant prevalence of mental health disorders among people living with HIV/AIDS (PLHA) in India, indicating a critical need for targeted mental health support.

The study identifies gaps in existing policies and programs that fail to adequately address the mental health needs of PLHA, emphasizing the importance of addressing stigma and discrimination in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental health needs of people living with HIV/AIDS in India: a literature review. Das, S., Leibowitz, GS.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

An Internet-based self-help intervention for people with HIV and depressive symptoms: study protocol for a randomized controlled trial. [2018]

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

A randomized clinical trial of two telephone-delivered, mental health interventions for HIV-infected persons in rural areas of the United States. [2007]

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

In-home mental health treatment for individuals with HIV. [2021]

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

Feasibility, acceptability, and preliminary impact of telemedicine-administered cognitive behavioral therapy for adherence and depression among African American women living with HIV in the rural South. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Improving mental health among people living with HIV: a review of intervention trials in low- and middle-income countries. [2022]

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

Examining How Health Navigation Affects Mental Health Among Gay, Bisexual, and Other Men Who Have Sex with Men Living with Human Immunodeficiency Virus in Guatemala. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

[Psychological distress in persons afflicted with HIV in Montreal]. [2006]

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

The prevalence of mental health disorders in people with HIV and the effects on the HIV care continuum. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Telephone-delivered behavioral health interventions for people living with HIV: patients' perspectives from a qualitative study. [2022]

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

Mental Health Burden Among Impoverished HIV-Positive Patients in Peru. [2018]

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

What is the relevance of mental health to HIV/AIDS care and treatment programs in developing countries? A systematic review. [2022]

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

Mental health needs of people living with HIV/AIDS in India: a literature review. [2018]