400 Participants Needed

Collaborative Care for Substance Use and Mental Health Disorders

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Overseen ByOluwaseun Falade-Nwulia, MBBS, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a research study to assess the effectiveness of a peer-led collaborative care model for integrating treatment for substance use and or mental health disorders into HIV care settings.Depending on whether or not participants enroll in this study, participants will be assigned randomly (by chance, like drawing a number from a hat) to one of two groups. In group 1, participants would receive usual clinical care. In group 2, participants would work with a peer-case manager who would help support participants to engage in substance use or mental health disorder care. Regardless of the group participants are in, participants will fill out a survey when first enrolled in the study, and then again 12 months later.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that participants are not currently receiving treatment for mental health or substance use disorders.

Is Collaborative Care for Substance Use and Mental Health Disorders safe for humans?

Collaborative Care models, including those with peer support, have been implemented in various healthcare settings and are generally considered safe. They focus on improving mental health care through teamwork and support, and while challenges exist in integration, no specific safety concerns have been highlighted in the research.12345

How is the Peer Supported Collaborative Care treatment different from other treatments for substance use and mental health disorders?

Peer Supported Collaborative Care is unique because it integrates primary care and behavioral health teams to provide comprehensive treatment, involving peers with lived experience to support whole health and wellness, which is not typically a component of standard treatments.13678

What data supports the effectiveness of the treatment Peer Supported Collaborative Care for Substance Use and Mental Health Disorders?

Research shows that collaborative care models, which involve team-based approaches to integrate mental health and medical care, are effective in improving outcomes for mental health conditions in primary care settings. Additionally, peer support, which involves individuals with lived experience providing support to others, has been shown to improve health outcomes and lower system costs when integrated into clinical settings.2391011

Who Is on the Research Team?

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Oluwaseun Falade-Nwulia, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18-99 receiving HIV care who aren't currently treated for mental health or substance use disorders. They must speak English and have screened positive for these disorders at the Bartlett HIV clinic.

Inclusion Criteria

accessing HIV care at the Bartlett HIV clinic
Screened positive for a Mental health disorder or substance use disorder based on a computerized self-administered screen with Patient Health Questionnaire (PHQ-9)(score>10), General Anxiety Disorder (GAD-7) (score>10), National Institute on Drug Abuse Drug Use Screening Tool: 3 Question Quick Screen (Response of "Yes" to one or more heavy drinking days or "Yes" to use of illegal drugs or prescription drugs for non-medical reasons.
I am not currently receiving treatment for any mental health or substance use issues.
See 1 more

Exclusion Criteria

I am unable to make medical decisions for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either usual care or a peer-supported collaborative care model for mental health and substance use disorder treatment integrated into HIV care settings

12 months
Initial visit and ongoing care management

Follow-up

Participants are monitored for changes in mental health and substance use disorder outcomes and HIV virologic suppression

12 months
Survey at enrollment and 12 months later

What Are the Treatments Tested in This Trial?

Interventions

  • Peer Supported Collaborative Care
Trial Overview The study tests a peer-led collaborative care model versus usual clinical care to integrate treatment for substance use and mental health into HIV care settings. Participants are randomly assigned to one of the two groups.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Collaborate Care (CC) ModelExperimental Treatment1 Intervention
Group II: Usual Care (UC)Active Control1 Intervention

Peer Supported Collaborative Care is already approved in United States for the following indications:

🇺🇸
Approved in United States as Collaborative Care Model for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Published Research Related to This Trial

A collaborative care model was evaluated in rural Virginia to improve access to both behavioral health and primary care services, addressing the shortage of psychiatric specialists and the overlap of chronic illnesses with psychiatric conditions.
The study emphasized the importance of advanced practice nursing roles and enhanced collaboration among healthcare providers, recommending evidence-based interventions and wellness programs to improve health outcomes.
Barriers to Clinical Practice.Parks, MD.[2020]
Collaborative care models (CCMs) effectively integrate mental health and medical care in primary care settings, improving patient outcomes through team-based interventions and support systems.
CCMs are cost-efficient and can enhance care for various mental health conditions, but their successful implementation depends on aligning financial incentives and adapting to different practice settings.
Mental health collaborative care and its role in primary care settings.Goodrich, DE., Kilbourne, AM., Nord, KM., et al.[2022]
Mental health peer support is recognized as an effective method to enhance mental health services, improve patient outcomes, and reduce costs, as highlighted in Canada's mental health strategy.
The study identifies key strategies for integrating peer support into clinical settings, such as gradual implementation, building support among staff, and prioritizing patient-centered care, which can help overcome challenges in adoption.
Integrating mental health peer support in clinical settings: Lessons from Canada and Norway.Mulvale, G., Wilson, F., Jones, S., et al.[2019]

Citations

Barriers to Clinical Practice. [2020]
Mental health collaborative care and its role in primary care settings. [2022]
Integrating mental health peer support in clinical settings: Lessons from Canada and Norway. [2019]
The effectiveness of an integrated collaborative care model vs. a shifted outpatient collaborative care model on community functioning, residential stability, and health service use among homeless adults with mental illness: a quasi-experimental study. [2022]
Perceived barriers and facilitators to implementation of peer support in Veterans Health Administration Primary Care-Mental Health Integration settings. [2021]
How do care providers evaluate collaboration? - qualitative process evaluation of a cluster-randomized controlled trial of collaborative and stepped care for patients with mental disorders. [2021]
Improving Payment for Collaborative Mental Health Care in Primary Care. [2023]
Strategies and Lessons Learned for Supporting and Supervising Peer Specialists. [2022]
Addressing the Poverty Barrier in Collaborative Care for Adults Experiencing Homelessness: A Case-Based Report. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Collaborative Care: Integrating Behavioral Health Into the Primary Care Setting. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Integrated care: wellness-oriented peer approaches: a key ingredient for integrated care. [2013]
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