AI Support for Mental Health Conditions

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Eleos Health

Disqualifiers: Concurrent research study, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an AI platform can help case managers in a mental health and substance use disorder clinic become more effective and satisfied with their work. It compares traditional case management practices to those using the AI tool, which aims to document services more quickly and accurately. Good candidates for the trial are adults receiving case management services from Centerstone, a nonprofit health system. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve the quality of mental health care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if your medications might interfere with the study outcomes, you may not be eligible to participate.

What prior data suggests that this AI platform is safe for use by case managers?

Research shows that the AI platform used in this trial is designed to help case managers work more efficiently. Although specific safety data is unavailable because it is a tool, not a drug or device, it adheres to strict privacy rules. It complies with HIPAA, protecting patient information according to federal guidelines.

AI tools like the one in this trial generally aim to reduce the workload for healthcare providers. They can speed up tasks like writing progress notes, potentially improving productivity without adding physical risks to users.

Overall, there are no reports of negative effects because the platform is a digital tool, not a medication or treatment that could cause physical harm. The focus remains on making work easier and more efficient, suggesting it is safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AI platform for mental health conditions because it offers a new way for providers to document patient interactions more efficiently. Unlike traditional methods that rely on manual note-taking, this AI-powered tool allows providers to quickly complete progress notes on their phones and seamlessly integrate them into electronic health records. This not only saves time but also enhances the accuracy and consistency of documentation, potentially improving patient care. Additionally, the platform is secure and HIPAA-compliant, ensuring patient information is protected while streamlining the workflow for mental health professionals.

What evidence suggests that this AI platform is effective for mental health conditions?

This trial will compare Eleos Health's AI platform with services-as-usual (SAU) for mental health care. Research has shown that Eleos Health's AI platform can significantly enhance mental health care. In past studies, this platform reduced symptoms of depression and anxiety when integrated into therapy. The AI aids therapists by managing routine tasks and predicting patient needs, resulting in improved care. It also streamlines paperwork, allowing case managers more time to focus on clients. Overall, early evidence suggests this AI tool can be a valuable component of mental health services. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for case managers working in a nonprofit health system that deals with mental health and substance use disorders. They will be using an AI platform to manage around 250 adult clients. To participate, these case managers should be currently active and providing case management services.

Inclusion Criteria

I am 18 years old or older.

Participants must be receiving case management services from a Centerstone provider

Exclusion Criteria

Participants currently involved in any other concurrent research study will be excluded to avoid potential confounding factors

I don't have any health issues or take medications that could affect the study results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Services-as-usual (SAU)

Providers deliver routine case management services and report these services in the usual way

3 months

AI Platform Implementation

Providers use the AI-based platform for documenting services, with access to the Eleos Health platform

3 months

Follow-up

Participants are monitored for productivity and satisfaction after AI platform implementation

4 months

What Are the Treatments Tested in This Trial?

Interventions

• AI Platform

Trial Overview

The study is testing the impact of an AI platform on the productivity and satisfaction of case managers dealing with traumatic stress, depression, anxiety, and substance use disorders. It compares their performance before and after implementing this technology.

How Is the Trial Designed?

Group I: Artificial Intelligence (AI) Experimental Treatment 1 Intervention

Once randomized to start using the AI-based platform for documenting their services, providers will have access to the Eleos Health platform, a secure and HIPAA-compliant tool specifically designed for documenting behavioral health encounters. This AI-powered platform enables providers to complete progress notes more quickly. Providers will complete the progress notes on their phones, and these notes will be integrated into the client's electronic health records.

Group II: Services-as-usual (SAU) Active Control 1 Intervention

During the services-as-usual (SAU) phase of this study, providers will deliver the routine case management services offered by Centerstone and report these services in the usual way they do.

Who Is Running the Clinical Trial?

Eleos Health

Lead Sponsor

Trials

2

Recruited

330+

Centerstone Research Institute

Collaborator

Trials

4

Recruited

1,700+

Published Research Related to This Trial

AI technologies in mental health can enhance patient access and care quality, but current studies mainly address challenges faced by policymakers rather than frontline clinicians.

The proposed framework for 'pragmatic AI-augmentation' categorizes AI technologies into automation, engagement, and clinical decision support, highlighting their potential benefits and the practical challenges clinicians may encounter when integrating them into daily practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic AI-augmentation in mental healthcare: Key technologies, potential benefits, and real-world challenges and solutions for frontline clinicians. Kellogg, KC., Sadeh-Sharvit, S.[2022]

The use of artificial intelligence (AI) in psychiatry has increased significantly, especially during the COVID-19 pandemic, to address the shortage of mental health providers and improve access to mental health care.

AI applications, such as chatbots and therapy bots, are being developed to assist with psychiatric diagnoses, symptom tracking, and emotional coping mechanisms, showing promise in enhancing mental health support and treatment delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial Intelligence and Chatbots in Psychiatry. Pham, KT., Nabizadeh, A., Selek, S.[2022]

Project AFFECT aims to create an AI-based software, LyssnCBT, to automatically assess the quality of cognitive behavioral therapy (CBT) sessions, which could enhance training and supervision for therapists and improve treatment outcomes for clients.

In a planned Phase II trial involving 1,875 clients, the effectiveness of LyssnCBT will be evaluated to see if it can improve therapist skills, client outcomes, and reduce client drop-out rates, marking a significant step towards scalable quality assurance in psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the quality of cognitive behavioral therapy in community mental health through artificial intelligence generated fidelity feedback (Project AFFECT): a study protocol. Creed, TA., Salama, L., Slevin, R., et al.[2023]

In a study involving 301 participants with depression or anxiety, the IntelliCare platform demonstrated strong engagement, with 84% of users continuing to use the apps for a median of 92 days post-treatment.

Coaching improved anxiety outcomes significantly compared to self-guided treatment, while weekly app recommendations enhanced depression outcomes, indicating that both methods can effectively support mental health through app engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Effects of Coaching and Receipt of App Recommendations on Depression, Anxiety, and Engagement in the IntelliCare Platform: Factorial Randomized Controlled Trial. Mohr, DC., Schueller, SM., Tomasino, KN., et al.[2020]

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