Optimizing Behavioral Healthcare Delivery Through Technology

January 30, 2024 updated by: Eleos Health

The goal of this randomized controlled clinical trial is to determine the feasibility, acceptability, and preliminary efficacy of an artificial intelligence platform )שׁ( for behavioral health in facilitating better clinical outcomes for adult patients receiving outpatient therapy.

The main question[s] it aims to answer are:

  • whether an AI platform designed for behavioral healthcare would be feasible and acceptable to patients and therapists.
  • whether the depression and anxiety outcomes of adults receiving outpatient cognitive-behavioral therapy (CBT) in a community-based clinic would be superior among patients whose therapists used an AI-based platform to support clinical decision making and administrative tasks compared to patients receiving treatment-as-usual (TAU).

Participants will receive CBT for depression or anxiety and complete standardized assessments. Participants will be followed for the first two months of therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The need for scalable delivery of mental health care services that are efficient and effective is now a major public health priority. Artificial intelligence (AI) tools have the potential to improve behavioral healthcare services by helping clinicians collect objective data on patients' progress, streamline their workflow, and automate administrative tasks.

The goal of this study is to determine the feasibility, acceptability, and preliminary efficacy of an AI platform for behavioral health in facilitating better clinical outcomes for patients receiving outpatient therapy.

This open randomized clinical trial will compare an AI platform provided by Eleos Health to treatment-as-usual (TAU) during the first 2 months of therapy. The study will be conducted at a community-based clinic in the U.S. Participants will be adults referred for outpatient, individual cognitive behavioral therapy for a main diagnosis of a depressive or anxiety disorder. Patients will be randomized to receive either therapy provided with the support of an AI platform developed by Eleos Health or TAU at the same clinic.

Data analysis will be carried out based on intention-to-treat principle. The primary outcomes include the feasibility and acceptability of the AI platform. Secondary outcomes include changes in depression (Patient Health Questionnaire-9) and anxiety (Generalized Anxiety Disorder-7) scores as well as treatment attendance and satisfaction.

Findings of this study will inform the optimization of future trials and services offered to individuals seeking mental health support in the U.S.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Joplin, Missouri, United States, 64804
        • The Ozark Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Older than 18 years old.
  2. Presenting for an outpatient CBT for a depressive or anxiety disorder.

Exclusion Criteria:

  1. Age <18.
  2. individuals who are medically unstable for outpatient treatment.
  3. a severe mental health condition that might interfere with treatment compliance (e.g., psychotic depression, psychosis, active substance dependence).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Eleos Health Platform
Therapists in the AI group will use the HIPAA-compliant, secure, password-protected Eleos Health platform. This AI tool was designed for behavioral health to support clinical decision-making and automation of administrative tasks. The platform captures the therapist and patient's utterances during a treatment session, analyzes the data, and offers feedback on the implementation of EBPs. The platform also incorporates a measurement-based care component, wherein standardized assessment scales completed by clients are immediately summarized and graphed for the therapist, who can use these data to inform therapy and share them with the patient. Insights and key indicators from the session data and MBC are summarized into a progress note draft which the therapist can then submit or edit as needed.
Behavioral: Cognitive behavioral therapy with AI
Cognitive behavioral therapy is a psycho-social intervention that aims to reduce symptoms of various mental health conditions, primarily depression and anxiety disorders. The Eleos Health platform provides real-time data that optimizes this therapy and helps the provider tailor the intervention to the specific client.
Active Comparator: Treatment as Usual
Participants randomized to the control group will receive the routine services provided in the center. Therapists providing TAU will be permitted to use the strategies they deen would be most successful.
Behavioral: Cognitive behavioral therapy
Cognitive behavioral therapy is a psycho-social intervention that aims to reduce symptoms of various mental health conditions, primarily depression and anxiety disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline
The PHQ-9 is intended as a tool to assist clinicians with identifying and diagnosing depression.
Baseline
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 1 month
The PHQ-9 is intended as a tool to assist clinicians with identifying and diagnosing depression.
1 month
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 2 months
The PHQ-9 is intended as a tool to assist clinicians with identifying and diagnosing depression.
2 months
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline
The GAD-7 is intended as a tool to assist clinicians with identifying and diagnosing anxiety.
Baseline
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 1 month
The GAD-7 is intended as a tool to assist clinicians with identifying and diagnosing anxiety.
1 month
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 2 months
The GAD-7 is intended as a tool to assist clinicians with identifying and diagnosing anxiety.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eleos Health

Collaborators

Missouri Department of Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • O1Z2A3R4K5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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