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OpenTrials
Completed

NCT Number: NCT05745103

Optimizing Behavioral Healthcare Delivery Through Technology

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.

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Key information

Conditions

Mood Disorders Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ozark Center

Joplin, Missouri, 64804, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cognitive behavioral therapy with AI

Behavioral

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.

Cognitive behavioral therapy

Behavioral

Cognitive behavioral therapy is a psycho-social intervention that aims to reduce symptoms of various mental health conditions, primarily depression and anxiety disorders.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Eleos Health

Industry

Collaborators

  • Missouri Department of Mental Health

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 27, 2023
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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