Optimizing Behavioral Healthcare Delivery Through Technology

Not Applicable

Completed

• Conditions: Anxiety Disorders; Mood Disorders

• Registration Number: NCT05745103
• Lead Sponsor: Eleos Health

Brief Summary

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.

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 Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-27
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9 (PHQ-9)	2 months	The PHQ-9 is intended as a tool to assist clinicians with identifying and diagnosing depression.
Generalized Anxiety Disorder-7 (GAD-7)	2 months	The GAD-7 is intended as a tool to assist clinicians with identifying and diagnosing anxiety.

Trial Locations

Locations (1)

The Ozark Center; 🇺🇸 Joplin, Missouri, United States