Optimizing Behavioral Healthcare Delivery Through Technology

Anxiety Disorders Clinical Trial

Official title:

Optimizing Behavioral Healthcare Delivery Through Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05745103
• Other study ID #: O1Z2A3R4K5
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: January 2024
• Source: Eleos Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorders
• Mood Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Ozark Center	Joplin	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Eleos Health	Missouri Department of Mental Health

Country where clinical trial is conducted

United States, 

References & Publications (4)

Kellogg KC, Sadeh-Sharvit S. Pragmatic AI-augmentation in mental healthcare: Key technologies, potential benefits, and real-world challenges and solutions for frontline clinicians. Front Psychiatry. 2022 Sep 6;13:990370. doi: 10.3389/fpsyt.2022.990370. eCollection 2022. — View Citation

Peretz G, Taylor CB, Ruzek JI, Jefroykin S, Sadeh-Sharvit S. Machine Learning Model to Predict Assignment of Therapy Homework in Behavioral Treatments: Algorithm Development and Validation. JMIR Form Res. 2023 May 15;7:e45156. doi: 10.2196/45156. — View Citation

Sadeh-Sharvit S, Camp TD, Horton SE, Hefner JD, Berry JM, Grossman E, Hollon SD. Effects of an Artificial Intelligence Platform for Behavioral Interventions on Depression and Anxiety Symptoms: Randomized Clinical Trial. J Med Internet Res. 2023 Jul 10;25: — View Citation

Sadeh-Sharvit S, Rego SA, Jefroykin S, Peretz G, Kupershmidt T. A Comparison Between Clinical Guidelines and Real-World Treatment Data in Examining the Use of Session Summaries: Retrospective Study. JMIR Form Res. 2022 Aug 16;6(8):e39846. doi: 10.2196/39846. — View Citation

Outcome

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