Mood DisordersNCT05745103
Optimizing Behavioral Healthcare Delivery Through Technology
A study testing Cognitive behavioral therapy with AI and Cognitive behavioral therapy in people with Mood Disorders and Anxiety Disorders, run by Eleos Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mood Disorders, Anxiety Disorders
- What is being tested?
- Cognitive behavioral therapy with AI and Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years old.
- Presenting for an outpatient CBT for a depressive or anxiety disorder.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Mood Disorders, Anxiety Disorders
- Being tested
- Cognitive behavioral therapy with AI, Cognitive behavioral therapy
- Keywords
- Mood Disorders, Anxiety Disorders, Evidence-Based Practices, Community-Based Clinics, Artificial Intelligence
- Medical subject headings
- Mood Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy with AIBehavioural
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 therapyBehavioural
Cognitive behavioral therapy is a psycho-social intervention that aims to reduce symptoms of various mental health conditions, primarily depression and anxiety disorders.
| Study group | Role | What they receive |
|---|---|---|
| The Eleos Health Platform | Experimental | 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. Receives: Behavioral: Cognitive behavioral therapy with AI |
| Treatment as Usual | Active comparator | 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. Receives: Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is intended as a tool to assist clinicians with identifying and diagnosing depression.
Measured: Baseline
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is intended as a tool to assist clinicians with identifying and diagnosing depression.
Measured: 1 month
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is intended as a tool to assist clinicians with identifying and diagnosing depression.
Measured: 2 months
Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is intended as a tool to assist clinicians with identifying and diagnosing anxiety.
Measured: Baseline
Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is intended as a tool to assist clinicians with identifying and diagnosing anxiety.
Measured: 1 month
Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is intended as a tool to assist clinicians with identifying and diagnosing anxiety.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Sep 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eleos Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Missouri Department of Mental Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745103
- Sponsor's protocol ID
- O1Z2A3R4K5
- Status last verified
- Jan 2024
- First submitted
- 7 Feb 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37184927Kellogg 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.
PubMed 36147984Sadeh-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.
PubMed 35972782Sadeh-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:e46781. doi: 10.2196/46781.
PubMed 37428547
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Behavioral Healthcare Delivery Through Technology
- ClinicalTrials.gov ID
- NCT05745103
- Acronym / sponsor ID
- O1Z2A3R4K5
- Conditions
- Mood Disorders, Anxiety Disorders
- Keywords
- Mood Disorders, Anxiety Disorders, Evidence-Based Practices, Community-Based Clinics, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Eleos HealthIndustry (pharma, biotech, devices)
- Collaborators
- Missouri Department of Mental Health
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| The Eleos Health Platform | Experimental | Behavioral: Cognitive behavioral therapy with AITherapists 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. |
| Treatment as Usual | Active comparator | Behavioral: Cognitive behavioral therapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older than 18 years old.
- Presenting for an outpatient CBT for a depressive or anxiety disorder.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapy with AICognitive 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. | Behavioural | The Eleos Health Platform |
| Cognitive behavioral therapyCognitive behavioral therapy is a psycho-social intervention that aims to reduce symptoms of various mental health conditions, primarily depression and anxiety disorders. | Behavioural | Treatment as Usual |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 37184927Peretz 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.
- Background: PubMed 36147984Kellogg 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.
- Background: PubMed 35972782Sadeh-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.
- Results publication: PubMed 37428547Sadeh-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:e46781. doi: 10.2196/46781.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy with AI and Cognitive behavioral therapy in people with Mood Disorders and Anxiety Disorders, run by Eleos Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05745103, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.