Depressive DisorderNCT06280170
AI to Support Mental Health Case Management Providers
A study testing Artificial Intelligence platform for case managers in people with Depressive Disorder and Anxiety Disorders, run by Eleos Health at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess the effectiveness of an artificial intelligence (AI) platform for case managers in a nonprofit health system specializing in mental health and substance use disorder. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Anxiety Disorders, Substance Use Disorders
- What is being tested?
- Artificial Intelligence platform for case managers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2024to 31 Dec 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be adults.
- Participants must be receiving case management services from a Centerstone provider
Who cannot join
- Participants currently involved in any other concurrent research study will be excluded to avoid potential confounding factors.
- Participants with any medical conditions or medications that may significantly interfere with the study outcomes will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AI for All: Harnessing the Power of Artificial Intelligence in Mental Health Case Management
The goal of this clinical trial is to assess the effectiveness of an artificial intelligence (AI) platform for case managers in a nonprofit health system specializing in mental health and substance use disorder. The main questions it aims to answer are:
- Is the AI platform acceptable and feasible for case managers?
- Does the AI platform improve providers' productivity and reported interventions? Participants will be approximately 30 case managers and their 250 adult clients receiving case management services. Researchers will compare the provider productivity and work satisfaction prior to the implementation of the AI platform to following its implementation.
- Conditions
- Depressive Disorder, Anxiety Disorders, Substance Use Disorders, Post Traumatic Stress Disorder
- Being tested
- Artificial Intelligence platform for case managers
- Keywords
- Case management, Artificial Intelligence, Provider productivity, Mental health services, Provider satisfaction
- Medical subject headings
- Depressive Disorder, Anxiety Disorders, Substance-Related Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence platform for case managersOther
Providers will have access to the Eleos Health mobile AI platform to document their case management encounters.
| Study group | Role | What they receive |
|---|---|---|
| Services-as-usual (SAU) | No intervention | During the services-as-usual (SAU) phase of this study, providers will deliver the routine case management services offered by Centerstone and report these services in the usual way they do. |
| Artificial Intelligence (AI) | Experimental | Once randomized to start using the AI-based platform for documenting their services, providers will have access to the Eleos Health platform, a secure and HIPAA-compliant tool specifically designed for documenting behavioral health encounters. This AI-powered platform enables providers to complete progress notes more quickly. Providers will complete the progress notes on their phones, and these notes will be integrated into the client's electronic health records. Receives: Other: Artificial Intelligence platform for case managers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Case manager satisfaction
Providers will complete a self-report assessment about their experience providing case management services. Providers will be asked to (a) report the number of of hours spent on documentation per week; (b) respond on a Likert Scale (1-5, 1="Not at all" and 5="highly stressed" regarding their stress level about documentation; and (c) respond on a Likert scale 1-5 (1="Not at all satisfied", 5="Highly satisfied"), indicating their satisfaction with their current role as a case manager.
Measured: Baseline, and 4 months after the rollout of the Eleos Health tool.
Case manager productivity
We will collect the number of encounters (i.e., case management visits provided) per month in the three months preceding the start of the study, and months 3-6 after the AI platform rollout.
Measured: 3 months before and 3 month after study start date
Case manager note completion time
We will record progress note completion time by hours since the time of service delivery (average, standard deviation, and range).
Measured: 3 months before and 3 month after study start date
Secondary outcomes (1)
Clients' crisis services utilization
Data on the clients' healthcare crisis encounters reported in the system will be collected
Measured: 6 months before and 6 month after study start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start19 Feb 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study will follow a stepped-wedge, randomized controlled design, where each provider team will undergo two phases: SAU and the AI platform phase. All teams will initially start with SAU, and the AI platform will be sequentially introduced to teams over time. Teams will be randomly assigned to different time periods for the AI platform phase using simple randomization. The order of implementation will be determined by randomly selecting the number of the team from sealed envelopes every two months. In both phases, the study will enroll new and existing clients. At the end of the trial all teams would have used Eleos for a few months
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eleos Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centerstone Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280170
- Sponsor's protocol ID
- ST11480
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The confidentiality and privacy of the participants' data are paramount, and sharing individual-level data could compromise their privacy. Therefore, the study does not include provisions for sharing IPD with other researchers.
Publications
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.
PubMed 36147984Sadeh-Sharvit S, Hollon SD. Leveraging the Power of Nondisruptive Technologies to Optimize Mental Health Treatment: Case Study. JMIR Ment Health. 2020 Nov 26;7(11):e20646. doi: 10.2196/20646.
PubMed 33242025Sadeh-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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI for All: Harnessing the Power of Artificial Intelligence in Mental Health Case Management
- ClinicalTrials.gov ID
- NCT06280170
- Acronym / sponsor ID
- ST11480
- Conditions
- Depressive Disorder, Anxiety Disorders, Substance Use Disorders, Post Traumatic Stress Disorder
- Keywords
- Case management, Artificial Intelligence, Provider productivity, Mental health services, Provider satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Eleos HealthIndustry (pharma, biotech, devices)
- Collaborators
- Centerstone Research Institute
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Feb 2024 (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 clinical trial is to assess the effectiveness of an artificial intelligence (AI) platform for case managers in a nonprofit health system specializing in mental health and substance use disorder. The main questions it aims to answer are:
- Is the AI platform acceptable and feasible for case managers?
- Does the AI platform improve providers' productivity and reported interventions? Participants will be approximately 30 case managers and their 250 adult clients receiving case management services. Researchers will compare the provider productivity and work satisfaction prior to the implementation of the AI platform to following its implementation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will follow a stepped-wedge, randomized controlled design, where each provider team will undergo two phases: SAU and the AI platform phase. All teams will initially start with SAU, and the AI platform will be sequentially introduced to teams over time. Teams will be randomly assigned to different time periods for the AI platform phase using simple randomization. The order of implementation will be determined by randomly selecting the number of the team from sealed envelopes every two months. In both phases, the study will enroll new and existing clients. At the end of the trial all teams would have used Eleos for a few months
| Arm | Type | Receives |
|---|---|---|
| Services-as-usual (SAU) | No intervention | –During the services-as-usual (SAU) phase of this study, providers will deliver the routine case management services offered by Centerstone and report these services in the usual way they do. |
| Artificial Intelligence (AI) | Experimental | Other: Artificial Intelligence platform for case managersOnce randomized to start using the AI-based platform for documenting their services, providers will have access to the Eleos Health platform, a secure and HIPAA-compliant tool specifically designed for documenting behavioral health encounters. This AI-powered platform enables providers to complete progress notes more quickly. Providers will complete the progress notes on their phones, and these notes will be integrated into the client's electronic health records. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must be adults.
- Participants must be receiving case management services from a Centerstone provider
Key exclusion criteria (2 listed)
- Participants currently involved in any other concurrent research study will be excluded to avoid potential confounding factors.
- Participants with any medical conditions or medications that may significantly interfere with the study outcomes will be excluded.
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 |
|---|---|---|
| Artificial Intelligence platform for case managersProviders will have access to the Eleos Health mobile AI platform to document their case management encounters. | Other | Artificial Intelligence (AI) |
Primary outcome
Case manager satisfaction
Time frame: Baseline, and 4 months after the rollout of the Eleos Health tool.
Providers will complete a self-report assessment about their experience providing case management services. Providers will be asked to (a) report the number of of hours spent on documentation per week; (b) respond on a Likert Scale (1-5, 1="Not at all" and 5="highly stressed" regarding their stress level about documentation; and (c) respond on a Likert scale 1-5 (1="Not at all satisfied", 5="Highly satisfied"), indicating their satisfaction with their current role as a case manager.
Case manager productivity
Time frame: 3 months before and 3 month after study start date
We will collect the number of encounters (i.e., case management visits provided) per month in the three months preceding the start of the study, and months 3-6 after the AI platform rollout.
Case manager note completion time
Time frame: 3 months before and 3 month after study start date
We will record progress note completion time by hours since the time of service delivery (average, standard deviation, and range).
1 secondary outcome
Clients' crisis services utilization
Time frame: 6 months before and 6 month after study start date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- 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 33242025Sadeh-Sharvit S, Hollon SD. Leveraging the Power of Nondisruptive Technologies to Optimize Mental Health Treatment: Case Study. JMIR Ment Health. 2020 Nov 26;7(11):e20646. doi: 10.2196/20646.
- Background: 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.
- Link to Eleos Health's science pageLink provided by the sponsor.
- Link to Centerstone Research InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: No. The confidentiality and privacy of the participants' data are paramount, and sharing individual-level data could compromise their privacy. Therefore, the study does not include provisions for sharing IPD with other researchers.
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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 Artificial Intelligence platform for case managers in people with Depressive Disorder 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 2 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: status not confirmed, as of the sponsor's last update on 28 Feb 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?
Results are not available in the source record.
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?
Case manager satisfaction (time frame: Baseline, and 4 months after the rollout of the Eleos Health tool.). The study lists 3 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 NCT06280170, which also lists 3 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 28 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.