Wellness, PsychologicalNCT07087119
Artificial Intelligence Powered Mental Health Support Tool For Physicians In Training
A study testing utilization of artificial intelligence powered mental health support session through a web browser in people with Wellness, Psychological and Mental Health Wellness 1, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate the acceptability of an artificial intelligence powered mental health support tool for mental health wellness amongst physicians in training. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wellness, Psychological, Mental Health Wellness 1
- What is being tested?
- utilization of artificial intelligence powered mental health support session through a web browser
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Individuals 18 years old or older are included.
- Training physicians in Internal Medicine residency and Gastroenterology fellowship at Cedars Sinai.
- Study is limited to Cedars-Sinai employees who are known to speak English.
Who cannot join
- Active treatment of severe and uncontrolled anxiety or depression with a health care professional
- Unwilling and or unable to participate
- Non-English speakers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Barbara Hollander, MD contact
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Pilot Study: Exploring The Role Of an Artificial Intelligence Powered Mental Health Support Tool For Mental Health Wellness For Physicians In Training
The purpose of this pilot study is to evaluate the acceptability of an artificial intelligence powered mental health support tool for mental health wellness amongst physicians in training.
The primary research procedures are:
Read more
The primary research procedure will be the utilization of artificial intelligence powered mental health support session through a web browser for physicians in training to address symptoms related to depression and anxiety. A pre and post intervention survey, evaluating depression symptoms with the standardized PHQ-9 questionnaire and anxiety symptoms with the standardized GAD-7 questionnaire will be conducted to assess changes in mental health wellness.
The study will enroll physicians in training, including Internal Medicine residents and Gastroenterology fellows.
The study includes at least 4 sessions. The total study duration for each subject is 3 months.
Read the detailed description
This is a prospective pilot study with internal medicine residents and gastroenterology fellows to evaluate the role of AI mental health support tool as a wellness resource.
Participants will be invited via e-mail to participate in the study. The invitation e-mail will describe the study and ask that those who meet exclusion criteria do not participate in this pilot study. The e-mail will also include a file with information of the study for participants to review including how study members are blinded and the de-coding process required for participants to be contacted by a study member should they score >15 on PHQ-9 and or >10 on GAD-7. Those who choose to participate will be asked to email a study member who will send the participants a REDCap link to the consent, survey and a code to be used in the survey.
Participants will be asked to complete a set of questionnaires to evaluate their mental health and factors that contribute to mental health as well as four AI powered mental health support sessions over a four-week period. This will conclude the active phase of their participations. Participants will then be sent a questionnaire at 3 months from study initiation to complete a questionnaire evaluating their mental health and if they would be interested in additional AI powered mental health support sessions.
The questionnaires will be administered before the AI sessions and at the end of the study period to evaluate for changes in mental health scores. The questionnaires will include the validated PHQ-9 for a standardized depression score and the GAD-7 for a standardized anxiety score to evaluate symptoms related to depression and anxiety. In addition, a set of questions will focus on demographics, work and home environment to evaluate factors that may contribute to mental health prior to the AI sessions and a set of questions related to the AI sessions at the end of the study period. The questionnaire will be administered via REDCap.
The AI powered sessions will be administered via a web browser such as a computer, laptop, tablets or cellphone. Participants can complete the session in the privacy of their home or in a private location at work such as a call-room. Participants will be asked to complete one 20-minute session per week during the 4-week study period for a total of four sessions.
The AI program used will be the XAIA software program. Participants will be sent an email with the link to use the XAIA software. This includes a tutorial on how to use XAIA.
The duration of the study session is 4 weeks and total duration of the study is three months.
The study will be conducted at one site only, Cedars-Sinai or participants may conduct the sessions at the privacy of their own home.
- Conditions
- Wellness, Psychological, Mental Health Wellness 1
- Being tested
- utilization of artificial intelligence powered mental health support session through a web browser
- Keywords
- artificial intelligence, physician in training, mental health, wellness
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
utilization of artificial intelligence powered mental health support session through a web browserBehavioural
utilization of artificial intelligence powered mental health support session with the software XAIA through a web browser for physicians in training to address symptoms related to depression and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| physicians in training will enroll with maintained privacy into just the study group | Experimental | Participants will be able to engage in artificial intelligence powered mental health support session through a web browser in private sessions Receives: Behavioral: utilization of artificial intelligence powered mental health support session through a web browser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using Artificial Intelligence sessions as a wellness resource
Investigators will evaluate the percentage of participants who find the Artificial Intelligence Sessions to be easily accessible and helpful.
Measured: 3 months
Secondary outcomes (2)
Prevalence of depression and anxiety in training physicians
Determine the % of participants who have symptoms of depression and anxiety in training
Measured: 3 months
Determine work-related and home-related factors that impact trainee mental health
Evaluate percentage of participants who have work-related and home-related factors impacting mental health
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start21 Jul 2025 (estimated)
- Primary completion20 Jun 2026 (estimated)
- Study completionDec 2026 (estimated)
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 Wellness, PsychologicalStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kavya Reddy, Cedars-Sinai Medical Center
- Investigators
- Kavya Reddy, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087119
- Sponsor's protocol ID
- STUDY00003196
- Status last verified
- Jul 2025
- First submitted
- 9 Jun 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant privacy
Publications
Collier VU, McCue JD, Markus A, Smith L. Stress in medical residency: status quo after a decade of reform? Ann Intern Med. 2002 Mar 5;136(5):384-90. doi: 10.7326/0003-4819-136-5-200203050-00011.
PubMed 11874311Guille C, Frank E, Zhao Z, Kalmbach DA, Nietert PJ, Mata DA, Sen S. Work-Family Conflict and the Sex Difference in Depression Among Training Physicians. JAMA Intern Med. 2017 Dec 1;177(12):1766-1772. doi: 10.1001/jamainternmed.2017.5138.
PubMed 29084311West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009 Sep 23;302(12):1294-300. doi: 10.1001/jama.2009.1389.
PubMed 19773564Dutheil F, Aubert C, Pereira B, Dambrun M, Moustafa F, Mermillod M, Baker JS, Trousselard M, Lesage FX, Navel V. Suicide among physicians and health-care workers: A systematic review and meta-analysis. PLoS One. 2019 Dec 12;14(12):e0226361. doi: 10.1371/journal.pone.0226361. eCollection 2019.
PubMed 31830138
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Exploring The Role Of an Artificial Intelligence Powered Mental Health Support Tool For Mental Health Wellness For Physicians In Training
- ClinicalTrials.gov ID
- NCT07087119
- Acronym / sponsor ID
- STUDY00003196
- Conditions
- Wellness, Psychological, Mental Health Wellness 1
- Keywords
- artificial intelligence, physician in training, mental health, wellness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 21 Jul 2025 (estimated)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jul 2025 (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 purpose of this pilot study is to evaluate the acceptability of an artificial intelligence powered mental health support tool for mental health wellness amongst physicians in training.
The primary research procedures are:
The primary research procedure will be the utilization of artificial intelligence powered mental health support session through a web browser for physicians in training to address symptoms related to depression and anxiety. A pre and post intervention survey, evaluating depression symptoms with the standardized PHQ-9 questionnaire and anxiety symptoms with the standardized GAD-7 questionnaire will be conducted to assess changes in mental health wellness.
The study will enroll physicians in training, including Internal Medicine residents and Gastroenterology fellows.
The study includes at least 4 sessions. The total study duration for each subject is 3 months.
Detailed description
This is a prospective pilot study with internal medicine residents and gastroenterology fellows to evaluate the role of AI mental health support tool as a wellness resource.
Participants will be invited via e-mail to participate in the study. The invitation e-mail will describe the study and ask that those who meet exclusion criteria do not participate in this pilot study. The e-mail will also include a file with information of the study for participants to review including how study members are blinded and the de-coding process required for participants to be contacted by a study member should they score >15 on PHQ-9 and or >10 on GAD-7. Those who choose to participate will be asked to email a study member who will send the participants a REDCap link to the consent, survey and a code to be used in the survey.
Participants will be asked to complete a set of questionnaires to evaluate their mental health and factors that contribute to mental health as well as four AI powered mental health support sessions over a four-week period. This will conclude the active phase of their participations. Participants will then be sent a questionnaire at 3 months from study initiation to complete a questionnaire evaluating their mental health and if they would be interested in additional AI powered mental health support sessions.
The questionnaires will be administered before the AI sessions and at the end of the study period to evaluate for changes in mental health scores. The questionnaires will include the validated PHQ-9 for a standardized depression score and the GAD-7 for a standardized anxiety score to evaluate symptoms related to depression and anxiety. In addition, a set of questions will focus on demographics, work and home environment to evaluate factors that may contribute to mental health prior to the AI sessions and a set of questions related to the AI sessions at the end of the study period. The questionnaire will be administered via REDCap.
The AI powered sessions will be administered via a web browser such as a computer, laptop, tablets or cellphone. Participants can complete the session in the privacy of their home or in a private location at work such as a call-room. Participants will be asked to complete one 20-minute session per week during the 4-week study period for a total of four sessions.
The AI program used will be the XAIA software program. Participants will be sent an email with the link to use the XAIA software. This includes a tutorial on how to use XAIA.
The duration of the study session is 4 weeks and total duration of the study is three months.
The study will be conducted at one site only, Cedars-Sinai or participants may conduct the sessions at the privacy of their own home.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| physicians in training will enroll with maintained privacy into just the study group | Experimental | Behavioral: utilization of artificial intelligence powered mental health support session through a web browserParticipants will be able to engage in artificial intelligence powered mental health support session through a web browser in private sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals 18 years old or older are included.
- Training physicians in Internal Medicine residency and Gastroenterology fellowship at Cedars Sinai.
- Study is limited to Cedars-Sinai employees who are known to speak English.
Key exclusion criteria (3 listed)
- Active treatment of severe and uncontrolled anxiety or depression with a health care professional
- Unwilling and or unable to participate
- Non-English speakers.
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 |
|---|---|---|
| utilization of artificial intelligence powered mental health support session through a web browserutilization of artificial intelligence powered mental health support session with the software XAIA through a web browser for physicians in training to address symptoms related to depression and anxiety. | Behavioural | physicians in training will enroll with maintained privacy into just the study group |
Primary outcome
Feasibility of using Artificial Intelligence sessions as a wellness resource
Time frame: 3 months
Investigators will evaluate the percentage of participants who find the Artificial Intelligence Sessions to be easily accessible and helpful.
2 secondary outcomes
Prevalence of depression and anxiety in training physicians
Time frame: 3 months
Determine work-related and home-related factors that impact trainee mental health
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Background: PubMed 11874311Collier VU, McCue JD, Markus A, Smith L. Stress in medical residency: status quo after a decade of reform? Ann Intern Med. 2002 Mar 5;136(5):384-90. doi: 10.7326/0003-4819-136-5-200203050-00011.
- Background: PubMed 29084311Guille C, Frank E, Zhao Z, Kalmbach DA, Nietert PJ, Mata DA, Sen S. Work-Family Conflict and the Sex Difference in Depression Among Training Physicians. JAMA Intern Med. 2017 Dec 1;177(12):1766-1772. doi: 10.1001/jamainternmed.2017.5138.
- Background: PubMed 19773564West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009 Sep 23;302(12):1294-300. doi: 10.1001/jama.2009.1389.
- Background: PubMed 31830138Dutheil F, Aubert C, Pereira B, Dambrun M, Moustafa F, Mermillod M, Baker JS, Trousselard M, Lesage FX, Navel V. Suicide among physicians and health-care workers: A systematic review and meta-analysis. PLoS One. 2019 Dec 12;14(12):e0226361. doi: 10.1371/journal.pone.0226361. eCollection 2019.
- Individual participant dataSharing planned: No. Participant privacy
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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.
Barbara Hollander, MD contact
Kavya Reddy, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing utilization of artificial intelligence powered mental health support session through a web browser in people with Wellness, Psychological and Mental Health Wellness 1, run by Cedars-Sinai Medical Center 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 3 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: opening soon, as of the sponsor's last update on 25 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kavya Reddy, MD ((310) 423-2811, kavya.reddy@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of using Artificial Intelligence sessions as a wellness resource (time frame: 3 months). 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 NCT07087119, 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 25 Jul 2025.