[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07087119":3,"trial-entities:NCT07087119":106,"trial-summary:NCT07087119":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":45,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":66,"locations":69,"central_contacts":79,"overall_officials":88,"references":91,"see_also_links":105},"NCT07087119","STUDY00003196","Artificial Intelligence Powered Mental Health Support Tool For Physicians In Training","A Pilot Study: Exploring The Role Of an Artificial Intelligence Powered Mental Health Support Tool For Mental Health Wellness For Physicians In Training","NOT_YET_RECRUITING","2026-12","2025-07","2025-07-25","2025-07-21","Cedars-Sinai Medical Center","OTHER",false,"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.\n\nThe primary research procedures are:\n\nThe 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.\n\nThe study will enroll physicians in training, including Internal Medicine residents and Gastroenterology fellows.\n\nThe study includes at least 4 sessions. The total study duration for each subject is 3 months.","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.\n\nParticipants 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.\n\nParticipants 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nThe duration of the study session is 4 weeks and total duration of the study is three months.\n\nThe study will be conducted at one site only, Cedars-Sinai or participants may conduct the sessions at the privacy of their own home.",[19,20],"Wellness, Psychological","Mental Health Wellness 1",[22,23,24,25],"artificial intelligence","physician in training","mental health","wellness","INTERVENTIONAL","SUPPORTIVE_CARE",[29],"NA",{"count":31,"type":32},20,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","utilization of artificial intelligence powered mental health support session through a web browser","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.",[39],"physicians in training will enroll with maintained privacy into just the study group",[41],{"measure":42,"description":43,"timeFrame":44},"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.","3 months",[46,49],{"measure":47,"description":48,"timeFrame":44},"Prevalence of depression and anxiety in training physicians","Determine the % of participants who have symptoms of depression and anxiety in training",{"measure":50,"description":51,"timeFrame":44},"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","ALL","18 Years",null,true,{"inclusion":57,"exclusion":61,"raw_text":65},[58,59,60],"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.",[62,63,64],"Active treatment of severe and uncontrolled anxiety or depression with a health care professional","Unwilling and or unable to participate","Non-English speakers.","Inclusion Criteria:\n\n* Individuals 18 years old or older are included.\n* Training physicians in Internal Medicine residency and Gastroenterology fellowship at Cedars Sinai.\n* Study is limited to Cedars-Sinai employees who are known to speak English.\n\nExclusion Criteria:\n\n* Active treatment of severe and uncontrolled anxiety or depression with a health care professional\n* Unwilling and or unable to participate\n* Non-English speakers.",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":71,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"Cedars Sinai Medical Center","Los Angeles","California","90048","United States",{"lat":77,"lon":78},34.05223,-118.24368,[80,85],{"name":81,"role":82,"phone":83,"email":84},"Kavya Reddy, MD","CONTACT","(310) 423-2811","kavya.reddy@cshs.org",{"name":86,"role":82,"email":87},"Barbara Hollander, MD","barbara.hollander@cshs.org",[89],{"name":81,"affiliation":13,"role":90},"PRINCIPAL_INVESTIGATOR",[92,96,99,102],{"pmid":93,"type":94,"citation":95},"11874311","BACKGROUND","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\u002F0003-4819-136-5-200203050-00011.",{"pmid":97,"type":94,"citation":98},"29084311","Guille 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\u002Fjamainternmed.2017.5138.",{"pmid":100,"type":94,"citation":101},"19773564","West 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\u002Fjama.2009.1389.",{"pmid":103,"type":94,"citation":104},"31830138","Dutheil 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\u002Fjournal.pone.0226361. eCollection 2019.",[],{"nct_id":4,"conditions":107,"biomarkers":110},[108,109],"Anxiety","Depression",[],{"nct_id":4,"found":55,"summary":112,"prompt_version":122},{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is a pilot study involving about 20 participants. It is a prospective study, meaning participants are followed forward in time.","completed","AI-Powered Mental Health Support for Physicians in Training","This study is testing an artificial intelligence (AI) tool called XAIA, which provides mental health support through a web browser. It's designed for physicians in training to help with symptoms of depression and anxiety. The main goal is to see if this AI tool is a practical and acceptable resource for wellness. You could join if you are an Internal Medicine resident or Gastroenterology fellow at Cedars-Sinai, are 18 or older, and speak English. The study is currently unclear on its recruitment status.","Participants will be followed for 3 months after starting the study to assess mental health changes and interest in further AI support.",83,"You would complete questionnaires before and after using the AI tool, and use the AI tool for four sessions over a four-week period. You will also complete a follow-up questionnaire at 3 months.","Not stated in the trial record.",[],"v2"]