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Набор скоро начнётся NCT07087119

Artificial Intelligence Powered Mental Health Support Tool For Physicians In Training

Без фазы С лечением Wellness, Psychological Mental Health Wellness 1

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: utilization of artificial intelligence powered mental health support session through a web browser.
Кому может быть актуально
Состояния в реестре: Wellness, Psychological, Mental Health Wellness 1. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Pilot Study: Exploring The Role Of an Artificial Intelligence Powered Mental Health Support Tool For Mental Health Wellness For Physicians In Training

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

  • Feasibility of using Artificial Intelligence sessions as a wellness resource [Срок оценки: 3 months]
Вторичные конечные точки (2)
  • Prevalence of depression and anxiety in training physicians [Срок оценки: 3 months]
  • Determine work-related and home-related factors that impact trainee mental health [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • Active treatment of severe and uncontrolled anxiety or depression with a health care professional
  • Unwilling and or unable to participate
  • Non-English speakers.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Cedars Sinai Medical Center — Los Angeles

Публикации

  • 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. PMID 11874311
  • 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/jamainternmed.2017.5138. PMID 29084311
  • 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/jama.2009.1389. PMID 19773564
  • 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/journal.pone.0226361. eCollection 2019. PMID 31830138

Идентификаторы

NCT: NCT07087119 · STUDY00003196

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗