A Study of a Mental Fitness Intervention for Anesthesiology Resident Wellbeing and Self-Compassion

Официальное название

A Pilot Randomized Controlled Trial of a Mental Fitness Intervention for Anesthesiology Resident Wellbeing and Self-Compassion

Обзор

The goal of this clinical trial is to learn if app-based wellness programs can help improve wellbeing and self-compassion for medical residents. This is a pilot study, which is done on a small group of people to learn if a larger study would be useful. The main questions it aims to answer are: 1. Are app-based wellness interventions feasible and acceptable in a high-stress population like medical residents? 2. Can app-based wellness programs improve wellbeing and self-compassion in medical residents? Researchers will compare the app-based wellness program to a time- and attention-matched control program. Participants will: * Complete online questionnaires at the start of the study and again after completion of the wellness program * Be assigned by chance (like a coin toss) to one of two different app-based programs, and will participate in the assigned program for 6 weeks. Both programs will involve weekly lessons and brief, daily exercises. Engagement with these exercises will not be mandatory but highly encouraged.

Вмешательства

• Другое App-based bundled mental fitness intervention
  A structured 6-week, self-guided program delivered via smartphone and web platform. Participants complete one video-based lesson per week and brief daily practice exercises lasting a few minutes each. The curriculum trains three core skills: recognizing recurring self-sabotaging patterns of thought and emotion; interrupting them through short attention-shifting exercises that redirect focus to present-moment sensory experience; and strengthening adaptive responses such as empathy, curiosity, per
• Другое App-based wellness module collection
  A structured 6-week comparison program delivered via smartphone and web platform, matched to the experimental arm in format, duration, and time commitment. Participants complete one lesson per week and brief daily activities of a few minutes each, mirroring the cadence of the active program. Content delivers general health and lifestyle education through didactic material and light reflective prompts. Unlike the experimental program, it does not train the targeted cognitive and emotional self-re

Первичные конечные точки

• Recruitment Rate [Срок оценки: Enrollment]
• Dyadic Enrollment Rate [Срок оценки: Enrollment]
• Retention Rate [Срок оценки: At the end of the study, up to 12 weeks after enrollment]
• Adherence [Срок оценки: End of study up to 12 weeks after enrollment]
• Intervention Acceptability (Acceptability of Intervention Measure, AIM) [Срок оценки: At the end of study up to 12 weeks after enrollment]
• Intervention Appropriateness (Intervention Appropriateness Measure, IAM) [Срок оценки: At the end of study up to 12 weeks after enrollment]
• Intervention Feasibility (Feasibility of Intervention Measure, FIM) [Срок оценки: At the end of study up to 12 weeks after enrollment]
• Net Promoter Score (NPS) [Срок оценки: At the end of study up to 12 weeks after enrollment]

Вторичные конечные точки (4)

• Self-compassion [Срок оценки: Change from enrollment to end of study up to 12 weeks after enrollment]
• Burnout [Срок оценки: Change from enrollment to end of study up to 12 weeks after enrollment]
• Depressive symptoms [Срок оценки: Change from enrollment to end of study up to 12 weeks after enrollment]
• Anxiety symptoms [Срок оценки: Change from enrollment to end of study up to 12 weeks after enrollment]

Критерии участия

Критерии включения

• Current PGY4 anesthesiology resident at Massachusetts General Hospital or Brigham and Women's Hospital
• Willingness to provide informed consent

Resident Loved One Inclusion Criteria

• The choice of a resident loved one will be at the discretion of the resident.
• This may include partners, family, friends or other loved ones.
• Only one individual per resident will be eligible to participate.
• Residents will be eligible to participate even if no loved one is identified.

Критерии исключения

• Inability to complete English-language questionnaires
• Inability to access and use the intervention components (smartphone app/web platform)
• Age <18 years
• Concurrent participation in another interventional study designed to target mental fitness or wellbeing

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

США · 2 центра

• Massachusetts General Hospital — Boston
• Brigham and Women's Hospital — Boston

Публикации

• West CP, Dyrbye LN, Shanafelt TD. Physician burnout: contributors, consequences and solutions. J Intern Med. 2018 Jun;283(6):516-529. doi: 10.1111/joim.12752. Epub 2018 Mar 24. PMID 29505159
• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. PMID 16717171
• Shanafelt TD, Noseworthy JH. Executive Leadership and Physician Well-being: Nine Organizational Strategies to Promote Engagement and Reduce Burnout. Mayo Clin Proc. 2017 Jan;92(1):129-146. doi: 10.1016/j.mayocp.2016.10.004. Epub 2016 Nov 18. PMID 27871627
• Sun H, Warner DO, Macario A, Zhou Y, Culley DJ, Keegan MT. Repeated Cross-sectional Surveys of Burnout, Distress, and Depression among Anesthesiology Residents and First-year Graduates. Anesthesiology. 2019 Sep;131(3):668-677. doi: 10.1097/ALN.0000000000002777. PMID 31166235
• Saddawi-Konefka D, Moutier CY, Ehrenfeld JM. Reducing Barriers to Mental Health Care for Physicians: An Overview and Strategic Recommendations. JAMA. 2025 Aug 14. doi: 10.1001/jama.2025.12587. Online ahead of print. PMID 40810984
• Neff KD. Self-Compassion: Theory, Method, Research, and Intervention. Annu Rev Psychol. 2023 Jan 18;74:193-218. doi: 10.1146/annurev-psych-032420-031047. Epub 2022 Aug 12. PMID 35961039
• Kunselman AR. A brief overview of pilot studies and their sample size justification. Fertil Steril. 2024 Jun;121(6):899-901. doi: 10.1016/j.fertnstert.2024.01.040. Epub 2024 Feb 6. PMID 38331310
• Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27. PMID 18752852

Идентификаторы

NCT: NCT07639827 · 2026P000564

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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