A Study of a Mental Fitness Intervention for Anesthesiology Resident Wellbeing and Self-Compassion
2026年6月13日 更新者：Johanna Lee、Massachusetts General Hospital
A Pilot Randomized Controlled Trial of a Mental Fitness Intervention for Anesthesiology Resident Wellbeing and Self-Compassion
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:
- Are app-based wellness interventions feasible and acceptable in a high-stress population like medical residents?
- 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.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Johanna M Lee, MD
- 電話番号：201-421-7864
- メール：jlee184@mgb.org
研究連絡先のバックアップ
- 名前：Daniel Saddawi-Konefka, MD, MBA
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Brigham and Women's Hospital
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コンタクト：
- Johanna Lee, MD
- 電話番号：201-421-7864
- メール：jlee184@mgb.org
-
Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
-
コンタクト：
- Johanna Lee, MD
- 電話番号：201-421-7864
- メール：jlee184@mgb.org
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：PQ App
PQ bundled mental fitness intervention
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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, perspective-taking, and decisive action.
The approach draws on cognitive-behavioral, mindfulness, and positive-psychology principles, with daily repetition intended to build durable habits.
Lessons build cumulatively across the six weeks.
Daily and weekly engagement is encouraged but not required.
Participants may optionally invite one loved one to take part alongside them.
他の名前：
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プラセボコンパレーター：Control App
Time- and attention-matched control wellness app
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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-regulation skills (recognizing self-sabotaging patterns, attention-shifting practice, or deliberate cultivation of adaptive responses).
This holds participant time and attention constant across arms so the trial can isolate the effect of the active components.
Daily and weekly engagement is encouraged but not required.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment Rate
時間枠：Enrollment
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Percentage of eligible residents who consent to participate
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Enrollment
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Dyadic Enrollment Rate
時間枠：Enrollment
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Percentage of consenting residents who enroll a loved one
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Enrollment
|
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Retention Rate
時間枠：At the end of the study, up to 12 weeks after enrollment
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Percentage of enrolled participants who complete the post-study assessment
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At the end of the study, up to 12 weeks after enrollment
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Adherence
時間枠：End of study up to 12 weeks after enrollment
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Percent completion of weekly lessons and daily exercises
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End of study up to 12 weeks after enrollment
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Net Promoter Score (NPS)
時間枠：At the end of study up to 12 weeks after enrollment
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Single-item likelihood of recommending the assigned program, rated from 0 to 10. Reported as the Net Promoter Score (percentage of promoters [9-10] minus percentage of detractors [0-6]), which ranges from -100 to +100.
Administered to both arms.
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At the end of study up to 12 weeks after enrollment
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Intervention Acceptability (Acceptability of Intervention Measure, AIM)
時間枠：At the end of study up to 12 weeks after enrollment
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Acceptability of the assigned program, measured with the 4-item Acceptability of Intervention Measure (AIM).
Each item is rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree).
The mean score ranges from 1 to 5, with higher scores indicating greater acceptability.
Administered to both arms.
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At the end of study up to 12 weeks after enrollment
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Intervention Appropriateness (Intervention Appropriateness Measure, IAM)
時間枠：At the end of study up to 12 weeks after enrollment
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Perceived appropriateness and fit of the assigned program, measured with the 4-item Intervention Appropriateness Measure (IAM).
Each item is rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree).
The mean score ranges from 1 to 5, with higher scores indicating greater perceived appropriateness.
Administered to both arms.
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At the end of study up to 12 weeks after enrollment
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Intervention Feasibility (Feasibility of Intervention Measure, FIM)
時間枠：At the end of study up to 12 weeks after enrollment
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Perceived feasibility of the assigned program, measured with the 4-item Feasibility of Intervention Measure (FIM).
Each item is rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree).
The mean score ranges from 1 to 5, with higher scores indicating greater perceived feasibility.
Administered to both arms.
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At the end of study up to 12 weeks after enrollment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Self-compassion
時間枠：Change from enrollment to end of study up to 12 weeks after enrollment
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Self-Compassion Scale-Short Form (SCS-SF): Score is calculated by computing the mean of the six subscale means.
Minimum score 1, maximum score 5. Higher scores indicate high self-compassion.
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Change from enrollment to end of study up to 12 weeks after enrollment
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Burnout
時間枠：Change from enrollment to end of study up to 12 weeks after enrollment
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Single-item measures of emotional exhaustion and depersonalization, modified from Maslach Burnout Inventory.
Minimum score 0, maximum score 84.
Higher scores associated with more burnout.
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Change from enrollment to end of study up to 12 weeks after enrollment
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Depressive symptoms
時間枠：Change from enrollment to end of study up to 12 weeks after enrollment
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Patient Health Questionnaire-8 (PHQ-8).
Minimum score 0, maximum score 24.
Higher scores associated with more depressive symptoms.
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Change from enrollment to end of study up to 12 weeks after enrollment
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Anxiety symptoms
時間枠：Change from enrollment to end of study up to 12 weeks after enrollment
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Generalized Anxiety Disorder 7 (GAD-7).
Minimum score 0, maximum score 21.
Higher scores associated with more anxiety symptoms.
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Change from enrollment to end of study up to 12 weeks after enrollment
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Bell ML, Whitehead AL, Julious SA. Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clin Epidemiol. 2018 Jan 18;10:153-157. doi: 10.2147/CLEP.S146397. eCollection 2018.
- 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.
- Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- 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.
- Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933-40. doi: 10.1002/sim.4780141709.
- Dyrbye LN, West CP, Satele D, Boone S, Tan L, Sloan J, Shanafelt TD. Burnout among U.S. medical students, residents, and early career physicians relative to the general U.S. population. Acad Med. 2014 Mar;89(3):443-51. doi: 10.1097/ACM.0000000000000134.
- 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.
- 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.
- Wasson RS, Barratt C, O'Brien WH. Effects of Mindfulness-Based Interventions on Self-compassion in Health Care Professionals: a Meta-analysis. Mindfulness (N Y). 2020;11(8):1914-1934. doi: 10.1007/s12671-020-01342-5. Epub 2020 Mar 5.
- 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.
- 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.
- 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.
- 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.
- Bui D, Winegarner A, Kendall MC, Almeida M, Apruzzese P, De Oliveira G. Burnout and depression among anesthesiology trainees in the United States: An updated National Survey. J Clin Anesth. 2023 Feb;84:110990. doi: 10.1016/j.jclinane.2022.110990. Epub 2022 Nov 11.
- Dev V, Fernando AT 3rd, Consedine NS. Self-compassion as a Stress Moderator: A Cross-sectional Study of 1700 Doctors, Nurses, and Medical Students. Mindfulness (N Y). 2020;11(5):1170-1181. doi: 10.1007/s12671-020-01325-6. Epub 2020 Feb 11.
- Puah S, Pua CY, Shi J, Lim SM. The Effectiveness of a Digital Mental Fitness Program (Positive Intelligence) on Perceived Stress, Self-Compassion, and Ruminative Thinking of Occupational Therapy Undergraduate Students: Longitudinal Study. J Med Internet Res. 2024 Oct 7;26:e49505. doi: 10.2196/49505.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2027年1月1日
研究の完了 (推定)
2027年1月1日
試験登録日
最初に提出
2026年6月5日
QC基準を満たした最初の提出物
2026年6月5日
最初の投稿 (実際)
2026年6月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月16日
QC基準を満たした最後の更新が送信されました
2026年6月13日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。