A Study of a Mental Fitness Intervention for Anesthesiology Resident Wellbeing and Self-Compassion
13 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Johanna M Lee, MD
- Numéro de téléphone: 201-421-7864
- E-mail: jlee184@mgb.org
Sauvegarde des contacts de l'étude
- Nom: Daniel Saddawi-Konefka, MD, MBA
Lieux d'étude
-
-
Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Brigham and Women's Hospital
-
Contact:
- Johanna Lee, MD
- Numéro de téléphone: 201-421-7864
- E-mail: jlee184@mgb.org
-
Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
-
Contact:
- Johanna Lee, MD
- Numéro de téléphone: 201-421-7864
- E-mail: jlee184@mgb.org
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: PQ App
PQ 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, 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.
Autres noms:
|
|
Comparateur placebo: Control App
Time- and attention-matched control wellness app
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Recruitment Rate
Délai: Enrollment
|
Percentage of eligible residents who consent to participate
|
Enrollment
|
|
Dyadic Enrollment Rate
Délai: Enrollment
|
Percentage of consenting residents who enroll a loved one
|
Enrollment
|
|
Retention Rate
Délai: At the end of the study, up to 12 weeks after enrollment
|
Percentage of enrolled participants who complete the post-study assessment
|
At the end of the study, up to 12 weeks after enrollment
|
|
Adherence
Délai: End of study up to 12 weeks after enrollment
|
Percent completion of weekly lessons and daily exercises
|
End of study up to 12 weeks after enrollment
|
|
Net Promoter Score (NPS)
Délai: At the end of study up to 12 weeks after enrollment
|
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.
|
At the end of study up to 12 weeks after enrollment
|
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Intervention Acceptability (Acceptability of Intervention Measure, AIM)
Délai: At the end of study up to 12 weeks after enrollment
|
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.
|
At the end of study up to 12 weeks after enrollment
|
|
Intervention Appropriateness (Intervention Appropriateness Measure, IAM)
Délai: At the end of study up to 12 weeks after enrollment
|
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.
|
At the end of study up to 12 weeks after enrollment
|
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Intervention Feasibility (Feasibility of Intervention Measure, FIM)
Délai: At the end of study up to 12 weeks after enrollment
|
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.
|
At the end of study up to 12 weeks after enrollment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Self-compassion
Délai: Change from enrollment to end of study up to 12 weeks after enrollment
|
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.
|
Change from enrollment to end of study up to 12 weeks after enrollment
|
|
Burnout
Délai: Change from enrollment to end of study up to 12 weeks after enrollment
|
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.
|
Change from enrollment to end of study up to 12 weeks after enrollment
|
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Depressive symptoms
Délai: Change from enrollment to end of study up to 12 weeks after enrollment
|
Patient Health Questionnaire-8 (PHQ-8).
Minimum score 0, maximum score 24.
Higher scores associated with more depressive symptoms.
|
Change from enrollment to end of study up to 12 weeks after enrollment
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Anxiety symptoms
Délai: Change from enrollment to end of study up to 12 weeks after enrollment
|
Generalized Anxiety Disorder 7 (GAD-7).
Minimum score 0, maximum score 21.
Higher scores associated with more anxiety symptoms.
|
Change from enrollment to end of study up to 12 weeks after enrollment
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
1 janvier 2027
Achèvement de l'étude (Estimé)
1 janvier 2027
Dates d'inscription aux études
Première soumission
5 juin 2026
Première soumission répondant aux critères de contrôle qualité
5 juin 2026
Première publication (Réel)
10 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026P000564
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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