A Study of a Mental Fitness Intervention for Anesthesiology Resident Wellbeing and Self-Compassion
13. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Johanna M Lee, MD
- Telefonnummer: 201-421-7864
- E-post: jlee184@mgb.org
Studer Kontakt Backup
- Navn: Daniel Saddawi-Konefka, MD, MBA
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02115
- Brigham and Women's Hospital
-
Ta kontakt med:
- Johanna Lee, MD
- Telefonnummer: 201-421-7864
- E-post: jlee184@mgb.org
-
Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
-
Ta kontakt med:
- Johanna Lee, MD
- Telefonnummer: 201-421-7864
- E-post: jlee184@mgb.org
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
Andre navn:
|
|
Placebo komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment Rate
Tidsramme: Enrollment
|
Percentage of eligible residents who consent to participate
|
Enrollment
|
|
Dyadic Enrollment Rate
Tidsramme: Enrollment
|
Percentage of consenting residents who enroll a loved one
|
Enrollment
|
|
Retention Rate
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.
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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)
Tidsramme: 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)
Tidsramme: 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
|
|
Intervention Feasibility (Feasibility of Intervention Measure, FIM)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-compassion
Tidsramme: 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
|
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Burnout
Tidsramme: 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
Tidsramme: 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
|
|
Anxiety symptoms
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. august 2026
Primær fullføring (Antatt)
1. januar 2027
Studiet fullført (Antatt)
1. januar 2027
Datoer for studieregistrering
Først innsendt
5. juni 2026
Først innsendt som oppfylte QC-kriteriene
5. juni 2026
Først lagt ut (Faktiske)
10. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026P000564
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