A Study of a Mental Fitness Intervention for Anesthesiology Resident Wellbeing and Self-Compassion
A Pilot Randomized Controlled Trial of a Mental Fitness Intervention for Anesthesiology Resident Wellbeing and Self-Compassion
1 other identifier
interventional
60
1 country
2
Brief Summary
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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2026
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2026
CompletedFirst Posted
Study publicly available on registry
June 10, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
June 16, 2026
June 1, 2026
5 months
June 5, 2026
June 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Recruitment Rate
Percentage of eligible residents who consent to participate
Enrollment
Dyadic Enrollment Rate
Percentage of consenting residents who enroll a loved one
Enrollment
Retention Rate
Percentage of enrolled participants who complete the post-study assessment
At the end of the study, up to 12 weeks after enrollment
Adherence
Percent completion of weekly lessons and daily exercises
End of study up to 12 weeks after enrollment
Intervention Acceptability (Acceptability of Intervention Measure, AIM)
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)
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)
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
Net Promoter Score (NPS)
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
Secondary Outcomes (4)
Self-compassion
Change from enrollment to end of study up to 12 weeks after enrollment
Burnout
Change from enrollment to end of study up to 12 weeks after enrollment
Depressive symptoms
Change from enrollment to end of study up to 12 weeks after enrollment
Anxiety symptoms
Change from enrollment to end of study up to 12 weeks after enrollment
Study Arms (2)
PQ App
EXPERIMENTALPQ bundled mental fitness intervention
Control App
PLACEBO COMPARATORTime- and attention-matched control wellness app
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Current PGY4 anesthesiology resident at Massachusetts General Hospital or Brigham and Women's Hospital
- Willingness to provide informed consent
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (16)
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PMID: 29505159BACKGROUNDSpitzer 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: 16717171BACKGROUNDShanafelt 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: 27871627BACKGROUNDSun 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: 31166235BACKGROUNDSaddawi-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: 40810984BACKGROUNDNeff 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: 35961039BACKGROUNDKunselman 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: 38331310BACKGROUNDKroenke 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: 18752852BACKGROUNDBui 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.
PMID: 36375332BACKGROUNDBrowne 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.
PMID: 8532986BACKGROUNDBell 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.
PMID: 29403314BACKGROUNDDev 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.
PMID: 32435318BACKGROUNDWasson 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.
PMID: 32421083BACKGROUNDPuah 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.
PMID: 39374067BACKGROUNDDyrbye 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.
PMID: 24448053BACKGROUNDWeiner 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.
PMID: 28851459BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Daniel Saddawi-Konefka, MD, MBA
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Program Director, Anesthesiology Residency
Study Record Dates
First Submitted
June 5, 2026
First Posted
June 10, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
June 16, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share