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WellnessNCT07639827

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

A study testing App-based bundled mental fitness intervention and App-based wellness module collection in people with Wellness and Self Compassion, run by Massachusetts General Hospital at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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: 1. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Wellness, Self Compassion, Burnout
What is being tested?
App-based bundled mental fitness intervention and App-based wellness module collection
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
2 sitesUnited States
Study dates
Aug 2026to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Johanna M Lee, MD contact

201-421-7864

jlee184@mgb.org

Daniel Saddawi-Konefka, MD, MBA contact

United States2 sites
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Johanna Lee, MD, 201-421-7864, jlee184@mgb.org

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Johanna Lee, MD, 201-421-7864, jlee184@mgb.org

Other trials in United States

About this study

Official title: 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:

  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?
Read more

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.
Being tested
App-based bundled mental fitness intervention, App-based wellness module collection
Keywords
mental fitness, wellness, self compassion, burnout, app-based intervention, residents, graduate medical education, positive psychology, anxiety, depression
Medical subject headings
Burnout, Psychological, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • App-based bundled mental fitness interventionOther

    Also called PQ App, Wellness intervention, Mental fitness intervention, 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.

  • App-based wellness module collectionOther

    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.

Study groups in NCT07639827
Study groupRoleWhat they receive
PQ AppExperimentalPQ bundled mental fitness intervention
Receives: Other: App-based bundled mental fitness intervention
Control AppPlacebo comparatorTime- and attention-matched control wellness app
Receives: Other: App-based wellness module collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

    Percentage of eligible residents who consent to participate

    Measured: Enrollment

  2. Dyadic Enrollment Rate

    Percentage of consenting residents who enroll a loved one

    Measured: Enrollment

  3. Retention Rate

    Percentage of enrolled participants who complete the post-study assessment

    Measured: At the end of the study, up to 12 weeks after enrollment

  4. Adherence

    Percent completion of weekly lessons and daily exercises

    Measured: End of study up to 12 weeks after enrollment

  5. 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.

    Measured: At the end of study up to 12 weeks after enrollment

  6. 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.

    Measured: At the end of study up to 12 weeks after enrollment

  7. 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.

    Measured: At the end of study up to 12 weeks after enrollment

  8. 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.

    Measured: At the end of study up to 12 weeks after enrollment

Secondary outcomes (4)
  1. Self-compassion

    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.

    Measured: Change from enrollment to end of study up to 12 weeks after enrollment

  2. Burnout

    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.

    Measured: Change from enrollment to end of study up to 12 weeks after enrollment

  3. Depressive symptoms

    Patient Health Questionnaire-8 (PHQ-8). Minimum score 0, maximum score 24. Higher scores associated with more depressive symptoms.

    Measured: Change from enrollment to end of study up to 12 weeks after enrollment

  4. Anxiety symptoms

    Generalized Anxiety Disorder 7 (GAD-7). Minimum score 0, maximum score 21. Higher scores associated with more anxiety symptoms.

    Measured: Change from enrollment to end of study up to 12 weeks after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07639827
Sponsor's protocol ID
2026P000564
Status last verified
Jun 2026
First submitted
5 Jun 2026
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 18752852
  • 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.

    PubMed 36375332
  • 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.

    PubMed 8532986
  • 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.

    PubMed 29403314
  • 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.

    PubMed 32435318
  • 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.

    PubMed 32421083
  • 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.

    PubMed 39374067
  • 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.

    PubMed 24448053

Questions about this trial

What is this clinical trial studying?

A study testing App-based bundled mental fitness intervention and App-based wellness module collection in people with Wellness and Self Compassion, run by Massachusetts General Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Johanna M Lee, MD (201-421-7864, jlee184@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: Enrollment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07639827, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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