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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:
Researchers will compare the app-based wellness program to a time- and attention-matched control program.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PQ App | Experimental | PQ bundled mental fitness intervention |
|
| Control App | Placebo Comparator | Time- and attention-matched control wellness app |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App-based bundled mental fitness intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from enrollment to end of study up to 12 weeks after enrollment |
| Burnout |
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Inclusion Criteria:
Resident Loved One Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johanna M Lee, MD | Contact | 201-421-7864 | jlee184@mgb.org | |
| Daniel Saddawi-Konefka, MD, MBA | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29505159 | Background | 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. | |
| 16717171 | Background | 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. |
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|
|
| App-based wellness module collection | Other | 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. |
|
| 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 |
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 |
| Depressive symptoms | 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 | 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 |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
|
| 27871627 | Background | 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. |
| 31166235 | Background | 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. |
| 40810984 | Background | 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. |
| 35961039 | Background | 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. |
| 38331310 | Background | 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. |
| 18752852 | Background | 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. |
| 36375332 | Background | 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. |
| 8532986 | Background | 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. |
| 29403314 | Background | 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. |
| 32435318 | Background | 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. |
| 32421083 | Background | 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. |
| 39374067 | Background | 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. |
| 24448053 | Background | 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. |
| 28851459 | Background | 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. |
| ID | Term |
|---|---|
| D000077062 | Burnout, Psychological |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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