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?

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Burnout; Anxiety; Wellness; Self Compassion
• Intervention / Treatment: Other: App-based bundled mental fitness intervention; Other: App-based wellness module collection

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johanna M Lee, MD; Phone Number: 201-421-7864; Email: jlee184@mgb.org
• Study Contact Backup: Name: Daniel Saddawi-Konefka, MD, MBA

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
      • Contact: Johanna Lee, MD; Phone Number: 201-421-7864; Email: jlee184@mgb.org
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
      • Contact: Johanna Lee, MD; Phone Number: 201-421-7864; Email: jlee184@mgb.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Current PGY4 anesthesiology resident at Massachusetts General Hospital or Brigham and Women's Hospital
2. 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 (for both residents and resident loved ones):

1. Inability to complete English-language questionnaires
2. Inability to access and use the intervention components (smartphone app/web platform)
3. Age <18 years
4. Concurrent participation in another interventional study designed to target mental fitness or wellbeing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PQ App; PQ bundled mental fitness intervention	Other: App-based 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.; Other Names: Wellness intervention; PQ App; Mental fitness intervention; Bundled mental fitness intervention; Positive Intelligence
Placebo Comparator: Control App; Time- and attention-matched control wellness app	Other: App-based wellness module collection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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; Weiner et al., 2017). 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; Weiner et al., 2017). 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; Weiner et al., 2017). 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-compassion	Self-Compassion Scale-Short Form (SCS-SF)	Change from enrollment to end of study up to 12 weeks after enrollment
Burnout	Abbreviated Maslach Burnout Inventory - General Survey (MBI-GS)	Change from enrollment to end of study up to 12 weeks after enrollment
Depressive symptoms	Patient Health Questionnaire-8 (PHQ-8)	Change from enrollment to end of study up to 12 weeks after enrollment
Anxiety symptoms	Generalized Anxiety Disorder 7 (GAD-7)	Change from enrollment to end of study up to 12 weeks after enrollment

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: depression; anxiety; positive psychology; wellness; burnout; graduate medical education; residents; self compassion; mental fitness; app-based intervention
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Stress, Psychological; Behavior; Burnout, Psychological; Anxiety Disorders; Depression
• Other Study ID Numbers: 2026P000564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No