A Pilot Randomized Controlled Trial of a Mental Fitness Intervention for Anesthesiology Resident Wellbeing and Self-Compassion

NCT07639827 | Not Yet Recruiting

• 1 other identifier: 2026P000564
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 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.

Conditions

Wellness; Self Compassion; Burnout; Anxiety; Depression

Keywords

mental fitness; wellness; self compassion; burnout; app-based intervention; residents; graduate medical education; positive psychology; anxiety; depression

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; 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 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

EXPERIMENTAL

PQ bundled mental fitness intervention

Other: App-based bundled mental fitness intervention

Control App

PLACEBO COMPARATOR

Time- and attention-matched control wellness app

Other: App-based wellness module collection

Interventions

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.

Also known as: PQ App, Wellness intervention, Mental fitness intervention, Bundled mental fitness intervention, Positive Intelligence

PQ App

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.

Control App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current PGY4 anesthesiology resident at Massachusetts General Hospital or Brigham and Women's Hospital
• Willingness to provide informed consent

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Burnout, Psychological; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Johanna M Lee, MD

CONTACT

201-421-7864; jlee184@mgb.org

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 (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)