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CompletedNCT06914843Updated May 11, 2026

Digital Intervention to Promote Medical Trainee Well-being (OptimalWork Pilot)

An interventional study of OptimalWork and Podcast Listening in Mental Health Wellness 1, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Sep 2023, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This project aims to address stress, anxiety, burnout, and depression among medical trainees using a web-based intervention that teaches cognitive behavioral therapy (CBT)-based skills to increase resilience. The intervention is a web application ("OptimalWork", optimalwork.com) that includes a "MasterClass" consisting of about 20 interactive modules to be completed over four weeks (five days/week, 15-25 minutes/day). These modules teach principles and skills of CBT in an interactive manner and give tailored recommendations for how to apply and develop these skills in one's work and personal life. Participants who enroll in the study will be randomly assigned to either the MasterClass intervention or an active control (podcast listening) condition, and the control group will be given access to the MasterClass after 8 weeks. Measurements of well-being at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks will be compared between the groups as the primary outcome. Participant engagement as measured by MasterClass module completion and qualitative feedback will also be collected to guide future efforts at large-scale implementation in medical trainees and healthcare workers.

Read the detailed description

Medical students face significant mental health challenges, with burnout being a prevalent concern. Given the efficacy of cognitive behavioral therapy (CBT) and mindfulness-based approaches for treating mood and anxiety disorders, many individual-level interventions to reduce stress or prevent burnout have focused on teaching people these psychological skills, including digital approaches that aim to overcome the barriers to implementation of face-to-face therapy.

One such digital intervention is OptimalWork (optimalwork.com), an online platform that teaches CBT- and mindfulness-based skills as they apply in daily life and work. The focus of the intervention is learning to reframe challenges in one's everyday work as opportunities to grow according to one's ideals and to strengthen one's bonds with others. Our primary aims are to determine the feasibility, acceptability, and preliminary effect size of this intervention in medical students. The Investigators also aim to describe relationships between different measures of well-being, including some that measure clinical symptoms and others that measure flourishing. Finally, the investigators aim to identify barriers and facilitators to successful implementation in this population through exit interviews and other qualitative feedback.

We are conducting a 16-week randomized controlled trial, comparing the OptimalWork online program versus a Podcast Listening control group (described below). Podcasts were chosen from RadioLab to last about the same time as the OptimalWork program (10-15 minutes / day, 5 days / week for 4 weeks) but with content unrelated to wellness or mental health. The intervention period lasts 4 weeks, and outcome measures (surveys) are administered at baseline, 4, 8, 12, and 16 weeks. After 8 weeks and completion of the second follow-up survey, participants are given the option to access the other intervention if they so desired. This is to ensure equity in access to the intervention between groups.

Eligible participants are students currently enrolled at Washington University School of Medicine from all class years (M1-M4, including those on research years and MD/PhD students in the PhD years). Participants must not be participating in another behavioral health or well-being intervention at the time of enrollment. The investigators are not excluding participants based on mental health diagnosis or active treatment.

All participants provide informed consent electronically after reviewing the nature, risks, and benefits of the study, under protocols approved by the Washington University Human Research Protection Office.

Our primary outcomes at 8 weeks are: (1) Flourishing as assessed by the Human Flourishing Index (HFI) a broad, well-validated measure based around five domains (Happiness and Life Satisfaction, Mental and Physical Health, Meaning and Purpose, Character and Virtue, and Close Social Relationships); (2) Work engagement as assessed by the OptimalWork Inventory (OWI), comprised of four sub-domains (Friendships, Ideals, Mode of Working, Work-Life Harmony); and (3) Burnout as measured by the Professional Fulfillment Index (PFI), particularly the two domains of Interpersonal Disengagement and Work Exhaustion.

Secondary outcomes assess four additional domains: (1) Emotional Support (Patient-Reported Outcomes Measurement Information System ("PROMIS") - Emotional Support, 4 items); (2) Anxiety (PROMIS - Anxiety, 4 items); (3) Depression (PROMIS - Depression, 4 items); and (4) Stress (Brief Inventory of Perceived Stress, BIPS). The Stress measure comprises three sub-domains: Pushed, Conflict and Imposition, and Lack of Control. These measures are all reported on a 5-point Likert Scale. The investigators also include a one-item sleep assessment (Sleep Quality Scale, self-rated from 1-10).

For statistical analyses, the investigators will use repeated-measures mixed models to look at trajectories over 4 and 8 weeks with a time*intervention group interaction term to estimate the effect of the OptimalWork intervention on these well-being domains over time. Longer-term effects of the intervention on well-being measurements at 12- and 16-week follow-up were also assessed with similar models. Secondary analyses included between-group comparisons of trajectories of sub-domains of HFI, OWI, and PFI, as well as secondary outcomes (Emotional Support, Anxiety, Depression, Stress), modeled as above.

If successful, our findings will have implications for the feasibility, acceptability, and effectiveness of these sorts of interventions, with the long-term goal of informing future interventions targeting medical student well-being.

02

Conditions studied

  • Mental Health Wellness 1

Keywords

  • Cognitive Behavioral Therapy
  • Digital Mental Health
03

In context

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Current or incoming WashU School of Medicine Student

Exclusion criteria

Exclusion Criteria:

  • Currently participating in another behavioral health / well-being intervention
  • Unwilling or unable to provide informed consent
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    OptimalWork

    An online intervention that teaches concepts of cognitive restructuring, mindfulness, and behavioral activation as they apply in one's daily life and work. Users are given personalized content recommendations based on their inventory results and instructed to complete 15-25 minutes of content per day, 5 days/week for 4 weeks.

    Behavioral: OptimalWork

  • Active comparator
    Podcast Listening

    A curated series of podcasts on topics unrelated to cognitive behavioral therapy or mindfulness, modeled after a similar control from a study of a mindfulness based intervention (Basso et al. 2019). Users are instructed to complete one podcast per day on a digital platform (\~15 minutes/day), 5 days/week for 4 weeks.

    Behavioral: Podcast Listening

Interventions

  • BehavioralOptimalWork

    An online intervention that teaches concepts of cognitive restructuring, mindfulness, and behavioral activation as they apply in one's daily life and work. Users are given personalized content recommendations based on their inventory results and instructed to complete 15-25 minutes of content per day, 5 days/week for 4 weeks. (optimalwork.com)

  • BehavioralPodcast Listening

    A curated series of podcasts on topics unrelated to cognitive behavioral therapy or mindfulness, modeled after a similar control from a study of a mindfulness based intervention (Basso et al. 2019). Users are instructed to complete one podcast per day on a digital platform (\~15 minutes/day), 5 days/week for 4 weeks.

06

What researchers measure

Primary outcomes

  1. Human Flourishing Index

    Broad well-being based around 5 domains of happiness, mental and physical health, meaning and purpose, character and virtue, and close social relationships.

    Time frame: 8 weeks

  2. OptimalWork Inventory

    24-item survey designed to measure how well one is engaging challenges in one's work and personal life

    Time frame: 8 weeks

Secondary outcomes

  1. Stress - BIPS

    Brief Inventory of Perceived Stress

    Time frame: 8 weeks

  2. Burnout and professional fulfillment

    Professional Fulfillment Index (7 items)

    Time frame: 8 weeks

  3. Anxiety - PROMIS

    4-item survey from the Patient Reported Outcomes Measurement Information System

    Time frame: 8 weeks

  4. Depression - PROMIS

    4-item depression inventory from the Patient-Reported Outcomes Measurement Information System

    Time frame: 8 weeks

07

Study locations

1 site
  • Washington University School of Medicine in St. Louis
    St Louis, Missouri 63110, United States
08

References and documents

Publications

  • Sanchez JS, Perry D, Kinghorn A, Vermette D, Gray T, Duncan JG, Evanoff B, Nicol GE. Optimizing the Work of Learning for Flourishing: A Randomized Pilot Study of a Digital CBT-Based Intervention in Medical Students. Acad Psychiatry. 2026 Feb 7. doi: 10.1007/s40596-026-02308-w. Online ahead of print. PubMed 41652149 ↗

Study documents

  • Informed consent form · Jul 2, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06914843
Lead sponsor
Washington University School of Medicine
Responsible party
Ginger E Nicol (Associate Professor of Psychiatry (Child), Washington University School of Medicine) — Principal investigator
First posted
Apr 6, 2025
Start date
Sep 6, 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
May 11, 2026

Study contacts

Ginger E. Nicol, MD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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