NCT06914843

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
Last Updated

April 6, 2025

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

July 24, 2024

Last Update Submit

April 2, 2025

Conditions

Keywords

Cognitive Behavioral TherapyDigital Mental Health

Outcome Measures

Primary Outcomes (2)

  • 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.

    8 weeks

  • OptimalWork Inventory

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

    8 weeks

Secondary Outcomes (4)

  • Stress - BIPS

    8 weeks

  • Burnout and professional fulfillment

    8 weeks

  • Anxiety - PROMIS

    8 weeks

  • Depression - PROMIS

    8 weeks

Study Arms (2)

OptimalWork

EXPERIMENTAL

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

Podcast Listening

ACTIVE COMPARATOR

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

OptimalWorkBEHAVIORAL

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)

OptimalWork

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.

Podcast Listening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current or incoming WashU School of Medicine Student

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

Study Officials

  • Ginger E. Nicol, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants are randomized using a digital data management platform (REDCap) and investigators and analysts remain blinded to participant identifiers.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry (Child)

Study Record Dates

First Submitted

July 24, 2024

First Posted

April 6, 2025

Study Start

September 6, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 6, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations