Mental Health Wellness 1NCT06914843
Digital Intervention to Promote Medical Trainee Well-being (OptimalWork Pilot)
A study testing OptimalWork and Podcast Listening in people with Mental Health Wellness 1, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- OptimalWork and Podcast Listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current or incoming WashU School of Medicine Student
Who cannot join
- Currently participating in another behavioral health / well-being intervention
- Unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
About this study
Official title: A Randomized Controlled Pilot of a Web-based Intervention for Cognitive Behavioral Therapy-based Training to Improve Mental Health in Medical Trainees
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.
- Conditions
- Mental Health Wellness 1
- Being tested
- OptimalWork, Podcast Listening
- Keywords
- Cognitive Behavioral Therapy, Digital Mental Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptimalWorkBehavioural
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)
Podcast ListeningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Podcast Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
OptimalWork Inventory
24-item survey designed to measure how well one is engaging challenges in one's work and personal life
Measured: 8 weeks
Secondary outcomes (4)
Stress - BIPS
Brief Inventory of Perceived Stress
Measured: 8 weeks
Burnout and professional fulfillment
Professional Fulfillment Index (7 items)
Measured: 8 weeks
Anxiety - PROMIS
4-item survey from the Patient Reported Outcomes Measurement Information System
Measured: 8 weeks
Depression - PROMIS
4-item depression inventory from the Patient-Reported Outcomes Measurement Information System
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start6 Sep 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ginger E Nicol, Washington University School of Medicine
- Investigators
- Ginger E. Nicol, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914843
- Sponsor's protocol ID
- 202208152
- Status last verified
- Dec 2024
- First submitted
- 24 Jul 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot of a Web-based Intervention for Cognitive Behavioral Therapy-based Training to Improve Mental Health in Medical Trainees
- ClinicalTrials.gov ID
- NCT06914843
- Acronym / sponsor ID
- 202208152
- Conditions
- Mental Health Wellness 1
- Keywords
- Cognitive Behavioral Therapy, Digital Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OptimalWork | Experimental | Behavioral: OptimalWorkAn 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. |
| Podcast Listening | Active comparator | Behavioral: Podcast ListeningA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current or incoming WashU School of Medicine Student
Key exclusion criteria (2 listed)
- Currently participating in another behavioral health / well-being intervention
- Unwilling or unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OptimalWorkAn 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) | Behavioural | OptimalWork |
| Podcast ListeningA 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. | Behavioural | Podcast Listening |
Primary outcome
Human Flourishing Index
Time frame: 8 weeks
Broad well-being based around 5 domains of happiness, mental and physical health, meaning and purpose, character and virtue, and close social relationships.
OptimalWork Inventory
Time frame: 8 weeks
24-item survey designed to measure how well one is engaging challenges in one's work and personal life
4 secondary outcomes
Stress - BIPS
Time frame: 8 weeks
Burnout and professional fulfillment
Time frame: 8 weeks
Anxiety - PROMIS
Time frame: 8 weeks
Depression - PROMIS
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Derived from this study: PubMed 41652149Sanchez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ginger E. Nicol, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OptimalWork and Podcast Listening in people with Mental Health Wellness 1, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Flourishing Index (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06914843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.