Burn OutNCT06000488
Trial to Evaluate the Efficacy of a Manualized Reflective Writing Program for Clinical Phase Physician Assistant (PA) Students.
A study testing Reflective Writing Workshop Sessions in people with Burn Out and Student Burnout, run by Yale University at 1 site in United States.
Trial summary
The following will be an open label controlled efficacy trial of the effects of longitudinal participation in an existing reflective writing program for medical students on burnout in physician assistant students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burn Out, Student Burnout, Physician Assistant Student Burnout
- What is being tested?
- Reflective Writing Workshop Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2025to Jan 2026
- 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
- able to offer consent
- able to speak and read English.
- must be a student in Yale Physician Associate Program Class of 2024
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Controlled Trial to Evaluate the Efficacy of a Manualized Reflective Writing Program for Clinical Phase PA Students.
The following will be an open label controlled efficacy trial of the effects of longitudinal participation in an existing reflective writing program for medical students on burnout in physician assistant students.
Read the detailed description
The pilot of the reflective writing workshop for PA students will follow the existing curriculum used for the MD program. The workshops will run for 75 minutes with additional time at the end of the session to complete a post-intervention assessment survey. Planning and adaptation of the program materials will be conducted by a group of PA students and the current MD-student leaders of the reflective writing program under the guidance of Dr. Anna Reisman.
All PA student participants will be split up into 1-2 groups of 6-10 students based on the number of participants. Sessions are expected to be held in-person pending COVID-19 guidance and will be held in reserved classroom space in the PA program building (100 Church Street South) or in reserved conference rooms at the Cushing-Whitney Medical Library. Trained PA and/or MD student facilitators will then use prepared materials to guide each group through a series of prompts, each eliciting written reflections of varying lengths. While all participants are encouraged to reflect, write, and share their responses, participation at all levels remains optional. Facilitators will not solicit any participants for a response. All program participants will be asked to complete a brief post-assessment survey consisting of short-answer and Likert scale questions about their attitudes towards program participation. Responses collected will be used to assess the feasibility and acceptability of the program for PA students and as feedback to guide potential future implementation of the program.
- Being tested
- Reflective Writing Workshop Sessions
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflective Writing Workshop SessionsBehavioural
Three workshops of 75 minutes. Trained PA and/or MD student facilitators will then use prepared materials to guide each group through a series of prompts, each eliciting written reflections of varying lengths. While all participants are encouraged to reflect, write, and share their responses, participation at all levels remains optional.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| Reflective Writing Workshop Sessions (RWW) | Experimental | Participants will participate in three 75-minute RWW sessions scheduled to take place after students finish their 1st, 3rd, and 5th clinical rotations during the study period. reflective writing workshops Receives: Behavioral: Reflective Writing Workshop Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total burnout score over time as measured by the Copenhagen Burnout Inventory (CBI)
The Copenhagen Burnout Inventory (CBI) is a well-validated 19-item questionnaire used to measure burnout in different groups (e.g. employees, medical trainees, students) across three domains (personal, work, and client/customer). Total scores range from 0 to 100. Higher scores are associated with greater levels of burnout.
Measured: baseline (week 0), and weeks 4,12, and 26
Secondary outcomes (1)
Attitudes and mediators of behavioral change assessed by self report
Attitudes and potential mediators of behavioral change will be assessed using a post-assessment survey consisting of short-answer and Likert-scale questions to be answered only by individuals who complete the active intervention. The survey will be distributed and completed at the end of each reflective writing workshop session. Analysis of the short response questions will use a rapid qualitative analysis method to identify patterns and themes. Likert-scale data will be analyzed by calculating the percentage of responses selecting each of the 5 dichotomous answer choices. A mean total score will be calculated through summation of all Likert scale categories as a numeric variable from 1-5, with higher scores indicating more positive responses for each question (e.g. Completely agree = 5 pts).
Measured: week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: Yale PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn OutStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study sample will consist of clinical-phase PA students enrolled in the Yale Physician Associate Program Class of 2024.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathew Chiang, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000488
- Sponsor's protocol ID
- 2000035615
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2023
- Last updated
- 2 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Controlled Trial to Evaluate the Efficacy of a Manualized Reflective Writing Program for Clinical Phase PA Students.
- ClinicalTrials.gov ID
- NCT06000488
- Acronym / sponsor ID
- 2000035615
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Yale PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 21 Aug 2023 (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.
The following will be an open label controlled efficacy trial of the effects of longitudinal participation in an existing reflective writing program for medical students on burnout in physician assistant students.
Detailed description
The pilot of the reflective writing workshop for PA students will follow the existing curriculum used for the MD program. The workshops will run for 75 minutes with additional time at the end of the session to complete a post-intervention assessment survey. Planning and adaptation of the program materials will be conducted by a group of PA students and the current MD-student leaders of the reflective writing program under the guidance of Dr. Anna Reisman.
All PA student participants will be split up into 1-2 groups of 6-10 students based on the number of participants. Sessions are expected to be held in-person pending COVID-19 guidance and will be held in reserved classroom space in the PA program building (100 Church Street South) or in reserved conference rooms at the Cushing-Whitney Medical Library. Trained PA and/or MD student facilitators will then use prepared materials to guide each group through a series of prompts, each eliciting written reflections of varying lengths. While all participants are encouraged to reflect, write, and share their responses, participation at all levels remains optional. Facilitators will not solicit any participants for a response. All program participants will be asked to complete a brief post-assessment survey consisting of short-answer and Likert scale questions about their attitudes towards program participation. Responses collected will be used to assess the feasibility and acceptability of the program for PA students and as feedback to guide potential future implementation of the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study sample will consist of clinical-phase PA students enrolled in the Yale Physician Associate Program Class of 2024.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Reflective Writing Workshop Sessions (RWW) | Experimental | Behavioral: Reflective Writing Workshop SessionsParticipants will participate in three 75-minute RWW sessions scheduled to take place after students finish their 1st, 3rd, and 5th clinical rotations during the study period. reflective writing workshops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able to offer consent
- able to speak and read English.
- must be a student in Yale Physician Associate Program Class of 2024
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Reflective Writing Workshop SessionsThree workshops of 75 minutes. Trained PA and/or MD student facilitators will then use prepared materials to guide each group through a series of prompts, each eliciting written reflections of varying lengths. While all participants are encouraged to reflect, write, and share their responses, participation at all levels remains optional. | Behavioural | Reflective Writing Workshop Sessions (RWW) |
Primary outcome
Change in total burnout score over time as measured by the Copenhagen Burnout Inventory (CBI)
Time frame: baseline (week 0), and weeks 4,12, and 26
The Copenhagen Burnout Inventory (CBI) is a well-validated 19-item questionnaire used to measure burnout in different groups (e.g. employees, medical trainees, students) across three domains (personal, work, and client/customer). Total scores range from 0 to 100. Higher scores are associated with greater levels of burnout.
1 secondary outcome
Attitudes and mediators of behavioral change assessed by self report
Time frame: week 26
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- 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.
Mathew Chiang principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflective Writing Workshop Sessions in people with Burn Out and Student Burnout, run by Yale University 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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 2 Sep 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in total burnout score over time as measured by the Copenhagen Burnout Inventory (CBI) (time frame: baseline (week 0), and weeks 4,12, and 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2025.