Burnout, Healthcare WorkersNCT07053111
The Counselor Led Resident Wellness Study
A study testing Wellness Intervention in people with Burnout, Healthcare Workers and Anxiety, run by University of Nevada, Reno at 1 site in United States.
Trial summary
Residency is a challenging time in a physician's career. The investigators hope this study will provide a new wellness support model for residency programs to use for resident physicians. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout, Healthcare Workers, Anxiety, Wellness Program
- What is being tested?
- Wellness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2025to 12 Jun 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -All internal medicine residents at the University of Nevada, Reno whose continuity clinic site is the University Health (UNR Plumas) Clinic for the 2025-2026 academic year will be offered the opportunity to participate.
Who cannot join
- Must be a UNR internal medicine resident as described above
- Residents must be interested/willing to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University Health Internal Medicine Clinic
Reno, Nevada, 89519
About this study
Residency is a challenging time in a physician's career. The investigators hope this study will provide a new wellness support model for residency programs to use for resident physicians. The purpose of this study is to examine the impact of a wellness support model for residency programs that is lead by licensed counselors. The investigators expect that participating resident physicians will feel and perform better in their job and your life with this additional support.
Read the detailed description
Residency training has been identified as a challenging time in a physician's career. Prior studies have identified the positive effects of wellness support services on resident and attending physician wellbeing and burnout. A recent systematic review in PLoS One identified only one study in which counselors or psychologists, as opposed to peer mentors or other professionals including coaches, were utilized for the mental health wellness intervention. These studies show a benefit for some but not all metrics studied. Professional therapists may have additional skills or insight that may enhance wellness interventions. To help improve physician wellness at the University Health (UNR Plumas) Clinic, the investigators have developed an evidence based counselor wellness support group. The study will be a parallel group randomized controlled trial that seeks to build upon the above literature but also introduce additional novel components. Specifically, the study will utilize trained mental health counselors, instead of online or in person coaches or trained peer support, to provide in person physician wellness services to resident physicians. It will track the efficacy of a longitudinal, evidence-based curriculum by collecting data on wellness, depression, and anxiety using standard metrics, with the goal of increasing physician wellness in a cost-effective manner.
- Conditions
- Burnout, Healthcare Workers, Anxiety, Wellness Program, Depression Not Otherwise Specified
- Being tested
- Wellness Intervention
- Keywords
- Randomized Controlled Trial, Resident Wellness, Counselor
- Medical subject headings
- Burnout, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness InterventionBehavioural
Licensed counselors will provide evidence based curricula on the following: work/life balance, resilience building, stress management, self- care practices, imposter syndrome, psychological effects, compassion fatigue, peer support, and mindfulness practices.
| Study group | Role | What they receive |
|---|---|---|
| Counselor Wellness Intervention | Experimental | Evidenced based, counselor lead wellness intervention that will provide psychoeducational peer support/peer process groups. Topics may include: work/life balance, resilience building, stress management, self- care practices, imposter syndrome, psychological effects, compassion fatigue, peer support, and mindfulness practices. Other evidence based therapeutic concepts, such as Cognitive Behavior Therapy (CBT) and Dialectical Behavior Therapy (DBT), may also be introduced as appropriate. The intervention group will also receive standard access to all mental health and wellness interventions at the university. Receives: Behavioral: Wellness Intervention |
| Control Group | No intervention | Standard access to all mental health and wellness interventions at the university. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The World Health Organization-Five Well-Being Index (WHO-5)
The WHO-5 is a self-report instrument measuring mental well-being. It consists of five statements relating to the past two weeks. Each statement is rated on a 6-point scale, with higher scores indicating better mental well-being. Specifically, a score of 0 indicates the participant taking the survey has "At no time" experienced the statement in question, while a score of 5 indicates the participant experiences the statement "All of the time." A gradient of numbers in between 0-5 represents increasing in frequency of the given experience. The instrument has been translated into over 30 languages.
Measured: Approximately 10 months
Secondary outcomes (2)
Patient Health Questionnaire 9 (PHQ - 9)
Graded measurement of general depression severity. Participants answer 9 questions with scores from 0 (not at all) to 3 (nearly every day) for each question to determine depression severity. Higher numbers indicate higher possible depression severity.
Measured: ~10 months
GAD 7
Seven question general anxiety metric. Participants rate questions from 0 (not at all) to 3 (nearly every day) to give a general measure of anxiety severity. Higher numbers indicate higher anxiety severity.
Measured: ~10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start11 Jul 2025
- Primary completion12 Jun 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Burnout, Healthcare WorkersStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Kandel, University of Nevada, Reno
- Investigators
- Sean Kandel, DO, Principal investigator, University of Nevada, Reno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053111
- Sponsor's protocol ID
- 23347451
- Status last verified
- Sep 2025
- First submitted
- 30 Jun 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
PubMed 25831962Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
PubMed 17339617Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Butler AC, Chapman JE, Forman EM, Beck AT. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev. 2006 Jan;26(1):17-31. doi: 10.1016/j.cpr.2005.07.003. Epub 2005 Sep 30.
PubMed 16199119Eskander J, Rajaguru PP, Greenberg PB. Evaluating Wellness Interventions for Resident Physicians: A Systematic Review. J Grad Med Educ. 2021 Feb;13(1):58-69. doi: 10.4300/JGME-D-20-00359.1. Epub 2020 Dec 31.
PubMed 33680302Underdahl L, Ditri M, Duthely LM. Physician Burnout: Evidence-Based Roadmaps to Prioritizing and Supporting Personal Wellbeing. J Healthc Leadersh. 2024 Jan 4;16:15-27. doi: 10.2147/JHL.S389245. eCollection 2024.
PubMed 38192639Boet S, Etherington C, Dion PM, Desjardins C, Kaur M, Ly V, Denis-LeBlanc M, Andreas C, Sriharan A. Impact of coaching on physician wellness: A systematic review. PLoS One. 2023 Feb 7;18(2):e0281406. doi: 10.1371/journal.pone.0281406. eCollection 2023.
PubMed 36749760Mann A, Shah AN, Thibodeau PS, Dyrbye L, Syed A, Woodward MA, Thurmon K, Jones CD, Dunbar KS, Fainstad T. Online Well-Being Group Coaching Program for Women Physician Trainees: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2335541. doi: 10.1001/jamanetworkopen.2023.35541.
PubMed 37792378Palamara K, Chu JT, Chang Y, Yu L, Cosco D, Higgins S, Tulsky A, Mourad R, Singh S, Steinhauser K, Donelan K. Who Benefits Most? A Multisite Study of Coaching and Resident Well-being. J Gen Intern Med. 2022 Feb;37(3):539-547. doi: 10.1007/s11606-021-06903-5. Epub 2021 Jun 7.
PubMed 34100238Solms L, van Vianen A, Koen J, Theeboom T, de Pagter APJ, De Hoog M; Challenge & Support Research Network. Turning the tide: a quasi-experimental study on a coaching intervention to reduce burn-out symptoms and foster personal resources among medical residents and specialists in the Netherlands. BMJ Open. 2021 Jan 25;11(1):e041708. doi: 10.1136/bmjopen-2020-041708.
PubMed 33495254Sofka S, Lerfald N, Reece J, Davisson L, Howsare J, Thompson J. Universal Well-Being Assessment Associated With Increased Resident Utilization of Mental Health Resources and Decrease in Professionalism Breaches. J Grad Med Educ. 2021 Feb;13(1):83-88. doi: 10.4300/JGME-D-20-00352.1. Epub 2020 Dec 31.
PubMed 33680305Raimo J, LaVine S, Spielmann K, Akerman M, Friedman KA, Katona K, Chaudhry S. The Correlation of Stress in Residency With Future Stress and Burnout: A 10-Year Prospective Cohort Study. J Grad Med Educ. 2018 Oct;10(5):524-531. doi: 10.4300/JGME-D-18-00273.1.
PubMed 30386477Salyers MP, Bonfils KA, Luther L, Firmin RL, White DA, Adams EL, Rollins AL. The Relationship Between Professional Burnout and Quality and Safety in Healthcare: A Meta-Analysis. J Gen Intern Med. 2017 Apr;32(4):475-482. doi: 10.1007/s11606-016-3886-9. Epub 2016 Oct 26.
PubMed 27785668Neumann M, Edelhauser F, Tauschel D, Fischer MR, Wirtz M, Woopen C, Haramati A, Scheffer C. Empathy decline and its reasons: a systematic review of studies with medical students and residents. Acad Med. 2011 Aug;86(8):996-1009. doi: 10.1097/ACM.0b013e318221e615.
PubMed 21670661Harvey SB, Epstein RM, Glozier N, Petrie K, Strudwick J, Gayed A, Dean K, Henderson M. Mental illness and suicide among physicians. Lancet. 2021 Sep 4;398(10303):920-930. doi: 10.1016/S0140-6736(21)01596-8.
PubMed 34481571
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Counselor Led Resident Wellness Study
- ClinicalTrials.gov ID
- NCT07053111
- Acronym / sponsor ID
- 23347451
- Conditions
- Burnout, Healthcare Workers, Anxiety, Wellness Program, Depression Not Otherwise Specified
- Keywords
- Randomized Controlled Trial, Resident Wellness, Counselor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 8 Jul 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.
Residency is a challenging time in a physician's career. The investigators hope this study will provide a new wellness support model for residency programs to use for resident physicians. The purpose of this study is to examine the impact of a wellness support model for residency programs that is lead by licensed counselors. The investigators expect that participating resident physicians will feel and perform better in their job and your life with this additional support.
Detailed description
Residency training has been identified as a challenging time in a physician's career. Prior studies have identified the positive effects of wellness support services on resident and attending physician wellbeing and burnout. A recent systematic review in PLoS One identified only one study in which counselors or psychologists, as opposed to peer mentors or other professionals including coaches, were utilized for the mental health wellness intervention. These studies show a benefit for some but not all metrics studied. Professional therapists may have additional skills or insight that may enhance wellness interventions. To help improve physician wellness at the University Health (UNR Plumas) Clinic, the investigators have developed an evidence based counselor wellness support group. The study will be a parallel group randomized controlled trial that seeks to build upon the above literature but also introduce additional novel components. Specifically, the study will utilize trained mental health counselors, instead of online or in person coaches or trained peer support, to provide in person physician wellness services to resident physicians. It will track the efficacy of a longitudinal, evidence-based curriculum by collecting data on wellness, depression, and anxiety using standard metrics, with the goal of increasing physician wellness in a cost-effective manner.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counselor Wellness Intervention | Experimental | Behavioral: Wellness InterventionEvidenced based, counselor lead wellness intervention that will provide psychoeducational peer support/peer process groups. Topics may include: work/life balance, resilience building, stress management, self- care practices, imposter syndrome, psychological effects, compassion fatigue, peer support, and mindfulness practices. Other evidence based therapeutic concepts, such as Cognitive Behavior Therapy (CBT) and Dialectical Behavior Therapy (DBT), may also be introduced as appropriate. The intervention group will also receive standard access to all mental health and wellness interventions at the university. |
| Control Group | No intervention | –Standard access to all mental health and wellness interventions at the university. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -All internal medicine residents at the University of Nevada, Reno whose continuity clinic site is the University Health (UNR Plumas) Clinic for the 2025-2026 academic year will be offered the opportunity to participate.
Key exclusion criteria (2 listed)
- Must be a UNR internal medicine resident as described above
- Residents must be interested/willing to participate
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 |
|---|---|---|
| Wellness InterventionLicensed counselors will provide evidence based curricula on the following: work/life balance, resilience building, stress management, self- care practices, imposter syndrome, psychological effects, compassion fatigue, peer support, and mindfulness practices. | Behavioural | Counselor Wellness Intervention |
Primary outcome
The World Health Organization-Five Well-Being Index (WHO-5)
Time frame: Approximately 10 months
The WHO-5 is a self-report instrument measuring mental well-being. It consists of five statements relating to the past two weeks. Each statement is rated on a 6-point scale, with higher scores indicating better mental well-being. Specifically, a score of 0 indicates the participant taking the survey has "At no time" experienced the statement in question, while a score of 5 indicates the participant experiences the statement "All of the time." A gradient of numbers in between 0-5 represents increasing in frequency of the given experience. The instrument has been translated into over 30 languages.
2 secondary outcomes
Patient Health Questionnaire 9 (PHQ - 9)
Time frame: ~10 months
GAD 7
Time frame: ~10 months
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 25 Sep 2026.
- Background: PubMed 25831962Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
- Background: PubMed 17339617Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 16199119Butler AC, Chapman JE, Forman EM, Beck AT. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev. 2006 Jan;26(1):17-31. doi: 10.1016/j.cpr.2005.07.003. Epub 2005 Sep 30.
- Background: PubMed 33680302Eskander J, Rajaguru PP, Greenberg PB. Evaluating Wellness Interventions for Resident Physicians: A Systematic Review. J Grad Med Educ. 2021 Feb;13(1):58-69. doi: 10.4300/JGME-D-20-00359.1. Epub 2020 Dec 31.
- Background: PubMed 38192639Underdahl L, Ditri M, Duthely LM. Physician Burnout: Evidence-Based Roadmaps to Prioritizing and Supporting Personal Wellbeing. J Healthc Leadersh. 2024 Jan 4;16:15-27. doi: 10.2147/JHL.S389245. eCollection 2024.
- Background: PubMed 36749760Boet S, Etherington C, Dion PM, Desjardins C, Kaur M, Ly V, Denis-LeBlanc M, Andreas C, Sriharan A. Impact of coaching on physician wellness: A systematic review. PLoS One. 2023 Feb 7;18(2):e0281406. doi: 10.1371/journal.pone.0281406. eCollection 2023.
- Background: PubMed 37792378Mann A, Shah AN, Thibodeau PS, Dyrbye L, Syed A, Woodward MA, Thurmon K, Jones CD, Dunbar KS, Fainstad T. Online Well-Being Group Coaching Program for Women Physician Trainees: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2335541. doi: 10.1001/jamanetworkopen.2023.35541.
- Background: PubMed 34100238Palamara K, Chu JT, Chang Y, Yu L, Cosco D, Higgins S, Tulsky A, Mourad R, Singh S, Steinhauser K, Donelan K. Who Benefits Most? A Multisite Study of Coaching and Resident Well-being. J Gen Intern Med. 2022 Feb;37(3):539-547. doi: 10.1007/s11606-021-06903-5. Epub 2021 Jun 7.
- Background: PubMed 33495254Solms L, van Vianen A, Koen J, Theeboom T, de Pagter APJ, De Hoog M; Challenge & Support Research Network. Turning the tide: a quasi-experimental study on a coaching intervention to reduce burn-out symptoms and foster personal resources among medical residents and specialists in the Netherlands. BMJ Open. 2021 Jan 25;11(1):e041708. doi: 10.1136/bmjopen-2020-041708.
- Background: PubMed 33680305Sofka S, Lerfald N, Reece J, Davisson L, Howsare J, Thompson J. Universal Well-Being Assessment Associated With Increased Resident Utilization of Mental Health Resources and Decrease in Professionalism Breaches. J Grad Med Educ. 2021 Feb;13(1):83-88. doi: 10.4300/JGME-D-20-00352.1. Epub 2020 Dec 31.
- Background: PubMed 30386477Raimo J, LaVine S, Spielmann K, Akerman M, Friedman KA, Katona K, Chaudhry S. The Correlation of Stress in Residency With Future Stress and Burnout: A 10-Year Prospective Cohort Study. J Grad Med Educ. 2018 Oct;10(5):524-531. doi: 10.4300/JGME-D-18-00273.1.
- 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.
Sean Kandel, DO principal investigator
University of Nevada, Reno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness Intervention in people with Burnout, Healthcare Workers and Anxiety, run by University of Nevada, Reno 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 25 Sep 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?
The World Health Organization-Five Well-Being Index (WHO-5) (time frame: Approximately 10 months). 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 NCT07053111, which also lists 15 linked publications.
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 25 Sep 2026.