- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07053111
- Original Trial
The Counselor Led Resident Wellness Study
April 28, 2026 updated by: Sean Kandel, University of Nevada, Reno
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nevada
-
Reno, Nevada, United States, 89519
- University Health Internal Medicine Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
-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.
Exclusion Criteria:
- Must be a UNR internal medicine resident as described above
- Residents must be interested/willing to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Counselor Wellness Intervention
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.
|
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.
|
|
No Intervention: Control Group
Standard access to all mental health and wellness interventions at the university.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Approximately 10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire 9 (PHQ - 9)
Time Frame: ~10 months
|
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.
|
~10 months
|
|
GAD 7
Time Frame: ~10 months
|
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.
|
~10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sean Kandel, DO, University of Nevada, Reno
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kroenke 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.
- 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.
- Kroenke 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.
- Salyers 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.
- Butler 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.
- Eskander 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.
- Underdahl 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.
- Boet 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.
- Mann 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.
- Palamara 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.
- Solms 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.
- Sofka 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.
- Raimo 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.
- Neumann 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.
- Harvey 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 11, 2025
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
June 30, 2025
First Submitted That Met QC Criteria
June 30, 2025
First Posted (Actual)
July 8, 2025
Study Record Updates
Last Update Posted (Actual)
May 5, 2026
Last Update Submitted That Met QC Criteria
April 28, 2026
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23347451
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
University of CalabriaNot yet recruitingAnxiety | Anxiety Disease | Anxiety and Distress | Public Speaking AnxietyItaly
-
Clinica Alemana de SantiagoUniversidad del DesarrolloRecruitingAnxiety | Induction of Anesthesia | Anxiety Preoperative | Technology Use | Child Anxiety | Anesthesia Care | Anxiety After SurgeryChile
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston University; Johns Hopkins... and other collaboratorsCompletedAnxiety Disorders | Anxiety | Anxiety Symptoms | Child Anxiety | Anxiety, Mild to Moderate | Pediatric Anxiety DisordersUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Abant Izzet Baysal UniversityRecruitingAnxiety | Parental AnxietyTurkey (Türkiye)
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiActive, not recruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Florida State UniversityRecruitingAnxiety | Generalized Anxiety Disorder (GAD) | WorryingUnited States
-
Institut National de la Santé Et de la Recherche...Active, not recruitingAnxiety Disorders | Anxiety | Anxiety and FearFrance
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
Clinical Trials on Wellness Intervention
-
The University of Texas Health Science Center at...National Cancer Institute (NCI); Wake Forest University Health Sciences; Arizona... and other collaboratorsRecruitingDepression | Inflammation | Cancer | Fatigue | Anxiety | Sleep DisturbanceUnited States
-
University of MiamiTerminatedMelanomaUnited States
-
Virginia Commonwealth UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
VA Office of Research and DevelopmentBoston University; Tufts Medical CenterCompleted
-
University of MinnesotaNational Institute of Mental Health (NIMH)Completed
-
University of FloridaNational Heart, Lung, and Blood Institute (NHLBI); Duke UniversityCompletedObesityUnited States
-
Temple UniversityColumbia University; Centers for Disease Control and Prevention; Nova Southeastern...Unknown
-
Beloit CollegeCompletedDepression | Anxiety | Wellness | Cognitive FunctioningUnited States
-
M.D. Anderson Cancer CenterNational Institute on Drug Abuse (NIDA)Completed
-
University of California, San DiegoNational Institute of Nursing Research (NINR)CompletedSedentary LifestyleUnited States