Job StressNCT05743205
Advanced Practice Provider Intervention Study to Promote Wellness
A study testing voluntary consultative wellness session in people with Job Stress and Professional Burnout, run by Colleen J Klein at 1 site in United States.
Trial summary
This exploratory pilot study is designed as interventional study to examine the efficacy of a wellness initiative that involves use of a licensed clinical professional counselor (LCPC) to assist in the development of diverse coping strategies such as management of stressors, self-care, time management, and any other… Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Job Stress, Professional Burnout
- What is being tested?
- voluntary consultative wellness session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2022to 22 Dec 2025
- 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 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- employment within non-profit health care setting as a health care professional
- working at least 50% of time in direct patient care
- availability and interest in initial and follow-up wellness visits
Who cannot join
- actively participating in formalized counseling sessions through other services at time of recruitment into the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Intervention Study to Promote Wellness in Advanced Practice Providers (APPs)
This exploratory pilot study is designed as interventional study to examine the efficacy of a wellness initiative that involves use of a licensed clinical professional counselor (LCPC) to assist in the development of diverse coping strategies such as management of stressors, self-care, time management, and any other goals, problems or concerns that APPs would like assistance with during the intervention period.
Read the detailed description
The purpose of this study is to evaluate an educational professional wellness program designed to assist professional clinicians in developing self-awareness and self-care choices as a means to improve engagement and resilience and to avoid/reduce burnout.
- Conditions
- Job Stress, Professional Burnout
- Being tested
- voluntary consultative wellness session
- Keywords
- Resilience, Burnout, Work engagement
- Medical subject headings
- Occupational Stress, Burnout, Professional, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voluntary consultative wellness sessionBehavioural
Professional wellness counseling sessions provided to health care professionals through voluntary enrollment. Consultative sessions will conducted throughout the course of 1 year and number of subsequent sessions will be determined by the participant.
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention | Experimental | Educational intervention Receives: Behavioral: voluntary consultative wellness session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Holmes-Rahe Life Stress Inventory; The Social Readjustment Rating Scale
The Holmes-Rahe Scale is used to life changes that may impact stress. Minimum values =150 pts or less; maximum values = 300 pts. or more; higher scores indicate higher susceptibility to stress-induced health problems.
Measured: change from baseline stress measure at 1 year and 2 years.
The Brief Resilience Scale
The Brief Resilience Scale developed by Smith et al. (2008) is used to measure resilience. Minimum value =6 and maximum value = 30; mean value is used to determine scoring with higher value indicating more resilience.
Measured: change from baseline in resilience measure at 6 months, 1 year and 2 years.
The Work and Well-being Survey (UWES)© Engagement Scale
Work engagement is measured using the Utrecht Work and Well-being Survey Engagement instrument (UWES). The minimum value =0 and the maximum value = 54. Mean is used to determine scoring. Higher value indicates greater work engagement.
Measured: change from baseline engagement measure at 6 months, 1 year and 2 years.
Advanced Practice Provider Well-being Index
measures the increased probability of distress risk for personal or professional consequences. Minimum value =0 and maximum value =7. Mean and standard deviation is computed and compared to normative data.
Measured: change from baseline well-being measure at 6 months, 1 year and 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start21 Dec 2022
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Job StressStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colleen J Klein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Colleen J Klein, OSF Healthcare System
- Investigators
- Colleen Klein, PhD, RN, Principal investigator, OSF Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743205
- Sponsor's protocol ID
- 1537818
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klein CJ, Weinzimmer LG, Cooling M, Lizer S, Pierce L, Dalstrom M. Exploring burnout and job stressors among advanced practice providers. Nurs Outlook. 2020 Mar-Apr;68(2):145-154. doi: 10.1016/j.outlook.2019.09.005. Epub 2019 Nov 8.
PubMed 31708107Klein CJ, Dalstrom M, Lizer S, Cooling M, Pierce L, Weinzimmer LG. Advanced Practice Provider Perspectives on Organizational Strategies for Work Stress Reduction. West J Nurs Res. 2020 Sep;42(9):708-717. doi: 10.1177/0193945919896606. Epub 2019 Dec 22.
PubMed 31868125Klein CJ, Dalstrom MD, Weinzimmer LG, Cooling M, Pierce L, Lizer S. Strategies of Advanced Practice Providers to Reduce Stress at Work. Workplace Health Saf. 2020 Sep;68(9):432-442. doi: 10.1177/2165079920924060. Epub 2020 Jun 3.
PubMed 32491978Klein CJ, Weinzimmer LG, Dalstrom M, Lizer S, Cooling M, Pierce L. Investigating practice-level and individual factors of advanced practice registered nurses and physician assistants and their relationship to resilience. J Am Assoc Nurse Pract. 2021 Jul 29;34(2):310-321. doi: 10.1097/JXX.0000000000000639.
PubMed 34334766Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
PubMed 18696313Dyrbye LN, Johnson PO, Johnson LM, Halasy MP, Gossard AA, Satele D, Shanafelt T. Efficacy of the Well-Being Index to identify distress and stratify well-being in nurse practitioners and physician assistants. J Am Assoc Nurse Pract. 2019 Jul;31(7):403-412. doi: 10.1097/JXX.0000000000000179.
PubMed 30829967Klein CJ, Riggenbach-Hays JJ, Sollenberger LM, Harney DM, McGarvey JS. Quality of Life and Compassion Satisfaction in Clinicians: A Pilot Intervention Study for Reducing Compassion Fatigue. Am J Hosp Palliat Care. 2018 Jun;35(6):882-888. doi: 10.1177/1049909117740848. Epub 2017 Nov 23.
PubMed 29169248Klein CJ, Pierce LM, Cooling M, Stoecker B, Weinzimmer LG. Investigating and supporting wellness of advanced practice nurses and physician associates: Associated challenges before, during, and after the Covid-19 pandemic. J Am Assoc Nurse Pract. 2026 Aug 1;38(8):626-636. doi: 10.1097/JXX.0000000000001270. Epub 2026 Mar 18.
PubMed 41848432
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Intervention Study to Promote Wellness in Advanced Practice Providers (APPs)
- ClinicalTrials.gov ID
- NCT05743205
- Acronym / sponsor ID
- 1537818
- Conditions
- Job Stress, Professional Burnout
- Keywords
- Resilience, Burnout, Work engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Colleen J KleinUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 24 Feb 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.
This exploratory pilot study is designed as interventional study to examine the efficacy of a wellness initiative that involves use of a licensed clinical professional counselor (LCPC) to assist in the development of diverse coping strategies such as management of stressors, self-care, time management, and any other goals, problems or concerns that APPs would like assistance with during the intervention period.
Detailed description
The purpose of this study is to evaluate an educational professional wellness program designed to assist professional clinicians in developing self-awareness and self-care choices as a means to improve engagement and resilience and to avoid/reduce burnout.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention | Experimental | Behavioral: voluntary consultative wellness sessionEducational intervention |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- employment within non-profit health care setting as a health care professional
- working at least 50% of time in direct patient care
- availability and interest in initial and follow-up wellness visits
Key exclusion criteria (1 listed)
- actively participating in formalized counseling sessions through other services at time of recruitment into the study
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 |
|---|---|---|
| voluntary consultative wellness sessionProfessional wellness counseling sessions provided to health care professionals through voluntary enrollment. Consultative sessions will conducted throughout the course of 1 year and number of subsequent sessions will be determined by the participant. | Behavioural | Educational Intervention |
Primary outcome
Holmes-Rahe Life Stress Inventory; The Social Readjustment Rating Scale
Time frame: change from baseline stress measure at 1 year and 2 years.
The Holmes-Rahe Scale is used to life changes that may impact stress. Minimum values =150 pts or less; maximum values = 300 pts. or more; higher scores indicate higher susceptibility to stress-induced health problems.
The Brief Resilience Scale
Time frame: change from baseline in resilience measure at 6 months, 1 year and 2 years.
The Brief Resilience Scale developed by Smith et al. (2008) is used to measure resilience. Minimum value =6 and maximum value = 30; mean value is used to determine scoring with higher value indicating more resilience.
The Work and Well-being Survey (UWES)© Engagement Scale
Time frame: change from baseline engagement measure at 6 months, 1 year and 2 years.
Work engagement is measured using the Utrecht Work and Well-being Survey Engagement instrument (UWES). The minimum value =0 and the maximum value = 54. Mean is used to determine scoring. Higher value indicates greater work engagement.
Advanced Practice Provider Well-being Index
Time frame: change from baseline well-being measure at 6 months, 1 year and 2 years.
measures the increased probability of distress risk for personal or professional consequences. Minimum value =0 and maximum value =7. Mean and standard deviation is computed and compared to normative data.
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 27 Feb 2026.
- Background: PubMed 31708107Klein CJ, Weinzimmer LG, Cooling M, Lizer S, Pierce L, Dalstrom M. Exploring burnout and job stressors among advanced practice providers. Nurs Outlook. 2020 Mar-Apr;68(2):145-154. doi: 10.1016/j.outlook.2019.09.005. Epub 2019 Nov 8.
- Background: PubMed 31868125Klein CJ, Dalstrom M, Lizer S, Cooling M, Pierce L, Weinzimmer LG. Advanced Practice Provider Perspectives on Organizational Strategies for Work Stress Reduction. West J Nurs Res. 2020 Sep;42(9):708-717. doi: 10.1177/0193945919896606. Epub 2019 Dec 22.
- Background: PubMed 32491978Klein CJ, Dalstrom MD, Weinzimmer LG, Cooling M, Pierce L, Lizer S. Strategies of Advanced Practice Providers to Reduce Stress at Work. Workplace Health Saf. 2020 Sep;68(9):432-442. doi: 10.1177/2165079920924060. Epub 2020 Jun 3.
- Background: PubMed 34334766Klein CJ, Weinzimmer LG, Dalstrom M, Lizer S, Cooling M, Pierce L. Investigating practice-level and individual factors of advanced practice registered nurses and physician assistants and their relationship to resilience. J Am Assoc Nurse Pract. 2021 Jul 29;34(2):310-321. doi: 10.1097/JXX.0000000000000639.
- Background: PubMed 18696313Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
- Results publication: PubMed 30829967Dyrbye LN, Johnson PO, Johnson LM, Halasy MP, Gossard AA, Satele D, Shanafelt T. Efficacy of the Well-Being Index to identify distress and stratify well-being in nurse practitioners and physician assistants. J Am Assoc Nurse Pract. 2019 Jul;31(7):403-412. doi: 10.1097/JXX.0000000000000179.
- Results publication: PubMed 29169248Klein CJ, Riggenbach-Hays JJ, Sollenberger LM, Harney DM, McGarvey JS. Quality of Life and Compassion Satisfaction in Clinicians: A Pilot Intervention Study for Reducing Compassion Fatigue. Am J Hosp Palliat Care. 2018 Jun;35(6):882-888. doi: 10.1177/1049909117740848. Epub 2017 Nov 23.
- Derived from this study: PubMed 41848432Klein CJ, Pierce LM, Cooling M, Stoecker B, Weinzimmer LG. Investigating and supporting wellness of advanced practice nurses and physician associates: Associated challenges before, during, and after the Covid-19 pandemic. J Am Assoc Nurse Pract. 2026 Aug 1;38(8):626-636. doi: 10.1097/JXX.0000000000001270. Epub 2026 Mar 18.
- 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.
Colleen Klein, PhD, RN principal investigator
OSF Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing voluntary consultative wellness session in people with Job Stress and Professional Burnout, run by Colleen J Klein 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: finished, as of the sponsor's last update on 27 Feb 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?
Holmes-Rahe Life Stress Inventory; The Social Readjustment Rating Scale (time frame: change from baseline stress measure at 1 year and 2 years.). The study lists 4 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 NCT05743205, which also lists 8 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 27 Feb 2026; AzTrials last refreshed its copy on 28 Oct 2026.