NCT05743205

Brief 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 goals, problems or concerns that APPs would like assistance with during the intervention period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2025

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

February 14, 2023

Last Update Submit

February 26, 2026

Conditions

Keywords

ResilienceBurnoutWork engagement

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    change from baseline well-being measure at 6 months, 1 year and 2 years.

Study Arms (1)

Educational Intervention

EXPERIMENTAL

Educational intervention

Behavioral: voluntary consultative wellness session

Interventions

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.

Educational Intervention

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • actively participating in formalized counseling sessions through other services at time of recruitment into the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OSF HealthCare System

Peoria, Illinois, 61602, United States

Location

Related Publications (8)

  • 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.

    PMID: 31708107BACKGROUND
  • Klein 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.

    PMID: 31868125BACKGROUND
  • Klein 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.

    PMID: 32491978BACKGROUND
  • Klein 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.

    PMID: 34334766BACKGROUND
  • Smith 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.

    PMID: 18696313BACKGROUND
  • Dyrbye 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.

  • Klein 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.

  • Klein 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 Mar 18. doi: 10.1097/JXX.0000000000001270. Online ahead of print.

MeSH Terms

Conditions

Occupational StressBurnout, ProfessionalBurnout, Psychological

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Colleen Klein, PhD, RN

    OSF Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Education and Research Scientist

Study Record Dates

First Submitted

February 14, 2023

First Posted

February 24, 2023

Study Start

December 21, 2022

Primary Completion

December 22, 2025

Study Completion

December 22, 2025

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations