CClinicalTrials.gg
CompletedNCT03645512Updated Feb 19, 2020

Resilience Intervention for Critical Care Nurses

An interventional study of Corporate Athlete Resilience (CAR) Training Program in Stress, sponsored by AdventHealth. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-19.

Sponsored by AdventHealth · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

The Corporate Athlete® Resilience (CAR) Training Program is a 1-day training program that uses a holistic approach that focuses on moving between stress and strategic recovery to help build resilience and enable higher performance.

The purpose of this RCT is to determine whether the CAR Training Program has significant impact on nurses' resilience and stress mindset in their personal lives and their working environment. Knowledge from this study can be applied to interventions in the future to improve resilience behavior.

Read the detailed description

The ongoing nursing shortage in the U.S health care system is a multifaceted issue. One factor leading to the nursing shortage is high turnover, particularly among critical care nurses due to their experiences with stressful work environments, ethical dilemmas, and high rates of patient morbidity and mortality. There is also a high prevalence of psychological disorders, such as anxiety, depression, and Post Traumatic Stress Disorder (PTSD) among critical care nurses. Consequences of turnover and low nurse staffing include lower quality of care, lower patient satisfaction, increased medical errors, increased rates of health care associated infections, and higher 30-day mortality rates.

Resilience is defined as "the ability to adapt to life's ever-changing landscape and recover quickly from the stressors and potential stressors". It is a learned psychological characteristic that can be used to bounce back after disruption and successfully adapt to stressful work experiences in a positive manner.

02

Conditions studied

  • Stress

Keywords

  • Resilience
  • High Performance
  • Critical Care Nurse
03

In context

Lead sponsor

AdventHealth is the lead sponsor of 107 studies on the registry; 25 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Adult ≥ 18 years old
  2. Employed as a critical care nurse at Florida Hospital in an adult ICU, PICU, PCVICU, or Level 3 NICU at the Altamonte, Orlando, or Winter Park campus
  3. Able to speak, read, and understand English fluently
  4. Able to provide informed consent
  5. Meet ≥ 2 stress experience level parameters on the Stress Mindset Measure - General (SMM-G)
  6. Meet ≤ 4.3 on the Brief Resilience Scale (BRS)
  7. Willing to attend a full-day training program at HPI on the designated training date
  8. Willing and able to comply with all study procedures and requirements for the duration of the study.

Exclusion criteria

Exclusion Criteria:

  1. Meet \< 2 stress experience level parameters on the SMM-G
  2. Meet > 4.3 on the BRS
  3. Receive a high score of ≥ 27 on the Emotional Exhaustion domain and/or a high score of ≥ 13 on the Depersonalization domain of the Maslach Burnout Inventory (MBI)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • Experimental
    Intervention

    The intervention group will attend in the 1-day Corporate Athlete Resilience (CAR) Training Program in Lake Nona.

    Behavioral: Corporate Athlete Resilience (CAR) Training Program

  • No intervention
    Control

    The control group will attend the 1-day CAR Training Program in Lake Nona after a 3-month wait list period, which will be three months after the intervention group attends the intervention.

Interventions

  • BehavioralCorporate Athlete Resilience (CAR) Training Program

    A 1-day training program developed by the J\&J Human Performance Institute (HPI), which uses a holistic approach that focuses on moving between stress and strategic recovery to help build resilience and enable higher performance.

06

What researchers measure

Primary outcomes

  1. Stress Mindset Measure - General (SMM-G)

    Participants will respond to an 8-item questionnaire measuring stress. Responses will be provided on the following 5-point scale: 0=Strongly Disagree, 1=Disagree, 2=Neither Agree nor Disagree, 3=Agree, 4=Strongly Agree.

    Time frame: Change from Baseline SMM-G score at 6-months post CAR Training

Secondary outcomes

  1. Perceived Stress Scale (PSS)

    Participants will respond to a 10-item questionnaire measuring perceived stress. Responses will be provided on the following 5-point scale: 0=Never, 1=Almost Never, 2=Sometimes, 3=Fairly Often, 4=Very Often.

    Time frame: Change from Baseline PSS score at 6-months post CAR Training

  2. Brief Resilience Scale (BRS)

    Participants will respond to a 6-item questionnaire measuring resilience. Responses will be provided on the following 5-point scale: 1=Strongly Disagree, 2=Disagree, 3=Neutral, 4=Agree, 5=Strongly Agree.

    Time frame: Change from Baseline BRS score at 6-months post CAR Training

  3. Maslach Burnout Inventory Human Serices Survey (MBI-HSS) for Medical Personnel (MP)

    Participants will respond to a 22-item questionnaire measuring burnout. Responses will be provided on the following 7-point scale: 0=Never, 1=A few times a year or less, 2=Once a month or less, 3=A few times a month, 4=Once a week, 5=A few times a week, 6=Everyday.

    Time frame: Change from Baseline MBI-HSS (MP) score at 6-months post CAR Training

  4. Public Health Surveillance - Wellbeing Scale (PHS-WB)

    Participants will respond to a 10-item questionnaire measuring perception of personal well-being and satisfaction. Responses will be provided on a 5-point scale (6 items) and a 10-point scale (4 items).

    Time frame: Change from Baseline PHS-WB score at 6-months post CAR Training

  5. RAND Medial Outcomes Study (MOS) Sleep Scale Survey

    Participants will respond to a 12-item questionnaire with self-reported information related to sleep patterns. Responses will be provided on the following 6-point scale: 1=All of the time, 2=Most of the time, 3=A good bit of the time, 4=Some of the time, 5=A little of the time, 6=None of the time.

    Time frame: Change from Baseline RAND MOS Sleep Scale Survey score at 6-months post CAR Training

  6. RAND 36-Item Short Form Health Survey (SF-36)

    Participants will respond to a 36-item questionnaire with self-reported health ratings and perceived impact of one's health on a variety of daily activities. Response options for questionnaire items vary from 3-point scale, 5-point scale, and Yes/No responses.

    Time frame: Change from Baseline RAND SF-36 score at 6-months post CAR Training

  7. Absenteeism & Presenteeism questions of the World Health Organization's Health and Work Performance Questionnaire (WHO-HPQ)

    Participants will respond to 11 absenteeism and presenteeism questions abstracted from the full HPQ. Responses for 2 items require self-reported information regarding hours worked and hours the employer expects the participant to work in 7 days. 6 items require participants to provide work experience information from the past 4 weeks. Responses for 3 items are provided on a 10-point scale in which 0=Worst Performance, and 10=Top Performance. Responses are input into a provided formula for scoring; a higher absenteeism score indicates higher amount of absenteeism, while a higher presenteeism score indicates lower amount of lost performance.

    Time frame: Change from Baseline WHO-HPQ score at 6-months post CAR Training

  8. Work Productivity and Activity Impairment Questionnaire (WPAI)

    Participants will respond to a 6-item questionnaire, answering questions about the perceived effect of personal health problems on one's ability to work or perform activities. Responses are provided in a Yes/No format or using a 10-point scale in which 0=Health problems had no effect on my work and 10=Health problems completely prevented me from working.

    Time frame: Change from Baseline WPAI score at 6-months post CAR Training

  9. Energy Management Behaviors Questionnaire (EMB)

    Participants will respond to a 21-item questionnaire, providing a self-reported level of engagement in various activities. Responses are provided using the following 7-point scale: 1=Never, 2=Almost never, 3=Seldom, 4=Sometimes, 5=Usually, 6=Very Often, 7=Always.

    Time frame: Change from Baseline EMB score at 6-months post CAR Training

07

Study locations

1 site
  • Florida Hospital
    Orlando, Florida 32804, United States
08

References and documents

Publications

  • Acker KH. Do critical care nurses face burnout, PTSD, or is it something else?: getting help for the helpers. AACN Clin Issues Crit Care Nurs. 1993 Aug;4(3):558-65. PubMed 8136229 ↗
  • Bann CM, Kobau R, Lewis MA, Zack MM, Luncheon C, Thompson WW. Development and psychometric evaluation of the public health surveillance well-being scale. Qual Life Res. 2012 Aug;21(6):1031-43. doi: 10.1007/s11136-011-0002-9. Epub 2011 Sep 23. PubMed 21947657 ↗
  • Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK2651/ PubMed 21328752 ↗
  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. PubMed 6668417 ↗
  • Crum AJ, Salovey P, Achor S. Rethinking stress: the role of mindsets in determining the stress response. J Pers Soc Psychol. 2013 Apr;104(4):716-33. doi: 10.1037/a0031201. Epub 2013 Feb 25. PubMed 23437923 ↗
  • Johnson & Johnson Health & Wellness Solutions Research Team. 2017. Validation and Analysis of Johnson & Johnson Human Performance Institute™ (HPI) Assessment Inventory. Unpublished manuscript.
  • Kessler RC, Barber C, Beck A, Berglund P, Cleary PD, McKenas D, Pronk N, Simon G, Stang P, Ustun TB, Wang P. The World Health Organization Health and Work Performance Questionnaire (HPQ). J Occup Environ Med. 2003 Feb;45(2):156-74. doi: 10.1097/01.jom.0000052967.43131.51. PubMed 12625231 ↗
  • Maslach, C., Jackson, S. E., & Leiter, M. P. (1996). Maslach Burnout Inventory manual (3rd ed.). Palo Alto, CA: Consulting Psychologists Press.
  • Mealer ML, Shelton A, Berg B, Rothbaum B, Moss M. Increased prevalence of post-traumatic stress disorder symptoms in critical care nurses. Am J Respir Crit Care Med. 2007 Apr 1;175(7):693-7. doi: 10.1164/rccm.200606-735OC. Epub 2006 Dec 21. PubMed 17185650 ↗
  • Mealer M, Burnham EL, Goode CJ, Rothbaum B, Moss M. The prevalence and impact of post traumatic stress disorder and burnout syndrome in nurses. Depress Anxiety. 2009;26(12):1118-26. doi: 10.1002/da.20631. PubMed 19918928 ↗
  • Mealer M, Conrad D, Evans J, Jooste K, Solyntjes J, Rothbaum B, Moss M. Feasibility and acceptability of a resilience training program for intensive care unit nurses. Am J Crit Care. 2014 Nov;23(6):e97-105. doi: 10.4037/ajcc2014747. Erratum In: Am J Crit Care. 2016 Mar;25(2):172. doi: 10.4037/ajcc2016417. PubMed 25362680 ↗
  • Mealer M, Jones J, Newman J, McFann KK, Rothbaum B, Moss M. The presence of resilience is associated with a healthier psychological profile in intensive care unit (ICU) nurses: results of a national survey. Int J Nurs Stud. 2012 Mar;49(3):292-9. doi: 10.1016/j.ijnurstu.2011.09.015. Epub 2011 Oct 5. PubMed 21974793 ↗
  • Pipe TB, Buchda VL, Launder S, Hudak B, Hulvey L, Karns KE, Pendergast D. Building personal and professional resources of resilience and agility in the healthcare workplace. Stress Health. 2012 Feb;28(1):11-22. doi: 10.1002/smi.1396. Epub 2011 Mar 13. PubMed 22259154 ↗
  • RAND Corporation. (2018). Sleep Scale Survey. Retrieved from https://www.rand.org/health/surveys_tools/mos/sleep-scale.html.
  • RAND Corporation. (2018). 36-Item Short Form Survey (SF-36). Retrieved from https://www.rand.org/health/surveys_tools/mos/36-item-short-form.html.
  • Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006. PubMed 10146874 ↗
  • 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. PubMed 18696313 ↗
  • Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2. PubMed 32627860 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03645512
Lead sponsor
AdventHealth
Collaborators
Johnson & Johnson
Responsible party
Sponsor
First posted
Aug 24, 2018
Start date
Oct 26, 2018
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019
Last update
Feb 19, 2020

Study contacts

Amanda T Sawyer, PhD
principal investigator · AdventHealth

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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