- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03645707
Resilience Insight Self Compassion and Empowerment (RISE) Pilot
A Mixed Methods Evaluation of a Resilience Intervention With Psychoeducational Sessions for Critical Care Nurses
Study Overview
Status
Conditions
Intervention / Treatment
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.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Orlando, Florida, United States, 32804
- AdventHealth
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult ≥ 18 years old.
- Employed as a critical care nurse at Florida Hospital in an adult ICU, PICU, PCVICU, or Level 3 NICU.
- Able to speak, read, and understand English fluently.
- Able to provide informed consent.
- 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) as part of Florida Hospital IRBNet #1234568.
- Willing to attend a full-day training program at HPI on the designated training date.
- Willing and able to comply with all study procedures and requirements for the duration of the study.
Exclusion Criteria:
1. At imminent risk of harm to themselves or others
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: CAR Training and Psychoeducational Sessions
This is a secondary study to the primary study titled "A Randomized Controlled Trial of a Resilience Intervention for Critical Care Nurses" (IRBNet #1234568). In the primary study, participants will be randomized into the intervention group or wait-list control group. In this secondary study, all participants will attend the 1-day CAR Training Program and the follow-up psychoeducational group sessions. |
Participation in the CAR Training Program, a 1-day training program developed by the J&J Human Performance Institute (HPI). The CAR Training Program uses a holistic approach that focuses on moving between stress and strategic recovery to help build resilience and enable higher performance. Participants will attend eight weekly follow-up psychoeducational group sessions facilitated by a licensed mental health counselor that will meet for 90 minutes. The themes of these sessions will be RISE - Resilience, Insight, Self-Compassion, and Empowerment. Due to limited time and flexibility in sessions, participants will practice skills through optional homework activities to facilitate learning between sessions. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress Mindset Measure - General (SMM-G)
Time Frame: Change from Baseline SMM-G score at 6-months post CAR Training
|
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.
|
Change from Baseline SMM-G score at 6-months post CAR Training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale (PSS)
Time Frame: Change from Baseline PSS score at 6-months post CAR Training
|
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.
|
Change from Baseline PSS score at 6-months post CAR Training
|
|
Brief Resilience Scale (BRS)
Time Frame: Change from Baseline BRS score at 6-months post CAR Training
|
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.
|
Change from Baseline BRS score at 6-months post CAR Training
|
|
Maslach Burnout Inventory Human Services Survey (MBI-HSS) for Medical Personnel (MP)
Time Frame: Change from Baseline MBI-HSS (MP) score at 6-months post CAR Training
|
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.
|
Change from Baseline MBI-HSS (MP) score at 6-months post CAR Training
|
|
Public Health Surveillance - Wellbeing Scale (PHS-WB)
Time Frame: Change from Baseline PHS-WBscore at 6-months post CAR Training
|
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).
|
Change from Baseline PHS-WBscore at 6-months post CAR Training
|
|
RAND Medical Outcomes Study (MOS) Sleep Scale Survey
Time Frame: Change from Baseline RAND MOS Sleep Scale score at 6-months post CAR Training
|
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.
|
Change from Baseline RAND MOS Sleep Scale score at 6-months post CAR Training
|
|
RAND 36-Item Short Form Health Survey (SF-36)
Time Frame: Change from Baseline SF-36 score at 6-months post CAR Training
|
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.
|
Change from Baseline SF-36 score at 6-months post CAR Training
|
|
Absenteeism and Presenteeism questions of the World Health Organization's Health and Work Performance Questionnaire (WHO-HPQ)
Time Frame: Change from Baseline WHO-HPQ score at 6-months post CAR Training
|
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.
|
Change from Baseline WHO-HPQ score at 6-months post CAR Training
|
|
Work Productivity and Activity Impairment Questionnaire (WPAI)
Time Frame: Change from Baseline WPAI score at 6-months post CAR Training
|
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.
|
Change from Baseline WPAI score at 6-months post CAR Training
|
|
Self-Reflection and Insight Scale (SRIS)
Time Frame: Change from Baseline SRIS score at 6-months post CAR Training
|
Participants will respond to a 20-item questionnaire using a 6-point scale where 1=Strongly disagree and 6=Strongly agree.
|
Change from Baseline SRIS score at 6-months post CAR Training
|
|
Self-Compassion Scale - Short Form (SCS-SF)
Time Frame: Change from Baseline SCS-SF score at 6-months post CAR Training
|
Participants will respond to a 12-item questionnaire, indicating how often certain behaviors are personally experienced when in difficult times.
Responses are provided on 5-point scale in which 1=Almost never and 5=Almost always.
|
Change from Baseline SCS-SF score at 6-months post CAR Training
|
|
Psychological Empowerment Instrument
Time Frame: Change from Baseline Psychological Empowerment Instrument score at 6-months post CAR Training
|
Participants will respond to a 12-item questionnaire to items regarding self-orientations people may have with regard to their work role.
Responses are provided on the following 7-point scale: 1=Very strongly disagree, 2=Strongly disagree, 3=Disagree, 4=Neutral, 5=Agree, 6=Strongly Agree, 7=Very Strongly Agree.
|
Change from Baseline Psychological Empowerment Instrument score at 6-months post CAR Training
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amanda T. Sawyer, PhD, AdventHealth
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Carayon P, Gurses AP. Nursing Workload and Patient Safety-A Human Factors Engineering Perspective. In: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Chapter 30. Available from http://www.ncbi.nlm.nih.gov/books/NBK2657/
- 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.
- Grant, A. M., Franklin, J., & Langford, P. (2002). The Self-Reflection and Insight Scale: A new measure of private self-consciousness. Social Behavior and Personality, 30(8), 821-836.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
- 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.
- 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.
- Spreitzer, G. M. (1995). Psychological empowerment in the workplace: Dimensions, measurement, and validation. Academy of Management Journal, 38(5), 1442-1465.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1256670
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
Center for Advanced Facial Plastic SurgeryCompletedStress | Stress, Physiological | Stress Response | Stress (Psychology) | Healthy Adult Female Participants | Stress, Psychologic | Stress Perception | Stress Levels | Stress, Psychological CumulativeUnited States
-
Amsterdam UMC, location VUmcRigshospitalet, Denmark; Universitätsklinikum Hamburg-EppendorfNot yet recruitingStress | Stress and Burnout | Stress BiomarkersGermany, Denmark
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...CompletedStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
Amasya UniversityCompletedThe Effect of Online Stress Management Program on Nurses' Individual Workload Perception, and StressStress | Nursing | Stress ManagementTurkey (Türkiye)
-
Canterbury Christ Church UniversitySussex Partnership NHS Foundation TrustEnrolling by invitationOccupational Stress or Workplace StressUnited Kingdom
-
University of PadovaCompletedStress | Stress Disorder | Work Related StressItaly
-
University of Thi-QarCompletedPsychological Stress | Academic StressIraq
-
Dana-Farber Cancer InstituteCompletedStress | Post Traumatic Stress Disorder | Work Related StressUnited States
-
University of North Carolina, Chapel HillWashington University School of Medicine; United States Department of Defense; University of Florida and other collaboratorsRecruitingPost-traumatic Stress Disorder | Acute Stress Disorder | Acute Stress ReactionUnited States
Clinical Trials on CAR Training and Psychoeducational Sessions
-
Rambam Health Care CampusUnknownPatients Diagnosed With Severe Mental IllnessIsrael
-
University of MiamiNational Institute on Drug Abuse (NIDA)CompletedRisk Behavior | Substance Use Disorders | Psychiatric Disorders | Family DysfunctionUnited States
-
Arizona State UniversityNational Institute on Aging (NIA)RecruitingDementia | Mild Cognitive Impairment (MCI) | Alzheimer DiseaseUnited States
-
Institut Català d'OncologiaInstitut d'Investigació Biomèdica de Bellvitge; Carlos III Health InstituteNot yet recruitingBreast Cancer | Cognitive Dysfunction
-
BaycrestSunnybrook Health Sciences CentreUnknownTransient Ischemic Attack | Mild Stroke | Ischemic White Matter Disease | Stroke RiskCanada
-
University of CyprusRecruitingAging | Cognitive Decline | Memory Impairment | Mild Cognitive DisorderCyprus
-
Arizona State UniversityCompletedDementia | Alzheimer Disease | Memory LossUnited States
-
Queen's UniversityCompletedMental DisordersCanada
-
Yale UniversityNational Institute of Mental Health (NIMH); University of Pittsburgh; Emory University and other collaboratorsCompletedChild Development Disorders, PervasiveUnited States
-
Kent State UniversityCompletedDating ViolenceUnited States