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StressNCT03645707

Resilience Insight Self Compassion and Empowerment (RISE) Pilot

A study testing CAR Training and Psychoeducational Sessions in people with Stress, run by AdventHealth at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this pilot study is to determine whether the combination of the Corporate Athlete® Resilience (CAR) Training Program and follow-up psychoeducational group sessions has significant impact on nurses' resilience and stress mindset in their personal lives and their working environment. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Stress
What is being tested?
CAR Training and Psychoeducational Sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
30 Oct 2018to 30 Aug 2019
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 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 1. At imminent risk of harm to themselves or others

Trial locations and contacts

1 site in 1 country.

United States1 site

  • AdventHealth

    Orlando, Florida, 32804

Other trials in United States

About this study

Official title: A Mixed Methods Evaluation of a Resilience Intervention With Psychoeducational Sessions for Critical Care Nurses

The purpose of this pilot study is to determine whether the combination of the Corporate Athlete® Resilience (CAR) Training Program and follow-up psychoeducational group sessions 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.

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.

Conditions
Stress
Being tested
CAR Training and Psychoeducational Sessions
Keywords
Critical Care Nurse, Resilience, Stress Mindset

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAR Training and Psychoeducational SessionsBehavioural

    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.

Study groups in NCT03645707
Study groupRoleWhat they receive
CAR Training and Psychoeducational SessionsExperimentalThis 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.
Receives: Behavioral: CAR Training and Psychoeducational Sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (11)

  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.

    Measured: 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.

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

  3. Maslach Burnout Inventory Human Services 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.

    Measured: 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).

    Measured: Change from Baseline PHS-WBscore at 6-months post CAR Training

  5. RAND Medical 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.

    Measured: Change from Baseline RAND MOS Sleep Scale 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.

    Measured: Change from Baseline SF-36 score at 6-months post CAR Training

  7. Absenteeism and 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.

    Measured: 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.

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

  9. Self-Reflection and Insight Scale (SRIS)

    Participants will respond to a 20-item questionnaire using a 6-point scale where 1=Strongly disagree and 6=Strongly agree.

    Measured: Change from Baseline SRIS score at 6-months post CAR Training

  10. Self-Compassion Scale - Short Form (SCS-SF)

    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.

    Measured: Change from Baseline SCS-SF score at 6-months post CAR Training

  11. Psychological Empowerment Instrument

    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.

    Measured: Change from Baseline Psychological Empowerment Instrument score at 6-months post CAR Training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2018
  2. Study start30 Oct 2018
  3. Primary completion31 Jul 2019
  4. Study completion30 Aug 2019

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a secondary study to the primary study titled "A Randomized Controlled Trial of a Resilience Intervention for Critical Care Nurses" (Florida Hospital IRBNet #1234568). In the primary study, participants will be randomized into the intervention group or wait-list control group. However, in this secondary study, all participants will attend the 1-day CAR Training Program and the follow-up psychoeducational group sessions.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03645707
Sponsor's protocol ID
1256670
Status last verified
Feb 2022
First submitted
21 Aug 2018
Last updated
28 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

  • 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.

    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.

    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

  • 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.

    PubMed 21584907

Questions about this trial

What is this clinical trial studying?

A study testing CAR Training and Psychoeducational Sessions in people with Stress, run by AdventHealth 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 7 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 28 Feb 2022. 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?

Stress Mindset Measure - General (SMM-G) (time frame: Change from Baseline SMM-G score at 6-months post CAR Training). 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 NCT03645707, which also lists 20 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 28 Feb 2022.

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