Resilience Insight Self Compassion and Empowerment (RISE) Pilot

NCT ID: NCT03645707

Last Updated: 2022-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-30

Study Completion Date

2019-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

CAR Training and Psychoeducational Sessions

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CAR Training and Psychoeducational 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
3. Able to speak, read, and understand English fluently.
4. Able to provide informed consent.
5. 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.
6. Willing to attend a full-day training program at HPI on the designated training date.
7. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AdventHealth

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amanda T. Sawyer, PhD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AdventHealth

Orlando, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 8136229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21947657 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 21328752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6668417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23437923 (View on PubMed)

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.

Reference Type BACKGROUND

Johnson & Johnson Health & Wellness Solutions Research Team. 2017. Validation and Analysis of Johnson & Johnson Human Performance Institute™ (HPI) Assessment Inventory. Unpublished manuscript.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 12625231 (View on PubMed)

Maslach, C., Jackson, S. E., & Leiter, M. P. (1996). Maslach Burnout Inventory manual (3rd ed.). Palo Alto, CA: Consulting Psychologists Press.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 17185650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19918928 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25362680 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21974793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22259154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21584907 (View on PubMed)

RAND Corporation. (2018). Sleep Scale Survey. Retrieved from https://www.rand.org/health/surveys_tools/mos/sleep-scale.html.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 10146874 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18696313 (View on PubMed)

Spreitzer, G. M. (1995). Psychological empowerment in the workplace: Dimensions, measurement, and validation. Academy of Management Journal, 38(5), 1442-1465.

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1256670

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

RISE for Nurse Managers Retreat
NCT07298018 NOT_YET_RECRUITING NA