NCT04952441

Brief Summary

The purpose of this study is to determine whether the RISE program has a significant impact on nurses' resilience, insight, self-compassion, and empowerment, as well as mental and physical well-being, in their personal lives and their working environment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

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

March 19, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

June 17, 2021

Last Update Submit

July 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from Baseline to 3 month follow up

Secondary Outcomes (11)

  • Measure Name: Brief Resilience Scale (BRS)

    Change from Baseline to 3 month follow up

  • Self-Compassion Scale - Short Form (SCS-SF)

    Change from Baseline to 3 month follow up

  • Psychological Empowerment Instrument (PEI)

    Change from Baseline to 3 month follow up

  • Stress Mindset Measure - General (SMM-G)

    Change from Baseline to 3 month follow up

  • Perceived Stress Scale (PSS)

    Change from Baseline to 3 month follow up

  • +6 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intervention group will attend the RISE program which consists of eight 90-minute weekly psychoeducational group sessions facilitated by a licensed mental health counselor

Behavioral: RISE Program

Wait-list Control Group

ACTIVE COMPARATOR

The control group will attend the RISE program after the 3 month wait-list period (study months 6-7)

Behavioral: RISE Program

Interventions

RISE ProgramBEHAVIORAL

Psychoeducational sessions designed to impact Resilience, Insight, Self-Compassion, and Empowerment

Intervention GroupWait-list Control Group

Eligibility Criteria

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

You may qualify if:

  • Adult ≥ 18 years old
  • Licensed as an RN
  • RN employed by AdventHealth in a hospital-based setting at the Altamonte, Apopka, Celebration, Daytona Beach, DeLand, East, Fish Memorial, Kissimmee, New Smyrna Beach, Orlando, Palm Coast, Waterman, or Winter Park campus
  • Able to speak, read, and understand English fluently
  • Able to provide informed consent
  • Willing and able to comply with all study procedures and requirements for the duration of the study.

You may not qualify if:

  • Employed as an ARNP
  • Employed in a role that completes another RN's annual evaluations
  • A participant of the study in IRBNet #1234568 or IRBNet #1256670
  • At imminent risk of harm to themselves or others.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AdventHealth

Orlando, Florida, 32804, United States

Location

Related Publications (16)

  • 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.

    PMID: 8136229BACKGROUND
  • 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.

    PMID: 21947657BACKGROUND
  • 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.

    PMID: 6668417BACKGROUND
  • 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.

    PMID: 23437923BACKGROUND
  • 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.

    PMID: 12625231BACKGROUND
  • 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.

    PMID: 17185650BACKGROUND
  • 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.

    PMID: 19918928BACKGROUND
  • 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.

    PMID: 25362680BACKGROUND
  • 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.

    PMID: 21974793BACKGROUND
  • 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.

    PMID: 21584907BACKGROUND
  • 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.

    PMID: 10146874BACKGROUND
  • 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
  • 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/

    PMID: 21328752BACKGROUND
  • Grant AM, Franklin J, Langford P. The Self-Reflection and Insight Scale: A new measure of private self-consciousness. Social Behavior and Personality. 2002; 30(8): 821-836

    BACKGROUND
  • Maslach C, Jackson SE, Leiter MP. (1996). Maslach Burnout Inventory manual (3rd ed.). Palo Alto, CA: Consulting Psychologists Press

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

    BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Amanda Sawyer, PhD

    AdventHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomized into either the intervention group or the wait-list control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2021

First Posted

July 7, 2021

Study Start

March 19, 2019

Primary Completion

March 1, 2020

Study Completion

June 1, 2021

Last Updated

July 7, 2021

Record last verified: 2021-07

Locations