AzTrials
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StressRISENCT05254600

RISE RCT for Nurse Leaders

A study testing RISE for Nurse Leaders Program in people with Stress and Burnout, 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 study is to determine whether RISE for Nurse Leaders has a significant impact on nurse leaders' post-traumatic growth, resilience, insight, self-compassion, and empowerment, as well as mental well-being, in their personal lives and their working environment. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stress, Burnout
What is being tested?
RISE for Nurse Leaders Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
28 Mar 2022to 15 May 2023
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult ≥ 18 years old
  • Licensed as an RN
  • Unit-based nurse leader (i.e., assistant nurse manager, nurse manager) employed by AdventHealth in a hospital-based setting at the Altamonte Springs, Apopka, Celebration, Daytona Beach, DeLand, East Orlando, 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.

Who cannot join

  • Employed as a direct care nurse or in another level of nursing leadership (i.e., director of nursing, executive leader)
  • A study participant of IRBNet #1504917 titled A Pilot Study of RISE for Nurse Managers

Trial locations and contacts

1 site in 1 country.

United States1 site

  • AdventHealth Orlando

    Orlando, Florida, 32804

Other trials in United States

About this study

Official title: A Randomized Controlled Trial of RISE for Nurse Leaders

The purpose of this study is to determine whether RISE for Nurse Leaders has a significant impact on nurse leaders' post-traumatic growth, resilience, insight, self-compassion, and empowerment, as well as mental well-being, in their personal lives and their working environment.

Conditions
Stress, Burnout
Being tested
RISE for Nurse Leaders Program
Medical subject headings
Burnout, Psychological

What participants receive

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

  • RISE for Nurse Leaders ProgramBehavioural

    Psychoeducational sessions designed to impact resilience, insight, self-compassion, and empowerment

Study groups in NCT05254600
Study groupRoleWhat they receive
Intervention groupExperimentalIntervention group will attend the RISE for Nurse Leaders program, which consists of nine 90-minute weekly psychoeducational group sessions facilitated by a licensed mental health counselor (LMHC)
Receives: Behavioral: RISE for Nurse Leaders Program
Wait-list control groupActive comparatorControl group will attend the RISE for Nurse Leaders program after the 3-month wait-list period
Receives: Behavioral: RISE for Nurse Leaders Program

What is being measured

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

  1. Posttraumatic Growth Inventory

    21 item questionnaire with a scale of 0-5, with 0 meaning I did not experience this change as a result of my crisis; and 5 meaning I experienced this change to a very great degree as a result of my crisis

    Measured: Group comparison from baseline to 3-month follow-up

Secondary outcomes (7)

  1. Brief Index of Affective Job Satisfaction

    4 item questionnaire with a scale of 1-5, with 1 meaning strongly disagree; and 5 meaning strongly agree

    Measured: Group comparison from baseline to 3-month follow-up

  2. Brief Resilience Scale

    6 item questionnaire with a scale of 1-5, with 1 meaning strongly disagree; and 5 meaning strongly agree

    Measured: Group comparison from baseline to 3-month follow-up

  3. General Self-Efficacy Scale

    10 item questionnaire with a scale of 1-4, with 1 meaning not at all true; and 4 meaning exactly true

    Measured: Group comparison from baseline to 3-month follow-up

  4. Perceived Stress Scale

    10 item questionnaire with a scale of 0-4, with 0 meaning never; and 4 meaning very often

    Measured: Group comparison from baseline to 3-month follow-up

  5. Professional Quality of Life (ProQOL) Scale

    30 item questionnaire with a scale of 1-5 with 1 meaning never; and 5 meaning very often

    Measured: Group comparison from baseline to 3-month follow-up

  6. Psychological Empowerment Instrument

    12 item questionnaire with a scale of A-G, with A meaning very strongly disagree; and G meaning very strongly agree

    Measured: Group comparison from baseline to 3-month follow-up

  7. Self-Reflection and Insight Scale

    20 item questionnaire with a scale of 1-6; with 1 meaning strongly disagree; and 6 meaning strongly agree

    Measured: Group comparison from baseline to 3-month follow-up

Timeline

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

  1. First posted24 Feb 2022
  2. Study start28 Mar 2022
  3. Primary completion15 Mar 2023
  4. Study completion15 May 2023

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05254600
Sponsor's protocol ID
1839775
Acronym
RISE
Status last verified
Jun 2023
First submitted
15 Feb 2022
Last updated
28 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy Scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. (pp. 35-37). Windsor, UK: NFER-NELSON

  • 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

  • Kath LM, Stichler JF, Ehrhart MG. Moderators of the negative outcomes of nurse manager stress. J Nurs Adm. 2012 Apr;42(4):215-21. doi: 10.1097/NNA.0b013e31824ccd25.

    PubMed 22441404

  • Kath LM, Stichler JF, Ehrhart MG, Sievers A. Predictors of nurse manager stress: a dominance analysis of potential work environment stressors. Int J Nurs Stud. 2013 Nov;50(11):1474-80. doi: 10.1016/j.ijnurstu.2013.02.011. Epub 2013 Mar 21.

    PubMed 23522937

  • Labrague LJ, McEnroe-Petitte DM, Leocadio MC, Van Bogaert P, Cummings GG. Stress and ways of coping among nurse managers: An integrative review. J Clin Nurs. 2018 Apr;27(7-8):1346-1359. doi: 10.1111/jocn.14165. Epub 2018 Jan 24.

    PubMed 29148110

  • Lee H, Cummings GG. Factors influencing job satisfaction of front line nurse managers: a systematic review. J Nurs Manag. 2008 Oct;16(7):768-83. doi: 10.1111/j.1365-2834.2008.00879.x.

    PubMed 19017239

  • • 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.

  • • Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005; 4(4): 287-291.

  • 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

  • Shirey MR, McDaniel AM, Ebright PR, Fisher ML, Doebbeling BN. Understanding nurse manager stress and work complexity: factors that make a difference. J Nurs Adm. 2010 Feb;40(2):82-91. doi: 10.1097/NNA.0b013e3181cb9f88.

    PubMed 20124961

  • 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

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

  • • Stamm, B. H. (2009). Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL). http://www.proqol.org.

  • Steege LM, Pinekenstein BJ, Arsenault Knudsen E, Rainbow JG. Exploring nurse leader fatigue: a mixed methods study. J Nurs Manag. 2017 May;25(4):276-286. doi: 10.1111/jonm.12464. Epub 2017 Feb 27.

    PubMed 28244184

  • • Thompson ER & Phua FTT. A Brief Index of Affective Job Satisfaction. Group & Organization Management. 2012; 37(3): 275-307.

Questions about this trial

What is this clinical trial studying?

A study testing RISE for Nurse Leaders Program in people with Stress and Burnout, 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 6 inclusion and 2 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 Jun 2023. 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?

Posttraumatic Growth Inventory (time frame: Group comparison from baseline to 3-month follow-up). 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 NCT05254600, which also lists 16 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 Jun 2023.

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