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Self CompassionNCT04987697

A Pilot Study of RISE for Nurse Managers

A study testing counseling in people with Self Compassion and 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 study is to determine whether RISE for Nurse Managers has a significant impact on nurse managers' 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
Self Compassion, Stress, Burn-Out
What is being tested?
counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
13 Apr 2021to 31 Dec 2021
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
  • Nurse manager employed by AdventHealth in a hospital-based setting at the Altamonte Springs, Apopka, Carrollwood, Celebration, Connerton, Dade City, Daytona Beach, DeLand, East Orlando, Fish Memorial, Heart of Florida, Kissimmee, Lake Placid, Lake Wales, New Smyrna Beach, North Pinellas, Ocala, Orlando, Palm Coast, Sebring, Tampa, Waterman, Wauchula, Wesley Chapel, Winter Garden, Winter Park, or Zephyrhills 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

  • 1. Employed as a direct care nurse or in another level of nursing leadership (i.e., assistant nurse manager, director of nursing, executive leader)

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 Pilot Study of RISE (Resilience, Insight, Self-Compassion, Empowerment) for Nurse Managers

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

Being tested
counseling
Medical subject headings
Burnout, Psychological

What participants receive

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

  • counselingBehavioural

    nine 90-minute weekly psychoeducational group sessions facilitated by a licensed mental health counselor (LMHC).

Study groups in NCT04987697
Study groupRoleWhat they receive
Counseling and SurveysOthernine 90-minute weekly psychoeducational group sessions facilitated by a licensed mental health counselor (LMHC).
Receives: Behavioral: counseling

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 to 5 meaning I experienced this change to a very great degree as a result of my crisis

    Measured: Change from Baseline to 6 months

Secondary outcomes (8)

  1. Brief Cope

    28 item questionnaire with a scale of 1-4, with 1 meaning I haven't been doing this at all; and 4 meaning I've been doing this a lot

    Measured: Change from Baseline to 6 months

  2. 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: Change from Baseline to 6 months

  3. Brief Resilience Scale

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

    Measured: Change from Baseline to 6 months

  4. 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: Change from Baseline to 6 months

  5. Perceived Stress Scale

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

    Measured: Change from Baseline to 6 months

  6. Maslach Burnout Inventory General Survey

    16 item questionnaire with a scale of 0-6 with 0 meaning never; and 6 meaning everyday

    Measured: Change from Baseline to 6 months

  7. Self-Compassion Scale - Short Form

    12 item questionnaire with a scale of 1-5, with 1 meaning almost never; and 5 meaning almost always

    Measured: Change from Baseline to 6 months

  8. 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: Change from Baseline to 6 months

Timeline

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

  1. First posted3 Aug 2021
  2. Study start13 Apr 2021
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

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
Not applicable
Intervention model
Single group
Model description
Pilot Study
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04987697
Sponsor's protocol ID
1504917
Status last verified
Feb 2022
First submitted
3 Mar 2020
Last updated
28 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.

    PubMed 16250744

  • 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.

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

  • 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.

  • 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 counseling in people with Self Compassion and 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 6 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?

Posttraumatic Growth Inventory (time frame: Change from Baseline to 6 months). 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 NCT04987697, which also lists 17 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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