AzTrials
AzTrials

Stress, PsychologicalNCT04952441

RISE Program for Nurses

A study testing RISE Program in people with Stress, Psychological, 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
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stress, Psychological
What is being tested?
RISE Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteUnited States
Study dates
19 Mar 2019to 1 Jun 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
  • 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.

Who cannot join

  • 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.

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 Randomized Controlled Trial of the RISE Program for Nurses

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.

Read the detailed description

This study will include the face-to-face visits of eight weekly 90-minute psychoeducational group sessions in a private conference room at AdventHealth. No absences are permitted due to lack of engagement. Participants will only be compensated for the number of attended sessions. The LMHC facilitator will send a reminder email to the control group participants after the intervention group participants attend their eighth session.

There will be three unpaid optional follow-up monthly booster sessions that focus on skill development. Participants will be invited to attend these booster sessions during the 3 months following their group's RISE Program. Attendance will be recorded. No other data will be collected during the booster sessions.

The following assessments will be used to measure study outcomes: Brief Resilience Scale (BRS); Self-Reflection and Insight Scale (SRIS); Self-Compassion Scale - Short Form (SCS-SF); Psychological Empowerment Instrument (PEI); Stress Mindset Measure - General (SMM-G); Perceived Stress Survey (PSS); Maslach Burnout Inventory (MBI); Public Health Surveillance - Wellbeing Scale (PHS-WB); RAND MOS Sleep Scale Survey; RAND 36-Item Short Form Health Survey (SF-36); World Health Organization Health and Work Performance questionnaire (WHO-HPQ); and Work Productivity and Activity Impairment (WPAI) questionnaire. In addition, demographic assessments will be collected. Employment with AdventHealth will also be tracked longitudinally at 12 months with Human Resources.

Being tested
RISE Program
Medical subject headings
Stress, Psychological

What participants receive

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

  • RISE ProgramBehavioural

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

Study groups in NCT04952441
Study groupRoleWhat they receive
Intervention GroupExperimentalIntervention group will attend the RISE program which consists of eight 90-minute weekly psychoeducational group sessions facilitated by a licensed mental health counselor
Receives: Behavioral: RISE Program
Wait-list Control GroupActive comparatorThe control group will attend the RISE program after the 3 month wait-list period (study months 6-7)
Receives: Behavioral: RISE Program

What is being measured

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

  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.

    Measured: Change from Baseline to 3 month follow up

Secondary outcomes (11)

  1. Measure Name: 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 to 3 month follow up

  2. 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 to 3 month follow up

  3. Psychological Empowerment Instrument (PEI)

    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 to 3 month follow up

  4. 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 to 3 month follow up

  5. 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 to 3 month follow up

  6. 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 to 3 month follow up

  7. 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 to 3 month follow up

  8. 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 to 3 month follow up

  9. 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 to 3 month follow up

  10. 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 to 3 month follow up

  11. 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 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 posted7 Jul 2021
  2. Study start19 Mar 2019
  3. Primary completion1 Mar 2020
  4. Study completion1 Jun 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
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized into either the intervention group or the wait-list control group
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04952441
Sponsor's protocol ID
1361876
Status last verified
Jul 2021
First submitted
17 Jun 2021
Last updated
7 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

  • 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

  • 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

  • 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

  • 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

  • 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.

    PubMed 10146874

  • 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

  • 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

  • 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

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

Questions about this trial

What is this clinical trial studying?

A study testing RISE Program in people with Stress, Psychological, 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 4 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 7 Jul 2021. 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?

Self-Reflection and Insight Scale (SRIS) (time frame: Change 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 NCT04952441, 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 7 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in