RISE Program for Nurses

July 2, 2021 updated by: AdventHealth

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Orlando, Florida, United States, 32804
        • AdventHealth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult ≥ 18 years old
  2. Licensed as an RN
  3. 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
  4. Able to speak, read, and understand English fluently
  5. Able to provide informed consent
  6. Willing and able to comply with all study procedures and requirements for the duration of the study.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Intervention group will attend the RISE program which consists of eight 90-minute weekly psychoeducational group sessions facilitated by a licensed mental health counselor
Psychoeducational sessions designed to impact Resilience, Insight, Self-Compassion, and Empowerment
Active Comparator: Wait-list Control Group
The control group will attend the RISE program after the 3 month wait-list period (study months 6-7)
Psychoeducational sessions designed to impact Resilience, Insight, Self-Compassion, and Empowerment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Reflection and Insight Scale (SRIS)
Time Frame: Change from Baseline to 3 month follow up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure Name: Brief Resilience Scale (BRS)
Time Frame: Change from Baseline to 3 month follow up
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.
Change from Baseline to 3 month follow up
Self-Compassion Scale - Short Form (SCS-SF)
Time Frame: Change from Baseline to 3 month follow up
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.
Change from Baseline to 3 month follow up
Psychological Empowerment Instrument (PEI)
Time Frame: Change from Baseline to 3 month follow up
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.
Change from Baseline to 3 month follow up
Stress Mindset Measure - General (SMM-G)
Time Frame: Change from Baseline to 3 month follow up
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.
Change from Baseline to 3 month follow up
Perceived Stress Scale (PSS)
Time Frame: Change from Baseline to 3 month follow up
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.
Change from Baseline to 3 month follow up
Maslach Burnout Inventory Human Services Survey (MBI-HSS) for Medical Personnel (MP)
Time Frame: Change from Baseline to 3 month follow up
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.
Change from Baseline to 3 month follow up
Public Health Surveillance - Wellbeing Scale (PHS-WB)
Time Frame: Change from Baseline to 3 month follow up
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).
Change from Baseline to 3 month follow up
RAND Medical Outcomes Study (MOS) Sleep Scale Survey
Time Frame: Change from Baseline to 3 month follow up
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.
Change from Baseline to 3 month follow up
RAND 36-Item Short Form Health Survey (SF-36)
Time Frame: Change from Baseline to 3 month follow up
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.
Change from Baseline to 3 month follow up
Absenteeism and Presenteeism questions of the World Health Organization's Health and Work Performance Questionnaire (WHO-HPQ)
Time Frame: Change from Baseline to 3 month follow up
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.
Change from Baseline to 3 month follow up
Work Productivity and Activity Impairment Questionnaire (WPAI)
Time Frame: Change from Baseline to 3 month follow up
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.
Change from Baseline to 3 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Amanda Sawyer, PhD, AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

July 2, 2021

First Posted (Actual)

July 7, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1361876

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress, Psychological

Clinical Trials on RISE Program

Subscribe