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Enhanced Stress Resilience Training for Critical Care Nurses

Primary Purpose

Job Stress, Burnout

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Stress Resilience Training
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Job Stress focused on measuring Burnout, Job stress, Resilience, Nurse, Critical care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adult critical care nurses employed at UCSF Health. Exclusion Criteria: Those who cannot commit to participation in all five ESRT sessions Temporary travel nurses.

Sites / Locations

  • University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ESRT Intervention

Waitlist Control

Arm Description

Five 1-hour weekly ESRT sessions

The control group will receive ESRT after the intervention group finishes the 5-week ESRT program.

Outcomes

Primary Outcome Measures

Changes in burnout score
A 9-item short version of the Maslach Burnout Inventory-Human Services Survey (MBI-HSS) will be used. The MBI-HSS has 3 subscales of emotional exhaustion (EE, 3 items), depersonalization (DP, 3 items), and personal accomplishment (PA, 3 items). Each subscale is measured by 7-point response categories (1=Never ~ 4= A few times a month ~ 7=Every day). Higher scores of EE and DP and a lower score of PA indicated higher burnout.

Secondary Outcome Measures

Changes in mindfulness score
Mindfulness reflects the mental skills of attention, emotional regulation and metacognition and will be measured by the 10-item Cognitive Affective Mindfulness Scale-Revised (CAMS-R). Response categories include 1=rarely/not at all, 2=sometimes, 3=often, 4=almost always. Higher scores indicate higher mindfulness.
Changes in resilience score
Resilience refers to "an ability to bounce back or recover from stress" and will be measured by the 6-item Brief Resilience Scale (BRS). 5-point Likert response categories are used: 1=Strongly disagree to 5=Strongly agree. Three items are negatively worded, and the scores of these items will be reverse-coded. Higher scores indicate higher resilience.
Changes in work ability score
Physical and mental work ability will be assessed by three questions from the Work Ability Scale: (1) Current work ability compared to your highest work ability ever (0=cannot work at all ~ 10=able to work at my best), (2) current ability to work with respect to the physical job demands (poor, fair, good, very good, excellent), (3) current ability to work with respect to the mental job demands (poor, fair, good, very good, excellent). Higher scores indicate higher work ability.
Changes in professional fulfillment index score
Professional Fulfillment Index (PFI) will be measured by the 6-item Professional Fulfillment Subscale (0=not at all true to 4=completely true). The PFI score is calculated by averaging the item scores and ranges from 0 to 4. Higher scores indicate higher professional fulfillment.
Changes in psychological safety score
The Psychological Safety Scale (10 items) will be used to measure psychological safety. The response format uses a 5-point Likert scale (1=Strongly disagree to 5=Strongly agree). Higher scores indicate higher psychological safety.
Percentage of participants who are satisfied with the job
Job satisfaction will be asked by one question: How satisfied are you with your current job in this hospital? The 4-point Likert-Type response format (Very dissatisfied, A little dissatisfied, Moderately satisfied, Very satisfied) will be used. The response will be dichotomized into dissatisfied and satisfied.
Changes in perceived stress score
Perceived stress will be measured by Cohen's Perceived Stress Scale (PSS), which includes 10 items and uses a 5-point response format (1=never to 5=very often). Higher scores indicate higher stress.
Changes in depressive symptom score
Depressive symptoms will be measured by the Patient Health Questionnaire-8 (PHQ-8) using 4-point response format (1=not at all to 4=nearly every day). Higher scores indicate higher depression.
Percentage of participants who have the intention to leave the job
Intention to leave the job will be measure by the question "How likely are your to leave your current position in the next year?" using a 7-point Likert-Type response format (7=Definitely leaving ~ 4=Neutral ~ 1=Not leaving). Responses will be dichotomized: 1-4 Not leaving and 5-7 Having the intention to leave the job

Full Information

First Posted
May 22, 2023
Last Updated
June 6, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05905991
Brief Title
Enhanced Stress Resilience Training for Critical Care Nurses
Official Title
Feasibility and Efficacy of Enhanced Stress Resilience Training for Psychosocial and Occupational Wellbeing of Critical Care Nurses
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Job stress and burnout are significant problems affecting physical health, emotional well-being, job performance, and retention of nurses. Enhanced Stress Resilience Training (ESRT) is a theory-driven, evidence-based intervention to increase stress resilience and decrease burnout among clinicians. This study is a randomized waitlist-controlled trial to examine the efficacy, feasibility, and long-term sustainability of the 5-week ESRT intervention to improve psychosocial and occupational well-being of critical care nurses.
Detailed Description
The critical care setting is a stressful work environment where nurses provide intensive care to patients with life-threatening conditions. Regular job stress from the complex and fast-paced critical care work environment has been further intensified during the COVID-19 pandemic, which resulted in unprecedented challenges to health systems and has affected psychosocial and occupational wellbeing of healthcare workers. High or chronic job stress that is not properly managed can lead to burnout, which is characterized by emotional exhaustion, depersonalization, and decreased personal accomplishment. Burnout has negative impacts on physical and mental health (e.g., fatigue, anxiety, depression, sleep disorders), job performance or productivity (e.g., absenteeism, presenteeism), quality of care and patient care outcomes. Burnout also negatively affects nurses' retention and job turnover. The global prevalence of burnout among nurses ranges from 0.1% to 47.8% (pooled prevalence 11.2%) and critical care nurses are reported to have the highest prevalence of burnout (14.4%) among all specialties. Therefore, there is a substantial need to address burnout and promote occupational wellness of critical care nurses. Enhanced Stress Resilience Training (ESRT) is a theory-driven, evidence-based intervention developed by UCSF Associate Professor of Surgery, Dr. Carter Lebares aimed at increasing stress resilience and decreasing burnout among clinicians. The purpose of this study is to examine the efficacy, feasibility, and long-term sustainability of the 5-week ESRT intervention to improve psychosocial and occupational well-being among critical care nurses. The study will conduct a randomized waitlist-controlled trial among 100 UCSF critical care nurses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Job Stress, Burnout
Keywords
Burnout, Job stress, Resilience, Nurse, Critical care

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESRT Intervention
Arm Type
Experimental
Arm Description
Five 1-hour weekly ESRT sessions
Arm Title
Waitlist Control
Arm Type
Other
Arm Description
The control group will receive ESRT after the intervention group finishes the 5-week ESRT program.
Intervention Type
Other
Intervention Name(s)
Enhanced Stress Resilience Training
Intervention Description
The ESRT intervention will consist of 1) five weekly one-hour sessions (in-person or virtual) led by a certified instructor; 2) smartphone-based exercises that bring informal practice into daily life; 3) videos on principles and concepts taught each week; and 4) meditation recordings of various lengths and styles supporting the prescribed daily practice of up to 20 min/day. Weekly didactic and experiential activities will cover mindfulness-based intervention concepts and skills, such as cultivating resilience, awareness of the body, managing thoughts, responding versus reacting, transforming circumstances, and advocacy through mindful communication. The ESRT smartphone app ("Mindful Brian") houses all course materials (pre-class materials and post-class materials) and sends class reminders and messages. Considering nurses' shifts, ESRT will be offered in two separate sessions each week.
Primary Outcome Measure Information:
Title
Changes in burnout score
Description
A 9-item short version of the Maslach Burnout Inventory-Human Services Survey (MBI-HSS) will be used. The MBI-HSS has 3 subscales of emotional exhaustion (EE, 3 items), depersonalization (DP, 3 items), and personal accomplishment (PA, 3 items). Each subscale is measured by 7-point response categories (1=Never ~ 4= A few times a month ~ 7=Every day). Higher scores of EE and DP and a lower score of PA indicated higher burnout.
Time Frame
Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
Secondary Outcome Measure Information:
Title
Changes in mindfulness score
Description
Mindfulness reflects the mental skills of attention, emotional regulation and metacognition and will be measured by the 10-item Cognitive Affective Mindfulness Scale-Revised (CAMS-R). Response categories include 1=rarely/not at all, 2=sometimes, 3=often, 4=almost always. Higher scores indicate higher mindfulness.
Time Frame
Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
Title
Changes in resilience score
Description
Resilience refers to "an ability to bounce back or recover from stress" and will be measured by the 6-item Brief Resilience Scale (BRS). 5-point Likert response categories are used: 1=Strongly disagree to 5=Strongly agree. Three items are negatively worded, and the scores of these items will be reverse-coded. Higher scores indicate higher resilience.
Time Frame
Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
Title
Changes in work ability score
Description
Physical and mental work ability will be assessed by three questions from the Work Ability Scale: (1) Current work ability compared to your highest work ability ever (0=cannot work at all ~ 10=able to work at my best), (2) current ability to work with respect to the physical job demands (poor, fair, good, very good, excellent), (3) current ability to work with respect to the mental job demands (poor, fair, good, very good, excellent). Higher scores indicate higher work ability.
Time Frame
Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
Title
Changes in professional fulfillment index score
Description
Professional Fulfillment Index (PFI) will be measured by the 6-item Professional Fulfillment Subscale (0=not at all true to 4=completely true). The PFI score is calculated by averaging the item scores and ranges from 0 to 4. Higher scores indicate higher professional fulfillment.
Time Frame
Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
Title
Changes in psychological safety score
Description
The Psychological Safety Scale (10 items) will be used to measure psychological safety. The response format uses a 5-point Likert scale (1=Strongly disagree to 5=Strongly agree). Higher scores indicate higher psychological safety.
Time Frame
Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
Title
Percentage of participants who are satisfied with the job
Description
Job satisfaction will be asked by one question: How satisfied are you with your current job in this hospital? The 4-point Likert-Type response format (Very dissatisfied, A little dissatisfied, Moderately satisfied, Very satisfied) will be used. The response will be dichotomized into dissatisfied and satisfied.
Time Frame
Baseline, immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention
Title
Changes in perceived stress score
Description
Perceived stress will be measured by Cohen's Perceived Stress Scale (PSS), which includes 10 items and uses a 5-point response format (1=never to 5=very often). Higher scores indicate higher stress.
Time Frame
Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention 3-month after the 5-week ESRT
Title
Changes in depressive symptom score
Description
Depressive symptoms will be measured by the Patient Health Questionnaire-8 (PHQ-8) using 4-point response format (1=not at all to 4=nearly every day). Higher scores indicate higher depression.
Time Frame
Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention th, and 3-month after the 5-week ESRT
Title
Percentage of participants who have the intention to leave the job
Description
Intention to leave the job will be measure by the question "How likely are your to leave your current position in the next year?" using a 7-point Likert-Type response format (7=Definitely leaving ~ 4=Neutral ~ 1=Not leaving). Responses will be dichotomized: 1-4 Not leaving and 5-7 Having the intention to leave the job
Time Frame
Baseline, immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention
Other Pre-specified Outcome Measures:
Title
Percentage of participants in each ESRT session
Description
The number of participants in each weekly session and the number of sessions that each subject attends will be observed and recorded.
Time Frame
5-week intervention period
Title
ESRT acceptability scores
Description
ESRT acceptability will be measured by the 6-item Credibility-Expectancy Questionnaire (CEQ) and one question "I would recommend this course to a peer". Response formats are 0-10 or 0-100%. Higher scores indicate higher acceptability.
Time Frame
Immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention
Title
The frequency of ESRT skill use (ESRT sustainability)
Description
Participants will be asked about the frequency of ESRT skill use (daily, several times a week, several times a month, rarely, never). The frequency will be described by the count and percentage by category.
Time Frame
Immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult critical care nurses employed at UCSF Health. Exclusion Criteria: Those who cannot commit to participation in all five ESRT sessions Temporary travel nurses.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soo-Jeong Lee
Phone
4154763221
Email
soo-jeong.lee@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo-Jeong Lee
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo-Jeong Lee, PhD
Phone
415-476-3221
Email
soo-jeong.lee@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Soo-Jeong Lee, PhD
First Name & Middle Initial & Last Name & Degree
Brian Cunningham, BS
First Name & Middle Initial & Last Name & Degree
Mya Childers, MS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31267619
Citation
Ghawadra SF, Abdullah KL, Choo WY, Phang CK. Mindfulness-based stress reduction for psychological distress among nurses: A systematic review. J Clin Nurs. 2019 Nov;28(21-22):3747-3758. doi: 10.1111/jocn.14987. Epub 2019 Jul 22.
Results Reference
background
PubMed Identifier
31939795
Citation
Kleinpell R, Moss M, Good VS, Gozal D, Sessler CN. The Critical Nature of Addressing Burnout Prevention: Results From the Critical Care Societies Collaborative's National Summit and Survey on Prevention and Management of Burnout in the ICU. Crit Care Med. 2020 Feb;48(2):249-253. doi: 10.1097/CCM.0000000000003964.
Results Reference
background
PubMed Identifier
31125095
Citation
Lebares CC, Guvva EV, Olaru M, Sugrue LP, Staffaroni AM, Delucchi KL, Kramer JH, Ascher NL, Harris HW. Efficacy of Mindfulness-Based Cognitive Training in Surgery: Additional Analysis of the Mindful Surgeon Pilot Randomized Clinical Trial. JAMA Netw Open. 2019 May 3;2(5):e194108. doi: 10.1001/jamanetworkopen.2019.4108.
Results Reference
background
PubMed Identifier
30167655
Citation
Lebares CC, Hershberger AO, Guvva EV, Desai A, Mitchell J, Shen W, Reilly LM, Delucchi KL, O'Sullivan PS, Ascher NL, Harris HW. Feasibility of Formal Mindfulness-Based Stress-Resilience Training Among Surgery Interns: A Randomized Clinical Trial. JAMA Surg. 2018 Oct 1;153(10):e182734. doi: 10.1001/jamasurg.2018.2734. Epub 2018 Oct 17.
Results Reference
background
PubMed Identifier
33538823
Citation
Shah MK, Gandrakota N, Cimiotti JP, Ghose N, Moore M, Ali MK. Prevalence of and Factors Associated With Nurse Burnout in the US. JAMA Netw Open. 2021 Feb 1;4(2):e2036469. doi: 10.1001/jamanetworkopen.2020.36469. Erratum In: JAMA Netw Open. 2021 Mar 1;4(3):e215373. JAMA Netw Open. 2023 Apr 3;6(4):e2312593.
Results Reference
background
PubMed Identifier
31668282
Citation
Lebares CC, Guvva EV, Desai A, Herschberger A, Ascher NL, Harris HW, O'Sullivan P. Key factors for implementing mindfulness-based burnout interventions in surgery. Am J Surg. 2020 Feb;219(2):328-334. doi: 10.1016/j.amjsurg.2019.10.025. Epub 2019 Oct 17.
Results Reference
background
PubMed Identifier
35307128
Citation
Sulosaari V, Unal E, Cinar FI. The effectiveness of mindfulness-based interventions on the psychological well-being of nurses: A systematic review. Appl Nurs Res. 2022 Apr;64:151565. doi: 10.1016/j.apnr.2022.151565. Epub 2022 Jan 15.
Results Reference
background
PubMed Identifier
32007680
Citation
Woo T, Ho R, Tang A, Tam W. Global prevalence of burnout symptoms among nurses: A systematic review and meta-analysis. J Psychiatr Res. 2020 Apr;123:9-20. doi: 10.1016/j.jpsychires.2019.12.015. Epub 2020 Jan 22.
Results Reference
background

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Enhanced Stress Resilience Training for Critical Care Nurses

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