- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05905991
Enhanced Stress Resilience Training for Critical Care Nurses
February 27, 2024 updated by: University of California, San Francisco
Feasibility and Efficacy of Enhanced Stress Resilience Training for Psychosocial and Occupational Wellbeing of Critical Care Nurses
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
48
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
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ESRT Intervention
Five 1-hour weekly ESRT sessions
|
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.
|
|
Other: Waitlist Control
The control group will receive ESRT after the intervention group finishes the 5-week ESRT program.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in burnout score
Time Frame: Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
|
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.
|
Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in mindfulness score
Time Frame: Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
|
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.
|
Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
|
|
Changes in resilience score
Time Frame: Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
|
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.
|
Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
|
|
Changes in work ability score
Time Frame: Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
|
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.
|
Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
|
|
Changes in professional fulfillment index score
Time Frame: Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
|
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.
|
Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
|
|
Changes in psychological safety score
Time Frame: Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
|
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.
|
Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
|
|
Percentage of participants who are satisfied with the job
Time Frame: Baseline, immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention
|
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.
|
Baseline, immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention
|
|
Changes in perceived stress score
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
|
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.
|
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
|
|
Changes in depressive symptom score
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
|
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.
|
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
|
|
Percentage of participants who have the intention to leave the job
Time Frame: Baseline, immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention
|
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
|
Baseline, immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of participants in each ESRT session
Time Frame: 5-week intervention period
|
The number of participants in each weekly session and the number of sessions that each subject attends will be observed and recorded.
|
5-week intervention period
|
|
ESRT acceptability scores
Time Frame: Immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention
|
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.
|
Immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention
|
|
The frequency of ESRT skill use (ESRT sustainability)
Time Frame: Immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention
|
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.
|
Immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Soo-Jeong Lee, University of California, San Francisco
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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)
April 25, 2023
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
May 22, 2023
First Submitted That Met QC Criteria
June 6, 2023
First Posted (Actual)
June 15, 2023
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 27, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNR-2022-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.