Clinical trial NCT05905991: 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
Overall status: COMPLETED
Phase: NA
Conditions: Job Stress
Burnout
Keywords: Burnout
Job stress
Resilience
Nurse
Critical care
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Changes in burnout score
timeFrame: Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
Secondary outcomes:
measure: Changes in mindfulness score
timeFrame: Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
measure: Changes in resilience score
timeFrame: Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
measure: Changes in work ability score
timeFrame: Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
measure: Changes in professional fulfillment index score
timeFrame: Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
measure: Changes in psychological safety score
timeFrame: Baseline to immediately post-ESRT intervention; Baseline to 1 month after ESRT intervention; Baseline to 3 months after ESRT intervention
measure: Percentage of participants who are satisfied with the job
timeFrame: Baseline, immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention
measure: Changes in perceived stress score
timeFrame: 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
measure: Changes in depressive symptom score
timeFrame: 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
measure: Percentage of participants who have the intention to leave the job
timeFrame: Baseline, immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention
Other outcomes:
measure: Percentage of participants in each ESRT session
timeFrame: 5-week intervention period
measure: ESRT acceptability scores
timeFrame: Immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention
measure: The frequency of ESRT skill use (ESRT sustainability)
timeFrame: Immediately post-ESRT intervention, 1-month and 3-month after ESRT intervention
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Soo-Jeong Lee
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.