Enhanced Stress Resilience Training for Critical Care Nurses

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT05905991
Collaborator
(none)
100
1
2
8.2
12.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Enhanced Stress Resilience Training
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Feasibility and Efficacy of Enhanced Stress Resilience Training for Psychosocial and Occupational Wellbeing of Critical Care Nurses
Actual Study Start Date :
Apr 25, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ESRT Intervention

Five 1-hour weekly ESRT sessions

Other: Enhanced Stress Resilience Training
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.

Other: Enhanced Stress Resilience Training
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.

Outcome Measures

Primary Outcome Measures

  1. Changes in burnout score [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.

Secondary Outcome Measures

  1. Changes in mindfulness score [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.

  2. Changes in resilience score [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.

  3. Changes in work ability score [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.

  4. Changes in professional fulfillment index score [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.

  5. Changes in psychological safety score [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.

  6. Percentage of participants who are satisfied with the job [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.

  7. Changes in perceived stress score [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.

  8. Changes in depressive symptom score [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.

  9. Percentage of participants who have the intention to leave the job [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

Other Outcome Measures

  1. Percentage of participants in each ESRT session [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.

  2. ESRT acceptability scores [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.

  3. The frequency of ESRT skill use (ESRT sustainability) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Francisco San Francisco California United States 94143

Sponsors and Collaborators

  • University of California, San Francisco

Investigators

  • Principal Investigator: Soo-Jeong Lee, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT05905991
Other Study ID Numbers:
  • CNR-2022-02
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of California, San Francisco
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2023