Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06035666 |
| Other study ID # |
9642 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
January 1, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Erasmus Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Introduction Up to half of hospital employees worldwide are experiencing symptoms of burnout.
Therefore, interventions to improve mental health among hospital workers are urgently needed.
Your World is an inexpensive and easy-to-use intervention that aims to reduce stress and
increase resilience among hospital employees. Your world uses a blended approach, which
includes a real-life personal session and challenges in the Your World app (for smartphone).
Hypothesis The investigators hypothesize that Your World will improve resilience and
well-being and reduce stress among hospital employees.
Research objectives Main objective
- Does Your World reduce stress among hospital employees as measured by the PSS-10?
Design Randomised controlled trial
Population Employees of the Erasmus University Medical Center including students and
volunteers
Methods and study procedures Five hundred participants will be randomized 1:1 to receive
either Your World (intervention) or the control app (control). In the intervention group,
subjects will participate in one 'vitality session' before installing the app. At baseline
and after 3 months hair samples questionnaires will be collected among the participants of
both groups. At 6 months, same questionnaires will be collected.
Burden and risks There are no risks associated with participation in this study. The
questionnaires can be filled out online in 15 minutes, hair collection takes 5 minutes. The
vitality sessions take 1 hour and the use of the app takes 5 minutes a day.
Description:
1. Introduction and rationale Hospital employees are under a lot of pressure due to a large
physical and emotional workload and time constraints (1). This may lead to exhaustion,
psychological or physical distress and eventually burnout. Maslach et al. (2) have
defined three dimensions of burnout: exhaustion, cynicism/depersonalization and sense of
inefficacy/low personal accomplishment. Burnout among health care professionals has been
an under-recognized and under-reported problem. There is increasing data about burnout
and mental vitality among health care workers; up to half of hospital employees are
experiencing symptoms of burnout (3-7). Psychological problems among health care workers
can cause decreased job satisfaction, decreased efficiency and productivity,
absenteeism, abandonment of the medical profession and even poor quality of care and
impaired patient safety (4,8-11). Several interventions have been developed to promote
well-being and reduce psychological problems among health care workers, including
coaching programs and mindfulness and cognitive-behavioral therapy-based interventions
(12,13). Although effective, these programs are usually expensive and time-consuming.
To increase availability (and to reduce costs) of mental support for healthcare
professionals, Your World has been developed. Your World is designed to improve
employees' well-being and resilience by implementing new habits according to the
'Healthy Mind Platter' (HMP) (14). Contrary to most existing interventions, Your World
is inexpensive and time-efficient, taking only a couple of minutes a day. The healthy
mind platter consists of seven neuro-cognitive activities or 'ingredients' that are
important for stress reduction: physical time (exercise), sleep time, focus time
(planning moments for work or hobbies without interruptions), time in (self-reflection),
down time (moments without scheduled tasks), play time (playing and humor) and
connecting time (social interaction or time spent with nature). In the Your World app,
an eighth dimension was added: earth time, which is related to nature connectedness and
pro-environmental behavior.
Through weekly challenges (trying out a new habit) and encouraging messages, the app
motivates the users to implement new HMP activities into their daily life, in order to
improve mental well-being.
The investigators hypothesize that Your World will improve resilience and mental
vitality and reduce stress among health care employees. Eventually, this will reduce
negative psychological outcomes like burnout and its practical consequences
(absenteeism, dropout).
2. Objective(s)
Main objective
- Does Your World reduce stress among hospital employees as measured by the PSS-10?
Secondary objectives
- Does Your World reduce stress among hospital employees as measured by hair cortisol
levels?
- Does Your World improve vitality among hospital employees as measured by the
Vita-16?
- Which factors (e.g. age, gender, job and department) influence stress and vitality
of hospital employees?
- What is the relation between different measurements (i.e. PSS-10, vita-16, vitality
scores, mood scores and hair cortisol) of stress and vitality?
- Which factors (e.g. stress, vitality, age, gender, job) influence the use of the
Your World app?
3. Study type
3.1 Study type:
Prospective randomized controlled trial
4. Methods
4.1 Methods In total, 500 participants will be randomized to the intervention or the control
group. Participants in the intervention group will undergo a vitality session and receive a
code needed to download and use the Your World app. The control group will not participate in
vitality sessions, but they will receive access to the control app. In both groups, hair
samples and stress / vitality questionnaires will be collected at baseline and after 3
months. Questionnaires will be collected again after 6 months.
References
1. Dubale BW, Friedman LE, Chemali Z, Denninger JW, Mehta DH, Alem A, Fricchione GL,
Dossett ML, Gelaye B. Systematic review of burnout among healthcare providers in
sub-Saharan Africa. BMC Public Health. 2019;19(1):1247.
2. Maslach C. Job Burnout:New Directions in Research and Intervention. Current Directions
in Psychological Science. 2003;12(5):189-192.
3. Shanafelt TD, Hasan O, Dyrbye LN, Sinsky C, Satele D, Sloan J, West CP. Changes in
Burnout and Satisfaction With Work-Life Balance in Physicians and the General US Working
Population Between 2011 and 2014. Mayo Clin Proc. 2015;90(12):1600-1613.
4. Williams ES, Konrad TR, Scheckler WE, Pathman DE, Linzer M, McMurray JE, Gerrity M,
Schwartz M. Understanding Physicians' Intentions to Withdraw from Practice: The Role of
Job Satisfaction, Job Stress, Mental and Physical Health. Health Care Management Review.
2001;26(1).
5. Ramirez AJ, Graham J, Richards MA, Cull A, Gregory WM, Leaning MS, Snashall DC, Timothy
AR. Burnout and psychiatric disorder among cancer clinicians. British Journal of Cancer.
1995;71(6):1263-1269.
6. Goldberg R, Boss RW, Chan L, Goldberg J, Mallon WK, Moradzadeh D, Goodman EA, McConkie
ML. Burnout and Its Correlates in Emergency Physicians: Four Years' Experience with a
Wellness Booth. Academic Emergency Medicine. 1996;3(12):1156-1164.
7. Rotenstein LS, Torre M, Ramos MA, Rosales RC, Guille C, Sen S, Mata DA. Prevalence of
Burnout Among Physicians: A Systematic Review. Jama. 2018;320(11):1131-1150.
8. Shanafelt TD, Sloan JA, Habermann TM. The well-being of physicians. Am J Med.
2003;114(6):513-519.
9. Hall LH, Johnson J, Watt I, Tsipa A, O'Connor DB. Healthcare Staff Wellbeing, Burnout,
and Patient Safety: A Systematic Review. PLoS One. 2016;11(7):e0159015.
10. DiMatteo MR, Sherbourne CD, Hays RD, Ordway L, Kravitz RL, McGlynn EA, Kaplan S, Rogers
WH. Physicians' Characteristics Influence Patients' Adherence to Medical Treatment:
Results From the Medical Outcomes Study. Health Psychology. 1993;12(2):93-102.
11. Van der Heijden B, Brown Mahoney C, Xu Y. Impact of Job Demands and Resources on Nurses'
Burnout and Occupational Turnover Intention Towards an Age-Moderated Mediation Model for
the Nursing Profession. Int J Environ Res Public Health. 2019;16(11).
12. Solms L, van Vianen A, Koen J, Theeboom T, de Pagter APJ, De Hoog M, Challenge, Support
Research N. Turning the tide: a quasi-experimental study on a coaching intervention to
reduce burn-out symptoms and foster personal resources among medical residents and
specialists in the Netherlands. BMJ Open. 2021;11(1):e041708.
13. Melnyk BM, Kelly SA, Stephens J, Dhakal K, McGovern C, Tucker S, Hoying J, McRae K, Ault
S, Spurlock E, Bird SB. Interventions to Improve Mental Health, Well-Being, Physical
Health, and Lifestyle Behaviors in Physicians and Nurses: A Systematic Review. Am J
Health Promot. 2020;34(8):929-941.
14. Rock D, Siegel DJ, Poelmans SAY, Payne J. The Healthy Mind Platter.
NeuroLeadershipjournal. 2012(4):1-23.
15. Baik SH, Fox RS, Mills SD, Roesch SC, Sadler GR, Klonoff EA, Malcarne VL. Reliability
and validity of the Perceived Stress Scale-10 in Hispanic Americans with English or
Spanish language preference. J Health Psychol. 2019;24(5):628-639.
16. Lee B, Jeong HI. Construct validity of the perceived stress scale (PSS-10) in a sample
of early childhood teacher candidates. Psychiatry and Clinical Psychopharmacology.
2019;29(1):76-82.
