AzTrials
AzTrials

Mental Health IssueRESILIENTNCT06035666

REducing Stress and Improving professionaLs' vItality Using innovativE iNtervenTions

A study testing Your World in people with Mental Health Issue and Healthy Lifestyle, run by Erasmus Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 66 yearsHealthy volunteers can take part
What is being tested?
Your World
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
1 siteNetherlands
Study dates
1 Jan 2023to 1 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 66 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Employee, student, trainee or volunteer at the Erasmus University Medical Center
  • 18-66 years old

Who cannot join

  • Inadequate comprehension of the Dutch language

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Erasmus MC, University Medical Center Rotterdam

    Rotterdam, South Holland, 3015GD

Other trials in Netherlands

About this study

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.

Read more

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.

Read the detailed 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?
  1. Study type 3.1 Study type: Prospective randomized controlled trial
  2. 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.
Being tested
Your World, Control app
Keywords
eHealth, Vitality, Stress, Heath care workers, App, Your World
Medical subject headings
Stress, Psychological, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Your WorldOther

    Your World consists of a vitality session and use of the Your World app

  • Control appOther

    Control app, no effect on stress/vitality

Study groups in NCT06035666
Study groupRoleWhat they receive
ControlSham comparatorControl app
Receives: Other: Control app
InterventionExperimentalYour World (vitality session + app)
Receives: Other: Your World

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PSS-10

    Perceived stress scale 10

    Measured: T=0 months, T=3 months, T=6 months

Secondary outcomes (2)
  1. Vita-16

    Vitality scale

    Measured: T=0 months, T=3 months, T=6 months

  2. Hair cortisol

    Concentration of cortisol in hair. Measurement of longterm stress

    Measured: T=0 months, T=3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start1 Jan 2023
  3. Primary completion1 Jan 2024 (estimated)
  4. Study completion1 Jan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective randomized controlled trial
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06035666
Sponsor's protocol ID
9642
Acronym
RESILIENT
Status last verified
Sep 2023
First submitted
4 Sep 2023
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data available upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing Your World in people with Mental Health Issue and Healthy Lifestyle, run by Erasmus Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PSS-10 (time frame: T=0 months, T=3 months, T=6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in