xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06035666</url>
    </required_header>
    <id_info>
      <org_study_id>9642</org_study_id>
      <nct_id>NCT06035666</nct_id>
    </id_info>
    <brief_title>REducing Stress and Improving professionaLs' vItality Using innovativE iNtervenTions</brief_title>
    <acronym>RESILIENT</acronym>
    <official_title>REducing Stress and Improving professionaLs' vItality Using innovativE iNtervenTions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erasmus Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Erasmus Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Introduction Up to half of hospital employees worldwide are experiencing symptoms of burnout.&#xD;
        Therefore, interventions to improve mental health among hospital workers are urgently needed.&#xD;
        Your World is an inexpensive and easy-to-use intervention that aims to reduce stress and&#xD;
        increase resilience among hospital employees. Your world uses a blended approach, which&#xD;
        includes a real-life personal session and challenges in the Your World app (for smartphone).&#xD;
  &#xD;
        Hypothesis The investigators hypothesize that Your World will improve resilience and&#xD;
        well-being and reduce stress among hospital employees.&#xD;
  &#xD;
        Research objectives Main objective&#xD;
  &#xD;
        - Does Your World reduce stress among hospital employees as measured by the PSS-10?&#xD;
  &#xD;
        Design Randomised controlled trial&#xD;
  &#xD;
        Population Employees of the Erasmus University Medical Center including students and&#xD;
        volunteers&#xD;
  &#xD;
        Methods and study procedures Five hundred participants will be randomized 1:1 to receive&#xD;
        either Your World (intervention) or the control app (control). In the intervention group,&#xD;
        subjects will participate in one 'vitality session' before installing the app. At baseline&#xD;
        and after 3 months hair samples questionnaires will be collected among the participants of&#xD;
        both groups. At 6 months, same questionnaires will be collected.&#xD;
  &#xD;
        Burden and risks There are no risks associated with participation in this study. The&#xD;
        questionnaires can be filled out online in 15 minutes, hair collection takes 5 minutes. The&#xD;
        vitality sessions take 1 hour and the use of the app takes 5 minutes a day.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Introduction and rationale Hospital employees are under a lot of pressure due to a large&#xD;
             physical and emotional workload and time constraints (1). This may lead to exhaustion,&#xD;
             psychological or physical distress and eventually burnout. Maslach et al. (2) have&#xD;
             defined three dimensions of burnout: exhaustion, cynicism/depersonalization and sense of&#xD;
             inefficacy/low personal accomplishment. Burnout among health care professionals has been&#xD;
             an under-recognized and under-reported problem. There is increasing data about burnout&#xD;
             and mental vitality among health care workers; up to half of hospital employees are&#xD;
             experiencing symptoms of burnout (3-7). Psychological problems among health care workers&#xD;
             can cause decreased job satisfaction, decreased efficiency and productivity,&#xD;
             absenteeism, abandonment of the medical profession and even poor quality of care and&#xD;
             impaired patient safety (4,8-11). Several interventions have been developed to promote&#xD;
             well-being and reduce psychological problems among health care workers, including&#xD;
             coaching programs and mindfulness and cognitive-behavioral therapy-based interventions&#xD;
             (12,13). Although effective, these programs are usually expensive and time-consuming.&#xD;
  &#xD;
             To increase availability (and to reduce costs) of mental support for healthcare&#xD;
             professionals, Your World has been developed. Your World is designed to improve&#xD;
             employees' well-being and resilience by implementing new habits according to the&#xD;
             'Healthy Mind Platter' (HMP) (14). Contrary to most existing interventions, Your World&#xD;
             is inexpensive and time-efficient, taking only a couple of minutes a day. The healthy&#xD;
             mind platter consists of seven neuro-cognitive activities or 'ingredients' that are&#xD;
             important for stress reduction: physical time (exercise), sleep time, focus time&#xD;
             (planning moments for work or hobbies without interruptions), time in (self-reflection),&#xD;
             down time (moments without scheduled tasks), play time (playing and humor) and&#xD;
             connecting time (social interaction or time spent with nature). In the Your World app,&#xD;
             an eighth dimension was added: earth time, which is related to nature connectedness and&#xD;
             pro-environmental behavior.&#xD;
  &#xD;
             Through weekly challenges (trying out a new habit) and encouraging messages, the app&#xD;
             motivates the users to implement new HMP activities into their daily life, in order to&#xD;
             improve mental well-being.&#xD;
  &#xD;
             The investigators hypothesize that Your World will improve resilience and mental&#xD;
             vitality and reduce stress among health care employees. Eventually, this will reduce&#xD;
             negative psychological outcomes like burnout and its practical consequences&#xD;
             (absenteeism, dropout).&#xD;
  &#xD;
          2. Objective(s)&#xD;
  &#xD;
             Main objective&#xD;
  &#xD;
             - Does Your World reduce stress among hospital employees as measured by the PSS-10?&#xD;
  &#xD;
             Secondary objectives&#xD;
  &#xD;
               -  Does Your World reduce stress among hospital employees as measured by hair cortisol&#xD;
                  levels?&#xD;
  &#xD;
               -  Does Your World improve vitality among hospital employees as measured by the&#xD;
                  Vita-16?&#xD;
  &#xD;
               -  Which factors (e.g. age, gender, job and department) influence stress and vitality&#xD;
                  of hospital employees?&#xD;
  &#xD;
               -  What is the relation between different measurements (i.e. PSS-10, vita-16, vitality&#xD;
                  scores, mood scores and hair cortisol) of stress and vitality?&#xD;
  &#xD;
               -  Which factors (e.g. stress, vitality, age, gender, job) influence the use of the&#xD;
                  Your World app?&#xD;
  &#xD;
          3. Study type&#xD;
  &#xD;
             3.1 Study type:&#xD;
  &#xD;
             Prospective randomized controlled trial&#xD;
  &#xD;
          4. Methods&#xD;
  &#xD;
        4.1 Methods In total, 500 participants will be randomized to the intervention or the control&#xD;
        group. Participants in the intervention group will undergo a vitality session and receive a&#xD;
        code needed to download and use the Your World app. The control group will not participate in&#xD;
        vitality sessions, but they will receive access to the control app. In both groups, hair&#xD;
        samples and stress / vitality questionnaires will be collected at baseline and after 3&#xD;
        months. Questionnaires will be collected again after 6 months.&#xD;
  &#xD;
        References&#xD;
  &#xD;
          1. Dubale BW, Friedman LE, Chemali Z, Denninger JW, Mehta DH, Alem A, Fricchione GL,&#xD;
             Dossett ML, Gelaye B. Systematic review of burnout among healthcare providers in&#xD;
             sub-Saharan Africa. BMC Public Health. 2019;19(1):1247.&#xD;
  &#xD;
          2. Maslach C. Job Burnout:New Directions in Research and Intervention. Current Directions&#xD;
             in Psychological Science. 2003;12(5):189-192.&#xD;
  &#xD;
          3. Shanafelt TD, Hasan O, Dyrbye LN, Sinsky C, Satele D, Sloan J, West CP. Changes in&#xD;
             Burnout and Satisfaction With Work-Life Balance in Physicians and the General US Working&#xD;
             Population Between 2011 and 2014. Mayo Clin Proc. 2015;90(12):1600-1613.&#xD;
  &#xD;
          4. Williams ES, Konrad TR, Scheckler WE, Pathman DE, Linzer M, McMurray JE, Gerrity M,&#xD;
             Schwartz M. Understanding Physicians' Intentions to Withdraw from Practice: The Role of&#xD;
             Job Satisfaction, Job Stress, Mental and Physical Health. Health Care Management Review.&#xD;
             2001;26(1).&#xD;
  &#xD;
          5. Ramirez AJ, Graham J, Richards MA, Cull A, Gregory WM, Leaning MS, Snashall DC, Timothy&#xD;
             AR. Burnout and psychiatric disorder among cancer clinicians. British Journal of Cancer.&#xD;
             1995;71(6):1263-1269.&#xD;
  &#xD;
          6. Goldberg R, Boss RW, Chan L, Goldberg J, Mallon WK, Moradzadeh D, Goodman EA, McConkie&#xD;
             ML. Burnout and Its Correlates in Emergency Physicians: Four Years' Experience with a&#xD;
             Wellness Booth. Academic Emergency Medicine. 1996;3(12):1156-1164.&#xD;
  &#xD;
          7. Rotenstein LS, Torre M, Ramos MA, Rosales RC, Guille C, Sen S, Mata DA. Prevalence of&#xD;
             Burnout Among Physicians: A Systematic Review. Jama. 2018;320(11):1131-1150.&#xD;
  &#xD;
          8. Shanafelt TD, Sloan JA, Habermann TM. The well-being of physicians. Am J Med.&#xD;
             2003;114(6):513-519.&#xD;
  &#xD;
          9. Hall LH, Johnson J, Watt I, Tsipa A, O'Connor DB. Healthcare Staff Wellbeing, Burnout,&#xD;
             and Patient Safety: A Systematic Review. PLoS One. 2016;11(7):e0159015.&#xD;
  &#xD;
         10. DiMatteo MR, Sherbourne CD, Hays RD, Ordway L, Kravitz RL, McGlynn EA, Kaplan S, Rogers&#xD;
             WH. Physicians' Characteristics Influence Patients' Adherence to Medical Treatment:&#xD;
             Results From the Medical Outcomes Study. Health Psychology. 1993;12(2):93-102.&#xD;
  &#xD;
         11. Van der Heijden B, Brown Mahoney C, Xu Y. Impact of Job Demands and Resources on Nurses'&#xD;
             Burnout and Occupational Turnover Intention Towards an Age-Moderated Mediation Model for&#xD;
             the Nursing Profession. Int J Environ Res Public Health. 2019;16(11).&#xD;
  &#xD;
         12. Solms L, van Vianen A, Koen J, Theeboom T, de Pagter APJ, De Hoog M, Challenge, Support&#xD;
             Research N. Turning the tide: a quasi-experimental study on a coaching intervention to&#xD;
             reduce burn-out symptoms and foster personal resources among medical residents and&#xD;
             specialists in the Netherlands. BMJ Open. 2021;11(1):e041708.&#xD;
  &#xD;
         13. Melnyk BM, Kelly SA, Stephens J, Dhakal K, McGovern C, Tucker S, Hoying J, McRae K, Ault&#xD;
             S, Spurlock E, Bird SB. Interventions to Improve Mental Health, Well-Being, Physical&#xD;
             Health, and Lifestyle Behaviors in Physicians and Nurses: A Systematic Review. Am J&#xD;
             Health Promot. 2020;34(8):929-941.&#xD;
  &#xD;
         14. Rock D, Siegel DJ, Poelmans SAY, Payne J. The Healthy Mind Platter.&#xD;
             NeuroLeadershipjournal. 2012(4):1-23.&#xD;
  &#xD;
         15. Baik SH, Fox RS, Mills SD, Roesch SC, Sadler GR, Klonoff EA, Malcarne VL. Reliability&#xD;
             and validity of the Perceived Stress Scale-10 in Hispanic Americans with English or&#xD;
             Spanish language preference. J Health Psychol. 2019;24(5):628-639.&#xD;
  &#xD;
         16. Lee B, Jeong HI. Construct validity of the perceived stress scale (PSS-10) in a sample&#xD;
             of early childhood teacher candidates. Psychiatry and Clinical Psychopharmacology.&#xD;
             2019;29(1):76-82.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Prospective randomized controlled trial</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Not possible</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>PSS-10</measure>
      <time_frame>T=0 months, T=3 months, T=6 months</time_frame>
      <description>Perceived stress scale 10</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Vita-16</measure>
      <time_frame>T=0 months, T=3 months, T=6 months</time_frame>
      <description>Vitality scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hair cortisol</measure>
      <time_frame>T=0 months, T=3 months</time_frame>
      <description>Concentration of cortisol in hair. Measurement of longterm stress</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Other study parameters</measure>
      <time_frame>T=0 months, T=3 months, T=6 months</time_frame>
      <description>Age, gender, profession, department, fulltime/part-time employment, use of corticosteroids, intoxications, hair characteristics, use of Your World among colleagues. After the study period we will also ask participants to evaluate the app. Study parameters collected from the Your World app: use of the Your World app, vitality scores, mood scores, challenges started and completed</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Mental Health Issue</condition>
    <condition>Healthy Lifestyle</condition>
    <condition>Stress, Psychological</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Control app</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Your World (vitality session + app)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Your World</intervention_name>
      <description>Your World consists of a vitality session and use of the Your World app</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control app</intervention_name>
      <description>Control app, no effect on stress/vitality</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Employee, student, trainee or volunteer at the Erasmus University Medical Center&#xD;
  &#xD;
            -  18-66 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inadequate comprehension of the Dutch language&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>66 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Erasmus MC, University Medical Center Rotterdam</name>
        <address>
          <city>Rotterdam</city>
          <state>Zuid-Holland</state>
          <zip>3015GD</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
      <investigator_full_name>dr. Laura C. G. de Graaff-Herder</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>eHealth</keyword>
    <keyword>Vitality</keyword>
    <keyword>Stress</keyword>
    <keyword>Heath care workers</keyword>
    <keyword>App</keyword>
    <keyword>Your World</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stress, Psychological</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data available upon reasonable request.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06035666
  org study id: 9642
  nct id: NCT06035666
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective randomized controlled trial
  primary purpose: Prevention
  masking: None (Open Label)
  masking description: Not possible
  measure: PSS-10
  time frame: T=0 months, T=3 months, T=6 months
  description: Perceived stress scale 10
  measure: Vita-16
  time frame: T=0 months, T=3 months, T=6 months
  description: Vitality scale
  measure: Hair cortisol
  time frame: T=0 months, T=3 months
  description: Concentration of cortisol in hair. Measurement of longterm stress
  measure: Other study parameters
  time frame: T=0 months, T=3 months, T=6 months
  description: Age, gender, profession, department, fulltime/part-time employment, use of corticosteroids, intoxications, hair characteristics, use of Your World among colleagues. After the study period we will also ask participants to evaluate the app. Study parameters collected from the Your World app: use of the Your World app, vitality scores, mood scores, challenges started and completed
  arm group label: Control
  arm group type: Sham Comparator
  description: Control app
  arm group label: Intervention
  arm group type: Experimental
  description: Your World (vitality session + app)
  intervention type: Other
  intervention name: Your World
  description: Your World consists of a vitality session and use of the Your World app
  arm group label: Intervention
  intervention type: Other
  intervention name: Control app
  description: Control app, no effect on stress/vitality
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 66 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Erasmus Medical Center
  investigator full name: dr. Laura C. G. de Graaff-Herder
  investigator title: Principal Investigator
  mesh term: Stress, Psychological
  sharing ipd: No
  ipd description: Data available upon reasonable request.