The Use of a Mobile Application to Reduce Work-related Stress Symptoms Among Healthcare Workers

Stress, Psychological Clinical Trial

— DIARY  

Official title:

Diary of a Pandemic: The Use of a Mobile Application to Reduce Work-related Stress Symptoms Among Healthcare Workers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04719351
• Other study ID #: 4-2092/2020
• Secondary ID: 2020-05800
• Status: Completed
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: June 14, 2021

Study information

• Verified date: June 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current pandemic highlighted an urgent need for early interventions to mitigate the psychological effects of extreme work demands that healthcare workers currently experience. This project aims at developing a data driven monitoring system to efficiently track work-related stress reactions over time. The system will also include a self-awareness intervention grounded on evidence-based strategies to improve workers' recovery. The solution will be delivered through a mobile application for a rapid implementation among healthcare workers and related professions. The mobile application will be developed through an initial analysis of pilot data, a factorial experiment and a user-experience analysis. Qualitative user experience data will also be used to validate the functionality of the monitoring system. The solution developed in this project will be easily scalable to related occupations, for example workers at elderly homes and social workers. After the pandemic, it can also be used as a preventive intervention for workers who are at risk of burnout and as a support for patients returning to work after treatment for common mental disorders.

Description:

Symptoms indicating possibly pathological stress reactions among healthcare workers are more prevalent during the current pandemic than they were before. Possible reasons for that include higher levels of known risk factors such as cognitive, emotional, and physical demands at work; new stressors such as risk for moral injury and worry about personal safety; and diminished protective mechanisms, which include recovery opportunities and psychological detachment. Thus, frontline healthcare workers should be given priority in access to psychological support. Despite the urgent need for it, a rapid implementation of psychological support for healthcare workers has proved to be challenging during previous crises and the current pandemic. Guidelines published thus far underline the necessity of close real-time monitoring in order to early identify at risk populations and individuals, who should be referred to seek professional support. However, appropriate tools for efficient real-time monitoring of stress responses and early screening for possibly pathological reactions among healthcare workers are currently lacking. Available tools focus either on tracking of stress indicators e.g. sleep disturbances, or on teaching strategies to better cope with stress e.g. mindfulness. In this study, the investigators will test whether a separate use or a combination of these different functions may be the most efficient in managing work-related stress symptoms among healthcare workers. The study has a factorial design in order to closely investigate the functionalities focused on real-time monitoring of emotional responses and the functionalities based on evidence-based strategies to improve workers' recovery, as well as the possible interactions among them.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: June 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult participants
• working (active employment)

Exclusion Criteria:

• no active employment e.g. sick leave, maternity leave during the entire period of an intervention (four weeks)

Related Conditions & MeSH terms

• Burnout, Professional
• Occupational Stress
• Stress, Psychological

Intervention

Behavioral:
• The DIARY mobile application
The mobile application has two main functionalities. First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress). The assessment is done daily for four weeks. Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g. remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.

Locations

Country	Name	City	State
Sweden	Aleksandra Sjostrom-Bujacz	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dropout rate	Investigates the dropout rate during the four weeks of the intervention.	Immediately post-intervention
Other	Protocol adherence	Investigates how often (i.e. how many days) participants engage with the intervention.	Immediately post-intervention
Other	Participant engagement	Investigates to what extent participants engage with the intervention, as measured with the meta-data available through the mobile application e.g. time spent engaging with the content of the mobile application.	Immediately post-intervention
Other	Usability: User experience, relevance, and content appreciation	Investigates basic usability questions in a post-intervention survey. Includes questions about the experience users had of using the mobile application, if they found the intervention relevant, and if they found the content useful.; Survey questions focus on specific aspects of the mobile application used in this study. The survey includes 10 items scored on a 4-point Likert scale. High scores refer to higher usability, relevance and content appreciation.	Immediately post-intervention
Primary	Burnout symptoms immediate effect	Burnout is measured using Oldenburg Burnout Inventory (Olbi), an instrument designed to measure exhaustion and disengagement: (Demerouti, E, Bakker, A.B, Vardakou, I, & Kantas, A. [2003]. The convergent validity of two burnout instruments : a multitrait-multimethod analysis. European Journal of Psychological Assessment : Official Organ of the European Association of Psychological Assessment, 19(1), 12-23. https://doi.org/10.1027//1015-5759.19.1.12); The full Olbi scale consists of twelve items, and this study uses a subset of seven items. The study uses a Swedish version: Gustavsson, J. P., Hallsten, L., & Rudman, A. (2010). Early career burnout among nurses: modelling a hypothesized process using an item response approach. International Journal of Nursing Studies, 47(7), 864-875.; The items are scored on a 4-point Likert scale (1 = Not at all, 4 = Exactly).	Immediately post-intervention
Primary	Burnout symptoms delayed effect	Burnout is measured using Oldenburg Burnout Inventory (Olbi), an instrument designed to measure exhaustion and disengagement: (Demerouti, E, Bakker, A.B, Vardakou, I, & Kantas, A. [2003]. The convergent validity of two burnout instruments : a multitrait-multimethod analysis. European Journal of Psychological Assessment : Official Organ of the European Association of Psychological Assessment, 19(1), 12-23. https://doi.org/10.1027//1015-5759.19.1.12); The full Olbi scale consists of twelve items, and this study uses a subset of seven items. The study uses a Swedish version: Gustavsson, J. P., Hallsten, L., & Rudman, A. (2010). Early career burnout among nurses: modelling a hypothesized process using an item response approach. International Journal of Nursing Studies, 47(7), 864-875.; The items are scored on a 4-point Likert scale (1 = Not at all, 4 = Exactly).	A month after completed intervention
Primary	Emotional exhaustion immediate effect	Emotional exhaustion is measured using Shirom-Melamed Burnout questionnaire (SMBQ), a 22-item instrument designed to assess burnout: Shirom, A., & Melamed, S. (2006). A comparison of the construct validity of two burnout measures in two groups of professionals. International journal of stress management, 13(2), 176.; This study uses the SMBQ-6, a subset of six items, specifically measuring emotional exhaustion. A Swedish version is used for this study: Lundgren-Nilsson, Å., Jonsdottir, I. H., Pallant, J., & Ahlborg, G. (2012). Internal construct validity of the Shirom-Melamed Burnout questionnaire (SMBQ). BMC public health, 12(1), 1.; Items are scored on a 7-point Likert scale (1 = Very rarely, 7 = Very frequently).	Immediately post-intervention
Primary	Emotional exhaustion delayed effect	Emotional exhaustion is measured using Shirom-Melamed Burnout questionnaire (SMBQ), a 22-item instrument designed to assess burnout: Shirom, A., & Melamed, S. (2006). A comparison of the construct validity of two burnout measures in two groups of professionals. International journal of stress management, 13(2), 176.; This study uses the SMBQ-6, a subset of six items, specifically measuring emotional exhaustion. A Swedish version is used for this study: Lundgren-Nilsson, Å., Jonsdottir, I. H., Pallant, J., & Ahlborg, G. (2012). Internal construct validity of the Shirom-Melamed Burnout questionnaire (SMBQ). BMC public health, 12(1), 1.; Items are scored on a 7-point Likert scale (1 = Very rarely, 7 = Very frequently).	A month after completed intervention
Primary	Stress symptoms immediate effect	Stress is measured using the Perceived Stress Scale (PSS), designed to measure "the degree to which situations in one´s life are appraised as stressful" (Cohen, S., Kamarck, T., & Mermelstein, R. [1983]. A global measure of perceived stress. Journal of health and social behavior, 385-396).; The original scale contains 14 items, and this study uses the PSS-10 version which contains 10 items. A Swedish translation of the scale is used: Nordin, M., & Nordin, S. (2013). Psychometric evaluation and normative data of the Swedish version of the 10-item perceived stress scale. Scandinavian journal of psychology, 54(6), 502-507.; The items are scored on a 5-point Likert scale (1 = Never, 5 = Very often).	Immediately post-intervention
Primary	Stress symptoms delayed effect	Stress is measured using the Perceived Stress Scale (PSS), designed to measure "the degree to which situations in one´s life are appraised as stressful" (Cohen, S., Kamarck, T., & Mermelstein, R. [1983]. A global measure of perceived stress. Journal of health and social behavior, 385-396).; The original scale contains 14 items, and this study uses the PSS-10 version which contains 10 items. A Swedish translation of the scale is used: Nordin, M., & Nordin, S. (2013). Psychometric evaluation and normative data of the Swedish version of the 10-item perceived stress scale. Scandinavian journal of psychology, 54(6), 502-507.; The items are scored on a 5-point Likert scale (1 = Never, 5 = Very often).	A month after completed intervention
Secondary	Anxiety symptoms immediate effect	Anxiety is measured using the GAD-7 scale, a 7-item questionnaire designed to assess generalized anxiety disorder (Spitzer, R. L., Kroenke, K., Williams, J. B., & Löwe, B. [2006]. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of internal medicine, 166(10), 1092-1097). A Swedish version of the scale will be used.; The items are scored on a 4-point Likert scale (1 = Not at all, 4 = Almost every day).	Immediately post-intervention
Secondary	Anxiety symptoms delayed effect	Anxiety is measured using the GAD-7 scale, a 7-item questionnaire designed to assess generalized anxiety disorder (Spitzer, R. L., Kroenke, K., Williams, J. B., & Löwe, B. [2006]. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of internal medicine, 166(10), 1092-1097). A Swedish version of the scale will be used.; The items are scored on a 4-point Likert scale (1 = Not at all, 4 = Almost every day).	A month after completed intervention
Secondary	Depressive symptoms immediate effect	Depressive symptoms are measured using the Patient Health Questionnaire-2 (PHQ-2), a 2-item screening tool for assessing depression (Kroenke, K., Spitzer, R. L., & Williams, J. B. [2003]. The Patient Health Questionnaire-2: validity of a two-item depression screener. Medical care, 1284-1292). A Swedish translation is used.; The items are scored on a 4-point Likert scale (1 = Not at all, 4 = Almost every day)	Immediately post-intervention
Secondary	Depressive symptoms delayed effect	Depressive symptoms are measured using the Patient Health Questionnaire-2 (PHQ-2), a 2-item screening tool for assessing depression (Kroenke, K., Spitzer, R. L., & Williams, J. B. [2003]. The Patient Health Questionnaire-2: validity of a two-item depression screener. Medical care, 1284-1292). A Swedish translation is used.; The items are scored on a 4-point Likert scale (1 = Not at all, 4 = Almost every day)	A month after completed intervention
Secondary	Post-traumatic stress immediate effect	PTSD is measured using the Posttraumatic Stress Disorder checklist (PCL-5), a widely used self-report measure of PTSD using criteria from the DSM-5 (Bovin, M. J., Marx, B. P., Weathers, F. W., Gallagher, M. W., Rodriguez, P., Schnurr, P. P., & Keane, T. M. [2015]. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in Veterans. Psychological Assessment, 28, 1379-1391. doi:10.1037/pas0000254).; The entire scale contains 20 items, and a subset of three items is used for this study. A Swedish version is used.; Items are scored on a 5-item Likert scale (1 = A lot, 5 = Not at all).	Immediately post-intervention
Secondary	Post-traumatic stress delayed effect	PTSD is measured using the Posttraumatic Stress Disorder checklist (PCL-5), a widely used self-report measure of PTSD using criteria from the DSM-5 (Bovin, M. J., Marx, B. P., Weathers, F. W., Gallagher, M. W., Rodriguez, P., Schnurr, P. P., & Keane, T. M. [2015]. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in Veterans. Psychological Assessment, 28, 1379-1391. doi:10.1037/pas0000254).; The entire scale contains 20 items, and a subset of three items is used for this study. A Swedish version is used.; Items are scored on a 5-item Likert scale (1 = A lot, 5 = Not at all).	A month after completed intervention
Secondary	Emotional awareness immediate effect	Awareness of emotions is measured using Mindful Attention Awareness Scale (MAAS) (Brown, K. W., & Ryan, R. M. [2009]. The Mindfulness Attention Awareness Scale (MAAS). Acceptance and Commitment Therapy. Measures Package, 82). This study uses a subset of six questions, focusing on emotional awareness. A Swedish version is used in this study. Items are rated on a 6-point Likert scale (1 = Very frequently, 6 = Very rarely).	Immediately post-intervention
Secondary	Emotional awareness delayed effect	Awareness of emotions is measured using Mindful Attention Awareness Scale (MAAS) (Brown, K. W., & Ryan, R. M. [2009]. The Mindfulness Attention Awareness Scale (MAAS). Acceptance and Commitment Therapy. Measures Package, 82). This study uses a subset of six questions, focusing on emotional awareness. A Swedish version is used in this study. Items are rated on a 6-point Likert scale (1 = Very frequently, 6 = Very rarely).	A month after completed intervention
Secondary	Controllability immediate effect	Controllability is measured using the "control" subscale from the Recovery Experience Questionnaire (REQ) (Sonnentag, S., & Fritz, C. [2007]. The Recovery Experience Questionnaire: development and validation of a measure for assessing recuperation and unwinding from work. Journal of occupational health psychology, 12(3), 204). This subscale includes 4 items that are scored on a 5-point Likert scale (1 = Not at all, 5 = Very much). A Swedish version is used.; To measure controllability in the work context, the study also uses the Task Crafting subscale from the Job Crafting Questionnaire (Slemp, G. R., & Vella-Brodrick, D. A. [2013]. The Job Crafting Questionnaire: A new scale to measure the extent to which employees engage in job crafting. International Journal of wellbeing, 3(2)). A Swedish version is used. This subscale includes 7 items scored on a 5-point Likert scale (1 = Hardly ever, 5 = Very often).	Immediately post-intervention
Secondary	Controllability delayed effect	Controllability is measured using the "control" subscale from the Recovery Experience Questionnaire (REQ) (Sonnentag, S., & Fritz, C. [2007]. The Recovery Experience Questionnaire: development and validation of a measure for assessing recuperation and unwinding from work. Journal of occupational health psychology, 12(3), 204). This subscale includes 4 items that are scored on a 5-point Likert scale (1 = Not at all, 5 = Very much). A Swedish version is used.; To measure controllability in the work context, the study also uses the Task Crafting subscale from the Job Crafting Questionnaire (Slemp, G. R., & Vella-Brodrick, D. A. [2013]. The Job Crafting Questionnaire: A new scale to measure the extent to which employees engage in job crafting. International Journal of wellbeing, 3(2)). A Swedish version is used. This subscale includes 7 items scored on a 5-point Likert scale (1 = Hardly ever, 5 = Very often).	A month after completed intervention
Secondary	Recovery experience immediate effect	Questions regarding the degree to which participants engage in behavioral recovery strategies, for instance spending time on a hobby or letting go of work-related thoughts. This is measured using the Recovery Experience Questionnaire (REQ) (Sonnentag, S., & Fritz, C. [2007]. The Recovery Experience Questionnaire: development and validation of a measure for assessing recuperation and unwinding from work. Journal of occupational health psychology, 12(3), 204). The study uses two subscales - psychological detachment and relaxation, resulting in 8 items. Items are scored on a 5-point Likert scale (1 = Not at all, 5 = Very much). A Swedish version is used.	Immediately post-intervention
Secondary	Recovery experience delayed effect	Questions regarding the degree to which participants engage in behavioral recovery strategies, for instance spending time on a hobby or letting go of work-related thoughts. This is measured using the Recovery Experience Questionnaire (REQ) (Sonnentag, S., & Fritz, C. [2007]. The Recovery Experience Questionnaire: development and validation of a measure for assessing recuperation and unwinding from work. Journal of occupational health psychology, 12(3), 204). The study uses two subscales - psychological detachment and relaxation, resulting in 8 items. Items are scored on a 5-point Likert scale (1 = Not at all, 5 = Very much). A Swedish version is used.	A month after completed intervention
Secondary	Social support immediate effect	Questions regarding the degree to which participants engage with their social context for emotional support. We use the Relation Crafting subscale from the Job Crafting Questionnaire: (Slemp, G. R., & Vella-Brodrick, D. A. (2013). The Job Crafting Questionnaire: A new scale to measure the extent to which employees engage in job crafting. International Journal of wellbeing, 3(2)). The subscale includes 7 items scored on a 5-point Likert scale (1 = Hardly ever, 5 = Very often).	Immediately post-intervention
Secondary	Social support delayed effect	Questions regarding the degree to which participants engage with their social context for emotional support. We use the Relation Crafting subscale from the Job Crafting Questionnaire: (Slemp, G. R., & Vella-Brodrick, D. A. (2013). The Job Crafting Questionnaire: A new scale to measure the extent to which employees engage in job crafting. International Journal of wellbeing, 3(2)). The subscale includes 7 items scored on a 5-point Likert scale (1 = Hardly ever, 5 = Very often).	A month after completed intervention