Clinical trial NCT04719351: The Use of a Mobile Application to Reduce Work-related Stress Symptoms Among Healthcare Workers
Official title: Diary of a Pandemic: The Use of a Mobile Application to Reduce Work-related Stress Symptoms Among Healthcare Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Stress, Psychological
Keywords: mobile application
healthcare workers
work stress
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2021-01-22
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The factorial experimental trial will randomize participants to one of 32 experimental conditions which consist of any combination of the five components: 1) questions about positive emotions (yes/no), 2) questions about work environment (yes/no), 3) questions about controllability (yes/no), 4) questions with open answers (yes/no), and 5) behavioral prompts (yes/no). The purpose of this factorial experiment is to estimate the main effects of the five intervention components and interactions between the components.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Burnout symptoms immediate effect
timeFrame: Immediately post-intervention
measure: Burnout symptoms delayed effect
timeFrame: A month after completed intervention
measure: Emotional exhaustion immediate effect
timeFrame: Immediately post-intervention
measure: Emotional exhaustion delayed effect
timeFrame: A month after completed intervention
measure: Stress symptoms immediate effect
timeFrame: Immediately post-intervention
measure: Stress symptoms delayed effect
timeFrame: A month after completed intervention
Secondary outcomes:
measure: Anxiety symptoms immediate effect
timeFrame: Immediately post-intervention
measure: Anxiety symptoms delayed effect
timeFrame: A month after completed intervention
measure: Depressive symptoms immediate effect
timeFrame: Immediately post-intervention
measure: Depressive symptoms delayed effect
timeFrame: A month after completed intervention
measure: Post-traumatic stress immediate effect
timeFrame: Immediately post-intervention
measure: Post-traumatic stress delayed effect
timeFrame: A month after completed intervention
measure: Emotional awareness immediate effect
timeFrame: Immediately post-intervention
measure: Emotional awareness delayed effect
timeFrame: A month after completed intervention
measure: Controllability immediate effect
timeFrame: Immediately post-intervention
measure: Controllability delayed effect
timeFrame: A month after completed intervention
measure: Recovery experience immediate effect
timeFrame: Immediately post-intervention
measure: Recovery experience delayed effect
timeFrame: A month after completed intervention
measure: Social support immediate effect
timeFrame: Immediately post-intervention
measure: Social support delayed effect
timeFrame: A month after completed intervention
Other outcomes:
measure: Dropout rate
timeFrame: Immediately post-intervention
measure: Protocol adherence
timeFrame: Immediately post-intervention
measure: Participant engagement
timeFrame: Immediately post-intervention
measure: Usability: User experience, relevance, and content appreciation
timeFrame: Immediately post-intervention
Locations:
city: Stockholm
country: Sweden
facility: Aleksandra Sjostrom-Bujacz
Study officials:
affiliation: Karolinska Institutet
name: Aleksandra Sjostrom-Bujacz, PhD
role: PRINCIPAL_INVESTIGATOR
References: