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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

330

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 months study duration

First Submitted

Initial submission to the registry

January 12, 2021

Completed

10 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed

1 month until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2021

Completed

Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

January 12, 2021

Last Update Submit

June 28, 2021

Conditions

Burnout, Professional Stress, Psychological

Keywords

mobile applicationhealthcare workerswork stress

Outcome Measures

Primary Outcomes (6)

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
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
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
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
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
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 Outcomes (14)

Anxiety symptoms immediate effect
Immediately post-intervention
Anxiety symptoms delayed effect
A month after completed intervention
Depressive symptoms immediate effect
Immediately post-intervention
Depressive symptoms delayed effect
A month after completed intervention
Post-traumatic stress immediate effect
Immediately post-intervention
+9 more secondary outcomes

Other Outcomes (4)

Dropout rate
Immediately post-intervention
Protocol adherence
Immediately post-intervention
Participant engagement
Immediately post-intervention
+1 more other outcomes

Study Arms (32)

Condition 1: Positive: no; Workload: no; Controllability: no; Open: no; Prompt: no;

EXPERIMENTAL

Component list: 1. Questions about positive emotions: not included; 2. Questions about workload/work environment: not included; 3. Questions about controllability: not included; 4. Questions with open answers: not included; 5. Behavioral prompts: not included;