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

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT04719351

Acronym / sponsor ID

DIARY / 4-2092/2020

Conditions

Burnout, Professional, Stress, Psychological

Keywords

mobile application, healthcare workers, work stress

Study type

Interventional

Recruitment status

Completed

Enrolment

330 participants (actual)

Lead sponsor

Karolinska InstitutetUniversity, hospital or other

Collaborators

The Swedish Research Council

Study start

22 Feb 2021 (actual)

Primary completion

14 Jun 2021 (actual)

Study completion

14 Jun 2021 (actual)

First posted

22 Jan 2021 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Factorial

Masking

None (open label)

Number of arms

32

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.

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Burnout symptoms immediate effect

   Time frame: Immediately post-intervention

   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).

2. Burnout symptoms delayed effect

   Time frame: A month after completed intervention

   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).

3. Emotional exhaustion immediate effect

   Time frame: Immediately post-intervention

   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).

4. Emotional exhaustion delayed effect

   Time frame: A month after completed intervention

   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).

5. Stress symptoms immediate effect

   Time frame: Immediately post-intervention

   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).

6. Stress symptoms delayed effect

   Time frame: A month after completed intervention

   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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
• Derived from this study: PubMed 41078177Kowalski L, Finnes A, Koch S, Bujacz A. Optimizing Intervention Components of a Preventive Stress Management mHealth Intervention for Health Care Workers: Experimental Factorial Study. JMIR Form Res. 2025 Aug 25;9:e71032. doi: 10.2196/71032.
• Individual participant dataSharing planned: Yes. An anonymized subset of the data relevant for a particular publication (including metadata and code for the analyses conducted) will be registered on the OSF repository and provided with the DOI number. Neither qualitative data (i.e. answers to open questions) nor any personal data (i.e. gender, age, occupation) will be shared to ensure complete anonymity of the study participants. Data regarding each publication will become available already at the pre-print stage of each publication (i.e. manuscript submitted for publication), under the CC-BY license. Data will be stored in .csv format and will include raw data as well as data analysis files (analysis code). The data publication may be postponed and restricted in case a patent application will be submitted for a review.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.