mHealth Intervention for Work-Related Stress

NCT06228495 | Completed

• 1 other identifier: SFO-V 2021-2022 ASB
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the trial is to pilot test the study protocol of a preventive, low-intensive mobile health (mHealth) intervention for work-related stress among nursing students. Work stress is a wide-spread problem affecting individual health as well as incurring substantial societal costs. mHealth solutions are among the most promising options for providing effective, scalable, and standardized interventions to employees.

Conditions

Work Related Stress

Keywords

work stress; work-related stress; occupational stress

Outcome Measures

Primary Outcomes (4)

• Adherence

  Adherence was operationalized as a count variable coded 0-28 representing the number of days that a given participant used the intervention.

  Over the course of the 28-day intervention.

• App Engagement

  App Engagement was measured using The App Engagement Scale, a 7-item questionnaire designed to measure engagement with mobile applications, translated into Swedish by the research team. This translation has been used previously by the research team and has preliminary evidence of good reliability. Items (e.g. "I enjoyed using the app") are scored on a 1-5 ordered categories scale (1 = Not at all, 5 = Fully agree).

  At post-intervention, immediately after finishing the 28-day intervention.

• Daily stress

  Stress was measured daily as the mean value of three items inspired by the Stress-Energy Questionnaire. This study used a Swedish translation which has been validated in a previous study by the research team. Items ("During the last day, to what extent have you felt tense / pressed / frustrated?") were rated on a 6-point ordered categories scale (1 = Not at all, 6 = Very much). This variable was measured daily during the intervention and was not included in the pre-, post-, and follow-up measures.

  This was measured at once daily during the course of the 28-day intervention.

• Acceptability

  Acceptability was measured using a set of single-item measures evaluating whether the intervention was relevant to the user, if they would like to use it again, quality of the prompts, and technical stability. These items were only included in the post-intervention measure.

  At post-intervention, immediately after finishing the 28-day intervention.

Secondary Outcomes (5)

• Change in anxiety as measured by the Generalized Anxiety Disorder 7-item scale between baseline and post and follow-up measures.

  This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.

• Change in mindfulness as measured by the Mindful Attention Awareness Scale between baseline, post and follow-up measures.

  This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.

• Change in recovery experiences as measured by the Recovery Experience Questionnaire between baseline, post and follow-up measures.

  This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.

• Change in exhaustion and disengagement from work as measured by the Oldenburg Burnout Questionnaire between baseline and post and follow-up measures.

  This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.

• Change in emotional exhaustion as measured by the Shirom-Melamed Burnout Questionnaire between baseline and post and follow-up measures.

  This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.

Study Arms (3)

Social Support

EXPERIMENTAL

This version of the intervention prompted users to engage in social support which is thought to buffer against the negative effects of stress. This effect is present in occupational settings, with several studies indicating that social support plays an important role in preventing burnout among nurses. Furthermore, interventions targeting social support in the workplace suggest that these have positive effects on mental health. Sample strategies included asking for help from co-workers, listening with compassion, and sharing authentic emotions.

Behavioral: Daily Intervention for Active Recovery

Physical Activity

ACTIVE COMPARATOR

This version of the interventions promoted an increase of physical activity in daily life. Physical activity is well-known to improve various health outcomes similar to our outcomes of interest, for instance reducing stress and burnout symptoms. Additionally, physical activity interventions in the workplace are widely used and have been found effective in many studies. Sample strategies included taking walks, going to the gym, and using the stairs instead of the elevator.

Behavioral: Daily Intervention for Active Recovery

Psychological Strategies

ACTIVE COMPARATOR

This version of the intervention promoted a variety of psychological strategies for stress reduction. Sample strategies included sleep quality improvement tips, mindfulness, and work detachment - evidence-based strategies that have a positive effect on outcomes of interest. Workplace interventions targeting these kinds of strategies have been found to be effective.

Behavioral: Daily Intervention for Active Recovery

Interventions

Daily Intervention for Active Recovery BEHAVIORAL

Daily Intervention for Active Recovery - DIARY - is a 28-day intervention during which participants are prompted once daily to engage with intervention content. Each daily intervention interaction includes a short questionnaire with questions regarding sleep quality, current mood (e.g., tense, relaxed), and energy levels. Participants were prompted to open the application through a notification at 18:00 each evening. In case they did not fill out the questionnaire, an additional reminder notification was sent out at 20:00. The questionnaire closed each night at 03:00 am, at which point it was no longer possible to access the questionnaire for that day. The questionnaire took at most 5 minutes to complete. Upon completing the daily questionnaire participants received a prompt - a "bit-size" amount of information regarding stress and recovery as well as suggestions for a specific recovery strategy.

Physical Activity; Psychological Strategies; Social Support

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active employee or student.

You may not qualify if:

• No psychiatric disorder.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska institutet

Stockholm, 17165, Sweden

Location

Related Publications (15)

• Hadzibajramovic E, Ahlborg G Jr, Grimby-Ekman A, Lundgren-Nilsson A. Internal construct validity of the stress-energy questionnaire in a working population, a cohort study. BMC Public Health. 2015 Feb 25;15:180. doi: 10.1186/s12889-015-1524-9.

  PMID: 25885917 BACKGROUND

• Hansen E, Lundh LG, Homman A, Wangby-Lundh M. Measuring mindfulness: pilot studies with the Swedish versions of the Mindful Attention Awareness Scale and the Kentucky Inventory of Mindfulness Skills. Cogn Behav Ther. 2009;38(1):2-15. doi: 10.1080/16506070802383230.

  PMID: 19125361 BACKGROUND

• Johansson R, Carlbring P, Heedman A, Paxling B, Andersson G. Depression, anxiety and their comorbidity in the Swedish general population: point prevalence and the effect on health-related quality of life. PeerJ. 2013 Jul 9;1:e98. doi: 10.7717/peerj.98. Print 2013.

  PMID: 23862109 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Sundstrom A, Soderholm A, Nordin M, Nordin S. Construct validation and normative data for different versions of the Shirom-Melamed burnout questionnaire/measure in a Swedish population sample. Stress Health. 2023 Aug;39(3):499-515. doi: 10.1002/smi.3200. Epub 2022 Oct 1.

  PMID: 36166816 BACKGROUND

• Lundgren-Nilsson A, Jonsdottir IH, Pallant J, Ahlborg G Jr. Internal construct validity of the Shirom-Melamed Burnout Questionnaire (SMBQ). BMC Public Health. 2012 Jan 3;12:1. doi: 10.1186/1471-2458-12-1.

  PMID: 22214479 BACKGROUND

• Peterson U, Bergstrom G, Samuelsson M, Asberg M, Nygren A. Reflecting peer-support groups in the prevention of stress and burnout: randomized controlled trial. J Adv Nurs. 2008 Sep;63(5):506-16. doi: 10.1111/j.1365-2648.2008.04743.x.

  PMID: 18727753 BACKGROUND

• Bakker D, Rickard N. Engagement in mobile phone app for self-monitoring of emotional wellbeing predicts changes in mental health: MoodPrism. J Affect Disord. 2018 Feb;227:432-442. doi: 10.1016/j.jad.2017.11.016. Epub 2017 Nov 9.

  PMID: 29154165 BACKGROUND

• Vega-Escano J, Porcel-Galvez AM, Diego-Cordero R, Romero-Sanchez JM, Romero-Saldana M, Barrientos-Trigo S. Insomnia Interventions in the Workplace: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2020 Sep 2;17(17):6401. doi: 10.3390/ijerph17176401.

  PMID: 32887475 BACKGROUND

• Karabinski T, Haun VC, Nubold A, Wendsche J, Wegge J. Interventions for improving psychological detachment from work: A meta-analysis. J Occup Health Psychol. 2021 Jun;26(3):224-242. doi: 10.1037/ocp0000280.

  PMID: 34096763 BACKGROUND

• Conn VS, Hafdahl AR, Cooper PS, Brown LM, Lusk SL. Meta-analysis of workplace physical activity interventions. Am J Prev Med. 2009 Oct;37(4):330-9. doi: 10.1016/j.amepre.2009.06.008.

  PMID: 19765506 BACKGROUND

• Hogan BE, Linden W, Najarian B. Social support interventions: do they work? Clin Psychol Rev. 2002 Apr;22(3):383-442. doi: 10.1016/s0272-7358(01)00102-7.

  PMID: 17201192 BACKGROUND

• Velando-Soriano A, Ortega-Campos E, Gomez-Urquiza JL, Ramirez-Baena L, De La Fuente EI, Canadas-De La Fuente GA. Impact of social support in preventing burnout syndrome in nurses: A systematic review. Jpn J Nurs Sci. 2020 Jan;17(1):e12269. doi: 10.1111/jjns.12269. Epub 2019 Oct 15.

  PMID: 31617309 BACKGROUND

• Naczenski LM, Vries JD, Hooff MLMV, Kompier MAJ. Systematic review of the association between physical activity and burnout. J Occup Health. 2017 Nov 25;59(6):477-494. doi: 10.1539/joh.17-0050-RA. Epub 2017 Oct 7.

  PMID: 28993574 BACKGROUND

• Ozbay F, Johnson DC, Dimoulas E, Morgan CA, Charney D, Southwick S. Social support and resilience to stress: from neurobiology to clinical practice. Psychiatry (Edgmont). 2007 May;4(5):35-40.

  PMID: 20806028 BACKGROUND

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Aleksandra Sjöström-Bujacz, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 29, 2024
• Study Start: May 2, 2022
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)