mHealth Intervention for Work-Related Stress

Work Related Stress Clinical Trial

— DIARY  

Official title:

Recovery at Your Fingertips: Pilot Study of an mHealth Intervention for Work-Related Stress Among Nursing Students (DIARY)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06228495
• Other study ID #: SFO-V 2021-2022 ASB
• Status: Completed
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: December 16, 2022

Study information

• Verified date: January 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Researchers generally agree that recovery is a key buffer against the negative consequences of stress. Recovery behaviors, such as mindfulness and physical activity, are well-known to have a positive effect on stress-related health problems. For this reason, a behavior change intervention that successfully improves recovery may be effective in combating the long-term effects of stress. In this pilot study, three groups of participants received different versions of an intervention, each version containing a distinct set of recovery strategies. The motivation of the present study is to pilot test the intervention and a study protocol in preparation for a future randomized controlled trial (RCT). Pilot testing the intervention and study procedures at an early stage is critical to identify potential pitfalls that need to be addressed before conducting a full-scale trial. Through investigating the study and intervention in preparatory phases we can refine the study protocol and intervention design in order to maximize the chances of a successful RCT. The research questions for this pilot study are: 1. Data collection procedure - What is the recruitment and retention rate of invited participants? Does the randomization algorithm function properly? 2. Engagement - How often do participants use the intervention? Do they find the application easy and engaging to use? 3. Acceptability - Do participants find the intervention overall satisfactory and perceive it as beneficial? Is the digital tool technically stable? 4. Measurement quality - What is the completion rate for questionnaire items? What is the within-person variability in the daily measures?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Active employee or student.

Exclusion Criteria:

• No psychiatric disorder.

Related Conditions & MeSH terms

• Occupational Stress
• Work Related Stress

Intervention

Behavioral:
• Daily Intervention for Active Recovery
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.

Locations

Country	Name	City	State
Sweden	Karolinska institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	Change in anxiety as measured by the Generalized Anxiety Disorder 7-item scale between baseline and post and follow-up measures.	Anxiety was measured using the GAD-7 questionnaire, a 7-item instrument designed to assess generalized anxiety disorder. This study uses a Swedish translation. Items (e.g. "Feeling nervous, anxious, or on edge") were scored on a 1-4 ordered categories scale (1 = Not at all, 4 = Nearly every day).	This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.
Secondary	Change in mindfulness as measured by the Mindful Attention Awareness Scale between baseline, post and follow-up measures.	Mindfulness was measured using the Mindful Attention Awareness Scale, a 15-item measure designed to assess attention and awareness of "what is occurring in the present moment". This study used a Swedish translation with six items centered around emotional self-awareness. Items ("I could be experiencing some emotion and not be conscious of it until some time later") are rated on a 1-7 ordered categories scale (1 = Almost never, 7 = Almost always).	This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.
Secondary	Change in recovery experiences as measured by the Recovery Experience Questionnaire between baseline, post and follow-up measures.	Recovery was measured using the Recovery Experience Questionnaire, a 16-item questionnaire designed to measure four dimensions of recovery - detachment, relaxation, autonomy, and mastery - using four items for each dimension. This study uses a Swedish translation. Items ("In my free time I don't think about work") are scored on a 1-7 ordered categories scale (1 = Almost never, 7 = Almost always).	This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.
Secondary	Change in exhaustion and disengagement from work as measured by the Oldenburg Burnout Questionnaire between baseline and post and follow-up measures.	Exhaustion and disengagement from work was measured using the Oldenburg Burnout Inventory, an instrument designed to measure burnout in an occupational context including the dimensions exhaustion and disengagement. This study used a Swedish translation with a subset of 7 items. Items (e.g. "after work I often feel tired and exhausted") are scored on a 4-point ordered categories scale (1 = Not at all, 4 = Exactly).	This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.
Secondary	Change in emotional exhaustion as measured by the Shirom-Melamed Burnout Questionnaire between baseline and post and follow-up measures.	Emotional exhaustion was measured using the Shirom-Melamed Burnout Questionnaire (SMBQ), an instrument designed to assess burnout symptoms. The study used a Swedish translation and subset of 6 items focused on the emotional exhaustion dimension of burnout. Items ("My batteries are empty") are rated on a 1-7 ordered categories scale (1 = Almost never, 7 = Almost always).	This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.