Clinical trial NCT06228495: mHealth Intervention for Work-Related Stress
Official title: Recovery at Your Fingertips: Pilot Study of an mHealth Intervention for Work-Related Stress Among Nursing Students (DIARY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Work Related Stress
Keywords: work stress
work-related stress
occupational stress
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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?

Eligibility criteria: Inclusion Criteria:

* Active employee or student.

Exclusion Criteria:

* No psychiatric disorder.

Primary outcomes:
measure: Adherence
timeFrame: Over the course of the 28-day intervention.
measure: App Engagement
timeFrame: At post-intervention, immediately after finishing the 28-day intervention.
measure: Daily stress
timeFrame: This was measured at once daily during the course of the 28-day intervention.
measure: Acceptability
timeFrame: At post-intervention, immediately after finishing the 28-day intervention.
Secondary outcomes:
measure: Change in anxiety as measured by the Generalized Anxiety Disorder 7-item scale between baseline and post and follow-up measures.
timeFrame: This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.
measure: Change in mindfulness as measured by the Mindful Attention Awareness Scale between baseline, post and follow-up measures.
timeFrame: This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.
measure: Change in recovery experiences as measured by the Recovery Experience Questionnaire between baseline, post and follow-up measures.
timeFrame: This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.
measure: Change in exhaustion and disengagement from work as measured by the Oldenburg Burnout Questionnaire between baseline and post and follow-up measures.
timeFrame: This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.
measure: Change in emotional exhaustion as measured by the Shirom-Melamed Burnout Questionnaire between baseline and post and follow-up measures.
timeFrame: This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska institutet
Study officials:
affiliation: Karolinska Institutet
name: Aleksandra Sjöström-Bujacz, PhD
role: PRINCIPAL_INVESTIGATOR
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