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Clinical Trials/NCT06228495
NCT06228495
Completed
Not Applicable

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

Karolinska Institutet1 site in 1 country16 target enrollmentMay 2, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Work Related Stress
Sponsor
Karolinska Institutet
Enrollment
16
Locations
1
Primary Endpoint
Acceptability
Status
Completed
Last Updated
2 years ago

Overview

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?

Registry
clinicaltrials.gov
Start Date
May 2, 2022
End Date
December 16, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aleksandra Sjöström-Bujacz

Assistant Professor

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • Active employee or student.

Exclusion Criteria

  • No psychiatric disorder.

Outcomes

Primary Outcomes

Acceptability

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

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.

Adherence

Time Frame: Over the course of the 28-day intervention.

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

App Engagement

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

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).

Daily stress

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

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.

Secondary Outcomes

  • 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 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 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.)
  • 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.)

Study Sites (1)

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