An interventional study of Daily Intervention for Active Recovery in Work Related Stress, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Prevention
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.
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:
236 studies on the registry are indexed under Occupational Stress; 64 are open to participants now.
This study's enrollment of 16 is below the median of 89 across 167 interventional studies indexed under Occupational Stress.
Browse Occupational Stress studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Exclusion Criteria:
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
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
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
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.
Adherence
Adherence was operationalized as a count variable coded 0-28 representing the number of days that a given participant used the intervention.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: At post-intervention, immediately after finishing the 28-day intervention.
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).
Time frame: 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.
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).
Time frame: 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.
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).
Time frame: 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.
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).
Time frame: 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.
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).
Time frame: This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.
Plan to share: No
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