Work Related StressDIARYNCT06228495
mHealth Intervention for Work-Related Stress
A study testing Daily Intervention for Active Recovery in people with Work Related Stress, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Work Related Stress
- What is being tested?
- Daily Intervention for Active Recovery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- 2 May 2022to 16 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active employee or student.
Who cannot join
- No psychiatric disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovery at Your Fingertips: Pilot Study of an mHealth Intervention for Work-Related Stress Among Nursing Students (DIARY)
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.
Read the 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:
- Data collection procedure - What is the recruitment and retention rate of invited participants? Does the randomization algorithm function properly?
- Engagement - How often do participants use the intervention? Do they find the application easy and engaging to use?
- Acceptability - Do participants find the intervention overall satisfactory and perceive it as beneficial? Is the digital tool technically stable?
- Measurement quality - What is the completion rate for questionnaire items? What is the within-person variability in the daily measures?
- Conditions
- Work Related Stress
- Being tested
- Daily Intervention for Active Recovery
- Keywords
- work stress, work-related stress, occupational stress
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Intervention for Active RecoveryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Daily Intervention for Active Recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Adherence was operationalized as a count variable coded 0-28 representing the number of days that a given participant used the intervention.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start2 May 2022
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Work Related StressStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Sjöström-Bujacz, Karolinska Institutet
- Investigators
- Aleksandra Sjöström-Bujacz, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228495
- Sponsor's protocol ID
- SFO-V 2021-2022 ASB
- Acronym
- DIARY
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25885917Hansen 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.
PubMed 19125361Johansson 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.
PubMed 23862109Spitzer 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.
PubMed 16717171Sundstrom 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.
PubMed 36166816Lundgren-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.
PubMed 22214479Peterson 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.
PubMed 18727753Bakker 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.
PubMed 29154165Vega-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.
PubMed 32887475Karabinski 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.
PubMed 34096763Conn 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.
PubMed 19765506Hogan 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.
PubMed 17201192Velando-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.
PubMed 31617309Naczenski 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.
PubMed 28993574Ozbay 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.
PubMed 20806028
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery at Your Fingertips: Pilot Study of an mHealth Intervention for Work-Related Stress Among Nursing Students (DIARY)
- ClinicalTrials.gov ID
- NCT06228495
- Acronym / sponsor ID
- DIARY / SFO-V 2021-2022 ASB
- Conditions
- Work Related Stress
- Keywords
- work stress, work-related stress, occupational stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Data collection procedure - What is the recruitment and retention rate of invited participants? Does the randomization algorithm function properly?
- Engagement - How often do participants use the intervention? Do they find the application easy and engaging to use?
- Acceptability - Do participants find the intervention overall satisfactory and perceive it as beneficial? Is the digital tool technically stable?
- Measurement quality - What is the completion rate for questionnaire items? What is the within-person variability in the daily measures?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Social Support | Experimental | Behavioral: Daily Intervention for Active RecoveryThis 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. |
| Physical Activity | Active comparator | Behavioral: Daily Intervention for Active RecoveryThis 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. |
| Psychological Strategies | Active comparator | Behavioral: Daily Intervention for Active RecoveryThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active employee or student.
Key exclusion criteria (1 listed)
- No psychiatric disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Intervention for Active RecoveryDaily 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. | Behavioural | Physical Activity, Psychological Strategies, Social Support |
Primary outcome
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.
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.
5 secondary outcomes
Change in anxiety as measured by the Generalized Anxiety Disorder 7-item scale between baseline and post and follow-up measures.
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.
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.
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.
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.
Time frame: This was measured at three time-points separated by one month each - baseline, post-intervention, follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Background: PubMed 25885917Hadzibajramovic 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.
- Background: PubMed 19125361Hansen 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.
- Background: PubMed 23862109Johansson 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.
- Background: PubMed 16717171Spitzer 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.
- Background: PubMed 36166816Sundstrom 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.
- Background: PubMed 22214479Lundgren-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.
- Background: PubMed 18727753Peterson 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.
- Background: PubMed 29154165Bakker 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.
- Background: PubMed 32887475Vega-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.
- Background: PubMed 34096763Karabinski 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.
- Background: PubMed 19765506Conn 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.
- Background: PubMed 17201192Hogan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Sjöström-Bujacz, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Intervention for Active Recovery in people with Work Related Stress, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: Over the course of the 28-day intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06228495, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.