- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04719351
The Use of a Mobile Application to Reduce Work-related Stress Symptoms Among Healthcare Workers (DIARY)
Diary of a Pandemic: The Use of a Mobile Application to Reduce Work-related Stress Symptoms Among Healthcare Workers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Symptoms indicating possibly pathological stress reactions among healthcare workers are more prevalent during the current pandemic than they were before. Possible reasons for that include higher levels of known risk factors such as cognitive, emotional, and physical demands at work; new stressors such as risk for moral injury and worry about personal safety; and diminished protective mechanisms, which include recovery opportunities and psychological detachment. Thus, frontline healthcare workers should be given priority in access to psychological support.
Despite the urgent need for it, a rapid implementation of psychological support for healthcare workers has proved to be challenging during previous crises and the current pandemic. Guidelines published thus far underline the necessity of close real-time monitoring in order to early identify at risk populations and individuals, who should be referred to seek professional support. However, appropriate tools for efficient real-time monitoring of stress responses and early screening for possibly pathological reactions among healthcare workers are currently lacking. Available tools focus either on tracking of stress indicators e.g. sleep disturbances, or on teaching strategies to better cope with stress e.g. mindfulness.
In this study, the investigators will test whether a separate use or a combination of these different functions may be the most efficient in managing work-related stress symptoms among healthcare workers. The study has a factorial design in order to closely investigate the functionalities focused on real-time monitoring of emotional responses and the functionalities based on evidence-based strategies to improve workers' recovery, as well as the possible interactions among them.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Stockholm, Sweden, 17165
- Aleksandra Sjostrom-Bujacz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adult participants
- working (active employment)
Exclusion Criteria:
- no active employment e.g. sick leave, maternity leave during the entire period of an intervention (four weeks)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Condition 1: Positive: no; Workload: no; Controllability: no; Open: no; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 2: Positive: yes; Workload: no; Controllability: no; Open: no; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 3: Positive: no; Workload: yes; Controllability: no; Open: no; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 4: Positive: yes; Workload: yes; Controllability: no; Open: no; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 5: Positive: no; Workload: no; Controllability: yes; Open: no; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 6: Positive: yes; Workload: no; Controllability: yes; Open: no; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 7: Positive: no; Workload: yes; Controllability: yes; Open: no; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 8: Positive: yes; Workload: yes; Controllability: yes; Open: no; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 9: Positive: no; Workload: no; Controllability: no; Open: yes; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 10: Positive: yes; Workload: no; Controllability: no; Open: yes; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 11: Positive: no; Workload: yes; Controllability: no; Open: yes; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 12: Positive: yes; Workload: yes; Controllability: no; Open: yes; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 13: Positive: no; Workload: no; Controllability: yes; Open: yes; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 14: Positive: yes; Workload: no; Controllability: yes; Open: yes; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 15: Positive: no; Workload: yes; Controllability: yes; Open: yes; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 16: Positive: yes; Workload: yes; Controllability: yes; Open: yes; Prompt: no;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 17: Positive: no; Workload: no; Controllability: no; Open: no; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 18: Positive: yes; Workload: no; Controllability: no; Open: no; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 19: Positive: no; Workload: yes; Controllability: no; Open: no; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 20: Positive: yes; Workload: yes; Controllability: no; Open: no; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 21: Positive: no; Workload: no; Controllability: yes; Open: no; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 22: Positive: yes; Workload: no; Controllability: yes; Open: no; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 23: Positive: no; Workload: yes; Controllability: yes; Open: no; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 24: Positive: yes; Workload: yes; Controllability: yes; Open: no; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 25: Positive: no; Workload: no; Controllability: no; Open: yes; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 26: Positive: yes; Workload: no; Controllability: no; Open: yes; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 27: Positive: no; Workload: yes; Controllability: no; Open: yes; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 28: Positive: yes; Workload: yes; Controllability: no; Open: yes; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 29: Positive: no; Workload: no; Controllability: yes; Open: yes; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 30: Positive: yes; Workload: no; Controllability: yes; Open: yes; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 31: Positive: no; Workload: yes; Controllability: yes; Open: yes; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
EXPERIMENTAL: Condition 32: Positive: yes; Workload: yes; Controllability: yes; Open: yes; Prompt: yes;
Component list:
|
The mobile application has two main functionalities.
First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress).
The assessment is done daily for four weeks.
Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g.
remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Burnout symptoms immediate effect
Time Frame: Immediately post-intervention
|
Burnout is measured using Oldenburg Burnout Inventory (Olbi), an instrument designed to measure exhaustion and disengagement: (Demerouti, E, Bakker, A.B, Vardakou, I, & Kantas, A. [2003]. The convergent validity of two burnout instruments : a multitrait-multimethod analysis. European Journal of Psychological Assessment : Official Organ of the European Association of Psychological Assessment, 19(1), 12-23. https://doi.org/10.1027//1015-5759.19.1.12) The full Olbi scale consists of twelve items, and this study uses a subset of seven items. The study uses a Swedish version: Gustavsson, J. P., Hallsten, L., & Rudman, A. (2010). Early career burnout among nurses: modelling a hypothesized process using an item response approach. International Journal of Nursing Studies, 47(7), 864-875. The items are scored on a 4-point Likert scale (1 = Not at all, 4 = Exactly). |
Immediately post-intervention
|
Burnout symptoms delayed effect
Time Frame: A month after completed intervention
|
Burnout is measured using Oldenburg Burnout Inventory (Olbi), an instrument designed to measure exhaustion and disengagement: (Demerouti, E, Bakker, A.B, Vardakou, I, & Kantas, A. [2003]. The convergent validity of two burnout instruments : a multitrait-multimethod analysis. European Journal of Psychological Assessment : Official Organ of the European Association of Psychological Assessment, 19(1), 12-23. https://doi.org/10.1027//1015-5759.19.1.12) The full Olbi scale consists of twelve items, and this study uses a subset of seven items. The study uses a Swedish version: Gustavsson, J. P., Hallsten, L., & Rudman, A. (2010). Early career burnout among nurses: modelling a hypothesized process using an item response approach. International Journal of Nursing Studies, 47(7), 864-875. The items are scored on a 4-point Likert scale (1 = Not at all, 4 = Exactly). |
A month after completed intervention
|
Emotional exhaustion immediate effect
Time Frame: Immediately post-intervention
|
Emotional exhaustion is measured using Shirom-Melamed Burnout questionnaire (SMBQ), a 22-item instrument designed to assess burnout: Shirom, A., & Melamed, S. (2006). A comparison of the construct validity of two burnout measures in two groups of professionals. International journal of stress management, 13(2), 176. This study uses the SMBQ-6, a subset of six items, specifically measuring emotional exhaustion. A Swedish version is used for this study: Lundgren-Nilsson, Å., Jonsdottir, I. H., Pallant, J., & Ahlborg, G. (2012). Internal construct validity of the Shirom-Melamed Burnout questionnaire (SMBQ). BMC public health, 12(1), 1. Items are scored on a 7-point Likert scale (1 = Very rarely, 7 = Very frequently). |
Immediately post-intervention
|
Emotional exhaustion delayed effect
Time Frame: A month after completed intervention
|
Emotional exhaustion is measured using Shirom-Melamed Burnout questionnaire (SMBQ), a 22-item instrument designed to assess burnout: Shirom, A., & Melamed, S. (2006). A comparison of the construct validity of two burnout measures in two groups of professionals. International journal of stress management, 13(2), 176. This study uses the SMBQ-6, a subset of six items, specifically measuring emotional exhaustion. A Swedish version is used for this study: Lundgren-Nilsson, Å., Jonsdottir, I. H., Pallant, J., & Ahlborg, G. (2012). Internal construct validity of the Shirom-Melamed Burnout questionnaire (SMBQ). BMC public health, 12(1), 1. Items are scored on a 7-point Likert scale (1 = Very rarely, 7 = Very frequently). |
A month after completed intervention
|
Stress symptoms immediate effect
Time Frame: Immediately post-intervention
|
Stress is measured using the Perceived Stress Scale (PSS), designed to measure "the degree to which situations in one´s life are appraised as stressful" (Cohen, S., Kamarck, T., & Mermelstein, R. [1983]. A global measure of perceived stress. Journal of health and social behavior, 385-396). The original scale contains 14 items, and this study uses the PSS-10 version which contains 10 items. A Swedish translation of the scale is used: Nordin, M., & Nordin, S. (2013). Psychometric evaluation and normative data of the Swedish version of the 10-item perceived stress scale. Scandinavian journal of psychology, 54(6), 502-507. The items are scored on a 5-point Likert scale (1 = Never, 5 = Very often). |
Immediately post-intervention
|
Stress symptoms delayed effect
Time Frame: A month after completed intervention
|
Stress is measured using the Perceived Stress Scale (PSS), designed to measure "the degree to which situations in one´s life are appraised as stressful" (Cohen, S., Kamarck, T., & Mermelstein, R. [1983]. A global measure of perceived stress. Journal of health and social behavior, 385-396). The original scale contains 14 items, and this study uses the PSS-10 version which contains 10 items. A Swedish translation of the scale is used: Nordin, M., & Nordin, S. (2013). Psychometric evaluation and normative data of the Swedish version of the 10-item perceived stress scale. Scandinavian journal of psychology, 54(6), 502-507. The items are scored on a 5-point Likert scale (1 = Never, 5 = Very often). |
A month after completed intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety symptoms immediate effect
Time Frame: Immediately post-intervention
|
Anxiety is measured using the GAD-7 scale, a 7-item questionnaire designed to assess generalized anxiety disorder (Spitzer, R. L., Kroenke, K., Williams, J. B., & Löwe, B. [2006]. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of internal medicine, 166(10), 1092-1097). A Swedish version of the scale will be used. The items are scored on a 4-point Likert scale (1 = Not at all, 4 = Almost every day). |
Immediately post-intervention
|
Anxiety symptoms delayed effect
Time Frame: A month after completed intervention
|
Anxiety is measured using the GAD-7 scale, a 7-item questionnaire designed to assess generalized anxiety disorder (Spitzer, R. L., Kroenke, K., Williams, J. B., & Löwe, B. [2006]. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of internal medicine, 166(10), 1092-1097). A Swedish version of the scale will be used. The items are scored on a 4-point Likert scale (1 = Not at all, 4 = Almost every day). |
A month after completed intervention
|
Depressive symptoms immediate effect
Time Frame: Immediately post-intervention
|
Depressive symptoms are measured using the Patient Health Questionnaire-2 (PHQ-2), a 2-item screening tool for assessing depression (Kroenke, K., Spitzer, R. L., & Williams, J. B. [2003]. The Patient Health Questionnaire-2: validity of a two-item depression screener. Medical care, 1284-1292). A Swedish translation is used. The items are scored on a 4-point Likert scale (1 = Not at all, 4 = Almost every day) |
Immediately post-intervention
|
Depressive symptoms delayed effect
Time Frame: A month after completed intervention
|
Depressive symptoms are measured using the Patient Health Questionnaire-2 (PHQ-2), a 2-item screening tool for assessing depression (Kroenke, K., Spitzer, R. L., & Williams, J. B. [2003]. The Patient Health Questionnaire-2: validity of a two-item depression screener. Medical care, 1284-1292). A Swedish translation is used. The items are scored on a 4-point Likert scale (1 = Not at all, 4 = Almost every day) |
A month after completed intervention
|
Post-traumatic stress immediate effect
Time Frame: Immediately post-intervention
|
PTSD is measured using the Posttraumatic Stress Disorder checklist (PCL-5), a widely used self-report measure of PTSD using criteria from the DSM-5 (Bovin, M. J., Marx, B. P., Weathers, F. W., Gallagher, M. W., Rodriguez, P., Schnurr, P. P., & Keane, T. M. [2015]. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in Veterans. Psychological Assessment, 28, 1379-1391. doi:10.1037/pas0000254). The entire scale contains 20 items, and a subset of three items is used for this study. A Swedish version is used. Items are scored on a 5-item Likert scale (1 = A lot, 5 = Not at all). |
Immediately post-intervention
|
Post-traumatic stress delayed effect
Time Frame: A month after completed intervention
|
PTSD is measured using the Posttraumatic Stress Disorder checklist (PCL-5), a widely used self-report measure of PTSD using criteria from the DSM-5 (Bovin, M. J., Marx, B. P., Weathers, F. W., Gallagher, M. W., Rodriguez, P., Schnurr, P. P., & Keane, T. M. [2015]. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in Veterans. Psychological Assessment, 28, 1379-1391. doi:10.1037/pas0000254). The entire scale contains 20 items, and a subset of three items is used for this study. A Swedish version is used. Items are scored on a 5-item Likert scale (1 = A lot, 5 = Not at all). |
A month after completed intervention
|
Emotional awareness immediate effect
Time Frame: Immediately post-intervention
|
Awareness of emotions is measured using Mindful Attention Awareness Scale (MAAS) (Brown, K. W., & Ryan, R. M. [2009].
The Mindfulness Attention Awareness Scale (MAAS).
Acceptance and Commitment Therapy.
Measures Package, 82).
This study uses a subset of six questions, focusing on emotional awareness.
A Swedish version is used in this study.
Items are rated on a 6-point Likert scale (1 = Very frequently, 6 = Very rarely).
|
Immediately post-intervention
|
Emotional awareness delayed effect
Time Frame: A month after completed intervention
|
Awareness of emotions is measured using Mindful Attention Awareness Scale (MAAS) (Brown, K. W., & Ryan, R. M. [2009].
The Mindfulness Attention Awareness Scale (MAAS).
Acceptance and Commitment Therapy.
Measures Package, 82).
This study uses a subset of six questions, focusing on emotional awareness.
A Swedish version is used in this study.
Items are rated on a 6-point Likert scale (1 = Very frequently, 6 = Very rarely).
|
A month after completed intervention
|
Controllability immediate effect
Time Frame: Immediately post-intervention
|
Controllability is measured using the "control" subscale from the Recovery Experience Questionnaire (REQ) (Sonnentag, S., & Fritz, C. [2007]. The Recovery Experience Questionnaire: development and validation of a measure for assessing recuperation and unwinding from work. Journal of occupational health psychology, 12(3), 204). This subscale includes 4 items that are scored on a 5-point Likert scale (1 = Not at all, 5 = Very much). A Swedish version is used. To measure controllability in the work context, the study also uses the Task Crafting subscale from the Job Crafting Questionnaire (Slemp, G. R., & Vella-Brodrick, D. A. [2013]. The Job Crafting Questionnaire: A new scale to measure the extent to which employees engage in job crafting. International Journal of wellbeing, 3(2)). A Swedish version is used. This subscale includes 7 items scored on a 5-point Likert scale (1 = Hardly ever, 5 = Very often). |
Immediately post-intervention
|
Controllability delayed effect
Time Frame: A month after completed intervention
|
Controllability is measured using the "control" subscale from the Recovery Experience Questionnaire (REQ) (Sonnentag, S., & Fritz, C. [2007]. The Recovery Experience Questionnaire: development and validation of a measure for assessing recuperation and unwinding from work. Journal of occupational health psychology, 12(3), 204). This subscale includes 4 items that are scored on a 5-point Likert scale (1 = Not at all, 5 = Very much). A Swedish version is used. To measure controllability in the work context, the study also uses the Task Crafting subscale from the Job Crafting Questionnaire (Slemp, G. R., & Vella-Brodrick, D. A. [2013]. The Job Crafting Questionnaire: A new scale to measure the extent to which employees engage in job crafting. International Journal of wellbeing, 3(2)). A Swedish version is used. This subscale includes 7 items scored on a 5-point Likert scale (1 = Hardly ever, 5 = Very often). |
A month after completed intervention
|
Recovery experience immediate effect
Time Frame: Immediately post-intervention
|
Questions regarding the degree to which participants engage in behavioral recovery strategies, for instance spending time on a hobby or letting go of work-related thoughts.
This is measured using the Recovery Experience Questionnaire (REQ) (Sonnentag, S., & Fritz, C. [2007].
The Recovery Experience Questionnaire: development and validation of a measure for assessing recuperation and unwinding from work.
Journal of occupational health psychology, 12(3), 204).
The study uses two subscales - psychological detachment and relaxation, resulting in 8 items.
Items are scored on a 5-point Likert scale (1 = Not at all, 5 = Very much).
A Swedish version is used.
|
Immediately post-intervention
|
Recovery experience delayed effect
Time Frame: A month after completed intervention
|
Questions regarding the degree to which participants engage in behavioral recovery strategies, for instance spending time on a hobby or letting go of work-related thoughts.
This is measured using the Recovery Experience Questionnaire (REQ) (Sonnentag, S., & Fritz, C. [2007].
The Recovery Experience Questionnaire: development and validation of a measure for assessing recuperation and unwinding from work.
Journal of occupational health psychology, 12(3), 204).
The study uses two subscales - psychological detachment and relaxation, resulting in 8 items.
Items are scored on a 5-point Likert scale (1 = Not at all, 5 = Very much).
A Swedish version is used.
|
A month after completed intervention
|
Social support immediate effect
Time Frame: Immediately post-intervention
|
Questions regarding the degree to which participants engage with their social context for emotional support.
We use the Relation Crafting subscale from the Job Crafting Questionnaire: (Slemp, G. R., & Vella-Brodrick, D. A. (2013).
The Job Crafting Questionnaire: A new scale to measure the extent to which employees engage in job crafting.
International Journal of wellbeing, 3(2)).
The subscale includes 7 items scored on a 5-point Likert scale (1 = Hardly ever, 5 = Very often).
|
Immediately post-intervention
|
Social support delayed effect
Time Frame: A month after completed intervention
|
Questions regarding the degree to which participants engage with their social context for emotional support.
We use the Relation Crafting subscale from the Job Crafting Questionnaire: (Slemp, G. R., & Vella-Brodrick, D. A. (2013).
The Job Crafting Questionnaire: A new scale to measure the extent to which employees engage in job crafting.
International Journal of wellbeing, 3(2)).
The subscale includes 7 items scored on a 5-point Likert scale (1 = Hardly ever, 5 = Very often).
|
A month after completed intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dropout rate
Time Frame: Immediately post-intervention
|
Investigates the dropout rate during the four weeks of the intervention.
|
Immediately post-intervention
|
Protocol adherence
Time Frame: Immediately post-intervention
|
Investigates how often (i.e.
how many days) participants engage with the intervention.
|
Immediately post-intervention
|
Participant engagement
Time Frame: Immediately post-intervention
|
Investigates to what extent participants engage with the intervention, as measured with the meta-data available through the mobile application e.g.
time spent engaging with the content of the mobile application.
|
Immediately post-intervention
|
Usability: User experience, relevance, and content appreciation
Time Frame: Immediately post-intervention
|
Investigates basic usability questions in a post-intervention survey. Includes questions about the experience users had of using the mobile application, if they found the intervention relevant, and if they found the content useful. Survey questions focus on specific aspects of the mobile application used in this study. The survey includes 10 items scored on a 4-point Likert scale. High scores refer to higher usability, relevance and content appreciation. |
Immediately post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aleksandra Sjöström-Bujacz, PhD, Karolinska Institutet
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2092/2020
- 2020-05800 (OTHER: The Swedish Research Council (VR))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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