Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924542
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2023-05-25
Brief Title:
Kelaa Mental Resilience App for Employees
Sponsor:
University of Wuerzburg
Organization:
University of Wuerzburg
Study Overview
Official Title:
The Smart Way to Beat Stress at Work - SOMA
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized control trial is to detect and prevent work-related psychological stress among European workers early on aiming to mitigate its adverse health consequences including burnout and depression Soma Analytics has developed a smartphone-based system that comprises a diagnostic module utilizing smartphone sensors to collect and analyze stress biomarkers and an interventional module to reduce stress levels The main questions this study aims to answer are
Hypothesis 1 Compared to the waitlist control after using the app for 4 weeks participants in the app group will report a lower levels of stress cognitive and general b higher levels of wellbeing c higher levels of resilience and d fewer sleeping troubles
Hypothesis 2 The observed effects will be more intense the more the user interacts with the app throughout the duration of the study
Participants employees from six organizations in three European countries will use the app for 4 weeks Their levels of stress well-being resilience and sleeping troubles are assessed at baseline after 2 weeks mid-intervention 4 weeks end of intervention and 6 weeks follow-up
Researchers will compare the intervention group with the waitlist control group to see if levels of stress well-being resilience and sleeping troubles change over time
Hypothesis 1 Compared to the waitlist control after using the app for 4 weeks participants in the app group will report a lower levels of stress cognitive and general b higher levels of wellbeing c higher levels of resilience and d fewer sleeping troubles
Hypothesis 2 The observed effects will be more intense the more the user interacts with the app throughout the duration of the study
Participants employees from six organizations in three European countries will use the app for 4 weeks Their levels of stress well-being resilience and sleeping troubles are assessed at baseline after 2 weeks mid-intervention 4 weeks end of intervention and 6 weeks follow-up
Researchers will compare the intervention group with the waitlist control group to see if levels of stress well-being resilience and sleeping troubles change over time
Detailed Description:
Work-related psycho-social risks and stress have a significant impact on numerous workplaces in Europe leading to adverse health and business outcomes as previous research has shown Prolonged stress have been shown to eventually result in burnout and depression In 2013 the total annual cost of work-related stress and depression in the EU-27 was estimated to be 617 billion This figure encompasses expenses borne by employers due to absenteeism 272 billion reduced productivity 242 billion healthcare costs 63 billion and social welfare expenses 39 billion
The primary objective of the project is to identify and prevent work-related psychological stress that can lead to negative health outcomes like burnout and depression To achieve this Soma Analytics has developed a comprehensive smartphone-based system that promotes mental resilience by continuously monitoring well-known stress biomarkers The solution consists of three modules a diagnostic module that utilizes smartphone sensors to gather and analyse stress biomarkers an interventional module comprising smartphone apps aimed at reducing stress levels and an analytics module that aggregates anonymous data to identify specific human resources issues such as abnormal stress levels in particular departments Somas approach to preventing stress and promoting positive mental health in the workplace includes validated psychological interventions that are tailored to each individual guiding users through a personalized micro-learning journey The extensive database of interventions covers a wide range of topics providing diverse options for users
This large-scale randomized controlled trial RCT involves participants from six organizations across three European countries It is conducted to validate the solutions effectiveness in reducing stress and improving overall well-being In a real-world work environment the investigators examine the effectiveness of Somas solution It was hypothesized that it may reduce stress levels enhance overall well-being boost resilience and reduce sleep difficulties compared to a waitlist control group
The primary objective of the project is to identify and prevent work-related psychological stress that can lead to negative health outcomes like burnout and depression To achieve this Soma Analytics has developed a comprehensive smartphone-based system that promotes mental resilience by continuously monitoring well-known stress biomarkers The solution consists of three modules a diagnostic module that utilizes smartphone sensors to gather and analyse stress biomarkers an interventional module comprising smartphone apps aimed at reducing stress levels and an analytics module that aggregates anonymous data to identify specific human resources issues such as abnormal stress levels in particular departments Somas approach to preventing stress and promoting positive mental health in the workplace includes validated psychological interventions that are tailored to each individual guiding users through a personalized micro-learning journey The extensive database of interventions covers a wide range of topics providing diverse options for users
This large-scale randomized controlled trial RCT involves participants from six organizations across three European countries It is conducted to validate the solutions effectiveness in reducing stress and improving overall well-being In a real-world work environment the investigators examine the effectiveness of Somas solution It was hypothesized that it may reduce stress levels enhance overall well-being boost resilience and reduce sleep difficulties compared to a waitlist control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None