Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
678 participants
INTERVENTIONAL
2018-01-15
2018-09-24
Brief Summary
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* 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
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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. Soma's 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 solution's effectiveness in reducing stress and improving overall well-being. In a real-world work environment, the investigators examine the effectiveness of Soma's 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention Group
Participants had access to the Kelaa Mental Resilience App for 4 weeks. Thus, participants in the intervention group could complete a maximum of 28 sessions and track a maximum of 28 nights. It was completely left to the user to what extent s/he wanted to engage with the app. The app seeks to translate insights from scientific research on psychology, sleep medicine, and neuroscience into an action-based program. It draws on the tenets of clinical, health, positive, cognitive, biological, and social psychology to foster recovery and growth. "Kelaa" aims to reduce stress and increase well-being of the user, specifically in the workplace. Users learn new behaviors and best practices through different means, for example, based on CBT and mindfulness based cognitive therapy. The app is designed to implement lifestyle changes through (1) measuring behavior, cognitions, and emotions (tracking module) and (2) providing psycho-educational content (intervention module).
Kelaa Mental Resilience App
Users can track their stress, wellbeing, and resilience via short in-app questionnaires. The app uses inbuilt sensors in smartphones to measure sleep quality and quantity. Personalized feedback on questionnaire scores and on sleep data are given. Users access structured science-based content on factors contributing to reduced stress and improved well-being. "Kelaa" provides the user with evidence-based interventions grounded in current research, e.g., from sleep science and psychology. Users can choose from a variety of topics, based on their results from the tracking module and personal interest, and then journey through the self-selected goals. Each goal includes six to seven "daily sessions", aiming to increase personal resources by providing information, exercises, and reflection. During each daily session, relevant research and expected benefits are outlined, before users are instructed, e.g., in specific stress management and resilience techniques, to encourage behavior change.
Wait-list Control Group
Participants in the waitlist control group received no intervention and no tracking opportunity for the duration of the trial (6 weeks), yet they had unrestricted access to treatment as usual within their companies. Upon completion of the trial, participants in the waitlist control group received access to the "Kelaa" app.
No interventions assigned to this group
Interventions
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Kelaa Mental Resilience App
Users can track their stress, wellbeing, and resilience via short in-app questionnaires. The app uses inbuilt sensors in smartphones to measure sleep quality and quantity. Personalized feedback on questionnaire scores and on sleep data are given. Users access structured science-based content on factors contributing to reduced stress and improved well-being. "Kelaa" provides the user with evidence-based interventions grounded in current research, e.g., from sleep science and psychology. Users can choose from a variety of topics, based on their results from the tracking module and personal interest, and then journey through the self-selected goals. Each goal includes six to seven "daily sessions", aiming to increase personal resources by providing information, exercises, and reflection. During each daily session, relevant research and expected benefits are outlined, before users are instructed, e.g., in specific stress management and resilience techniques, to encourage behavior change.
Eligibility Criteria
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Inclusion Criteria
* Having a mobile phone with internet access
* Accepting informed consent
* Being employed in one of the participating organizations at the time of the recruitment
Exclusion Criteria
* Being unemployed at the time of recruitment
18 Years
65 Years
ALL
Yes
Sponsors
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SOMA Analytics UK
UNKNOWN
University of Wuerzburg
OTHER
Responsible Party
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Dr. Silvana Weber
Lead Researcher
Principal Investigators
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Christopher P Lorenz
Role: PRINCIPAL_INVESTIGATOR
SOMA Analytics UK
Locations
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Soma Analytics UK
London, , United Kingdom
Countries
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References
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Weber S, Lorenz C, Hemmings N. Improving Stress and Positive Mental Health at Work via an App-Based Intervention: A Large-Scale Multi-Center Randomized Control Trial. Front Psychol. 2019 Dec 6;10:2745. doi: 10.3389/fpsyg.2019.02745. eCollection 2019.
de Miquel C, Moneta MV, Weber S, Lorenz C, Olaya B, Haro JM. The Mediating Role of General and Cognitive Stress on the Effect of an App-Based Intervention on Productivity Measures in Workers: Randomized Controlled Trial. J Med Internet Res. 2023 Jul 3;25:e42317. doi: 10.2196/42317.
Other Identifiers
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H2020-725832
Identifier Type: -
Identifier Source: org_study_id