StressNCT05924542
Kelaa Mental Resilience App for Employees
A study testing Kelaa Mental Resilience App in people with Stress and Presenteeism, run by University of Wuerzburg at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Presenteeism, Absenteeism
- What is being tested?
- Kelaa Mental Resilience App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 678 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2018to 24 Sep 2018
- 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
- Older than 18 years old
- Having a mobile phone with internet access
- Accepting informed consent
- Being employed in one of the participating organizations at the time of the recruitment
Who cannot join
- Younger than 18
- Being unemployed at the time of recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Smart Way to Beat Stress at Work - SOMA
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.
Read more
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.
Read the 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. 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
- Stress, Presenteeism, Absenteeism
- Being tested
- Kelaa Mental Resilience App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kelaa Mental Resilience AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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). Receives: Behavioral: Kelaa Mental Resilience App |
| Wait-list Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in General and Cognitive Stress
Self-reported levels of stress were assessed with the two subscales General Stress (four items, e.g., "How often have you been stressed?") and Cognitive Stress (four items, e.g., "How often have you had problems concentrating?") from the Copenhagen Psychosocial Questionnaire - Revised Version (COPSOQ II; Pejtersen et al., 2010).The items were answered on a five-point scale (1 = not at all; 2 = a small part of the time; 3 = part of the time; 4 = a large part of the time; 5 = all the time). Higher values indicate more stress.
Measured: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
Secondary outcomes (6)
Change in Wellbeing
Subjective wellbeing was measured with the Warwick-Edinburgh Mental Wellbeing Scale (Tennant et al., 2007). Seven items (e.g., "I've been feeling relaxed.") were answered on a five-point scale (1 = none of the time; 2 = rarely; 3 = some of the time; 4 = often; 5 = all of the time). Higher values indicate more wellbeing.
Measured: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
Change in Resilience
We assessed resilience with the 13-item Resilience Scale (RS-13; Leppert et al., 2008), a short form of the Resilience Scale (RS-25; Wagnild and Young, 1993). Items (e.g., "I usually take things in stride.") were answered on a seven-point scale (1 = strongly disagree to 7 = strongly agree). Higher values indicate more resilience.
Measured: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
Change in Sleeping Troubles
Participants were asked about sleeping troubles with the subscale Sleeping Troubles from the COPSOQ II (Pejtersen et al., 2010). Four items (e.g., "How often have you slept badly and restlessly?") were answered on a five-point scale (1 = not at all; 2 = a small part of the time; 3 = part of the time; 4 = a large part of the time; 5 = all the time). Higher values indicate more sleeping troubles.
Measured: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
Change in Social Community at Work
Participants indicated their sense of cooperation and social community at work with the subscale Social Community at Work from the COPSOQ II (Pejtersen et al., 2010). Three items (e.g., "Do you feel part of a community at your place of work?") were answered on a five-point scale (1 = not at all; 2 = a small part of the time; 3 = part of the time; 4 = a large part of the time; 5 = all the time). Higher values indicate more sense of social community.
Measured: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
Change in Physical Health Impairment
We assessed participants self-reported physical health levels with the SF-36 Version 2 (Jenkinson et al., 1999). Participants were asked to indicate their agreement to four items (e.g., "Because of your physical health, you were limited in the kind of work or other activities.") on a scale from 1 = none of the time to 5 = all of the time. Higher values indicate worse physical health.
Measured: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
Change in Work productivity and activity impairment
The Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH; Reilly et al., 1993) asked participants about the impact of health problems on their ability to work and perform regular activities over the past week. Three items (i.e., "During the past 7 days, how many hours did you miss from work because of your health problems?" "…, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?" "…, how many hours did you actually work?") were provided with open text fields. Two items asked for a rating on a bipolar 11-point scale (e.g., "…, how much did your health problems affect your productivity while you were working?"; 0 = Health problems had no effect on my work to 10 = Health problems completely prevented me from working).
Measured: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start15 Jan 2018
- Primary completion24 Sep 2018
- Study completion24 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- Model description
- RCT with intervention and wait-list control group.
- Masking
- None (open label)
- Enrolment
- 678 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wuerzburg
- Sponsor type
- University, hospital or other
- Collaborators
- SOMA Analytics UK
- Responsible party
- Principal investigator, Dr. Silvana Weber, University of Wuerzburg
- Investigators
- Christopher P Lorenz, Principal investigator, SOMA Analytics UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924542
- Sponsor's protocol ID
- H2020-725832
- Status last verified
- Jun 2023
- First submitted
- 25 May 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw data may be made available by the PI or lead researcher, without undue reservation, to any qualified researcher.
Publications
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.
PubMed 31866915de 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.
PubMed 37399056
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Smart Way to Beat Stress at Work - SOMA
- ClinicalTrials.gov ID
- NCT05924542
- Acronym / sponsor ID
- H2020-725832
- Conditions
- Stress, Presenteeism, Absenteeism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 678 participants (actual)
- Lead sponsor
- University of WuerzburgUniversity, hospital or other
- Collaborators
- SOMA Analytics UK
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 24 Sep 2018 (actual)
- Study completion
- 24 Sep 2018 (actual)
- First posted
- 29 Jun 2023 (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 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.
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. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT with intervention and wait-list control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Kelaa Mental Resilience AppParticipants 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). |
| Wait-list Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 18 years old
- Having a mobile phone with internet access
- Accepting informed consent
- Being employed in one of the participating organizations at the time of the recruitment
Key exclusion criteria (2 listed)
- Younger than 18
- Being unemployed at the time of recruitment
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 |
|---|---|---|
| Kelaa Mental Resilience AppUsers 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. | Behavioural | Intervention Group |
Primary outcome
Change in General and Cognitive Stress
Time frame: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
Self-reported levels of stress were assessed with the two subscales General Stress (four items, e.g., "How often have you been stressed?") and Cognitive Stress (four items, e.g., "How often have you had problems concentrating?") from the Copenhagen Psychosocial Questionnaire - Revised Version (COPSOQ II; Pejtersen et al., 2010).The items were answered on a five-point scale (1 = not at all; 2 = a small part of the time; 3 = part of the time; 4 = a large part of the time; 5 = all the time). Higher values indicate more stress.
6 secondary outcomes
Change in Wellbeing
Time frame: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
Change in Resilience
Time frame: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
Change in Sleeping Troubles
Time frame: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
Change in Social Community at Work
Time frame: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
Change in Physical Health Impairment
Time frame: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
Change in Work productivity and activity impairment
Time frame: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
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 Jun 2023.
- Results publication: PubMed 31866915Weber 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.
- Derived from this study: PubMed 37399056de 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.
- Individual participant dataSharing planned: Yes. The raw data may be made available by the PI or lead researcher, without undue reservation, to any qualified researcher.
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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.
Christopher P Lorenz principal investigator
SOMA Analytics UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kelaa Mental Resilience App in people with Stress and Presenteeism, run by University of Wuerzburg at 1 site in United Kingdom.
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 4 inclusion and 2 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 Jun 2023. 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 United Kingdom. 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?
Change in General and Cognitive Stress (time frame: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).). 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 NCT05924542, which also lists 2 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 Jun 2023.