Kelaa Mental Resilience App for Employees
- Conditions
- StressPresenteeismAbsenteeism
- Interventions
- Behavioral: Kelaa Mental Resilience App
- Registration Number
- NCT05924542
- Lead Sponsor
- University of Wuerzburg
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 678
- 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
- Younger than 18
- Being unemployed at the time of recruitment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Kelaa Mental Resilience App 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).
- Primary Outcome Measures
Name Time Method Change in General and Cognitive Stress 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.
- Secondary Outcome Measures
Name Time Method Change in Sleeping Troubles at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6). 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.
Change in Social Community at Work at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6). 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.
Change in Physical Health Impairment at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6). 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.
Change in Work productivity and activity impairment at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6). 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).
Change in Wellbeing at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6). 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.
Change in Resilience at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6). 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.
Trial Locations
- Locations (1)
Soma Analytics UK
🇬🇧London, United Kingdom