Kelaa Mental Resilience App for Employees
Condition: Stress; Presenteeism; Absenteeism
Study type: Interventional

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.
    

Intervention name(s): Kelaa Mental Resilience App
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT with intervention and wait-list control group.
Masking: None (Open Label)
Primary purpose: Prevention