Kelaa Mental Resilience App for Employees

Stress Clinical Trial

Official title: The Smart Way to Beat Stress at Work - SOMA

Status Completed

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Absenteeism
• Presenteeism
• Stress

• NCT number: NCT05924542
• Study type: Interventional
• Source: University of Wuerzburg
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Completion date: September 24, 2018