Clinical trial NCT05924542: Kelaa Mental Resilience App for Employees
Official title: The Smart Way to Beat Stress at Work - SOMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Presenteeism
Absenteeism
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
Collaborators: name: SOMA Analytics UK
First posted: 2023-06-29
Enrollment: 678
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT with intervention and wait-list control group.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Younger than 18
* Being unemployed at the time of recruitment

Primary outcomes:
measure: Change in General and Cognitive Stress
timeFrame: 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:
measure: Change in Wellbeing
timeFrame: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
measure: Change in Resilience
timeFrame: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
measure: Change in Sleeping Troubles
timeFrame: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
measure: Change in Social Community at Work
timeFrame: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
measure: Change in Physical Health Impairment
timeFrame: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
measure: Change in Work productivity and activity impairment
timeFrame: at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Soma Analytics UK
Study officials:
affiliation: SOMA Analytics UK
name: Christopher P Lorenz
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.