Kelaa Mental Resilience App for Employees

NCT05924542 | Completed

• 1 other identifier: H2020-725832
• Study Type: interventional
• Target: 678
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Presenteeism; Absenteeism

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  at baseline (T1, week 0), mid-intervention (T2, week 2), end-intervention (T3, week 4), and two-week follow-up (T4, week 6).

Study Arms (2)

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).

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.

Interventions

Kelaa Mental Resilience App BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wuerzburg: lead
• SOMA Analytics UK: collaborator

Study Sites (1)

Soma Analytics UK

London, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 31866915 RESULT

• de 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.

  PMID: 37399056 DERIVED

Study Officials

• Christopher P Lorenz

  SOMA Analytics UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Researcher

Model Details: RCT with intervention and wait-list control group.

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 29, 2023
• Study Start: January 15, 2018
• Primary Completion: September 24, 2018
• Study Completion: September 24, 2018
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: The raw data may be made available at any point in time until 10 years after this research has been completed (i.e. until September 2028).
• Access Criteria: The raw data may be made available by the PI or lead researcher upon request, without undue reservation, to any qualified researcher.

Locations

GB (1)