Digital Self-Assessment of Well-Being: Validation of the Libellules Tool Against Gold-Standard Psychological Scales
NCT ID: NCT07301879
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
800 participants
OBSERVATIONAL
2025-10-09
2025-10-26
Brief Summary
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This observational study includes approximately 800 adult participants divided into two cohorts: one group completes the self-assessment tool only, while the other group additionally performs a brief video-based relaxation exercise during the 15-day interval between evaluations.
Each participant completes the Libellules questionnaire and a set of validated gold-standard psychometric scales (including PSS-10, ISI-7, CFQ, SAS-SV, and PIUQ-9) at baseline and after 15 days.
The primary objective is to evaluate the convergent validity, internal consistency, and test-retest reliability of the Libellules items compared with established instruments. The study is fully anonymous, non-interventional, and conducted in compliance with data protection regulations (CNIL, GDPR).
Detailed Description
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The tool produces six numerical indicators-sleep and recovery, emotional climate, self-esteem, perceived autonomy, energy reservoir, and hyperconnection-derived from a short set of subjective items. During development, particular attention was given to clarity of wording, reduction of respondent fatigue, and the ability for individuals to understand and monitor their own "profile" over time. The instrument is fully digital and designed to be completed in under ten minutes, making it compatible with routine preventive practices.
The aim of the present study is to characterize the psychometric behavior of these digital indicators when used in real-life conditions. Because the tool is intended for repeated, short-interval use outside clinical contexts, the study examines how the indicators behave when measured twice over a two-week period. A two-cohort structure was employed to observe the natural stability of scores under standard conditions and to compare this with the evolution of scores in participants who voluntarily engaged with a brief relaxation video made available between the two time points. This simple stimulus was not intended as a clinical or therapeutic intervention but allowed exploration of short-term sensitivity while preserving the non-interventional nature of the study.
Data collection procedures were designed to guarantee complete anonymity. The platform was configured not to record IP addresses, names, emails, device identifiers, or free-text responses containing personal data. Only numerical questionnaire responses and non-identifying demographic categories were stored. This approach ensured compliance with GDPR and French CNIL requirements for anonymous observational research and removed the need for medical ethics board review.
The analytical approach focuses on commonly used psychometric properties relevant to short digital instruments. These include descriptive statistics, internal consistency of each dimension, temporal reproducibility between the two assessments, and correlations between the Libellules indicators and established psychometric scales covering conceptually related domains. All analyses were based exclusively on de-identified numerical data collected at baseline and follow-up. The purpose of these analyses is to document the measurement behavior of the six digital indicators and to determine whether their structure is compatible with future use in preventive, occupational, and public health contexts where rapid and repeated assessment is required.
The study does not involve clinical evaluation, diagnosis, treatment allocation, biological sampling, or medical follow-up. It provides foundational data for the future refinement of the WB6Dim instrument and for the development of scalable, user-friendly digital tools aimed at supporting well-being awareness and preventive initiatives at the individual and organizational level.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A - Standard self-assessment
Participants complete the digital self-assessment "Libellules / WB6Dim" at baseline (T0) and after 14 days (T14) without any additional intervention. This group serves as the control for test-retest reliability and internal consistency analyses.
No interventions assigned to this group
Cohort B - Self-assessment + micro-intervention
Participants complete the same digital self-assessment "Libellules / WB6Dim" at baseline (T0) and after 14 days (T14), with a short preventive video intervention (guided breathing exercise). This group is used to explore the tool's sensitivity to change and short-term preventive impact.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Able to read and understand French
* Access to an internet-connected device (computer, tablet, or smartphone)
* Willing to complete the digital self-assessment "Libellules / WB6Dim" at baseline and after 14 days
* Consent to anonymous data collection and analysis for research purposes
Exclusion Criteria
* Inability to read or understand French
18 Years
ALL
Yes
Sponsors
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INDUSTRY
Responsible Party
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Principal Investigators
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Frédérique RETORNAZ, MD, PhD
Role: STUDY_CHAIR
European Hospital, Unit of Care and Research in Internal Medicine and Infectious Diseases.
Locations
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Bandol, , France
Countries
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Other Identifiers
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WB6Dim
Identifier Type: -
Identifier Source: org_study_id