NCT07301879

Brief Summary

The Libellules (WB6Dim) study aims to validate a digital self-assessment tool for measuring individual well-being across six dimensions: sleep and recovery, emotional climate, self-esteem, perceived autonomy, energy reservoir, and hyperconnection. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

3 days

First QC Date

November 17, 2025

Last Update Submit

December 22, 2025

Conditions

Keywords

Well-being, Self-assessmentQuality of lifeHealth promotionStress perceptionWorkplace well-being

Outcome Measures

Primary Outcomes (15)

  • Internal Consistency (Cronbach's Alpha) of the WB6Dim Sleep and Recovery dimension

    Evaluation of the internal consistency (Cronbach's alpha) of the Sleep and Recovery well-being dimension assessed by the Libellules / WB6Dim digital questionnaire. Score range: From 0 to 100. Interpretation: The higher the score, the stronger your resources. Higher scores reflect better balance.

    From baseline (T0) to day 14 (T14).

  • Internal Consistency (Cronbach's Alpha) of the WB6Dim Emotional Climate dimension

    Evaluation of the internal consistency (Cronbach's alpha) of the Emotional Climate well-being dimension assessed by the Libellules / WB6Dim digital questionnaire. Score range: From 0 to 100. Interpretation: The higher the score, the stronger your resources. Higher scores reflect better balance.

    From baseline (T0) to day 14 (T14).

  • Internal Consistency (Cronbach's Alpha) of the WB6Dim Energy Reservoir dimension

    Evaluation of the internal consistency (Cronbach's alpha) of the Energy Reservoir well-being dimension assessed by the Libellules / WB6Dim digital questionnaire. Score range: From 0 to 100. Interpretation: The higher the score, the stronger your resources. Higher scores reflect better balance.

    From baseline (T0) to day 14 (T14).

  • Internal Consistency (Cronbach's Alpha) of the WB6Dim Perceived Autonomy dimension

    Evaluation of the internal consistency (Cronbach's alpha) of the Perceived Autonomy well-being dimension assessed by the Libellules / WB6Dim digital questionnaire. Score range: From 0 to 100. Interpretation: The higher the score, the stronger your resources. Higher scores reflect better balance.

    From baseline (T0) to day 14 (T14).

  • Internal Consistency (Cronbach's Alpha) of the WB6Dim Self-Esteem dimension

    Evaluation of the internal consistency (Cronbach's alpha) of the Self-Esteem well-being dimension assessed by the Libellules / WB6Dim digital questionnaire. Score range: From 0 to 100. Interpretation: The higher the score, the stronger your resources. Higher scores reflect better balance.

    From baseline (T0) to day 14 (T14).

  • Internal Consistency (Cronbach's Alpha) of the WB6Dim Internal Tension dimension

    Evaluation of the internal consistency (Cronbach's alpha) of the Internal Tension well-being dimension assessed by the Libellules / WB6Dim digital questionnaire. Score range: From 0 to 100. Interpretation: The higher the score, the stronger the tension. Lower scores reflect better balance.

    From baseline (T0) to day 14 (T14).

  • Internal Consistency (Cronbach's Alpha) of the WB6Dim Hyperconnection dimension

    Evaluation of the internal consistency (Cronbach's alpha) of the Hyperconnection well-being dimension assessed by the Libellules / WB6Dim digital questionnaire. Score range: From 0 to 100. Interpretation: The higher the score, the stronger the hyperconnection. Lower scores reflect better balance.

    From baseline (T0) to day 14 (T14).

  • Internal Consistency (Cronbach's Alpha) of the WB6Dim Cognitive Saturation dimension

    Evaluation of the internal consistency (Cronbach's alpha) of the Cognitive Saturation well-being dimension assessed by the Libellules / WB6Dim digital questionnaire. Score range: From 0 to 100. Interpretation: The higher the score, the stronger the saturation. Lower scores reflect better balance.

    From baseline (T0) to day 14 (T14).

  • Test-Retest Reliability (Intraclass Correlation Coefficient) of the WB6Dim Sleep and Recovery dimension

    Evaluation of the temporal stability of the Sleep and Recovery well-being dimension assessed by the Libellules / WB6Dim digital questionnaire over a 14-day interval. Score range: Intraclass Correlation Coefficient (ICC), from 0 to 1. Interpretation: Higher ICC values indicate greater temporal stability of the score over time.

    Day 0 to Day 14

  • Test-Retest Reliability (Intraclass Correlation Coefficient) of the WB6Dim Self-Esteem dimension

    Evaluation of the temporal stability of the Self-Esteem well-being dimension assessed by the Libellules / WB6Dim digital questionnaire over a 14-day interval. Score range: Intraclass Correlation Coefficient (ICC), from 0 to 1. Interpretation: Higher ICC values indicate greater temporal stability of the score over time.

    Day 0 to Day 14.

  • Test-Retest Reliability (Intraclass Correlation Coefficient) of the WB6Dim Perceived Autonomy dimension

    Evaluation of the temporal stability of the Perceived Autonomy well-being dimension assessed by the Libellules / WB6Dim digital questionnaire over a 14-day interval. Score range: Intraclass Correlation Coefficient (ICC), from 0 to 1. Interpretation: Higher ICC values indicate greater temporal stability of the score over time.

    Day 0 to Day 14.

  • Test-Retest Reliability (Intraclass Correlation Coefficient) of the WB6Dim Energy Reservoir dimension

    Evaluation of the temporal stability of the Energy Reservoir well-being dimension assessed by the Libellules / WB6Dim digital questionnaire over a 14-day interval. Score range: Intraclass Correlation Coefficient (ICC), from 0 to 1. Interpretation: Higher ICC values indicate greater temporal stability of the score over time.

    Day 0 to Day 14.

  • Test-Retest Reliability (Intraclass Correlation Coefficient) of the WB6Dim Internal Tension dimension

    Evaluation of the temporal stability of the Internal Tension well-being dimension assessed by the Libellules / WB6Dim digital questionnaire over a 14-day interval. Score range: Intraclass Correlation Coefficient (ICC), from 0 to 1. Interpretation: Higher ICC values indicate greater temporal stability of the score over time.

    Day 0 to Day 14.

  • Test-Retest Reliability (Intraclass Correlation Coefficient) of the WB6Dim Hyperconnection dimension

    Evaluation of the temporal stability of the Hyperconnection well-being dimension assessed by the Libellules / WB6Dim digital questionnaire over a 14-day interval. Score range: Intraclass Correlation Coefficient (ICC), from 0 to 1. Interpretation: Higher ICC values indicate greater temporal stability of the score over time.

    Day 0 to Day 14.

  • Test-Retest Reliability (Intraclass Correlation Coefficient) of the WB6Dim Cognitive Saturation dimension

    Evaluation of the temporal stability of the Cognitive Saturation well-being dimension assessed by the Libellules / WB6Dim digital questionnaire over a 14-day interval. Score range: Intraclass Correlation Coefficient (ICC), from 0 to 1. Interpretation: Higher ICC values indicate greater temporal stability of the score over time.

    Day 0 to Day 14.

Secondary Outcomes (15)

  • Convergent Validity of the WB6Dim Sleep and Recovery dimension vs Insomnia Severity Index (ISI-7)

    Day 0 and Day 14

  • Convergent Validity of the WB6Dim Sleep and Recovery dimension vs Perceived Stress Scale (PSS-10)

    Day 0 and Day 14.

  • Convergent Validity of the WB6Dim Sleep and Recovery dimension vs WHO-5 Well-Being Index

    Day 0 and Day 14.

  • Convergent Validity of the WB6Dim Self-Esteem dimension vs Rosenberg Self-Esteem Scale (RSES)

    Day 0 and Day 14.

  • Convergent Validity of the WB6Dim Self-Esteem dimension vs WHO-5 Well-Being Index

    Day 0 and Day 14.

  • +10 more secondary outcomes

Study Arms (2)

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult volunteers recruited from the general working population in France, including employees and independent workers participating in a health and well-being prevention program. Participants are not selected based on medical conditions but on their willingness to engage in a digital self-assessment of well-being. The cohort includes both men and women from diverse professional sectors, representing a broad spectrum of stress exposure, lifestyle, and occupational settings.

You may qualify if:

  • Adults aged 18 years or older
  • 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

You may not qualify if:

  • Individuals under 18 years of age
  • Inability to read or understand French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clover Link

Bandol, 83150, France

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Frédérique RETORNAZ, MD, PhD

    European Hospital, Unit of Care and Research in Internal Medicine and Infectious Diseases.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

December 24, 2025

Study Start

October 9, 2025

Primary Completion

October 12, 2025

Study Completion

October 26, 2025

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because all collected data are fully anonymized and aggregated for psychometric and statistical analyses only. No identifiable personal data are stored

Locations