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临床试验/NCT07301879
NCT07301879已完成不适用

Validation Study of the WB6Dim (Libellules) Digital Self-Assessment Tool for Well-Being Using Gold-Standard Psychometric Scales

Clover Link1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2025年10月9日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
800
试验地点
1
主要终点
Internal Consistency (Cronbach's Alpha) of the WB6Dim Sleep and Recovery dimension

研究概览

简要总结

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).

详细描述

Digital self-assessment tools are increasingly used in preventive health, workplace well-being programs, and population-level monitoring. However, most validated questionnaires currently available were designed for clinical or academic settings and rely on long item batteries that are difficult to deploy repeatedly in everyday contexts. The WB6Dim (Libellules) instrument was created to address this limitation by providing a brief, intuitive, and multidimensional representation of individual well-being suitable for large-scale, low-burden use.

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: From baseline (T0) to day 14 (T14).

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.

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

时间窗: From baseline (T0) to day 14 (T14).

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.

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

时间窗: From baseline (T0) to day 14 (T14).

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.

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

时间窗: From baseline (T0) to day 14 (T14).

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.

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

时间窗: From baseline (T0) to day 14 (T14).

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.

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

时间窗: From baseline (T0) to day 14 (T14).

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.

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

时间窗: From baseline (T0) to day 14 (T14).

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.

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

时间窗: From baseline (T0) to day 14 (T14).

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.

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

时间窗: Day 0 to Day 14

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.

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

时间窗: Day 0 to Day 14.

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.

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

时间窗: Day 0 to Day 14.

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.

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

时间窗: Day 0 to Day 14.

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.

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

时间窗: Day 0 to Day 14.

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.

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

时间窗: Day 0 to Day 14.

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.

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

时间窗: Day 0 to Day 14.

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.

次要结局

  • 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.)
  • Convergent Validity of the WB6Dim Perceived Autonomy dimension vs Basic Psychological Needs Satisfaction (BPNS)(Day 0 and Day 14.)
  • Convergent Validity of the WB6Dim Energy Reservoir dimension vs WHO-5 Well-Being Index(Day 0 and Day 14.)
  • Convergent Validity of the WB6Dim Energy Reservoir dimension vs Copenhagen Burnout Inventory (CBI)(Day 0 and Day 14)
  • Convergent Validity of the WB6Dim Internal Tension dimension vs Perceived Stress Scale (PSS-10)(Day 0 and Day 14)
  • Convergent Validity of the WB6Dim Internal Tension dimension vs Copenhagen Burnout Inventory (CBI)(Day 0 and Day 14)
  • Convergent Validity of the WB6Dim Internal Tension dimension vs UCLA Loneliness Scale (UCLA-3)(Day 0 and Day 14)
  • Convergent Validity of the WB6Dim Hyperconnection dimension vs Smartphone Addiction Scale - Short Version (SAS-SV)(Day 0 and Day 14)
  • Convergent Validity of the WB6Dim Hyperconnection dimension vs Cognitive Failures Questionnaire (CFQ-9)(Day 0 and Day 14)
  • Convergent Validity of the WB6Dim Cognitive Saturation dimension vs Cognitive Failures Questionnaire (CFQ-9)(Day 0 and Day 14)
  • Convergent Validity of the WB6Dim Cognitive Saturation dimension vs Perceived Stress Scale (PSS-10)(Day 0 and Day 14)

研究者

发起方
Clover Link
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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