- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433764
Test-Retest Reliability of the WB6Dim Digital Well-Being Tool: A 3-Day Interval Study (WB6Dim-TRT)
Psychometric Validation of Test-Retest Reliability of the WB6Dim Digital Self-Assessment Tool for Well-Being Using a 3-Day Interval Protocol and Contamination Control
This study aims to establish the test-retest reliability of the WB6Dim digital self-assessment tool across its eight well-being dimensions, using a 3-day interval protocol designed to minimize the probability of genuine well-being changes between assessments.
Participants complete the 28-item WB6Dim questionnaire at baseline (T1) and again 3 days later (T2). A single contamination control question at T2 identifies participants who experienced a significant life event during the interval; these pairs are excluded from primary ICC analyses and retained for exploratory analyses.
An optional third assessment at 9 weeks (T3) provides preliminary exploratory data on sensitivity to change following access to a well-being program. T3 is not part of the primary design.
Study Overview
Status
Conditions
Detailed Description
The first validation study of the WB6Dim instrument (NCT07301879) established strong internal consistency and convergent validity across N=295 participants. Test-retest reliability was assessed over a 14-day interval on N=92 usable pairs, yielding preliminary ICC estimates ranging from .49 to .77. However, the 14-day interval is methodologically suboptimal for a dynamic monitoring tool: real-life events occurring during two weeks cannot be distinguished from instrument instability, and confidence intervals were wide due to the limited number of pairs.
The present study addresses these limitations through three improvements. First, the interval is reduced to 3 days, substantially reducing contamination risk while avoiding memory-based response bias. Second, a contamination control question is administered at T2 to identify and exclude pairs where a significant life event occurred. Third, the target of N=220 usable pairs produces 95% confidence intervals with maximum width of .20 across all dimensions, meeting the precision threshold for definitive psychometric publication.
Only the 28 WB6Dim items are administered, with no additional gold-standard scales, reducing response burden to approximately 3 minutes per session. Participant matching is performed via email address.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: quentin ALITTA
- Phone Number: +33686505361
- Email: quentin.alitta@gmail.com
Study Locations
-
-
-
Bandol, France, 83150
- Recruiting
- Clover Link
-
Contact:
- ALITTA quentin
- Phone Number: +33686505361
- Email: quentin.alitta@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 years or older
- Able to read and understand French
- Access to an internet-connected device
- Willing to complete the WB6Dim questionnaire at T1 and T2
- Consent to anonymous data collection for research purposes
Exclusion Criteria:
- Under 18 years of age
- Unable to read or understand French
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Cohort C - Test-Retest Reliability
Adult volunteers recruited from a health and well-being newsletter subscriber base.
Participants complete the 28-item WB6Dim digital self-assessment at baseline (T1) and again 3 days later (T2).
A contamination control question at T2 identifies participants who experienced a significant life event during the interval.
An optional third assessment (T3) is completed at 9 weeks by participants who voluntarily accessed a well-being program after T2 completion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Test-Retest Reliability (ICC) of the WB6Dim Internal Tension Dimension
Time Frame: Day 0 to Day 3
|
ICC(1,1) on contamination-free T1/T2 pairs.
Score range: 0 to 1. Higher values indicate greater temporal stability.
|
Day 0 to Day 3
|
|
Test-Retest Reliability (ICC) of the WB6Dim Sleep and Recovery Dimension
Time Frame: Day 0 to Day 3
|
ICC(1,1) on contamination-free T1/T2 pairs.
Score range: 0 to 1. Higher values indicate greater temporal stability.
|
Day 0 to Day 3
|
|
Test-Retest Reliability (ICC) of the WB6Dim Energy Reservoir Dimension
Time Frame: Day 0 to Day 3
|
ICC(1,1) on contamination-free T1/T2 pairs.
Score range: 0 to 1. Higher values indicate greater temporal stability.
|
Day 0 to Day 3
|
|
Test-Retest Reliability (ICC) of the WB6Dim Self-Esteem Dimension
Time Frame: Day 0 to Day 3
|
ICC(1,1) on contamination-free T1/T2 pairs.
Score range: 0 to 1. Higher values indicate greater temporal stability.
|
Day 0 to Day 3
|
|
Test-Retest Reliability (ICC) of the WB6Dim Emotional Climate Dimension
Time Frame: Day 0 to Day 3
|
ICC(1,1) on contamination-free T1/T2 pairs.
Score range: 0 to 1. Higher values indicate greater temporal stability.
|
Day 0 to Day 3
|
|
Test-Retest Reliability (ICC) of the WB6Dim Cognitive Saturation Dimension
Time Frame: Day 0 to Day 3
|
ICC(1,1) on contamination-free T1/T2 pairs.
Score range: 0 to 1. Higher values indicate greater temporal stability.
|
Day 0 to Day 3
|
|
Test-Retest Reliability (ICC) of the WB6Dim Hyperconnection Dimension
Time Frame: Day 0 to Day 3
|
ICC(1,1) on contamination-free T1/T2 pairs.
Score range: 0 to 1.Higher values indicate greater temporal stability.
|
Day 0 to Day 3
|
|
Test-Retest Reliability (ICC) of the WB6Dim Perceived Autonomy Dimension
Time Frame: Day 0 to Day 3
|
ICC(1,1) on contamination-free T1/T2 pairs.
Score range: 0 to 1. Higher values indicate greater temporal stability.
|
Day 0 to Day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Contamination Rate at T2
Time Frame: Day 3
|
Proportion of T1/T2 pairs excluded due to a significant life event reported at T2 contamination control question.
Reported as percentage.
|
Day 3
|
|
ICC Comparison Between Contamination-Free and Contaminated Pairs
Time Frame: Day 0 to Day 3
|
Exploratory comparison of ICC(1,1) estimates across all 8 WB6Dim dimensions between contamination-free and contaminated pairs, to assess direction and magnitude of contamination effects.
|
Day 0 to Day 3
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exploratory Sensitivity to Change - Sleep and Recovery
Time Frame: Day 0 to Week 9
|
Pre-post change score (T1 to T3) and Cohen's d for the Sleep and Recovery dimension, among participants who completed the 9-week follow-up.
Reported descriptively if N≥30.
|
Day 0 to Week 9
|
|
Exploratory Sensitivity to Change - Internal Tension
Time Frame: Day 0 to Week 9
|
Pre-post change score (T1 to T3) and Cohen's d for the Internal Tension dimension, among participants who completed the 9-week follow-up.
Reported descriptively if N≥30.
|
Day 0 to Week 9
|
|
Exploratory Sensitivity to Change - Energy Reservoir
Time Frame: Day 0 to Week 9
|
Pre-post change score (T1 to T3) and Cohen's d for the Energy Reservoir dimension, among participants who completed the 9-week follow-up.
Reported descriptively if N≥30.
|
Day 0 to Week 9
|
|
Exploratory Sensitivity to Change - Self-Esteem
Time Frame: Day 0 to Week 9
|
Pre-post change score (T1 to T3) and Cohen's d for the Self-Esteem dimension, among participants who completed the 9-week follow-up.
Reported descriptively if N≥30.
|
Day 0 to Week 9
|
|
Exploratory Sensitivity to Change - Emotional Climate
Time Frame: Day 0 to Week 9
|
Pre-post change score (T1 to T3) and Cohen's d for the Emotional Climate dimension, among participants who completed the 9-week follow-up.
Reported descriptively if N≥30.
|
Day 0 to Week 9
|
|
Exploratory Sensitivity to Change - Cognitive Saturation
Time Frame: Day 0 to Week 9
|
Pre-post change score (T1 to T3) and Cohen's d for the Cognitive Saturation dimension, among participants who completed the 9-week follow-up.
Reported descriptively if N≥30.
|
Day 0 to Week 9
|
|
Exploratory Sensitivity to Change - Hyperconnection
Time Frame: Day 0 to Week 9
|
Pre-post change score (T1 to T3) and Cohen's d for the Hyperconnection dimension, among participants who completed the 9-week follow-up.
Reported descriptively if N≥30.
|
Day 0 to Week 9
|
|
Exploratory Sensitivity to Change - Perceived Autonomy
Time Frame: Day 0 to Week 9
|
Pre-post change score (T1 to T3) and Cohen's d for the Perceived Autonomy dimension, among participants who completed the 9-week follow-up.
Reported descriptively if N≥30.
|
Day 0 to Week 9
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Frédérique MD, PhD RETORNAZ, MD, PhD, European Hospital, Unit of Care and Research in Internal Medicine and Infectious Diseases.
Publications and helpful links
General Publications
- Alitta Q. Validation Study of the WB6Dim Digital Self-Assessment Tool for Well-Being Using Gold-Standard Psychometric Scales. ClinicalTrials.gov NCT07301879. First posted 2025-12-24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WB6Dim-C-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psychological Well Being
-
Samuel Lunenfeld Research Institute, Mount Sinai...Completed
-
Samuel Lunenfeld Research Institute, Mount Sinai...Completed
-
Aydin Adnan Menderes UniversityCompleted
-
Clover LinkCompletedPsychological Well BeingFrance
-
University of Wisconsin, MadisonTempleton World Charity FoundationRecruiting
-
University of RochesterCenters for Disease Control and PreventionActive, not recruitingWell-Being, PsychologicalUnited States
-
Ege UniversityCompletedPsychological Resilience | Psychological Well-beingTurkey (Türkiye)
-
Penn State UniversityNot yet recruiting
-
University of BucharestRecruitingSelf-Compassion | Resilience,Psychological | Well-Being, PsychologicalRomania
-
Izmir Democracy UniversityCompletedPsychological Resilience | Laughter Yoga | Psychological Well BeingTurkey (Türkiye)