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Bandol, 83150, France
Location status: Recruiting
NCT Number: NCT07433764
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bandol, 83150, France
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
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Industry
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
Acronym: WB6Dim-TRT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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