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EVASTRESS Healthy Subjects (EVASTRESS HS)

13 maggio 2026 aggiornato da: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Feasibility Study to Investigate the Use of a Stress Meter 'Stressometer' Four Times a Day for Two Weeks to Measure Perceived Stress and Correlation of the Results With Measures of Validated Psychometric Questionnaires Related to Anxiety, Stress, and Depression in a Population of Healthy University Students

The goal of this observational study is to learn the feasibility of using a mobile application "Stressometer" to measure perceived stresss levels several times per day. The study will also explore if the stress scores collected with the application are similar to results from standard questionnaires about stress, anxiety, and depression.

The main questions it aims to answer are:

Can participants regularly report their stress four times a day for two weeks using the mobile application? Do participants find the application easy and acceptable to use? Are stress scores collected with the application related to scores from validated questionnaires on stress, anxiety, and depression?

Participants will:

Use the Stressometer mobile application to rate their stress level four times per day for 14 days Complete questionnaires about stress, anxiety, and depression at the beginning and/or end of the study Provide feedback on how easy and acceptable the application is to use

Researchers will use this information to understand whether this mobile tool is practical for measuring stress in daily life and whether it provides results similar to established psychological questionnaires.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Stress is a dynamic psychological state that can fluctuate throughout the day. Traditional methods for assessing stress, such as validated psychometric questionnaires, typically rely on retrospective reporting and may not fully capture short-term variations in perceived stress. Mobile health technologies approaches offer the opportunity to measure stress in real time and in naturalistic settings.

The Stressometer is a mobile application developed to allow rapid and repeated self-assessment of perceived stress using a simple numeric scale. However, the feasibility of using such a tool multiple times per day over a sustained period, as well as its relationship with established psychometric measures, remains to be established.

In a preliminary study, feasibility was investigated in a sample of 30 healthy student participants. Participants were instructed to report their perceived stress level using the Stressometer application four times per day (morning, midday, evening, and bedtime) over a 14-day period. Compliance with repeated assessments and participant engagement were monitored throughout the study.

In addition to mobile-based stress assessments, participants completed validated psychometric questionnaires evaluating stress, anxiety, depression, and well-being. Mean stress scores obtained via the Stressometer were subsequently analyzed and correlated with questionnaire-derived scores to assess convergent validity.

This study aims to further evaluate the feasibility of intensive longitudinal stress measurement using a mobile application, focusing on compliance rates and user acceptability. It also seeks to examine the relationship between real-time stress ratings and standardized psychological measures, in order to determine whether the Stressometer provides a reliable and ecologically valid assessment of perceived stress in daily life.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

30

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • Évry, Francia, 91058
        • CERITD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

The study will include healthy adult university students aged 18 years or older. Participants will be recruited from a university setting and must be able to use a compatible smartphone to complete repeated stress assessments via a mobile application over a two-week period. Individuals with medical or psychiatric conditions that could interfere with participation or data interpretation will be excluded.

Descrizione

Inclusion Criteria:

Participants must meet all of the following criteria to be eligible for inclusion in the study:

  • Enrolled as a university student
  • Aged 18 years or older
  • Possession of a smartphone compatible with the Stressometer application
  • No self-reported psychiatric condition that could interfere with study participation or data collection
  • Willingness to participate and provision of non-opposition to participate in the study

Exclusion Criteria:

Participants will be excluded if they meet any of the following criteria:

  • Presence of any acute or chronic medical condition that may interfere with study participation or data interpretation, including but not limited to psychiatric disorders, severe sleep disorders, endocrine or metabolic diseases, cardiovascular diseases, neurological conditions, acute or chronic pain, respiratory diseases, substance use disorder or addiction, or current pregnancy or postpartum period
  • Individuals deprived of liberty by judicial or administrative decision
  • Individuals currently receiving compulsory psychiatric care
  • Refusal to participate in the study

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Healthy Volunteers
Healthy adult participants (students) who will use a mobile application (Stressometer) to report their perceived stress level four times per day over a 14-day period. Participants will also complete validated psychometric questionnaires
Comportamentale: Stressometer Mobile Application
A mobile application used to collect self-reported perceived stress levels multiple times per day using a numeric rating scale. Participants are prompted to complete four daily assessments (morning, midday, evening, and bedtime) over a 14-day period

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility - Compliance with Stressometer Assessments
Lasso di tempo: 14 days
Feasibility will be assessed by measuring participant compliance with repeated ecological momentary assessments using the Stressometer mobile application over a 14-day period. Compliance is defined as the proportion of completed stress assessments out of the total expected entries (56 assessments per participant). Participants will be considered highly compliant if they complete at least 80% of expected entries (≥45/56 assessments).
14 days
Usability and User Experience
Lasso di tempo: At end of study (Day 14)
User experience will be evaluated using a post-study questionnaire assessing perceived time burden, ease of use, technical issues, and effectiveness of reminders. Outcomes include descriptive statistics (frequency, percentage) and average completion time per assessment. This measure evaluates engagement, usability, technical reliability, and acceptability of the application.
At end of study (Day 14)
Perceived stress scores measured by Stressometer and Perceived Stress Scale (PSS-14)
Lasso di tempo: Baseline and Day 14
Perceived stress will be assessed using the Stressometer mobile application (mean score over 14 days) and the Perceived Stress Scale (PSS-14). The association between these measures will be evaluated using correlation coefficients (Pearson or Spearman).
Baseline and Day 14

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y)
Lasso di tempo: Baseline and Day 14
Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI-Y), including the State Anxiety (STAI-Y1) and Trait Anxiety (STAI-Y2) subscales. Total scores for each subscale will be collected and analyzed descriptively in relation to perceived stress levels measured by the Stressometer application.
Baseline and Day 14
Well-being score measured by the WHO-5 Well-Being Index
Lasso di tempo: Baseline and Day 14
Subjective well-being will be assessed using the World Health Organization 5-item Well-Being Index (WHO-5). Total questionnaire scores will be collected and analyzed descriptively in relation to perceived stress levels measured by the Stressometer application.
Baseline and Day 14
Daily sleep quality score measured by Visual Analog Scale (VAS)
Lasso di tempo: 14 days (daily repeated measures)

Subjective sleep quality will be assessed each morning using a Visual Analog Scale (VAS), where participants rate the quality of their sleep during the previous night on a continuous scale (e.g., 0-10). Daily sleep quality scores will be recorded over the 14-day study period.

The correlation between daily perceived stress scores and sleep quality scores will be assessed using Pearson or Spearman correlation coefficients.
14 days (daily repeated measures)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Collaboratori

Université d'Évry

Investigatori

  • Investigatore principale: Sylvia FRANC, MD, PhD, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 aprile 2025

Completamento primario (Effettivo)

16 marzo 2026

Completamento dello studio (Effettivo)

30 marzo 2026

Date di iscrizione allo studio

Primo inviato

14 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 maggio 2026

Primo Inserito (Effettivo)

18 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 2025-A00548-41

Piano per i dati dei singoli partecipanti (IPD)

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INDECISO

Descrizione del piano IPD

IPD will not be might not be shared publicly due to privacy and data protection concerns.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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