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EVASTRESS Healthy Subjects (EVASTRESS HS)

13. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Évry, Frankrig, 91058
        • CERITD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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
Adfærdsmæssigt: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility - Compliance with Stressometer Assessments
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Samarbejdspartnere

Université d'Évry

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. april 2025

Primær færdiggørelse (Faktiske)

16. marts 2026

Studieafslutning (Faktiske)

30. marts 2026

Datoer for studieregistrering

Først indsendt

14. april 2026

Først indsendt, der opfyldte QC-kriterier

13. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2025-A00548-41

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

IPD-planbeskrivelse

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

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Kliniske forsøg med Sunde voksne deltagere

Kliniske forsøg med Stressometer Mobile Application

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Betingelser

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