Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

EVASTRESS Healthy Subjects (EVASTRESS HS)

13. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

30

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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
Verhalten: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility - Compliance with Stressometer Assessments
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

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

Mitarbeiter

Université d'Évry

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

25. April 2025

Primärer Abschluss (Tatsächlich)

16. März 2026

Studienabschluss (Tatsächlich)

30. März 2026

Studienanmeldedaten

Zuerst eingereicht

14. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Mai 2026

Zuerst gepostet (Tatsächlich)

18. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 2025-A00548-41

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Gesunde erwachsene Teilnehmer

Klinische Studien zur Stressometer Mobile Application

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Bosnia & Herzegovina

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren