EVASTRESS Healthy Subjects (EVASTRESS HS)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Évry, Francia, 91058
- CERITD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feasibility - Compliance with Stressometer Assessments
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Sylvia FRANC, MD, PhD, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2025-A00548-41
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .