EVASTRESS Healthy Subjects

NCT07592078 | Completed

• 1 other identifier: 2025-A00548-41
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adult Participants

Keywords

Perceived Stress; Stress Monitoring; Mobile Health; Stressometer

Outcome Measures

Primary Outcomes (3)

• Feasibility - Compliance with Stressometer Assessments

  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

  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)

  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

Secondary Outcomes (3)

• Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y)

  Baseline and Day 14

• Well-being score measured by the WHO-5 Well-Being Index

  Baseline and Day 14

• Daily sleep quality score measured by Visual Analog Scale (VAS)

  14 days (daily repeated measures)

Study Arms (1)

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

Behavioral: Stressometer Mobile Application

Interventions

Stressometer Mobile Application BEHAVIORAL

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

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète: lead
• Université d'Évry: collaborator

Study Sites (1)

CERITD

Évry, 91058, France

Location

Study Officials

• Sylvia FRANC, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: May 18, 2026
• Study Start: April 25, 2025
• Primary Completion: March 16, 2026
• Study Completion: March 30, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

FR (1)