Healthy Adult ParticipantsEVASTRESS HSNCT07592078
EVASTRESS Healthy Subjects
An observational study of Healthy Adult Participants, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Stressometer Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2025to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
Read the detailed description
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.
- Conditions
- Healthy Adult Participants
- Being tested
- Stressometer Mobile Application
- Keywords
- Perceived Stress, Stress Monitoring, Mobile Health, Stressometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stressometer Mobile ApplicationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Stressometer Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: Baseline and Day 14
Secondary outcomes (3)
Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y)
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.
Measured: Baseline and Day 14
Well-being score measured by the WHO-5 Well-Being Index
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.
Measured: Baseline and Day 14
Daily sleep quality score measured by Visual Analog Scale (VAS)
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.
Measured: 14 days (daily repeated measures)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start25 Apr 2025
- Primary completion16 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Sponsor type
- University, hospital or other
- Collaborators
- Université d'Évry
- Responsible party
- Sponsor
- Investigators
- Sylvia FRANC, MD, PhD, Principal investigator, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592078
- Sponsor's protocol ID
- 2025-A00548-41
- Acronym
- EVASTRESS HS
- Status last verified
- May 2026
- First submitted
- 14 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will not be might not be shared publicly due to privacy and data protection concerns.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07592078
- Acronym / sponsor ID
- EVASTRESS HS / 2025-A00548-41
- Conditions
- Healthy Adult Participants
- Keywords
- Perceived Stress, Stress Monitoring, Mobile Health, Stressometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Collaborators
- Université d'Évry
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Behavioral: Stressometer Mobile ApplicationHealthy 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stressometer Mobile ApplicationA 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 | Behavioural | Healthy Volunteers |
Primary outcome
Feasibility - Compliance with Stressometer Assessments
Time frame: 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).
Usability and User Experience
Time frame: 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.
Perceived stress scores measured by Stressometer and Perceived Stress Scale (PSS-14)
Time frame: 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).
3 secondary outcomes
Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y)
Time frame: Baseline and Day 14
Well-being score measured by the WHO-5 Well-Being Index
Time frame: Baseline and Day 14
Daily sleep quality score measured by Visual Analog Scale (VAS)
Time frame: 14 days (daily repeated measures)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided. IPD will not be might not be shared publicly due to privacy and data protection concerns.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia FRANC, MD, PhD principal investigator
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adult Participants, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Compliance with Stressometer Assessments (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.