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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Évry、フランス、91058
- CERITD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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
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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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility - Compliance with Stressometer Assessments
時間枠：14 days
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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).
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14 days
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Usability and User Experience
時間枠：At end of study (Day 14)
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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.
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At end of study (Day 14)
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Perceived stress scores measured by Stressometer and Perceived Stress Scale (PSS-14)
時間枠：Baseline and Day 14
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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).
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Baseline and Day 14
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y)
時間枠：Baseline and Day 14
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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.
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Baseline and Day 14
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Well-being score measured by the WHO-5 Well-Being Index
時間枠：Baseline and Day 14
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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.
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Baseline and Day 14
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Daily sleep quality score measured by Visual Analog Scale (VAS)
時間枠：14 days (daily repeated measures)
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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)
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協力者と研究者
捜査官
- 主任研究者：Sylvia FRANC, MD, PhD、Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2025-A00548-41
個々の参加者データ (IPD) の計画
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IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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