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临床试验/NCT07592078
NCT07592078已完成不适用

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

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Feasibility - Compliance with Stressometer Assessments

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Stressometer Mobile Application (Behavioral)

结局指标

主要结局

Feasibility - Compliance with Stressometer Assessments

时间窗: 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

时间窗: 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)

时间窗: 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).

次要结局

  • 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))

研究者

发起方
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
申办方类型
Other
责任方
Sponsor

研究点 (1)

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