Mindfulness Meets Gamification: A Pilot Randomized Controlled Trial of a Web-Based Stress Reduction Intervention for University Students
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Perceived Stress Scale Score
研究概览
简要总结
The goal of this clinical trial is to learn whether a brief gamified digital mindfulness intervention can reduce perceived stress among university students. The main questions it aims to answer are:
- Does the digital mindfulness intervention reduce perceived stress, measured using the 10-item Perceived Stress Scale (PSS-10)?
- Is the intervention usable and acceptable to university students?
Researchers will compare participants assigned to the gamified digital mindfulness intervention with participants assigned to a control condition consisting of reading an informational article to determine whether the intervention produces a greater reduction in perceived stress.
Participants will:
- Complete a baseline assessment of perceived stress.
- Be randomly assigned to the intervention or control group.
- In the intervention group, complete five gamified mindfulness sessions of approximately three minutes each through a web application over a 10-day period.
- In the control group, read an informational article.
- Complete a follow-up assessment of perceived stress after the intervention period.
- If assigned to the intervention group, complete a questionnaire assessing the application's usability and acceptability.
详细描述
This pilot randomized clinical trial evaluated a brief, gamified, web-based mindfulness intervention designed to support stress management among university students. The intervention was developed using a user-centered design approach that incorporated feedback from potential users to adapt its content, language, interface, navigation, and gamification elements to the preferences and context of Peruvian university students. The study was intended to generate preliminary evidence regarding the intervention's feasibility, usability, acceptability, and potential effect on perceived stress.
After completing the baseline assessment, participants were randomly allocated to either the digital mindfulness intervention group or an active comparison group. Participants assigned to the intervention received access to a web application containing five brief mindfulness sessions, each lasting approximately three minutes. The sessions included guided activities intended to promote present-moment awareness, relaxation, and stress management. Gamification features were incorporated to encourage participation and progression through the intervention. Participants were asked to complete the sessions during a 10-day period using an internet-connected device.
Participants assigned to the comparison group received an informational article to read during the same study period. This condition was used to distinguish the potential effects of actively engaging with the digital mindfulness intervention from those of receiving general written information.
At the end of the intervention period, participants completed a follow-up assessment. Changes in perceived stress were compared between the intervention and comparison groups. Participants who used the application also evaluated its usability and acceptability. The study additionally documented participation, completion, and attrition to identify potential challenges affecting engagement with brief self-guided digital mental health interventions.
Because this was a pilot study, its purpose was not to establish definitive clinical effectiveness. Rather, it was designed to estimate preliminary intervention effects, assess the suitability of the study procedures and digital platform, and identify methodological and implementation considerations for a future adequately powered trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older
- •Currently enrolled as a university student.
- •Able to read and understand Spanish.
- •Access to an internet-connected computer, tablet, or smartphone.
- •Able to use the web-based intervention during the 10-day study period.
- •Willing and able to provide informed consent.
排除标准
- •Unable to provide informed consent.
- •Unable to access or use the web-based application.
- •Concurrent participation in another intervention study addressing stress or mindfulness.
- •Previous participation in the development or usability testing of the study application.
研究组 & 干预措施
Experimental arm: Gamified Digital Mindfulness Intervention
Participants assigned to this arm received access to a gamified web-based mindfulness application. They were asked to complete five guided mindfulness sessions, each lasting approximately three minutes, over a 10-day period. The application incorporated gamification features to support engagement and progression through the sessions. Participants completed perceived-stress assessments before and after the intervention period and evaluated the application's usability and acceptability after using it.
干预措施: Gamified Digital Mindfulness Intervention (Behavioral)
Active Comparator Arm: Informational Article Control
Participants assigned to this arm received an informational article related to mindfulness and stress management, which they were asked to read during the 10-day study period. They did not receive access to the gamified mindfulness application. Participants completed the same perceived-stress assessments at baseline and at the end of the study period.
干预措施: Informational Article (Behavioral)
结局指标
主要结局
Change in Perceived Stress Scale Score
时间窗: Baseline and Day 10
Change in perceived stress from baseline to the end of the 10-day study period, measured using the 10-item Perceived Stress Scale (PSS-10). Each item is scored from 0 to 4, producing a total score ranging from 0 to 40. Higher scores indicate greater perceived stress. The outcome will be calculated as the follow-up score minus the baseline score and compared between the gamified digital mindfulness intervention and active comparator groups.
次要结局
- Usability of the Gamified Digital Mindfulness Application(Day 10)
研究者
Andrea Estefanía Montero Quiñe
Principal Investigator
Universidad Peruana Cayetano Heredia