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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
20
A self-guided, gamified mindfulness intervention delivered through a web application. The intervention consisted of five guided mindfulness sessions, each lasting approximately three minutes, to be completed over a 10-day period. The sessions were designed to promote present-moment awareness and support stress management. The application incorporated gamification features to encourage engagement and progression through the intervention.
A written informational article related to mindfulness and stress management. Participants assigned to the active comparator arm were asked to read the article during the 10-day study period. They did not receive access to the gamified digital mindfulness application.
Universidad Peruana Cayetano Heredia
Lima, Lima Province, Peru
Change in Perceived Stress Scale Score
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.
Time frame: Baseline and Day 10
Usability of the Gamified Digital Mindfulness Application
Usability of the web-based intervention among participants assigned to the experimental arm, measured at the end of the intervention period using the mHealth App Usability Questionnaire (MAUQ). Items are rated on a 7-point Likert scale. Mean overall and domain scores are calculated, with higher scores indicating better perceived usability. Domains assessed include ease of use and satisfaction, system information arrangement, and usefulness. There are 21 items in the scale, with a minimum total score of 21 and maximum score of 147.
Time frame: Day 10
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