Gamified Web-Based Mindfulness for University Student Stress

NCT07813286 | Completed DMC

• 1 other identifier: 201794
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress

Keywords

mindfulness; gamification; mHealth; perceived stress; university students

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Day 10

Secondary Outcomes (1)

• Usability of the Gamified Digital Mindfulness Application

  Day 10

Study Arms (2)

Experimental arm: Gamified Digital Mindfulness Intervention

EXPERIMENTAL

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.

Behavioral: Gamified Digital Mindfulness Intervention

Active Comparator Arm: Informational Article Control

ACTIVE COMPARATOR

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.

Behavioral: Informational Article

Interventions

Informational Article BEHAVIORAL

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.

Active Comparator Arm: Informational Article Control

Gamified Digital Mindfulness Intervention BEHAVIORAL

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.

Experimental arm: Gamified Digital Mindfulness Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead

Study Sites (1)

Universidad Peruana Cayetano Heredia

Lima, Lima Province, 15102, Peru

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: December 9, 2024
• Primary Completion: December 18, 2024
• Study Completion: January 15, 2025
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

PE (1)