StressNCT07813286
Gamified Web-Based Mindfulness for University Student Stress
A study testing Gamified Digital Mindfulness Intervention and Informational Article in people with Stress, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Gamified Digital Mindfulness Intervention and Informational Article
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePeru
- Study dates
- 9 Dec 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness Meets Gamification: A Pilot Randomized Controlled Trial of a Web-Based Stress Reduction Intervention for University Students
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Stress
- Being tested
- Gamified Digital Mindfulness Intervention, Informational Article
- Keywords
- mindfulness, gamification, mHealth, perceived stress, university students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified Digital Mindfulness InterventionBehavioural
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.
Informational ArticleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Informational Article |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 10
Secondary outcomes (1)
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.
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start9 Dec 2024
- Primary completion18 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Estefanía Montero Quiñe, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813286
- Sponsor's protocol ID
- 201794
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Meets Gamification: A Pilot Randomized Controlled Trial of a Web-Based Stress Reduction Intervention for University Students
- ClinicalTrials.gov ID
- NCT07813286
- Acronym / sponsor ID
- 201794
- Conditions
- Stress
- Keywords
- mindfulness, gamification, mHealth, perceived stress, university students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm: Gamified Digital Mindfulness Intervention | Experimental | Behavioral: Gamified Digital Mindfulness InterventionParticipants 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. |
| Active Comparator Arm: Informational Article Control | Active comparator | Behavioral: Informational ArticleParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamified Digital Mindfulness InterventionA 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. | Behavioural | Experimental arm: Gamified Digital Mindfulness Intervention |
| Informational ArticleA 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. | Behavioural | Active Comparator Arm: Informational Article Control |
Primary outcome
Change in Perceived Stress Scale Score
Time frame: 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.
1 secondary outcome
Usability of the Gamified Digital Mindfulness Application
Time frame: Day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified Digital Mindfulness Intervention and Informational Article in people with Stress, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress Scale Score (time frame: Baseline and Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.