Mindfulness in University Students. ATENEU Program (NCT05929430) | Clinical Trial Compass
RecruitingNot Applicable
Mindfulness in University Students. ATENEU Program
Spain174 participantsStarted 2023-11-02
Plain-language summary
The study aims to examine the effects of a mindfulness-based intervention and a mindfulness-based intervention with virtual reality on occupational balance and on the reduction of psychological distress in university students (i.e. stress, anxiety and depression). The specific objectives will be to examine the effects of the intervention on other variables related to mental health, psychological functioning and occupations, and their maintenance at three months.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* being 18 years old or older
* being a degree, master or doctorate student at Miguel Hernández University
* speaking fluent Spanish
* signing the informed consent form
* having attended at least 4 of the 6 sessions (66% of the program)
* internet access from a computer or smartphone to complete the online assessments and formal practices during the program.
Exclusion Criteria:
* miss more than 2 out of 6 sessions (33% of the program)
* present a severe mental disorder in active phase diagnosed by a health professional (e.g., schizophrenia, bipolar disorder)
* are under the influence of alcohol or other drugs during sessions and/or assessments (determined by the program instructor)
* participate in another standardized meditation program during the study period
* withdrew before starting the intervention.
* Additionally, should any participants require psychological or psychiatric treatment during the study, they will be excluded and referred to specialized care services.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Occupational Balance
Timeframe: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
2
Change in Anxiety, Depression and Stress
Timeframe: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
3
Change in Academic stress
Timeframe: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
4
Change in Burnout
Timeframe: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).