Evaluating the Effectiveness of an Online Cognitive Behavioral Therapy Program for University Stu… (NCT07246239) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluating the Effectiveness of an Online Cognitive Behavioral Therapy Program for University Students With Depression and/or Anxiety
Spain108 participantsStarted 2025-09-15
Plain-language summary
The goal of this clinical trial is to learn if an Internet-based self-help program called VIVIM can help university students with depression and/or anxiety. The main question investigadors want to answer is:
\* Does the VIVIM program help participants to feel less depressed and/or anxious? The investigators will compare the VIVIM program with the usual psychological support that university counselling services offer to students.
Participants will:
* Be randomly assigned to either use the VIVIM program or receive usual help from university's counselling service.
* Fill out online questionnaires three times: at the beginning, 10 weeks and 6 months after being assigned either the VIVIM program or usual care.
Who can participate
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:
* To be enrolled as an undergraduate or postgraduate at of the participating Spanish universities.
* To report at least moderate symptoms of depression (PHQ\>o= 10) and/or anxiety (GAD-7\>o= 10).
Exclusion Criteria:
* To self-report having been diagnosed with bipolar and/or psychotic disorder.
* To report to be currently receiving psychotherapy/counselling and/or pharmacological treatment for emotional problems.
* To be unable to read, speak or understand Spanish.
* To be at risk of suicide.
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
Anxiety
Timeframe: From enrollment to 6 months after being randomized
2
Depression
Timeframe: From enrollment to 6 months after being randomized