Self-Help Plus for Distress in University Students (NCT06606249) | Clinical Trial Compass
RecruitingNot Applicable
Self-Help Plus for Distress in University Students
Italy210 participantsStarted 2025-03-10
Plain-language summary
Prrospective, multi-center, randomized controlled trial of a brief, transdiagnostic, guided self-help intervention (Self-Help Plus) for university students who experience significant distress and are behind on their coursework. The intervention will be tested in terms of efficacy and feasibility for outcomes related to distress, anxiety, depression and well-being, assessed immediately after the intervention and at 3-months follow-up.
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:
* University students across all years of higher education (i.e., bachelor and masters), enrolled in any degree course, starting from the second semester of the 1st year
* Currently behind coursework by at least 3 exams, including: exams failed, for which the obtained grade was not confirmed by the student (i.e., confirming the grade is mandatory in the Italian academic system), or postponed (i.e., not taken in the regularly scheduled period).
* Experience significant distress as assessed by the Kessler psychological distress scale (K-10) ≥ 16.
Exclusion Criteria:
• None
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
Kessler psychological distress scale
Timeframe: Baseline, After the intervention, At 3 months after the intervention