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Recruiting NCT06606249

NCT06606249 Self-Help Plus for Distress in University Students

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Clinical Trial Summary
NCT ID NCT06606249
Status Recruiting
Phase
Sponsor University of Padova
Condition Psychological Distress
Study Type INTERVENTIONAL
Enrollment 210 participants
Start Date 2025-03-10
Primary Completion 2026-10

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Self-Help Plus (SH+)Psychological First Aid (PFA)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 210 participants in total. It began in 2025-03-10 with a primary completion date of 2026-10.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Ioana Cristea, PhD

✉ ioanaalina.cristea@unipd.it

📞 390498276595

Principal Investigator

Ioana Cristea, PhD

PRINCIPAL INVESTIGATOR

University of Padova

Frequently Asked Questions

Who can join the NCT06606249 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Psychological Distress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06606249 currently recruiting?

Yes, NCT06606249 is actively recruiting participants. Contact the research team at ioanaalina.cristea@unipd.it for enrollment information.

Where is the NCT06606249 trial being conducted?

This trial is being conducted at Bari, Italy, Padova, Italy, Verona, Italy.

Who is sponsoring the NCT06606249 clinical trial?

NCT06606249 is sponsored by University of Padova. The principal investigator is Ioana Cristea, PhD at University of Padova. The trial plans to enroll 210 participants.

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