Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Self-Help Plus program for university students experiencing distress

Official title: Randomized Trial of a Brief, Transdiagnostic, Guided Self-help Intervention for University Students Who Are Behind on Their Coursework and Experience Distress

Run by University of Padova · NCT06606249 · Data updated 2026-11-12

This study is testing a self-help program to see if it can help university students who are feeling anxious or depressed improve their mental health and well-being.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment210 (estimated)
SponsorUniversity of Padova
Academic / other
Locations3 sites (Bari, Bari and 2 other locations)
StatusRecruiting
StartedMarch 10, 2025
Main results expectedOctober 2026
Study endsJanuary 2027
Registry record updatedMarch 13, 2026
Trial IDNCT06606249 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are university students enrolled in any degree course who are behind on their coursework and experiencing significant psychological distress.

Probably not a fit

Patients who are not currently enrolled in university or those who do not meet the distress criteria may not benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This intervention involves a multi-center, randomized controlled trial assessing the efficacy and feasibility of the Self-Help Plus program for university students facing significant psychological distress and academic challenges. The program aims to address issues such as anxiety, depression, and overall well-being through a guided self-help approach. Participants will be evaluated for their mental health outcomes immediately after the intervention and again at a three-month follow-up. The study seeks to provide an accessible mental health resource for students during a critical transition period in their lives.

Why it matters

Potential benefit: If successful, this program could significantly improve mental health outcomes and academic performance for university students experiencing distress.

How similar studies have gone: Other studies have shown success with similar self-help interventions for mental health, indicating potential for positive outcomes in this approach.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • University of Padova
    Padova, Italy
    Recruiting
  • Universita di Verona
    Verona, Italy
    Recruiting
  • University of Bari "Aldo Moro"
    Bari, Bari, Italy
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.