Self-Help Plus program for university students experiencing distress
Randomized Trial of a Brief, Transdiagnostic, Guided Self-help Intervention for University Students Who Are Behind on Their Coursework and Experience Distress
NA · University of Padova · NCT06606249
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Padova (other) |
| Locations | 3 sites (Bari, Bari and 2 other locations) |
| Trial ID | NCT06606249 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are university students enrolled in any degree course who are behind on their coursework and experiencing significant psychological distress.
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.
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 performed: Other studies have shown success with similar self-help interventions for mental health, indicating potential for positive outcomes in this approach.
Eligibility criteria
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 this trial is running
Bari, Bari and 2 other locations
- University of Bari "Aldo Moro" — Bari, Bari, Italy (NOT_YET_RECRUITING)
- University of Padova — Padova, Italy (RECRUITING)
- Universita di Verona — Verona, Italy (RECRUITING)
Study contacts
- Principal investigator: Ioana Cristea, PhD — University of Padova
- Study coordinator: Ioana Cristea, PhD
- Email: ioanaalina.cristea@unipd.it
- Phone: 390498276595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Psychological Distress, Psychological Well-Being, Depression, Anxiety, prevention, university students, academic deceit, emotion regulation