Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06606249

Self-Help Plus for Distress in University Students

Led by University of Padova · Updated on 2026-03-13

210

Participants Needed

3

Research Sites

94 weeks

Total Duration

On this page

Sponsors

U

University of Padova

Lead Sponsor

U

Universita di Verona

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Self-Help Plus for Distress in University Students

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • University students across all years of higher education, enrolled in any degree course starting from the second semester of the first year
  • Currently behind coursework by at least three exams, including failed, unconfirmed, or postponed exams
  • Experiencing significant distress with a Kessler psychological distress scale (K-10) score of 16 or higher
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 3 locations

1

University of Bari "Aldo Moro"

Bari, Bari, Italy, 70121

Not Yet Recruiting

2

University of Padova

Padova, Italy, 35131

Actively Recruiting

3

Universita di Verona

Verona, Italy

Actively Recruiting

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Research Team

I

Ioana Cristea, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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