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Recruiting Not applicable

Self-Help Plus for Distress in University Students

NCT06606249 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-03-10
Last updated
2026-03-13

Condition(s) studied

Psychological DistressPsychological Well-BeingDepressionAnxiety

Investigational drug(s) / intervention(s)

Self-Help Plus (SH+)Psychological First Aid (PFA)

Self-Help Plus (SH+): Self-Help Plus is a novel, brief, low-intensity intervention, recently developed by the World Health Organization (WHO) and intended to help people with and without mental disorders cope with distress stemming from diverse types of adversity.The key components of the program are based on acceptance and commitment therapy (ACT), a distinct form of cognitive-behavioural therapy. SH+ draws on ACT techniques of coping with stress, compassion and acceptance toward oneself and others, and living following one's values. An online version called "Doing what matters in times of stress" is available as an illustrated guide and pre-recorded audio.

Psychological First Aid (PFA): Psychological First Aid (PFA) is also developed by the WHO and is a general supportive intervention, aimed at listening and understanding the needs and concerns of people, providing support without pressuring them to talk.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Kessler psychological distress scale — Baseline, After the intervention, At 3 months after the intervention
    The Kessler psychological distress scale (K-10) is a simple measure of psychological distress. It consists of 10 questions about emotional states that can be answered from 1 (none of the time) to 5 (all of the time). Scores of the 10 items are then summed, yielding a minimum score of 10 and a maximum score of 50.

Trial sites (3)

FacilityCityRegionStatus
University of Bari "Aldo Moro" Bari Bari Not Yet Recruiting
University of Padova Padova Italy Recruiting
Universita di Verona Verona Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06606249 on ClinicalTrials.gov ↗ ← All trials in Italy