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NCT Number: NCT06606249

Self-Help Plus for Distress in University Students

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bari "Aldo Moro", Bari, Italy

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About this study

The university period usually overlaps with a particularly challenging developmental period of transition to adulthood, and a suite of significant and durable stressors, such as independent living, financial problems, interpersonal relationships with family or peers and academic pressure. Consequently, it represents a critical high-risk period for the onset of mental disorders, including anxiety, depression, substance abuse, self-harm and suicidal behavior. In the World Mental Health Surveys, a set of large-scale cross-national community epidemiological surveys, the 12-month prevalence of any mental disorder among university students was around 20%. Further compounding the problem, a large survey on first year university students in high-income countries showed that approximately 36% of students with any lifetime mental disorder or with suicidal thoughts or behaviors had received any treatment for emotional problems in the past year. Lack of awareness of the problem and fear of stigma might account for the low treatment uptake in university students.

Furthermore, university psychological counseling services, when available, have limited impact, due to their isolation from the general health care system and to the heterogeneity of the interventions offered. An alternative, innovative framework to promote access to mental health interventions while minimizing the risk of stigmatization is "indirect prevention". This approach includes interventions that address vulnerability factors increasing the risk of mental disorders while at the same time representing salient, everyday problems that students are motivated to change. In a diathesis-stress model, mental disorders are triggered by the interaction between individual vulnerability factors and stressors such as academic challenges.

A promising candidate intervention is Self-Help Plus (SH+), developed by the World Health Organization (WHO) and intended to help individuals cope with distress stemming from a diversity of stressors. In its individual online version called Doing What Matters in Times of Stress, SH+ might be particularly suitable for university students given its easily implementable structure (5 sessions of guided self-help), its contents (focused on self-compassion, coping with stress and personal values), and delivery format (not requiring specialized training). Only two randomized trials so far employed SH+ as a preventive intervention, targeting refugees in Western Europe and Turkey. This is the first attempt to test SH+ as a preventive intervention on university students.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Help Plus (SH+)

Behavioral

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.

Other names: Doing what matters in times of stress

Psychological First Aid (PFA)

Behavioral

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.

Primary outcomes

  1. Kessler psychological distress scale

    Time frame: 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.

Secondary outcomes

  1. Patient Health Questionnaire-9

    Time frame: Baseline, After the intervention, At 3 months after the intervention

    The Patient Health Questionnaire-9 (PHQ-9) is a self-report instrument to measure depression. It consists of 9 items, each rated on a 4-point scale ranging from 0 (not at all) to 3 (almost every day). Total scores range from 0 to 27.

  2. The Generalized Anxiety Disorder-7

    Time frame: Baseline, After the intervention, At 3 months after the intervention

    The General Anxiety Disorder-7 (GAD-7) scale is a measure of symptoms of generalized anxiety. It consists of 7 items that can be rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Total scores can range from 0 to 21.

  3. World Health Organization Well-Being Index

    Time frame: Baseline, After the intervention, At 3 months after the intervention

    World Health Organization Well-Being Index (WHO-5) assesses subjective well-being. It consists of 5 items, each rated on a 6-point scale ranging from 0 (at no time) to 5 (all of the time). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, ranging from 0 to 100.

  4. Numbers of exams sustained

    Time frame: Baseline, After the intervention, At 3 months after the intervention

    Self-reported number of exams sustained over the study period

  5. Academic deceit survey

    Time frame: Baseline, After the intervention, At 3 months after the intervention

    An ad hoc tool with three questions will be used: (a) did you lie to significant others about academic status; (b) how frequently, on a scale ranging from 0 (never) to 4 (always) and (c) in which situations (open ended)

Other outcomes

  1. Accesibility

    Time frame: Immediately after the intervention

    Easy access to the online intervention and to the rating scales

  2. Intervention dose

    Time frame: Immediately after the intervention

    Number of sessions attended by each participant, and the time spent in each session measured in minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Ioana Cristea, PhD

CONTACT

[email protected]

390498276595

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Collaborators

  • Universita di Verona
  • University of Bari Aldo Moro

Registry information

Official study title

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

Acronym: SSH+

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 20, 2024
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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