Clinical trial NCT06606249: Self-Help Plus for Distress in University Students
Official title: Randomized Trial of a Brief, Transdiagnostic, Guided Self-help Intervention for University Students Who Are Behind on Their Coursework and Experience Distress
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Distress
Psychological Well-Being
Depression
Anxiety
Keywords: prevention
university students
academic deceit
emotion regulation
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Universita di Verona
name: University of Bari Aldo Moro
First posted: 2024-09-20
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will involve three centers (Padova, Verona, Bari). Randomization will be individual and stratified by the three recruiting center, with an allocation rate of 1:1:1. A centralized system (Redcap) will be used to generate the randomization schedule, using randomly permuted blocks of unequal size.
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Kessler psychological distress scale
timeFrame: Baseline, After the intervention, At 3 months after the intervention
Secondary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: Baseline, After the intervention, At 3 months after the intervention
measure: The Generalized Anxiety Disorder-7
timeFrame: Baseline, After the intervention, At 3 months after the intervention
measure: World Health Organization Well-Being Index
timeFrame: Baseline, After the intervention, At 3 months after the intervention
measure: Numbers of exams sustained
timeFrame: Baseline, After the intervention, At 3 months after the intervention
measure: Academic deceit survey
timeFrame: Baseline, After the intervention, At 3 months after the intervention
Other outcomes:
measure: Accesibility
timeFrame: Immediately after the intervention
measure: Intervention dose
timeFrame: Immediately after the intervention
Locations:
city: Bari
country: Italy
facility: University of Bari "Aldo Moro"
city: Padova
country: Italy
facility: University of Padova
city: Verona
country: Italy
facility: Universita di Verona
Study officials:
affiliation: University of Padova
name: Ioana Cristea, PhD
role: PRINCIPAL_INVESTIGATOR
References: