Self-Help Plus for Distress in University Students (SSH+)

University of Padova

Status: Enrolling

Conditions: Psychological Well-Being; Depression; Anxiety; Psychological Distress

Treatments: Behavioral: Psychological First Aid (PFA); Behavioral: Self-Help Plus (SH+)

Study type: Interventional

Funder types: Other

Identifiers

NCT06606249

20224XSWRH

Details and patient eligibility

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 2 patient groups

Self-Help Plus (SH+)

Experimental group

Description:

The intervention is available in its individual online self-help version called "Doing What Matters in Time of Stress". It composed of an illustrate guide, divided into sessions, and pre-recorded audio. Participants will be required to access an online platform for attending the sessions. A total of 5 sessions of approximately an hour each are planned. Participants will be guided by facilitators with minimal qualifications and skills in providing psychosocial support. They will receive regular reminders and instructions from helpers at the beginning of the program and before any sessions via phone call, teleconferencing meeting, or message. Facilitators will receive brief training from specialized mental health professionals trained by WHO.

Treatment:

Behavioral: Self-Help Plus (SH+)

Psychological First Aid (PFA)

Active Comparator group

Description:

Psychological First Aid will also be delivered by facilitators through a phone call or teleconferencing meeting, for an approximate ranging from 20 to 45 minutes. Participants will also receive an information sheet with details about mental health services available for students experiencing distress at each of the centers.

Treatment:

Behavioral: Psychological First Aid (PFA)