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临床试验/NCT06606249
NCT06606249招募中不适用

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

University of Padova3 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2025年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
210
试验地点
3
主要终点
Kessler psychological distress scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

The three site investigators will not be made aware of the block size or have any access to the randomization schedule. The software allows for random allocation of participants after the baseline evaluation is performed and inclusion criteria are checked. The study statistician will also be blinded to group allocation.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

研究组 & 干预措施

Self-Help Plus (SH+)

Experimental

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.

干预措施: Self-Help Plus (SH+) (Behavioral)

Psychological First Aid (PFA)

Active Comparator

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.

干预措施: Psychological First Aid (PFA) (Behavioral)

结局指标

主要结局

Kessler psychological distress scale

时间窗: 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.

次要结局

  • Patient Health Questionnaire-9(Baseline, After the intervention, At 3 months after the intervention)
  • The Generalized Anxiety Disorder-7(Baseline, After the intervention, At 3 months after the intervention)
  • World Health Organization Well-Being Index(Baseline, After the intervention, At 3 months after the intervention)
  • Numbers of exams sustained(Baseline, After the intervention, At 3 months after the intervention)
  • Academic deceit survey(Baseline, After the intervention, At 3 months after the intervention)

研究者

发起方
University of Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

CRISTEA IOANA ALINA

Associate Professor

University of Padova

研究点 (3)

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