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Набор скоро начнётся NCT07654569

Italian YOLO: A Web-Based ACT Mental Health Promotion Intervention for University Students

Без фазы С лечением Psychological Distress Psychological Wellbeing Academic Stress

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Italian YOLO.
Кому может быть актуально
Состояния в реестре: Psychological Distress, Psychological Wellbeing, Academic Stress. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The mental health of university students requires urgent attention, as many students are exposed to increased risk of psychological distress, including symptoms of depression, anxiety, academic stress, and reduced well-being. Although many students experience mental health difficulties, most do not seek help. University counselling and health services may also face increasing demand and limited resources to meet students' needs. Acceptance and Commitment Therapy (ACT) is a transdiagnostic psychological approach that aims to increase psychological flexibility. Rather than focusing only on symptom reduction or problem solving, ACT helps individuals develop a more flexible relationship with difficult thoughts and emotions, clarify personally meaningful values, and engage in committed action. However, access to traditional psychological interventions may be limited by long waiting lists, time constraints, conflicts with academic schedules, high costs, stigma, and shortages of trained professionals. Web-based interventions may help reduce these barriers by providing accessible and flexible support that students can complete privately and at their own pace. Previous research suggests that ACT can be effectively adapted to online formats and may improve mental health and well-being outcomes in university student populations. The present study aims to evaluate the effectiveness of the YOLO web-based ACT intervention among students at the University of Bologna. Participants will be allocated to either immediate access to the YOLO program or a waitlist/delayed intervention condition. Outcomes will be assessed at baseline, post-intervention, and follow-up assessments, including psychological flexibility, depression, anxiety, psychological well-being, academic performance, academic self-efficacy, resilience, and purpose in life. The study will examine whether changes in psychological flexibility are consistent with the theoretical basis of the program. It will also assess the feasibility, acceptability, and usability of the intervention to inform its potential dissemination in other Italian higher education contexts. In addition, exploratory analyses will examine caregiving responsibilities among students with caregiving roles and assess whether caregiving demands are associated with mental health, well-being, and academic functioning.

Подробное описание

University students face a broad range of psychological, academic, and interpersonal demands during higher education. These demands may affect their general well-being, study motivation, and capacity to engage in personally meaningful activities. While some students may meet criteria for clinically relevant psychological symptoms, others may experience subclinical distress, reduced well-being, or difficulties managing academic and life transitions. A mental health promotion intervention based on a transdiagnostic model is therefore important to address both distress and positive functioning.

Acceptance and Commitment Therapy (ACT) provide a suitable framework for this purpose because it targets psychological flexibility, an important process that may influence different aspects of students' emotional functioning and quality of life. ACT focuses on helping individuals notice difficult internal experiences without being dominated by them, reduce avoidance-based patterns of behavior, clarify personally meaningful values, and take committed action in valued life domains. Previous research with university students has supported the effectiveness of ACT-based interventions, including web-based formats, in reducing psychological distress and improving well-being and ACT-related processes.

Web-based delivery may reduce barriers such as long waiting lists, limited availability of trained professionals, time constraints, conflicts with academic and examination schedules, high costs, and stigma associated with help-seeking. It may therefore make psychological interventions more accessible and acceptable to students. This delivery format is also useful because it can reach students across faculties, degree levels, and levels of distress, while allowing them to access the intervention in a private and flexible way.

The present randomized controlled trial aims to evaluate the effectiveness of the YOLO, a web-based ACT intervention among students at the University of Bologna. YOLO is a self-guided mental health promotion program adapted for the Italian university context. The program consists of four modules addressing core ACT processes, including values and committed action, cognitive defusion, acceptance, and mindfulness skills. The intervention will be delivered through a web-based platform, while all assessments will be administered through Qualtrics. Participants will receive automated notifications and reminder messages according to the study schedule to support module completion and assessment participation. Participants will complete assessments at T0 baseline/pre-intervention, T1 post-intervention, T2 3-month follow-up, and T3 6-month follow-up. The primary outcomes of the study will be depression, anxiety, and psychological wellbeing. Secondary outcome will include psychological flexibility, resilience, purpose in life, academic performance, and academic self-efficacy.

In addition to the primary and secondary outcomes, quantitative items will be used to assess the feasibility, acceptability, and usability of the intervention. System usability will be assessed using the System Usability Scale. Open-ended questions will also be included to collect participants' feedback on their experience with the intervention. Engagement with the intervention may be assessed through program-use indicators, including module access, module completion, and completion of study assessments.

The study will also include an exploratory analysis of a subsample of students with caregiving responsibilities. Young adult carers may experience additional emotional and practical demands because of their role in supporting an ill parent or another family member. These responsibilities may create difficulties in balancing academic demands with caregiving activities, reduce time available for leisure and social participation, and affect interpersonal relationships. Additional demographic and caregiving-related questions will be included to identify and describe this subgroup. Further analyses will examine whether caregiving demands, assessed through caregiving responsibilities, are associated with the primary and secondary outcomes. Data management will follow strict procedures to ensure confidentiality, integrity, and secure storage. All participant information will be de-identified and stored on secure, password-protected institutional servers or approved secure research platforms, with access restricted to authorized study personnel. Data collected through the Qualtrics platform will be exported and stored in accordance with applicable data protection regulations and University of Bologna research data management procedures. Participants reporting high suicide risk, acute psychiatric risk, or urgent clinical need will be directed to appropriate emergency, university, or community mental health services.

The intervention is expected to improve psychological flexibility, psychological well-being, academic performance, academic self-efficacy, resilience, and purpose in life, while reducing symptoms of depression and anxiety. Findings from the trial will contribute to understanding the effectiveness, feasibility, acceptability, and usability of self-guided web-based ACT mental health promotion for university students and may inform the dissemination of scalable psychological interventions within Italian higher education contexts.

Вмешательства

  • Поведенческое Italian YOLO
    Participants allocated to the experimental group will receive immediate access to the web-based YOLO program during the initial intervention period. They will be asked to complete one module per week, with each module based on the core principles of ACT. The intervention consists of four online modules designed to promote psychological flexibility. The content of the modules will cover the following topics: 1. Values and committed action 2. Cognitive defusion 3. Acceptance and willingness 4. M

Первичные конечные точки

  • Depression [Срок оценки: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)]
  • Anxiety [Срок оценки: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)]
  • Psychological well-being [Срок оценки: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)]
Вторичные конечные точки (5)
  • Psychological flexibility [Срок оценки: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)]
  • Resilience [Срок оценки: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)]
  • Purpose in life [Срок оценки: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)]
  • Academic performance [Срок оценки: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)]
  • Academic self-efficacy [Срок оценки: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)]

Критерии участия

Критерии включения

  • University Students

Критерии исключения

  • Not enrolled in university

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Италия · 1 центр
  • University of Bologna — Bologna

Идентификаторы

NCT: NCT07654569 · 0049408 · 0049408

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗