- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07654569
Italian YOLO: A Web-Based ACT Mental Health Promotion Intervention for University Students (YOLO)
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Giulia Landi Senior assistant professor, PhD
- Numer telefonu: +39 0547 338535
- E-mail: giulia.landi7@unibo.it
Lokalizacje studiów
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Bologna, Włochy
- University of Bologna
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Kontakt:
- Giulia Landi University of Bologna
- Numer telefonu: +39 0547 338535
- E-mail: giulia.landi7@unibo.it
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- University Students
Exclusion Criteria:
- Not enrolled in university
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Intervention Group
4-weeks web-based interventions
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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:
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Brak interwencji: Waitlist control
Participants allocated to the waitlist control group will complete the baseline assessment and the initial post-waitlist assessment before receiving access to the YOLO program.
During the waiting period, they will not have access to the intervention content.
After completing the post-waitlist assessment, they will be granted full access to the same web-based YOLO ACT program as the experimental group.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Depression
Ramy czasowe: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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The Patient Health Questionnaire-9 (PHQ-9) is used to assess depressive symptoms. The scale includes 9 items, each corresponding to a symptom domain of depression. Each item is rated on a scale from 0 ("Not at all") to 3 ("Nearly every day"), where participants indicate how often they have experienced each symptom during the previous two weeks. The total PHQ-9 score is calculated by summing all 9 items. Total scores range from 0 to 27. Higher scores indicate greater severity of depressive symptoms. The Italian version of the PHQ-9 has shown adequate psychometric properties in an Italian sample, with a reliability index of .80 and evidence of measurement invariance across age at the scalar level and across sex at the metric level. |
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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Anxiety
Ramy czasowe: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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The Generalized Anxiety Disorder-7 scale (GAD-7) is used to assess anxiety symptoms. The scale includes 7 items assessing symptoms such as nervousness, uncontrollable worry, difficulty relaxing, restlessness, irritability, and fear that something awful might happen. Each item is rated on a scale from 0 ("Not at all") to 3 ("Nearly every day"), where participants indicate how often they have experienced each symptom during the previous two weeks. The total GAD-7 score is calculated by summing all 7 items. Total scores range from 0 to 21. Higher scores indicate greater severity of anxiety symptoms. The Italian GAD-7 has shown good psychometric properties in an Italian coronary heart disease sample. Cronbach's alpha was .89 and the composite reliability index was .90. Measurement invariance across gender and age was supported at the scalar level. |
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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Psychological well-being
Ramy czasowe: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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The Generalized Anxiety Disorder-7 scale (GAD-7) is used to assess anxiety symptoms. The scale includes 7 items assessing symptoms such as nervousness, uncontrollable worry, difficulty relaxing, restlessness, irritability, and fear that something awful might happen. Each item is rated on a scale from 0 ("Not at all") to 3 ("Nearly every day"), where participants indicate how often they have experienced each symptom during the previous two weeks. The total GAD-7 score is calculated by summing all 7 items. Total scores range from 0 to 21. Higher scores indicate greater severity of anxiety symptoms. The Italian GAD-7 has shown good psychometric properties in an Italian coronary heart disease sample. Cronbach's alpha was .89 and the composite reliability index was .90. Measurement invariance across gender and age was supported at the scalar level. |
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Psychological flexibility
Ramy czasowe: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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The Multidimensional Psychological Flexibility Inventory Short Form (MPFI-24) is used to assess psychological flexibility and psychological inflexibility.
It includes 12 subscales, with two items assessing each ACT-related process, and yields two higher-order domains: psychological flexibility and psychological inflexibility.
Subscale scores are calculated by averaging the two corresponding items.
Scores range from 1 to 6, with higher psychological flexibility scores indicating greater flexible responding and higher psychological inflexibility scores indicating greater psychological inflexibility.
The Italian MPFI-24 also showed good internal consistency, with reliability coefficients ranging from .71 to .92 across global and subscale scores.
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T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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Resilience
Ramy czasowe: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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The Brief Resilience Scale (BRS) is used to assess participants' perceived ability to recover from stress and adversity. The scale includes 6 items rated on a 5-point scale from 1 ("Strongly disagree") to 5 ("Strongly agree"). The BRS includes both positively and negatively worded items. Negatively worded items are reverse scored before calculating the total score. The total score is calculated by summing the 6 items, with scores ranging from 6 to 30. Higher scores indicate greater perceived resilience. |
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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Purpose in life
Ramy czasowe: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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The Brief Purpose in Life Measure is used to assess participants' perceived sense of purpose in life. The scale includes 4 items assessing the extent to which participants experience their lives as meaningful and guided by personally significant aims. Items are rated on a scale from 1 ("Strongly disagree") to 5 ("Strongly agree"). Total scores are calculated by summing the 4 items, with scores ranging from 4 to 20. Higher scores indicate a stronger perceived sense of purpose in life. |
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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Academic performance
Ramy czasowe: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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The academic performance measure is adapted from the measure used in the YOLO trial by Viskovich and Pakenham (2020). It is used to assess students perceived academic functioning. Items are rated on a 10-point scale from 1 ("Performing at your worst") to 10 ("Performing at your best"), with an additional "Not applicable" option where relevant. Scores are calculated by averaging the valid items. Higher scores indicate better perceived academic performance and academic functioning. The total score reflects the mean level of perceived academic performance across the retained academic functioning items. |
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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Academic self-efficacy
Ramy czasowe: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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The General Academic Self-Efficacy Scale (GASE) is used to assess students' perceived confidence in their ability to manage academic tasks and demands. The scale includes 5 items rated on a 7-point scale from 1 ("Strongly disagree") to 7 ("Strongly agree"). The total score is calculated by summing the 5 items, with scores ranging from 5 to 35. Higher scores indicate stronger general academic self-efficacy. The GASE has shown good psychometric properties in university student samples. However, no Italian validation of the GASE was identified. Therefore, reliability and validity evidence for the Italian version used in the present study will be examined in the present sample. |
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Caregiving responsibilities
Ramy czasowe: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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The Caregiving Responsibilities subscale of the Young Carers of Parents Inventory-Revised (YCOPI-R) is used to assess caregiving responsibilities among students. The subscale includes 7 items assessing the extent to which participants feel responsible for helping or caring for a parent or family member, including household, practical, and care-related responsibilities. Each item is rated on a 5-point scale from 0 ("Strongly disagree") to 4 ("Strongly agree"). The score is calculated by averaging the 7 items. Scores range from 0 to 4, with higher scores indicating greater caregiving responsibilities. The Caregiving Responsibilities subscale of the Italian YCOPI-R has shown good internal consistency, with Cronbach's alpha = .80. |
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 0049408 (Inny identyfikator: Ethical Committee University of Bologna)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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Badania kliniczne na Italian YOLO
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Yolo Medical Inc.ZakończonyZmniejszenie obwodu taliiStany Zjednoczone
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