Italian YOLO: A Web-Based ACT Mental Health Promotion Intervention for University Students
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bologna
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
University Students
Disqualifiers
Not enrolled in university
Trial design
Design model
Parallel
Treatments tested in this trial
Italian YOLO
BehavioralParticipants 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. Mindfulness and observer self.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Waitlist controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Depression
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.
Time frame
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)2
Anxiety
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.
Time frame
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)3
Psychological well-being
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.
Time frame
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)Secondary outcomes
1
Psychological flexibility
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.
Time frame
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)2
Resilience
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.
Time frame
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)3
Purpose in life
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.
Time frame
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)4
Academic performance
The academic performance measure is adapted from the measure used in the YOLO trial. 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.
Time frame
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)Other outcomes
1
Caregiving responsibilities
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.
Time frame
T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Bologna
Lead sponsor
The University of Queensland
Collaborator
Source ClinicalTrials.gov