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

NCT07654569 | Recruiting

• 1 other identifier: 0049408
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychological Distress; Psychological Wellbeing; Academic Stress

Keywords

Italian YOLO

Outcome Measures

Primary Outcomes (3)

• 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.

  T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)

• 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.

  T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)

• 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.

  T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)

Secondary Outcomes (5)

• Psychological flexibility

  T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)

• Resilience

  T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)

• Purpose in life

  T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)

• Academic performance

  T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)

• Academic self-efficacy

  T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)

Other Outcomes (1)

• Caregiving responsibilities

  T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)

Study Arms (2)

Intervention Group

EXPERIMENTAL

4-weeks web-based interventions

Behavioral: Italian YOLO

Waitlist control

NO INTERVENTION

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.

Interventions

Italian YOLO BEHAVIORAL

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. Mindfulness and observer self.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• University Students

You may not qualify if:

• Not enrolled in university

Sponsors & Collaborators

• University of Bologna: lead
• The University of Queensland: collaborator

Study Sites (1)

Department of Psychology "Renzo Canestari"

Bologna, BO, 40127, Italy

RECRUITING

Central Study Contacts

Giulia Landi Senior assistant professor, PhD

CONTACT

+39 0547 338535; giulia.landi7@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior assistant professor

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 6 months after publication of the main results and for 2 years thereafter
• Access Criteria: Upon reasonable request, following approval of a methodologically sound proposal and execution of a data use agreement.

Locations

IT (1)