Psychological DistressYOLONCT07654569
Italian YOLO: A Web-Based ACT Mental Health Promotion Intervention for University Students
A study testing Italian YOLO in people with Psychological Distress and Psychological Wellbeing, run by University of Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Psychological Wellbeing, Academic Stress
- What is being tested?
- Italian YOLO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jun 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- University Students
Who cannot join
- Not enrolled in university
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Department of Psychology "Renzo Canestari"
Bologna, BO, 40127
Giulia Landi, Phd, giulia.landi7@unibo.it
About this study
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Italian YOLO
- Keywords
- Italian YOLO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Italian YOLOBehavioural
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:
- Values and committed action
- Cognitive defusion
- Acceptance and willingness
- Mindfulness and observer self.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 4-weeks web-based interventions Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
Secondary outcomes (5)
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.
Measured: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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.
Measured: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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.
Measured: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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.
Measured: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
Academic self-efficacy
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.
Measured: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start10 Jun 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Queensland
- Responsible party
- Principal investigator, Giulia Landi, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654569
- Sponsor's protocol ID
- 0049408
- Other IDs
- 0049408
- Acronym
- YOLO
- Status last verified
- Aug 2026
- First submitted
- 12 Jun 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications may be shared with qualified researchers upon reasonable request, following approval of a methodologically sound proposal and execution of a data use agreement. Shared materials may include the study protocol, statistical analysis plan, and data dictionary. Data will be available beginning 6 months after publication of the main results and for 2 years thereafter. Requests should be directed to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian YOLO: A Web-Based ACT Mental Health Promotion Intervention for University Students
- ClinicalTrials.gov ID
- NCT07654569
- Acronym / sponsor ID
- YOLO / 0049408
- Keywords
- Italian YOLO
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- The University of Queensland
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Italian YOLO4-weeks web-based interventions |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- University Students
Key exclusion criteria (1 listed)
- Not enrolled in university
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Italian YOLOParticipants 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. | Behavioural | Intervention Group |
Primary outcome
Depression
Time frame: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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.
Anxiety
Time frame: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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.
Psychological well-being
Time frame: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
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.
5 secondary outcomes
Psychological flexibility
Time frame: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
Resilience
Time frame: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
Purpose in life
Time frame: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
Academic performance
Time frame: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
Academic self-efficacy
Time frame: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications may be shared with qualified researchers upon reasonable request, following approval of a methodologically sound proposal and execution of a data use agreement. Shared materials may include the study protocol, statistical analysis plan, and data dictionary. Data will be available beginning 6 months after publication of the main results and for 2 years thereafter. Requests should be directed to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Italian YOLO in people with Psychological Distress and Psychological Wellbeing, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giulia Landi Senior assistant professor, PhD (+39 0547 338535, giulia.landi7@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: T0 (baseline); T1 (4-weeks); T2 (3 months); T2 (6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.