Healthy ParticipantsNCT07483762
VR for Hope: A Brief VR Self-help Protocol to Enhance Hope and Well-being in Young Adults
A study testing VR for Hope intervention in people with Healthy Participants and Young Adults, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
The objective of this study is to evaluate the feasibility of a brief self-help protocol based on immersive Virtual Reality (VR) to promote hope and psychological well-being in young adults while enhancing their mentalization capacity. The intervention consists of five sessions. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Young Adults
- What is being tested?
- VR for Hope intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2026to 8 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 30 years.
- Native Italian speakers or individuals with excellent comprehension of spoken and written Italian.
Who cannot join
- History of neurological disorders, presence of clinically significant maladaptive personality traits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VR for Hope: A Feasibility Study of a Brief Virtual Reality Self-Help Protocol to Foster Hope and Well-Being Among Young Adults
The objective of this study is to evaluate the feasibility of a brief self-help protocol based on immersive Virtual Reality (VR) to promote hope and psychological well-being in young adults while enhancing their mentalization capacity. The intervention consists of five sessions. The first session will be conducted in person and features an immersive VR experience, while the subsequent sessions will be delivered in a self-help format via audio and video materials. The intervention is designed to guide participants through personal reflection on key aspects of individual experience, such as hope and the understanding of one's own and others' mental states. Participants will complete self-report questionnaires before (T0) and after (T1) the intervention to assess levels of hope, psychological well-being, and mentalization capacity.
- Conditions
- Healthy Participants, Young Adults
- Being tested
- VR for Hope intervention
- Keywords
- Virtual Reality, Hope, Psychological Well-Being, Healthy young adults, Mentalization, Self-Help Protocol
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR for Hope interventionOther
VR for Hope implements a structured five-session protocol delivered over one week, centered on an immersive metaphorical virtual scenario titled "The River and the Leaf." Each exercise is linked to a specific symbolic element of the digital environment. In every session, participants first explore the virtual scenario and then complete a brief 10-minute guided exercise delivered through a prerecorded audio track, focusing on a particular symbolic element of the environment. Session 1 is conducted in person using immersive virtual reality; after experiencing the VR scenario, participants are guided to identify their achieved goals and their personal resources. Sessions 2-5 are completed remotely via smartphone and lead participants through different metaphorical elements of the virtual experience (e.g., the serene river, the sinking and resurfacing leaf, and the rose garden) to reflect on personal experiences, obstacles, personal resources, mentalization, and future achievements.
| Study group | Role | What they receive |
|---|---|---|
| VR for Hope intervention | Experimental | VR for Hope implements a structured five-session protocol delivered over one week. This one-week intervention consists of one daily exercise utilizing the "River and the Leaf" metaphorical VR scenario and brief audio-guided sessions to enhance hope, well-being and mentalization through a blend of in-person and remote activities. Receives: Other: VR for Hope intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult Hope Scale (AHS)
The Adult Hope Scale (AHS) (Snyder et al., 1991; Italian version translated by Alfieri et al., 2023) is a 12-item measure assessing dispositional hope in adults. The construct of hope is based on two core components: the ability to sustain motivation and determination to achieve meaningful goals (agency) and the capacity to identify pathways and strategies to overcome obstacles along the way (pathways). The scale consists of statements rated on a 4-Likert scale that assess both cognitive and affective aspects of hope. Total scores range from 8 to 32, where higher scores reflect a greater level of hope.
Measured: This questionnaire will be administered at T0 (baseline) and T1 (post-intervention - one week after the baseline assessment and immediately following the final exercise of the intervention).
Certainty about Mental States Questionnaire (CAMSQ)
The Certainty about Mental States Questionnaire (CAMSQ) (Müller et al., 2023; Italian version currently under validation by De Salve et al.) is a self-report measure of perceived mentalizing, defined as the ability to interpret one's own and others' mental states. The questionnaire consists of 20 items rated on a 7-point Likert scale ranging from 1 (never) to 7 (always). The instrument assesses two dimensions of mentalizing: certainty about one's own mental states and certainty about others' mental states. The scale was translated into Italian using a back-translation procedure, approved by the original German authors, and uploaded to the Open Science Framework (OSF). Higher scores reflect a greater level of perceived mentalizing.
Measured: This questionnaire will be administered at T0 (baseline) and T1 (post-intervention - one week after the baseline assessment and immediately following the final exercise of the intervention).
Flourishing Scale (FS)
The Flourishing Scale (FS) developed by Ryan and Deci (2001; Italian version Di Fabio, 2010), aims to investigate the elements that make up psychological well-being, including relationships, self-esteem, life purpose, and optimism. It consists of 8 items, and each is positively worded, and responses are measured on a 7-step Likert scale, where 1 means "strongly disagree" and 7 means "strongly agree." The score range is from 8 to 56 and higher scores reflect a greater level of flourishing.
Measured: This questionnaire will be administered at T0 (baseline) and T1 (post-intervention - one week after the baseline assessment and immediately following the final exercise of the intervention).
Mental Health Continuum Short Form (MHC-SF)
The Mental Health Continuum Short Form (MHC-SF) was developed by Keyes (2002; Petrillo et al., 2015) to measure emotional, social, and psychological well-being. The scale consists of 14 items, which can be answered using a 6-point Likert scale, where 0 indicates "never" and 5 "every day." To assess the three dimensions, the questionnaire is divided into three subscales: the Emotional Well-Being scale (EWB, items 1-3), the Social Well-Being scale (SWB, items 4-8), and the Psychological Well-Being scale (PWB, items 9-14). Higher scores on the MHC-SF indicate greater well-being.
Measured: This questionnaire will be administered at T0 (baseline) and T1 (post-intervention - one week after the baseline assessment and immediately following the final exercise of the intervention).
Secondary outcomes (3)
Personality Inventory for DSM-5 - Brief Form (PID-5-BF)
The Personality Inventory for DSM-5 - Brief Form (PID-5-BF) (Italian version by Fossati et al., 2017) is a self-report questionnaire developed to assess functioning across five personality domains: Negative Affectivity, Detachment, Antagonism, Disinhibition, and Psychoticism. The instrument consists of 25 items rated on a four-point scale ranging from 0 (Very False or Often False) to 3 (Very True or Often True). Higher average scores in each of the 5 domains indicate higher levels of the specific pathological personality trait.
Measured: This questionnaire will be administered at T0 (baseline).
Perceived usefulness and pleasantness of the exercises
Two ad hoc items to investigate perceived usefulness and pleasantness of the exercise just done. After each activity of the intervention, participants will be asked to rate perceived usefulness and pleasantness through a 7-step Likert scale where 1 corresponds to "very little" and 7 to "very much."
Measured: These items will be administered immediately after each of the 5 activities of the intervention.
Satisfaction and acceptability of the intervention
Participants' satisfaction with the intervention will be assessed through two ad hoc items designed to evaluate overall appreciation of the activities and the perceived ease of completing the remote sessions. Responses will be rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (very much).
Measured: These items will be administered at T1 (post-intervention - one week after the baseline assessment and immediately following the final exercise of the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start20 Mar 2026
- Primary completion8 May 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Villani, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483762
- Sponsor's protocol ID
- 26/25
- Status last verified
- May 2026
- First submitted
- 13 Mar 2026
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR for Hope: A Feasibility Study of a Brief Virtual Reality Self-Help Protocol to Foster Hope and Well-Being Among Young Adults
- ClinicalTrials.gov ID
- NCT07483762
- Acronym / sponsor ID
- 26/25
- Conditions
- Healthy Participants, Young Adults
- Keywords
- Virtual Reality, Hope, Psychological Well-Being, Healthy young adults, Mentalization, Self-Help Protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 8 May 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 19 Mar 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 objective of this study is to evaluate the feasibility of a brief self-help protocol based on immersive Virtual Reality (VR) to promote hope and psychological well-being in young adults while enhancing their mentalization capacity. The intervention consists of five sessions. The first session will be conducted in person and features an immersive VR experience, while the subsequent sessions will be delivered in a self-help format via audio and video materials. The intervention is designed to guide participants through personal reflection on key aspects of individual experience, such as hope and the understanding of one's own and others' mental states. Participants will complete self-report questionnaires before (T0) and after (T1) the intervention to assess levels of hope, psychological well-being, and mentalization capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR for Hope intervention | Experimental | Other: VR for Hope interventionVR for Hope implements a structured five-session protocol delivered over one week. This one-week intervention consists of one daily exercise utilizing the "River and the Leaf" metaphorical VR scenario and brief audio-guided sessions to enhance hope, well-being and mentalization through a blend of in-person and remote activities. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18 and 30 years.
- Native Italian speakers or individuals with excellent comprehension of spoken and written Italian.
Key exclusion criteria (1 listed)
- History of neurological disorders, presence of clinically significant maladaptive personality traits.
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 |
|---|---|---|
| VR for Hope interventionVR for Hope implements a structured five-session protocol delivered over one week, centered on an immersive metaphorical virtual scenario titled "The River and the Leaf." Each exercise is linked to a specific symbolic element of the digital environment. In every session, participants first explore the virtual scenario and then complete a brief 10-minute guided exercise delivered through a prerecorded audio track, focusing on a particular symbolic element of the environment. Session 1 is conducted in person using immersive virtual reality; after experiencing the VR scenario, participants are guided to identify their achieved goals and their personal resources. Sessions 2-5 are completed remotely via smartphone and lead participants through different metaphorical elements of the virtual experience (e.g., the serene river, the sinking and resurfacing leaf, and the rose garden) to reflect on personal experiences, obstacles, personal resources, mentalization, and future achievements. | Other | VR for Hope intervention |
Primary outcome
Adult Hope Scale (AHS)
Time frame: This questionnaire will be administered at T0 (baseline) and T1 (post-intervention - one week after the baseline assessment and immediately following the final exercise of the intervention).
The Adult Hope Scale (AHS) (Snyder et al., 1991; Italian version translated by Alfieri et al., 2023) is a 12-item measure assessing dispositional hope in adults. The construct of hope is based on two core components: the ability to sustain motivation and determination to achieve meaningful goals (agency) and the capacity to identify pathways and strategies to overcome obstacles along the way (pathways). The scale consists of statements rated on a 4-Likert scale that assess both cognitive and affective aspects of hope. Total scores range from 8 to 32, where higher scores reflect a greater level of hope.
Certainty about Mental States Questionnaire (CAMSQ)
Time frame: This questionnaire will be administered at T0 (baseline) and T1 (post-intervention - one week after the baseline assessment and immediately following the final exercise of the intervention).
The Certainty about Mental States Questionnaire (CAMSQ) (Müller et al., 2023; Italian version currently under validation by De Salve et al.) is a self-report measure of perceived mentalizing, defined as the ability to interpret one's own and others' mental states. The questionnaire consists of 20 items rated on a 7-point Likert scale ranging from 1 (never) to 7 (always). The instrument assesses two dimensions of mentalizing: certainty about one's own mental states and certainty about others' mental states. The scale was translated into Italian using a back-translation procedure, approved by the original German authors, and uploaded to the Open Science Framework (OSF). Higher scores reflect a greater level of perceived mentalizing.
Flourishing Scale (FS)
Time frame: This questionnaire will be administered at T0 (baseline) and T1 (post-intervention - one week after the baseline assessment and immediately following the final exercise of the intervention).
The Flourishing Scale (FS) developed by Ryan and Deci (2001; Italian version Di Fabio, 2010), aims to investigate the elements that make up psychological well-being, including relationships, self-esteem, life purpose, and optimism. It consists of 8 items, and each is positively worded, and responses are measured on a 7-step Likert scale, where 1 means "strongly disagree" and 7 means "strongly agree." The score range is from 8 to 56 and higher scores reflect a greater level of flourishing.
Mental Health Continuum Short Form (MHC-SF)
Time frame: This questionnaire will be administered at T0 (baseline) and T1 (post-intervention - one week after the baseline assessment and immediately following the final exercise of the intervention).
The Mental Health Continuum Short Form (MHC-SF) was developed by Keyes (2002; Petrillo et al., 2015) to measure emotional, social, and psychological well-being. The scale consists of 14 items, which can be answered using a 6-point Likert scale, where 0 indicates "never" and 5 "every day." To assess the three dimensions, the questionnaire is divided into three subscales: the Emotional Well-Being scale (EWB, items 1-3), the Social Well-Being scale (SWB, items 4-8), and the Psychological Well-Being scale (PWB, items 9-14). Higher scores on the MHC-SF indicate greater well-being.
3 secondary outcomes
Personality Inventory for DSM-5 - Brief Form (PID-5-BF)
Time frame: This questionnaire will be administered at T0 (baseline).
Perceived usefulness and pleasantness of the exercises
Time frame: These items will be administered immediately after each of the 5 activities of the intervention.
Satisfaction and acceptability of the intervention
Time frame: These items will be administered at T1 (post-intervention - one week after the baseline assessment and immediately following the final exercise of the intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR for Hope intervention in people with Healthy Participants and Young Adults, run by Catholic University of the Sacred Heart 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 2 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: finished, as of the sponsor's last update on 20 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adult Hope Scale (AHS) (time frame: This questionnaire will be administered at T0 (baseline) and T1 (post-intervention - one week after the baseline assessment and immediately following the final exercise of the intervention).). The study lists 4 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 20 May 2026.