- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07483762
VR for Hope: A Brief VR Self-help Protocol to Enhance Hope and Well-being in Young Adults
May 18, 2026 updated by: Daniela Villani, Catholic University of the Sacred Heart
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
MI
-
Milan, MI, Italy, 20123
- Universita Cattolica del Sacro Cuore
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age between 18 and 30 years.
- Native Italian speakers or individuals with excellent comprehension of spoken and written Italian.
Exclusion Criteria:
- History of neurological disorders, presence of clinically significant maladaptive personality traits.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR for Hope intervention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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)
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.
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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)
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.
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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)
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.
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Personality Inventory for DSM-5 - Brief Form (PID-5-BF)
Time Frame: This questionnaire will be administered at T0 (baseline).
|
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.
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This questionnaire will be administered at T0 (baseline).
|
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Perceived usefulness and pleasantness of the exercises
Time Frame: These items will be administered immediately after each of the 5 activities of the intervention.
|
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."
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These items will be administered immediately after each of the 5 activities of the intervention.
|
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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).
|
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).
|
These items will be administered at T1 (post-intervention - one week after the baseline assessment and immediately following the final exercise of the intervention).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2026
Primary Completion (Actual)
May 8, 2026
Study Completion (Actual)
May 8, 2026
Study Registration Dates
First Submitted
March 13, 2026
First Submitted That Met QC Criteria
March 16, 2026
First Posted (Actual)
March 19, 2026
Study Record Updates
Last Update Posted (Actual)
May 20, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26/25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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