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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Italy
    • MI
      • Milan, MI, Italy, 20123
        • Universita Cattolica del Sacro Cuore

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: VR for Hope intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
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."
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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Catholic University of the Sacred Heart

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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