NCT07483762

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

March 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2026

Completed
Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

March 13, 2026

Last Update Submit

May 18, 2026

Conditions

Keywords

Virtual RealityHopePsychological Well-BeingHealthy young adultsMentalizationSelf-Help Protocol

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    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)

    This questionnaire will be administered at T0 (baseline).

  • Perceived usefulness and pleasantness of the exercises

    These items will be administered immediately after each of the 5 activities of the intervention.

  • Satisfaction and acceptability of the intervention

    These items will be administered at T1 (post-intervention - one week after the baseline assessment and immediately following the final exercise of the intervention).

Study Arms (1)

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.

Other: VR for Hope intervention

Interventions

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.

VR for Hope intervention

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 30 years.
  • Native Italian speakers or individuals with excellent comprehension of spoken and written Italian.

You may not qualify if:

  • History of neurological disorders, presence of clinically significant maladaptive personality traits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Cattolica del Sacro Cuore

Milan, MI, 20123, Italy

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in General Psychology

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 19, 2026

Study Start

March 20, 2026

Primary Completion

May 8, 2026

Study Completion

May 8, 2026

Last Updated

May 20, 2026

Record last verified: 2026-05

Locations