Healthy ParticipantsNCT07140705
Personalized Virtual Reality for Promoting Well-Being and Psychological Flexibility in General Practitioners
A study testing Transformative Virtual Reality Experience and ACT for General Practitioners in people with Healthy Participants, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
General Practitioners (GPs) face significant daily challenges, and promoting their well-being is essential. In particular, psychological flexibility (PF) is a key indicator of well-being. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Transformative Virtual Reality Experience and ACT for General Practitioners
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 30 Nov 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being a General Practitioner and having an adequate understanding of the Italian language.
Who cannot join
- having pre-existing medical conditions that prevent the use of the Meta Quest 3 headset:
- presence of binocular visual abnormalities;
- history of seizures or epileptic conditions;
- presence of cardiac pacemakers, defibrillators, or implanted devices;
- use of hearing aids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Personalized Virtual Reality Experience for Promoting Well-Being and Psychological Flexibility in General Practitioners: a Feasibility Study
General Practitioners (GPs) face significant daily challenges, and promoting their well-being is essential. In particular, psychological flexibility (PF) is a key indicator of well-being. PF, conceptualized within Acceptance and Commitment Therapy (ACT), supports adaptation to change and fosters adaptive responses to demanding and complex situations. ACT identifies six core processes, which can be grouped into two functional units: the mindful acceptance of one's thoughts and emotions (acceptance, cognitive defusion, openness to internal experiences), and the commitment to engaging in actions that enrich one's life (values and committed action).
This project will investigate the feasibility of a transformative metaphorical Virtual Reality (VR) experience to promote psychological flexibility and well-being in GPs. Specifically, this goal will be pursued through the integration of a metaphorical virtual experience, previously validated by the research team for its capacity to foster a transformative experience (TE)-that is, an experience that enables individuals to explore new ways of thinking and contributes to reshaping self-perception-with guided reflection on personal values and support in enacting value-consistent behaviors.
A total of 25 GPs will participate in a single in-person session involving a 10-minute transformative VR experience ("The River and the Leaf"). Drawing on ACT metaphors, participants will be guided to reflect on aspects of the experience, on the professional challenges they face, and on the personal resources available to them. Following this experience, they will be supported in identifying the values that guide their everyday actions. After the in-person session, all participants will be encouraged to identify and implement value-based committed actions over the following two weeks, supported by two audio tracks.
- Conditions
- Healthy Participants
- Being tested
- Transformative Virtual Reality Experience and ACT for General Practitioners
- Keywords
- Virtual reality, Transformative Experience, Acceptance and Commitment Therapy, General Practitioners, Personal values, Committed action, Psychological flexibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transformative Virtual Reality Experience and ACT for General PractitionersOther
This intervention consists of an individual, in-person session in which each participant engages in a 10-minute transformative Virtual Reality (VR) experience entitled "The River and the Leaf", delivered through the Meta Quest 3 headset. Drawing on Acceptance and Commitment Therapy (ACT) metaphors, participants are guided to reflect on key aspects of the experience, their professional challenges, and the personal resources available to them. Following the VR session, participants are supported in clarifying the values that guide their everyday actions. After the in-person session, all participants are encouraged to identify and implement committed actions aligned with their values over the subsequent two weeks, supported by two dedicated audio tracks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Other: Transformative Virtual Reality Experience and ACT for General Practitioners |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Comprehensive assessment of ACT (CompACT)
This self-report scale was developed by Francis et al. (2016; Giovannetti et al., 2022) to measure psychological flexibility. The scale consists of 23 items, which can be answered using a 6-point Likert scale, where 0 indicates "completely disagree" and 6 "completely agree." The questionnaire is divided into three subscales: Openness to Experience (OE), Behavioral Awareness (BA), and Valued Action (VA), which correspond to the three pillars of psychological flexibility. Higher scores on the CompACT indicate greater psychological flexibility.
Measured: This questionnaire will be administered at T0 (baseline) and at T2 (post-intervention, i.e., two weeks after the individual in-person session).
Mental Health Continuum Short Form (MHC-SF)
This self-report scale 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 at T2 (post-intervention, i.e., two weeks after the individual in-person session).
Visual Analogue Scale (VAS) for the assessment of emotions
This scale aims to measure the intensity of positive and negative emotions (joy, contentment, pride, love, compassion, awe, hope, gratitude, sadness, fear, anger, admiration, inspiration, and awe) (Shiota et al., 2006; Cloos et al., 2023). The intensity can be expressed using a Likert scale, where 0 corresponds to "not at all" and 10 to "very much."
Measured: This questionnaire will be administered at T0 (baseline) and at T1 (immediately after the VR experience).
Ad hoc questionnaire to investigate the impact of the VR transformative experience
This 6-item questionnaire is designed to evaluate the transformative experience, its pleasantness, and its impact on self-expansion. Responses are provided on a 7-point Likert scale, where 1 indicates "not at all" and 7 indicates "very much."
Measured: This questionnaire will be administered at T1 (immediately after the VR experience).
Secondary outcomes (3)
Slater Usoh Steed Presence Questionnaire (SUS)
This self-report scale was developed by Usoh et al. (2000) to assess the user's sense of presence in the virtual environment. The instrument consists of 6 items, which are rated on a 7-point Likert scale. Higher scores on the SUS indicate a greater sense of presence.
Measured: This questionnaire will be administered at T1 (immediately after the VR experience).
Valued Living Questionnaire (VLQ)
This questionnaire is designed to assess valued living and is divided into two sections (Wilson et al., 2002; Miselli et al., 2008). In the first section, participants are asked to rate the importance of 10 life domains on a 10-point Likert scale (where 1 = not at all important and 10 = extremely important). The life domains are: (1) family, (2) marriage/partnership/intimate relationships, (3) parenting, (4) friendship, (5) work, (6) education, (7) recreation, (8) spirituality, (9) citizenship, and (10) self-care. The second section asks participants to rate the extent to which their actions over the past week were consistent with each value/domain. Responses are given on a 10-point Likert scale (where 1 = not at all consistent and 10 = extremely consistent).
Measured: This questionnaire will be administered at T1 (after the VR experience) and at T2 (post-intervention, i.e., two weeks after the individual in-person session).
Maslach Burnout Inventory (MBI)
This questionnaire was developed by Maslach et al. (1997) to measure levels of burnout. It consists of 16 items rated on a 7-point Likert scale, where 0 corresponds to "never" and 6 to "every day." The questionnaire is divided into three subscales: Emotional Exhaustion (EE), Depersonalization (DP), and Reduced Personal Accomplishment (PA), which represent the three core dimensions of burnout.
Measured: This questionnaire will be administered at T0 (baseline) and at T2 (post-intervention, i.e., two weeks after the individual in-person session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2025
- Study start1 Sep 2025
- Primary completion15 Nov 2025
- Study completion30 Nov 2025
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Italian Ministry of University and Research (MUR), European Union
- Responsible party
- Principal investigator, Daniela Villani, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140705
- Sponsor's protocol ID
- 19/25
- Status last verified
- Dec 2025
- First submitted
- 22 Aug 2025
- Last updated
- 23 Dec 2025
- 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 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Virtual Reality Experience for Promoting Well-Being and Psychological Flexibility in General Practitioners: a Feasibility Study
- ClinicalTrials.gov ID
- NCT07140705
- Acronym / sponsor ID
- 19/25
- Conditions
- Healthy Participants
- Keywords
- Virtual reality, Transformative Experience, Acceptance and Commitment Therapy, General Practitioners, Personal values, Committed action, Psychological flexibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Italian Ministry of University and Research (MUR), European Union
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 25 Aug 2025 (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.
General Practitioners (GPs) face significant daily challenges, and promoting their well-being is essential. In particular, psychological flexibility (PF) is a key indicator of well-being. PF, conceptualized within Acceptance and Commitment Therapy (ACT), supports adaptation to change and fosters adaptive responses to demanding and complex situations. ACT identifies six core processes, which can be grouped into two functional units: the mindful acceptance of one's thoughts and emotions (acceptance, cognitive defusion, openness to internal experiences), and the commitment to engaging in actions that enrich one's life (values and committed action).
This project will investigate the feasibility of a transformative metaphorical Virtual Reality (VR) experience to promote psychological flexibility and well-being in GPs. Specifically, this goal will be pursued through the integration of a metaphorical virtual experience, previously validated by the research team for its capacity to foster a transformative experience (TE)-that is, an experience that enables individuals to explore new ways of thinking and contributes to reshaping self-perception-with guided reflection on personal values and support in enacting value-consistent behaviors.
A total of 25 GPs will participate in a single in-person session involving a 10-minute transformative VR experience ("The River and the Leaf"). Drawing on ACT metaphors, participants will be guided to reflect on aspects of the experience, on the professional challenges they face, and on the personal resources available to them. Following this experience, they will be supported in identifying the values that guide their everyday actions. After the in-person session, all participants will be encouraged to identify and implement value-based committed actions over the following two weeks, supported by two audio tracks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Transformative Virtual Reality Experience and ACT for General Practitioners |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- being a General Practitioner and having an adequate understanding of the Italian language.
Key exclusion criteria (5 listed)
- having pre-existing medical conditions that prevent the use of the Meta Quest 3 headset:
- presence of binocular visual abnormalities;
- history of seizures or epileptic conditions;
- presence of cardiac pacemakers, defibrillators, or implanted devices;
- use of hearing aids.
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 |
|---|---|---|
| Transformative Virtual Reality Experience and ACT for General PractitionersThis intervention consists of an individual, in-person session in which each participant engages in a 10-minute transformative Virtual Reality (VR) experience entitled "The River and the Leaf", delivered through the Meta Quest 3 headset. Drawing on Acceptance and Commitment Therapy (ACT) metaphors, participants are guided to reflect on key aspects of the experience, their professional challenges, and the personal resources available to them. Following the VR session, participants are supported in clarifying the values that guide their everyday actions. After the in-person session, all participants are encouraged to identify and implement committed actions aligned with their values over the subsequent two weeks, supported by two dedicated audio tracks. | Other | Experimental group |
Primary outcome
The Comprehensive assessment of ACT (CompACT)
Time frame: This questionnaire will be administered at T0 (baseline) and at T2 (post-intervention, i.e., two weeks after the individual in-person session).
This self-report scale was developed by Francis et al. (2016; Giovannetti et al., 2022) to measure psychological flexibility. The scale consists of 23 items, which can be answered using a 6-point Likert scale, where 0 indicates "completely disagree" and 6 "completely agree." The questionnaire is divided into three subscales: Openness to Experience (OE), Behavioral Awareness (BA), and Valued Action (VA), which correspond to the three pillars of psychological flexibility. Higher scores on the CompACT indicate greater psychological flexibility.
Mental Health Continuum Short Form (MHC-SF)
Time frame: This questionnaire will be administered at T0 (baseline) and at T2 (post-intervention, i.e., two weeks after the individual in-person session).
This self-report scale 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.
Visual Analogue Scale (VAS) for the assessment of emotions
Time frame: This questionnaire will be administered at T0 (baseline) and at T1 (immediately after the VR experience).
This scale aims to measure the intensity of positive and negative emotions (joy, contentment, pride, love, compassion, awe, hope, gratitude, sadness, fear, anger, admiration, inspiration, and awe) (Shiota et al., 2006; Cloos et al., 2023). The intensity can be expressed using a Likert scale, where 0 corresponds to "not at all" and 10 to "very much."
Ad hoc questionnaire to investigate the impact of the VR transformative experience
Time frame: This questionnaire will be administered at T1 (immediately after the VR experience).
This 6-item questionnaire is designed to evaluate the transformative experience, its pleasantness, and its impact on self-expansion. Responses are provided on a 7-point Likert scale, where 1 indicates "not at all" and 7 indicates "very much."
3 secondary outcomes
Slater Usoh Steed Presence Questionnaire (SUS)
Time frame: This questionnaire will be administered at T1 (immediately after the VR experience).
Valued Living Questionnaire (VLQ)
Time frame: This questionnaire will be administered at T1 (after the VR experience) and at T2 (post-intervention, i.e., two weeks after the individual in-person session).
Maslach Burnout Inventory (MBI)
Time frame: This questionnaire will be administered at T0 (baseline) and at T2 (post-intervention, i.e., two weeks after the individual in-person session).
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 23 Dec 2025.
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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 Transformative Virtual Reality Experience and ACT for General Practitioners in people with Healthy Participants, 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 1 inclusion and 5 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 23 Dec 2025. 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?
The Comprehensive assessment of ACT (CompACT) (time frame: This questionnaire will be administered at T0 (baseline) and at T2 (post-intervention, i.e., two weeks after the individual in-person session).). 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 23 Dec 2025.