Mental WellbeingNCT07108556
Brief Mindfulness Workshop With or Without Virtual Reality: A Pilot Study
A study testing Mindfulness VR-Typical and Mindfulness Typical-VR in people with Mental Wellbeing, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The current study uses a randomized cross-over design, in which participants are exposed to brief mindfulness-based experiential sessions with and without incorporating virtual reality (i.e., the experimental and control conditions, respectively). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Wellbeing
- What is being tested?
- Mindfulness VR-Typical and Mindfulness Typical-VR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Aug 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- aged 18 years or older
- reads Chinese
- understands Cantonese
Who cannot join
- history of sever motion sickness or known intolerance to VR environments
- impairments that may interfere with the use of VR equipment
- concurrent or past structured mindfulness training
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Peter Ho contact
About this study
Official title: Brief Mindfulness Workshop With or Without Virtual Reality: A Randomized Crossover Design
The current study uses a randomized cross-over design, in which participants are exposed to brief mindfulness-based experiential sessions with and without incorporating virtual reality (i.e., the experimental and control conditions, respectively). Order of exposure to these two conditions are counter-balanced and participants are randomized into the two arms of exposure in a different order. Furthermore, this study includes the use of both subjective self-report and objective physiological measures of mental wellbeing. It is hypothesized that VR-incorporated mindfulness-based experiential session brings a greater improvement in state mindfulness, state affect, and stress response. Results shed light on the added value of incorporating VR into brief MBIs, particularly in reference to the typical practice of promoting mindfulness in the local community.
- Conditions
- Mental Wellbeing
- Being tested
- Mindfulness VR-Typical, Mindfulness Typical-VR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness VR-TypicalBehavioural
Participants first experience mindfulness exercise with virtual reality incorporated, then another mindfulness exercise with only audio-guidance as typically delivered without the technology
Mindfulness Typical-VRBehavioural
Participants first experience mindfulness exercise with only audio-guidance, then another mindfulness exercise with virtual reality incorporated
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Add-on (with VR-incorporated first) | Experimental | Mindfulness exercise with virtual reality incorporated as the first experiential session Receives: Behavioral: Mindfulness VR-Typical |
| Mindfulness Typical (audio-only first) | Active comparator | Mindfulness exercise with only audio guidance as the first experiential session Receives: Behavioral: Mindfulness Typical-VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in positive affect as measured by International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) after a brief practice of mindfulness.
Using a 5-point Likert scale from 1 = Never to 5 = Always, individuals rate on their experience of five positive affect in the present moment. Scores are summed across 5 items, with higher scores indicating higher levels of positive affect.
Measured: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).
Change in negative affect as measured by International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) after a brief practice of mindfulness.
Using a 5-point Likert scale from 1 = Never to 5 = Always, individuals rate on their experience of five negative affect in the present moment. Scores are summed across 5 items, with higher scores indicating higher levels of negative affect.
Measured: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).
Change in state mindfulness as measured by the State Mindfulness Scale (SMS) after a brief practice of mindfulness.
Individuals rate their state mindfulness on a 5-point Likert scale across 21 items, from 1 = Not at All to 5 = Very Much. Scores are summed to represent overall mindfulness and two subfactors differentiated by objects of mindfulness - (1) mind and (2) body. Higher scores indicate higher levels of mindfulness at the moment.
Measured: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).
Change in heart rate variability as measured with the Shimmer3 GSR+ (Galvanic Skin Response) unit after a brief practice of mindfulness.
The Shimmer3 GSR+ unit is strapped to a participant's wrist and fingers of the non-dominant hand. An optical pulse sensor is attached to the second finger to collect photoplethysmogram (PPG) signals over a 5-minute period, which are then transformed into HRV measures with artifacts corrected through automated detection using the Kubios HRV Scientific software. Higher values indicate greater heart rate variability.
Measured: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).
Change in skin conductance level as measured with the Shimmer3 GSR+ (Galvanic Skin Response) unit after a brief practice of mindfulness.
The Shimmer3 GSR+ unit is strapped to a participant's wrist and fingers of the non-dominant hand. Two additional electrodes are attached to the third and fourth fingers of the participants' non-dominant hand to collect both phasic and tonic skin conductance data. Higher values indicate greater skin conductance.
Measured: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).
Secondary outcomes (1)
Satisfaction with the intervention as measured by a single Likert item with open text entry designed specifically for this study
Participants complete a service evaluation form that includes rating on a 5-point Likert scale, from 1 - Strongly Disagree to 5 - Strongly Agree, designed specifically to assess their level of satisfaction with the intervention received in the current study. They are also asked in an open-ended way to provide narratives of their experience throughout the encounter.
Measured: At the end of the full program (i.e., one-time assessment; at minute 20).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start2 Aug 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental WellbeingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- New Life Psychiatric Rehabilitation Association
- Responsible party
- Principal investigator, Amanda Kingsze CHEUNG, The University of Hong Kong
- Investigators
- Amanda K Cheung, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108556
- Sponsor's protocol ID
- EA250376
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not covered in informed consent
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Mindfulness Workshop With or Without Virtual Reality: A Randomized Crossover Design
- ClinicalTrials.gov ID
- NCT07108556
- Acronym / sponsor ID
- EA250376
- Conditions
- Mental Wellbeing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- New Life Psychiatric Rehabilitation Association
- Study start
- 2 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 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.
The current study uses a randomized cross-over design, in which participants are exposed to brief mindfulness-based experiential sessions with and without incorporating virtual reality (i.e., the experimental and control conditions, respectively). Order of exposure to these two conditions are counter-balanced and participants are randomized into the two arms of exposure in a different order. Furthermore, this study includes the use of both subjective self-report and objective physiological measures of mental wellbeing. It is hypothesized that VR-incorporated mindfulness-based experiential session brings a greater improvement in state mindfulness, state affect, and stress response. Results shed light on the added value of incorporating VR into brief MBIs, particularly in reference to the typical practice of promoting mindfulness in the local community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Add-on (with VR-incorporated first) | Experimental | Behavioral: Mindfulness VR-TypicalMindfulness exercise with virtual reality incorporated as the first experiential session |
| Mindfulness Typical (audio-only first) | Active comparator | Behavioral: Mindfulness Typical-VRMindfulness exercise with only audio guidance as the first experiential session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 years or older
- reads Chinese
- understands Cantonese
Key exclusion criteria (3 listed)
- history of sever motion sickness or known intolerance to VR environments
- impairments that may interfere with the use of VR equipment
- concurrent or past structured mindfulness training
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 |
|---|---|---|
| Mindfulness VR-TypicalParticipants first experience mindfulness exercise with virtual reality incorporated, then another mindfulness exercise with only audio-guidance as typically delivered without the technology | Behavioural | Mindfulness Add-on (with VR-incorporated first) |
| Mindfulness Typical-VRParticipants first experience mindfulness exercise with only audio-guidance, then another mindfulness exercise with virtual reality incorporated | Behavioural | Mindfulness Typical (audio-only first) |
Primary outcome
Change in positive affect as measured by International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) after a brief practice of mindfulness.
Time frame: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).
Using a 5-point Likert scale from 1 = Never to 5 = Always, individuals rate on their experience of five positive affect in the present moment. Scores are summed across 5 items, with higher scores indicating higher levels of positive affect.
Change in negative affect as measured by International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) after a brief practice of mindfulness.
Time frame: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).
Using a 5-point Likert scale from 1 = Never to 5 = Always, individuals rate on their experience of five negative affect in the present moment. Scores are summed across 5 items, with higher scores indicating higher levels of negative affect.
Change in state mindfulness as measured by the State Mindfulness Scale (SMS) after a brief practice of mindfulness.
Time frame: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).
Individuals rate their state mindfulness on a 5-point Likert scale across 21 items, from 1 = Not at All to 5 = Very Much. Scores are summed to represent overall mindfulness and two subfactors differentiated by objects of mindfulness - (1) mind and (2) body. Higher scores indicate higher levels of mindfulness at the moment.
Change in heart rate variability as measured with the Shimmer3 GSR+ (Galvanic Skin Response) unit after a brief practice of mindfulness.
Time frame: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).
The Shimmer3 GSR+ unit is strapped to a participant's wrist and fingers of the non-dominant hand. An optical pulse sensor is attached to the second finger to collect photoplethysmogram (PPG) signals over a 5-minute period, which are then transformed into HRV measures with artifacts corrected through automated detection using the Kubios HRV Scientific software. Higher values indicate greater heart rate variability.
Change in skin conductance level as measured with the Shimmer3 GSR+ (Galvanic Skin Response) unit after a brief practice of mindfulness.
Time frame: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).
The Shimmer3 GSR+ unit is strapped to a participant's wrist and fingers of the non-dominant hand. Two additional electrodes are attached to the third and fourth fingers of the participants' non-dominant hand to collect both phasic and tonic skin conductance data. Higher values indicate greater skin conductance.
1 secondary outcome
Satisfaction with the intervention as measured by a single Likert item with open text entry designed specifically for this study
Time frame: At the end of the full program (i.e., one-time assessment; at minute 20).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No. Not covered in informed consent
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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.
Peter Ho contact
Amanda K Cheung principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness VR-Typical and Mindfulness Typical-VR in people with Mental Wellbeing, run by The University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 7 Aug 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harry Chung (+852-2319-2103, harrychung@nlpra.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in positive affect as measured by International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) after a brief practice of mindfulness. (time frame: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).). The study lists 5 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 7 Aug 2025.