Social PhobiaNCT03647605
Pilot Study: VR Mind and VR Mind+ Intervention
A study testing VR Mind in people with Social Phobia, run by Tomorrow Sp. z o.o. at 1 site in Poland.
Trial summary
The aim of the pilot study is feasibility, usability and safety assessment of VR Mind intervention. In particular the subject of assessment will be: the length of the laboratory session utilizing virtual reality exposure (feasibility), the ergonomics and ease of use for both patients and system operators (usability)… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Phobia
- What is being tested?
- VR Mind
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePoland
- Study dates
- 13 Sep 2018to 31 Jan 2019
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-50 y.o.
- Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD).
- Signing informed consent
Who cannot join
- Occurrence of SAD symptoms inconsistent with DSM-IV-TR criteria and with psychiatric interview (SCID-I; Structured Clinical Interview)
- Occurrence and/or recognition:
- psychosis,
- bipolar disorder,
- mental retardation
- Exclusion based on interview:
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- pregnancy,
- drug addiction,
- alcohol addiction,
- participating in the experimental session while intoxicated
- (current) neurological treatment of chronic disease of central nervous system,
- epilepsy,
- paroxysmal vertigo,
- presence of suicidal thoughts , tendencies or attempts,
- participant is taking drugs from benzodiazepine group, other sedatives, narcotic drugs
Trial locations and contacts
1 site in 1 country.
Poland1 site
Instytut Psychiatrii i Neurologii
Warsaw, Masovian Voivodeship, 02-957
About this study
Official title: Pilot Study: Feasibility, Usability and Safety Assessment of VR Mind and VR Mind+ Intervention
The aim of the pilot study is feasibility, usability and safety assessment of VR Mind intervention. In particular the subject of assessment will be:
- the length of the laboratory session utilizing virtual reality exposure (feasibility),
- the ergonomics and ease of use for both patients and system operators (usability),
- the frequency of side effect occurrence as a result of virtual reality exposure (ie. Vertigo) (safety).
The results pilot study will be used in the designing a clinical trial aimed for testing efficacy and safety of VR Mind intervention.
Read the detailed description
In this study, investigators will test the software developed by Tomorrow Sp. z o. o., named VR Mind. The software utilizes the concept of virtual reality exposure therapy to treat social anxiety disorder. The pilot investigators will be tested for the feasibility, usability and safety of the system in order to obtain information useful in further designs for the clinical trial. The research consists of four laboratory sessions. The first and the last session will be dedicated to participant assessment. During the second and third session the virtual reality scenarios (2 x 10 minutes for each session) will be presented to participants. The participants will be playing a role of someone who is giving a speech (Public speaking scenario) and someone who is speaking on a phone in public (Telephoning in public scenario).
- Conditions
- Social Phobia
- Being tested
- VR Mind
- Keywords
- vr, virtual reality, social phobia, vret, virtual reality exposure therapy
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR MindBehavioural
Two VR Mind sessions using virtual reality scenarios concerning social situations in which social phobics are prone to experience anxiety. The pilot study will consist of two scenarios: "Public Speaking in Lecture Hall" and "Telephoning in Public". Two sessions are planned, each containing two expositions to virtual reality environment, each lasting 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| VR Mind | Experimental | Two VR Mind sessions using experimental virtual reality scenarios. During these two sessions, participants will be exposed to virtual reality environment, for 2 x 10 min each session. Receives: Behavioral: VR Mind |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility_1: Number of participants, who have completed 4 laboratory sessions within 2 weeks.
Number of participants, who have completed 4 laboratory sessions within 2 weeks.
Measured: At the end of 4th laboratory session within 2 weeks
Feasibility_2: Number of virtual reality exposure sessions completed in predefined time.
Number of virtual reality exposure sessions completed in predefined time.
Measured: At the end of 2nd and 3th laboratory session within 2 weeks
Usability_ 3: immersion, perceived reality and engagement
3 items with 7-point scale, where 1 is "Totally agree" and 7 "Totally disagree":
- The virtual reality immersed me in all aspects (Immersion),
- The virtual reality resembled true experiences (Reality),
- The virtual reality was engaging (Engagement).
Measured: At the end of 2 and 3 laboratory session within 2 weeks
Safety_1: occurrence and severity of simulator sickness
Simulator sickness is expected adverse effect of the VR. Hence, the Simulator Sickness Questionnaire (SSQ; Kennedy, Lane, Berbaum, Lilienthal, 1993) will be administered as a primary outcome measure to evaluate safety of the VR intervention.
Total SSQ score equal to or higher than 10 will be used as a preliminary cut-off for simulator sickness (Balk et al., 2013). Individual scores will be corrected for baseline (pre-VR) symptom severity. Only items with a pre-VR - post-VR increase will contribute to a final SSQ score. All post-intervention SSQ scores >10 will be analyzed further for its association with study drop-outs and other intervention required. The adverse effect will be classified as:
- mild (no intervention required, all VR sessions completed),
- moderate (any intervention needed, e.g. session termination),
- severe (hospitalization required),
- life-threatening / death. Any unexpected adverse effects will be recorded by a physician and classified as described above.
Measured: During 2nd and 3th laboratory session within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start13 Sep 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social PhobiaStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomorrow Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Responsible party
- Sponsor
- Investigators
- Paweł Mierzejewski, prof, Principal investigator, Tomorrow Sp. z o.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647605
- Sponsor's protocol ID
- POIR.01.01.01-00-0636/16-00
- Status last verified
- Jan 2019
- First submitted
- 18 Jun 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Feasibility, Usability and Safety Assessment of VR Mind and VR Mind+ Intervention
- ClinicalTrials.gov ID
- NCT03647605
- Acronym / sponsor ID
- POIR.01.01.01-00-0636/16-00
- Conditions
- Social Phobia
- Keywords
- vr, virtual reality, social phobia, vret, virtual reality exposure therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tomorrow Sp. z o.o.Industry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 27 Aug 2018 (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 aim of the pilot study is feasibility, usability and safety assessment of VR Mind intervention. In particular the subject of assessment will be:
- the length of the laboratory session utilizing virtual reality exposure (feasibility),
- the ergonomics and ease of use for both patients and system operators (usability),
- the frequency of side effect occurrence as a result of virtual reality exposure (ie. Vertigo) (safety).
The results pilot study will be used in the designing a clinical trial aimed for testing efficacy and safety of VR Mind intervention.
Detailed description
In this study, investigators will test the software developed by Tomorrow Sp. z o. o., named VR Mind. The software utilizes the concept of virtual reality exposure therapy to treat social anxiety disorder. The pilot investigators will be tested for the feasibility, usability and safety of the system in order to obtain information useful in further designs for the clinical trial. The research consists of four laboratory sessions. The first and the last session will be dedicated to participant assessment. During the second and third session the virtual reality scenarios (2 x 10 minutes for each session) will be presented to participants. The participants will be playing a role of someone who is giving a speech (Public speaking scenario) and someone who is speaking on a phone in public (Telephoning in public scenario).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR Mind | Experimental | Behavioral: VR MindTwo VR Mind sessions using experimental virtual reality scenarios. During these two sessions, participants will be exposed to virtual reality environment, for 2 x 10 min each session. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18-50 y.o.
- Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD).
- Signing informed consent
Key exclusion criteria (15 listed)
- Occurrence of SAD symptoms inconsistent with DSM-IV-TR criteria and with psychiatric interview (SCID-I; Structured Clinical Interview)
- Occurrence and/or recognition:
- Exclusion based on interview:
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 |
|---|---|---|
| VR MindTwo VR Mind sessions using virtual reality scenarios concerning social situations in which social phobics are prone to experience anxiety. The pilot study will consist of two scenarios: "Public Speaking in Lecture Hall" and "Telephoning in Public". Two sessions are planned, each containing two expositions to virtual reality environment, each lasting 10 minutes. | Behavioural | VR Mind |
Primary outcome
Feasibility_1: Number of participants, who have completed 4 laboratory sessions within 2 weeks.
Time frame: At the end of 4th laboratory session within 2 weeks
Number of participants, who have completed 4 laboratory sessions within 2 weeks.
Feasibility_2: Number of virtual reality exposure sessions completed in predefined time.
Time frame: At the end of 2nd and 3th laboratory session within 2 weeks
Number of virtual reality exposure sessions completed in predefined time.
Usability_ 3: immersion, perceived reality and engagement
Time frame: At the end of 2 and 3 laboratory session within 2 weeks
3 items with 7-point scale, where 1 is "Totally agree" and 7 "Totally disagree": 1. The virtual reality immersed me in all aspects (Immersion), 2. The virtual reality resembled true experiences (Reality), 3. The virtual reality was engaging (Engagement).
Safety_1: occurrence and severity of simulator sickness
Time frame: During 2nd and 3th laboratory session within 2 weeks
Simulator sickness is expected adverse effect of the VR. Hence, the Simulator Sickness Questionnaire (SSQ; Kennedy, Lane, Berbaum, Lilienthal, 1993) will be administered as a primary outcome measure to evaluate safety of the VR intervention. Total SSQ score equal to or higher than 10 will be used as a preliminary cut-off for simulator sickness (Balk et al., 2013). Individual scores will be corrected for baseline (pre-VR) symptom severity. Only items with a pre-VR - post-VR increase will contribute to a final SSQ score. All post-intervention SSQ scores >10 will be analyzed further for its association with study drop-outs and other intervention required. The adverse effect will be classified as: * mild (no intervention required, all VR sessions completed), * moderate (any intervention needed, e.g. session termination), * severe (hospitalization required), * life-threatening / death. Any unexpected adverse effects will be recorded by a physician and classified as described above.
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 12 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Paweł Mierzejewski, prof principal investigator
Tomorrow Sp. z o.o.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Mind in people with Social Phobia, run by Tomorrow Sp. z o.o. at 1 site in Poland.
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 15 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 12 Feb 2019. 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 Poland. 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?
Feasibility_1: Number of participants, who have completed 4 laboratory sessions within 2 weeks. (time frame: At the end of 4th laboratory session within 2 weeks). 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 12 Feb 2019.