An interventional study of VR Mind in Social Phobia, sponsored by Tomorrow Sp. z o.o.. Completed at 1 site in Poland. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-12.
Sponsored by Tomorrow Sp. z o.o. · Not applicable, Interventional, and Other
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 results pilot study will be used in the designing a clinical trial aimed for testing efficacy and safety of VR Mind intervention.
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).
353 studies on the registry are indexed under Phobia, Social; 58 are open to participants now.
This study's enrollment of 10 is below the median of 77 across 325 interventional studies indexed under Phobia, Social.
Browse Phobia, Social studies →Tomorrow Sp. z o.o. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Occurrence and/or recognition:
Exclusion based on interview:
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.
Behavioral: VR Mind
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.
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.
Time frame: 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.
Time frame: 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": 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).
Time frame: 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.
Time frame: During 2nd and 3th laboratory session within 2 weeks
Clinical Global Impression
Clinical Global Impression (Guy, 1976) - is a single item, 7 point scale used by clinicians to asses the severity of illness, where 1 is labeled as "Normal, not at all ill" and 7 is labeled as "Among the most extremely ill patients".
Time frame: During 1st and 4th session within 2 weeks
Patient Global Impression
Patient Global Impression - is a single item, 4 point scale used by patients to asses their impression of severity of their illness and quality of their functioning in everyday life, where 1 is labeled as "Normal" and 4 is labeled as "Severe".
Time frame: During 1st and 4th session within 2 weeks
Liebowitz Social Anxiety Scale
Liebowitz Social Anxiety Scale (LSAS; Leibowitz, 1987) The scale is composed of 24 items, depicting various social situations. For each item, participants assess their fear (from 1 - "No fear" to 4 - "Severe") and avoidance (from 1 - "Never" to 4 - "Usually"). LSAS has 3 scores, summing the results for particular items - fear (0-72), avoidance (0-72) and total score (0-144).
Time frame: During 1st and 4th session within 2 weeks
Beck Depression Inventory
Time frame: During 1st and 4th session within 2 weeks
Subjective Units of Distress
Subjective Units of Distress (SUD) SUD is a subjective measure of perceived fear in certain situation. The scale range is from 0 ("Totally relaxed) to 100 ("Highest distress/fear/anxiety/discomfort that you have ever felt").
Time frame: During 2nd and 3th session within 2 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tomorrow Sp. z o.o.