Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Research and Development, Poland | OTHER |
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR Mind | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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":
| 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:
| During 2nd and 3th laboratory session within 2 weeks |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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". | During 1st and 4th session within 2 weeks |
| Patient Global Impression |
Inclusion Criteria:
Exclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paweł Mierzejewski, prof | Tomorrow Sp. z o.o. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instytut Psychiatrii i Neurologii | Warsaw | Masovian Voivodeship | 02-957 | Poland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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". |
| 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). | During 1st and 4th session within 2 weeks |
| Beck Depression Inventory | 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"). | During 2nd and 3th session within 2 weeks |