Clinical trial NCT03647605: Pilot Study: VR Mind and VR Mind+ Intervention
Official title: Pilot Study: Feasibility, Usability and Safety Assessment of VR Mind and VR Mind+ Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Phobia
Keywords: vr
virtual reality
social phobia
vret
virtual reality exposure therapy
Lead sponsor: Tomorrow Sp. z o.o.
Sponsor class: INDUSTRY
Collaborators: name: National Center for Research and Development, Poland
First posted: 2018-08-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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),
* 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).

Eligibility criteria: Inclusion Criteria:

1. Age: 18-50 y.o.
2. Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD).
3. Signing informed consent

Exclusion Criteria:

1. Occurrence of SAD symptoms inconsistent with DSM-IV-TR criteria and with psychiatric interview (SCID-I; Structured Clinical Interview)
2. Occurrence and/or recognition:

   1. psychosis,
   2. bipolar disorder,
   3. mental retardation
3. Exclusion based on interview:

   1. pregnancy,
   2. drug addiction,
   3. alcohol addiction,
   4. participating in the experimental session while intoxicated
   5. (current) neurological treatment of chronic disease of central nervous system,
   6. epilepsy,
   7. paroxysmal vertigo,
   8. presence of suicidal thoughts , tendencies or attempts,
   9. participant is taking drugs from benzodiazepine group, other sedatives, narcotic drugs

Primary outcomes:
measure: Feasibility_1: Number of participants, who have completed 4 laboratory sessions within 2 weeks.
timeFrame: At the end of 4th laboratory session within 2 weeks
measure: Feasibility_2: Number of virtual reality exposure sessions completed in predefined time.
timeFrame: At the end of 2nd and 3th laboratory session within 2 weeks
measure: Usability_ 3: immersion, perceived reality and engagement
timeFrame: At the end of 2 and 3 laboratory session within 2 weeks
measure: Safety_1: occurrence and severity of simulator sickness
timeFrame: During 2nd and 3th laboratory session within 2 weeks
Secondary outcomes:
Other outcomes:
measure: Clinical Global Impression
timeFrame: During 1st and 4th session within 2 weeks
measure: Patient Global Impression
timeFrame: During 1st and 4th session within 2 weeks
measure: Liebowitz Social Anxiety Scale
timeFrame: During 1st and 4th session within 2 weeks
measure: Beck Depression Inventory
timeFrame: During 1st and 4th session within 2 weeks
measure: Subjective Units of Distress
timeFrame: During 2nd and 3th session within 2 weeks
Locations:
city: Warszawa
country: Poland
facility: Instytut Psychiatrii i Neurologii
state: Mazowieckie
Study officials:
affiliation: Tomorrow Sp. z o.o.
name: Paweł Mierzejewski, prof
role: PRINCIPAL_INVESTIGATOR
References: