Pilot Study: VR Mind and VR Mind+ Intervention

Tomorrow Sp. z o.o.

Status: Completed

Conditions: Social Phobia

Treatments: Behavioral: VR Mind

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03647605

POIR.01.01.01-00-0636/16-00

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

VR Mind

Experimental group

Description:

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.

Treatment:

Behavioral: VR Mind