Pilot Study: VR Mind and VR Mind+ Intervention

NCT ID: NCT03647605

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-13
• Study Completion Date: 2019-01-31

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).

Conditions

Social Phobia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

VR Mind

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.

Group Type: EXPERIMENTAL

VR Mind

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Research and Development, Poland

OTHER

Sponsor Role: collaborator

Tomorrow Sp. z o.o.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paweł Mierzejewski, prof

Role: PRINCIPAL_INVESTIGATOR

Tomorrow Sp. z o.o.

Locations

Instytut Psychiatrii i Neurologii

Warsaw, Masovian Voivodeship, Poland

Countries

Poland

Other Identifiers

POIR.01.01.01-00-0636/16-00

Identifier Type: -

Identifier Source: org_study_id