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Pilot Study: VR Mind and VR Mind+ Intervention

Primary Purpose

Social Phobia

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
VR Mind
Sponsored by
Tomorrow Sp. z o.o.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Social Phobia focused on measuring vr, virtual reality, social phobia, vret, virtual reality exposure therapy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Instytut Psychiatrii i Neurologii

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VR Mind

Arm 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.

Outcomes

Primary Outcome Measures

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.
Feasibility_2: Number of virtual reality exposure sessions completed in predefined time.
Number of virtual reality exposure sessions completed in predefined time.
Usability_ 3: immersion, perceived reality and engagement
3 items with 7-point scale, where 1 is "Totally agree" and 7 "Totally disagree": The virtual reality immersed me in all aspects (Immersion), The virtual reality resembled true experiences (Reality), The virtual reality was engaging (Engagement).
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.

Secondary Outcome Measures

Full Information

First Posted
June 18, 2018
Last Updated
February 11, 2019
Sponsor
Tomorrow Sp. z o.o.
Collaborators
National Center for Research and Development, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT03647605
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 13, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tomorrow Sp. z o.o.
Collaborators
National Center for Research and Development, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
Keywords
vr, virtual reality, social phobia, vret, virtual reality exposure therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR Mind
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
VR Mind
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility_1: Number of participants, who have completed 4 laboratory sessions within 2 weeks.
Description
Number of participants, who have completed 4 laboratory sessions within 2 weeks.
Time Frame
At the end of 4th laboratory session within 2 weeks
Title
Feasibility_2: Number of virtual reality exposure sessions completed in predefined time.
Description
Number of virtual reality exposure sessions completed in predefined time.
Time Frame
At the end of 2nd and 3th laboratory session within 2 weeks
Title
Usability_ 3: immersion, perceived reality and engagement
Description
3 items with 7-point scale, where 1 is "Totally agree" and 7 "Totally disagree": The virtual reality immersed me in all aspects (Immersion), The virtual reality resembled true experiences (Reality), The virtual reality was engaging (Engagement).
Time Frame
At the end of 2 and 3 laboratory session within 2 weeks
Title
Safety_1: occurrence and severity of simulator sickness
Description
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
Other Pre-specified Outcome Measures:
Title
Clinical Global Impression
Description
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
Title
Patient Global Impression
Description
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
Title
Liebowitz Social Anxiety Scale
Description
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
Title
Beck Depression Inventory
Time Frame
During 1st and 4th session within 2 weeks
Title
Subjective Units of Distress
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: 18-50 y.o. Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD). Signing informed consent 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: psychosis, bipolar disorder, mental retardation Exclusion based on interview: pregnancy, drug addiction, alcohol addiction, participating in the experimental session while intoxicated (current) neurological treatment of chronic disease of central nervous system, epilepsy, paroxysmal vertigo, presence of suicidal thoughts , tendencies or attempts, participant is taking drugs from benzodiazepine group, other sedatives, narcotic drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paweł Mierzejewski, prof
Organizational Affiliation
Tomorrow Sp. z o.o.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instytut Psychiatrii i Neurologii
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-957
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Pilot Study: VR Mind and VR Mind+ Intervention

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