Pilot Study: VR Mind and VR Mind+ Intervention

Pilot Study: Feasibility, Usability and Safety Assessment of VR Mind and VR Mind+ Intervention

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.

Study Overview

• Status: Completed
• Conditions: Social Phobia
• Intervention / Treatment: Behavioral: VR Mind

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).

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-957
      • Instytut Psychiatrii i Neurologii

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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": The virtual reality immersed me in all aspects (Immersion),; The virtual reality resembled true experiences (Reality),; The virtual reality was engaging (Engagement).	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: 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.	During 2nd and 3th laboratory session within 2 weeks

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tomorrow Sp. z o.o.
• Collaborators: National Center for Research and Development, Poland
• Investigators: Principal Investigator: Paweł Mierzejewski, prof, Tomorrow Sp. z o.o.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: virtual reality; virtual reality exposure therapy; social phobia; vr; vret
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders; Phobia, Social
• Other Study ID Numbers: POIR.01.01.01-00-0636/16-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No