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Pilot Study: VR Mind and VR Mind+ Intervention

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ClinicalTrials.gov Identifier: NCT03647605
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
The National Centre for Research and Development
Information provided by (Responsible Party):
Tomorrow Sp. z o.o.

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.


Condition or disease Intervention/treatment Phase
Social Phobia Behavioral: VR Mind Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Study: Feasibility, Usability and Safety Assessment of VR Mind and VR Mind+ Intervention
Actual Study Start Date : September 13, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

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.




Primary Outcome Measures :
  1. Feasibility_1: Number of participants, who have completed 4 laboratory sessions within 2 weeks. [ Time Frame: At the end of 4th laboratory session within 2 weeks ]
    Number of participants, who have completed 4 laboratory sessions within 2 weeks.

  2. Feasibility_2: Number of virtual reality exposure sessions completed in predefined time. [ Time Frame: At the end of 2nd and 3th laboratory session within 2 weeks ]
    Number of virtual reality exposure sessions completed in predefined time.

  3. Usability_ 3: immersion, perceived reality and engagement [ Time Frame: At the end of 2 and 3 laboratory session within 2 weeks ]

    3 items with 7-point scale, where 1 is "Totally agree" and 7 "Totally disagree":

    1. The virtual reality immersed me in all aspects (Immersion),
    2. The virtual reality resembled true experiences (Reality),
    3. The virtual reality was engaging (Engagement).

  4. Safety_1: occurrence and severity of simulator sickness [ Time Frame: During 2nd and 3th laboratory session within 2 weeks ]

    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.


Other Outcome Measures:
  1. Clinical Global Impression [ Time Frame: During 1st and 4th session within 2 weeks ]
    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".

  2. Patient Global Impression [ Time Frame: During 1st and 4th session within 2 weeks ]
    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".

  3. Liebowitz Social Anxiety Scale [ Time Frame: During 1st and 4th session within 2 weeks ]

    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).


  4. Beck Depression Inventory [ Time Frame: During 1st and 4th session within 2 weeks ]
  5. Subjective Units of Distress [ Time Frame: During 2nd and 3th session within 2 weeks ]

    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").




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647605


Locations
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Poland
Instytut Psychiatrii i Neurologii
Warszawa, Mazowieckie, Poland, 02-957
Sponsors and Collaborators
Tomorrow Sp. z o.o.
The National Centre for Research and Development
Investigators
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Principal Investigator: Paweł Mierzejewski, prof Tomorrow Sp. z o.o.

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Responsible Party: Tomorrow Sp. z o.o.
ClinicalTrials.gov Identifier: NCT03647605     History of Changes
Other Study ID Numbers: POIR.01.01.01-00-0636/16-00
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tomorrow Sp. z o.o.:
vr
virtual reality
social phobia
vret
virtual reality exposure therapy

Additional relevant MeSH terms:
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Phobia, Social
Phobic Disorders
Anxiety Disorders
Mental Disorders