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Completed

NCT Number: NCT03647605

Pilot Study: 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.

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Key information

Conditions

Social Phobia Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instytut Psychiatrii i Neurologii

Warsaw, Masovian Voivodeship, 02-957, Poland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR Mind

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.

Primary outcomes

  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":

    • The virtual reality immersed me in all aspects (Immersion),
    • The virtual reality resembled true experiences (Reality),
    • 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 outcomes

  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").

Sponsors and collaborators

Lead sponsor

Tomorrow Sp. z o.o.

Industry

Collaborators

  • National Center for Research and Development, Poland

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 27, 2018
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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