Pilot Study: VR Mind and VR Mind+ Intervention

NCT03647605 | Completed

• 1 other identifier: POIR.01.01.01-00-0636/16-00
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Phobia

Keywords

vr; virtual reality; social phobia; vret; virtual reality exposure therapy

Outcome Measures

Primary Outcomes (4)

• 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": 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).

  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 Outcomes (5)

• Clinical Global Impression

  During 1st and 4th session within 2 weeks

• Patient Global Impression

  During 1st and 4th session within 2 weeks

• Liebowitz Social Anxiety Scale

  During 1st and 4th session within 2 weeks

Study Arms (1)

VR Mind

EXPERIMENTAL

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

Interventions

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.

VR Mind

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-50 y.o.
• Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD).
• Signing informed consent

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Tomorrow Sp. z o.o.: lead
• National Center for Research and Development, Poland: collaborator

Study Sites (1)

Instytut Psychiatrii i Neurologii

Warsaw, Masovian Voivodeship, 02-957, Poland

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Paweł Mierzejewski, prof

  Tomorrow Sp. z o.o.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: August 27, 2018
• Study Start: September 13, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: February 12, 2019

Record last verified: 2019-01

Locations

PL (1)