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Pilot Study: VR Mind and VR Mind+ Intervention

11. februar 2019 oppdatert av: Tomorrow Sp. z o.o.

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Faktiske)

10

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 50 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility_1: Number of participants, who have completed 4 laboratory sessions within 2 weeks.
Tidsramme: At the end of 4th laboratory session 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.
Tidsramme: At the end of 2nd and 3th laboratory session within 2 weeks
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
Tidsramme: 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).
At the end of 2 and 3 laboratory session within 2 weeks
Safety_1: occurrence and severity of simulator sickness
Tidsramme: 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.
During 2nd and 3th laboratory session within 2 weeks

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical Global Impression
Tidsramme: 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".
During 1st and 4th session within 2 weeks
Patient Global Impression
Tidsramme: 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".
During 1st and 4th session within 2 weeks
Liebowitz Social Anxiety Scale
Tidsramme: 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).
During 1st and 4th session within 2 weeks
Beck Depression Inventory
Tidsramme: During 1st and 4th session within 2 weeks
During 1st and 4th session within 2 weeks
Subjective Units of Distress
Tidsramme: 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").
During 2nd and 3th session within 2 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tomorrow Sp. z o.o.

Samarbeidspartnere

National Center for Research and Development, Poland

Etterforskere

  • Hovedetterforsker: Paweł Mierzejewski, prof, Tomorrow Sp. z o.o.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. september 2018

Primær fullføring (Faktiske)

31. januar 2019

Studiet fullført (Faktiske)

31. januar 2019

Datoer for studieregistrering

Først innsendt

18. juni 2018

Først innsendt som oppfylte QC-kriteriene

24. august 2018

Først lagt ut (Faktiske)

27. august 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. februar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. februar 2019

Sist bekreftet

1. januar 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • POIR.01.01.01-00-0636/16-00

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