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Completed

NCT Number: NCT03895957

VR Mind and VR Mind+ Intervention

The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions.

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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

Gabinet Psychoterapii, Warsaw, Poland

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About this study

In this study, investigators will test the software developed by Tomorrow Sp. z o. o., named VR Mind and VR Mind+. The software utilizes the concept of virtual reality exposure therapy to treat social anxiety disorder. The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions.

The research consists of fourteen sessions. The first and the last session will be dedicated to participant assessment. Subsequent sessions 2-13 will be performed according to the therapy protocol for each arm. Control group of participants (active comparative arm) will receive standard treatment for social anxiety disorder - cognitive behavioral therapy based on the protocol developed by the Principal Investigator [protocol adapted from the approach of Clark and Wells (Mayo-Wilson, Dias, Mavranezouli, 2014)]. Experimental group 1 will receive cognitive behavioral therapy with exposure in virtual environment. Experimental group 1 and control group were designed to be as similar as possible, with the exception of the modality for the delivery of exposure. All treatment session will be led by licensed therapist.

Participants of the experimental group 2 will independently conducts the self-therapy process. The intervention will consist of 12 therapeutic sessions. At each of the 12 sessions, the participant will selects a specific scenario of social situations that arouse fear (e.g. public speaking, job interview or other situations from everyday life).

Because of the risk of simulator sickness (e.g., headaches, nausea), exposure trials will last no longer than 20 minutes for each session.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD).
  • Signing informed consent
  • Unchanged doses of psychotropic medications within 3 months prior to baseline assessment and no change is anticipated

Exclusion criteria

  • occurrence of SAD symptoms inconsistent with DSM-IV-TR criteria and with psychiatric interview (SCID-I; Structured Clinical Interview)
  • psychosis,
  • bipolar disorder,
  • mental retardation
  • pregnancy,
  • drug addiction,
  • alcohol addiction,
  • psychoactive substances 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
  • current CBT treatment for Social Anxiety Disorder

Treatment and study plan

Virtual Reality Exposure Therapy VR Mind+

Behavioral

Virtual Reality Exposure Self-Therapy led by a participant

Virtual Reality Exposure Therapy VR Mind

Behavioral

Treatment with Virtual Reality Exposure Therapy led by a therapist

Cognitive behavioral therapy

Behavioral

Standard treatment for social phobia led by a therapist

Primary outcomes

  1. Efficacy: Liebowitz Social Anxiety Scale - Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987)

    Time frame: change from baseline: Pre-treatment at session 1, to session 9 (5 weeks) and to post-treatment at session 14 (7 weeks)

    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).

  2. Safety: Occurrence and severity of Simulator Sickness - Simulator Sickness Questionnaire (SSQ; Kennedy, Lane, Berbaum, Lilienthal, 1993)

    Time frame: Change from session to session with virtual reality exposure: at session 1, session 7 (4 weeks), session 8 (4 weeks), session 10 (5 weeks), session 11 (6 weeks) and session 12 (6 weeks)

    Simulator sickness is expected adverse effect of the VR.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),
    • moderate (any intervention needed, e.g. session termination),
    • severe (hospitalization required),
    • life-threatening / death.

    Some of the symptoms of anxiety may produce similar side effects as a simulator sickness. The results obtained in this case will be false positive. Therefore assessment of side effects for each case will be verified if the increase in SSQ score was triggered by rapid relapse of phobia symptoms.

Secondary outcomes

  1. Clinical Global Impression

    Time frame: Pre-treatment at session 1

    Clinical Global Impression (CGI; Guy, 1976) - is a single item, 7 point scale used by clinicians to assess 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. Clinician Global Impressions of Improvement

    Time frame: Post-treatment, approximately 7 weeks after initial session

    Global measure of change in severity of symptoms, ranging from 1 labeled as " Very much improved" to 7 labeled as "Very much worse".

  3. Patient Global Impression

    Time frame: Pre-treatment at session 1

    Patient Global Impression - is a single item, 4 point scale used by patients to assess 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".

  4. Patient Global Impressions of Improvement

    Time frame: Post-treatment, approximately 7 weeks after initial session

    Global measure of change in severity of symptoms, where 1 is labeled as "No change" and 7 is labeled as " Very much improved ".

  5. Beck Depression Inventory

    Time frame: Pre-treatment at session 1 to post-treatment at session 14 (7 weeks)

    A 21-question multiple-choice self-report inventory for measuring the severity of depression. Each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original:

    0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression

Other outcomes

  1. Subjective Units of Distress

    Time frame: Change from session to session with virtual reality exposure during the course of six 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

VR Mind™ and VR Mind +™ Intervention - Randomized, Open Label, Single Masking, Parallel Group Clinical Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2019
Registry last updated
Feb 11, 2020

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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