Clinical trial NCT03895957: VR Mind and VR Mind+ Intervention
Official title: VR Mind™ and VR Mind +™ Intervention - Randomized, Open Label, Single Masking, Parallel Group Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Phobia
Keywords: virtual reality
social phobia
vret
virtual reality exposure therapy
Lead sponsor: Tomorrow Sp. z o.o.
Sponsor class: INDUSTRY
Collaborators: name: National Center for Research and Development, Poland
First posted: 2019-03-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy: Liebowitz Social Anxiety Scale - Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987)
timeFrame: change from baseline: Pre-treatment at session 1, to session 9 (5 weeks) and to post-treatment at session 14 (7 weeks)
measure: Safety: Occurrence and severity of Simulator Sickness - Simulator Sickness Questionnaire (SSQ; Kennedy, Lane, Berbaum, Lilienthal, 1993)
timeFrame: 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)
Secondary outcomes:
measure: Clinical Global Impression
timeFrame: Pre-treatment at session 1
measure: Clinician Global Impressions of Improvement
timeFrame: Post-treatment, approximately 7 weeks after initial session
measure: Patient Global Impression
timeFrame: Pre-treatment at session 1
measure: Patient Global Impressions of Improvement
timeFrame: Post-treatment, approximately 7 weeks after initial session
measure: Beck Depression Inventory
timeFrame: Pre-treatment at session 1 to post-treatment at session 14 (7 weeks)
Other outcomes:
measure: Subjective Units of Distress
timeFrame: Change from session to session with virtual reality exposure during the course of six weeks
Locations:
city: Warsaw
country: Poland
facility: Tomorrow Sp. z o. o.
city: Warsaw
country: Poland
facility: Gabinet Psychoterapii
Study officials:
affiliation: Scientific Council
name: Paweł Mierzejewski, prof.
role: STUDY_CHAIR
affiliation: Scientific Council
name: Przemysław Bieńkowski, prof.
role: STUDY_DIRECTOR
affiliation: Scientific Council
name: Tadeusz Parnowski, prof.
role: STUDY_DIRECTOR
affiliation: Scientific Council
name: Sławomir Murawiec, PH.D.
role: STUDY_DIRECTOR
affiliation: Scientific Council
name: Izabela Stefaniak, M.D.
role: PRINCIPAL_INVESTIGATOR
References: