VR Mind and VR Mind+ Intervention

Tomorrow Sp. z o.o.

Status: Completed

Conditions: Social Phobia

Treatments: Behavioral: Cognitive Behavioral Therapy; Behavioral: Virtual Reality Exposure Therapy VR Mind; Behavioral: Virtual Reality Exposure Therapy VR Mind+

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03895957

TRR/POIR.01.01.01-00-0636

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Group 1: VR Mind+

Experimental group

Description:

Virtual Reality Exposure Therapy VR Mind+

Treatment:

Behavioral: Virtual Reality Exposure Therapy VR Mind+

Group 2: VR Mind

Experimental group

Description:

Virtual Reality Exposure Therapy VR Mind

Treatment:

Behavioral: Virtual Reality Exposure Therapy VR Mind

Control group: CBT

Active Comparator group

Description:

Cognitive Behavioral Therapy

Treatment:

Behavioral: Cognitive Behavioral Therapy