NCT03895957

VR Mind and VR Mind+ Intervention

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Tomorrow Sp. z o.o. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Social Phobia

Interventions

Type	Name	Description
BEHAVIORAL	Virtual Reality Exposure Therapy VR Mind+	Virtual Reality Exposure Self-Therapy led by a participant
BEHAVIORAL	Virtual Reality Exposure Therapy VR Mind	Treatment with Virtual Reality Exposure Therapy led by a therapist
BEHAVIORAL	Cognitive Behavioral Therapy	Standard treatment for social phobia led by a therapist

Timeline

• Start date: 2019-03-27
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2019-03-29
• Last updated: 2020-02-11

Locations

2 sites across 1 country: Poland