WP3: Clinical trials

Work package 3 in VR8 is the two clinical trials that together investigate the usefulness and treatment effect of the VR8 system.

3.1. Feasibility study

What do patients and clinicians think about the VR8 system?

The feasibility study is a preparatory step for the VR8 system to be used in a randomized controlled study. Feasibility deals with the usability of the system as well as the likelihood that patients and clinicians will use and benefit from the system, approx. 10 individuals with social anxiety, 10 individuals witouht anxiety, anf 5 clinicians from the Mental Health services in the Region of Southern Denmark will be invited to participate in the testing of the Vr8 system. Patients and clinicians will be interviewed with focus in the user experince.

The feasibility study will be carried out in close collaboration with the development work in work package 2. This will ensure the experiences from testing the equipment contribute to the development process. 

The goal of the feasibility study is to ensure the best possible product for the following RCT study. 

3.2. Randomized controlled trial

The randomized controlled trial (RCT) intends to measure the treatment effect using the VR8 system for people with social anxiety. Through the study, we hope to demonstrate a similar or better treatment effect than traditionel exposure therapy. 

This study will include 86 patietns. The patiens will be randomly allocated to one of the two types of treatment described below. Both treatment types include 10 weeks of therapy and consists of one weekly session with a therapist. The treatment will be based on cognitive behavioral therapy. 

Treatment 1: Cognitive behavioural therapy assisted by Virtual Reality with biofeedback
The sessions will focus on and work with thoughts, feelings, behaviour and bodily reactions that maintain the anxiety. During the session, there will be exposure exercises in virtual reality combined with biofeedback. There will also be tasks to do at home for example exposure exercises in real life.

Treatment 2: Cognitive behavioural therapy (traditional exposure therapy)
The sessions will focus on and work with thoughts, feelings, behaviour, and bodily reacion. There will be no exposure exercises during the therapy session but there will be tasks to do at home for example exposure exercises in real life.

Billede af arbejdspakkelederen af de kliniske forsøg: Tonny Elmose Andersen

Tonny Elmose Andersen

Work package leader for 'Clinical trials'

Associate Professor at the Department of Psychology, University of Southern Denmark. Psychologist and PhD.

Billede af Mathias Torp Ernst som er forsker i feasibility studiet

Mathias Torp Ernst

Researcher in the 'Feasibility study'

Psychologist at Centre for Digital Psychiatry, Research Unit.

Billede af Per Trads Ørskov som er forsker i det randomiserede kontrollerede studie

Per Trads Ørskov

Researcher in the 'Randomized controlled trial'

Postdoc at Centre for Digital Psyciatry, Research Unit. Psychologist and PhD.

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