WP3: Clinical trials
3.1. Feasibility study
What do patients and therapists think about the VR8 system?
The feasibility study is a preparatory step for the VR8 system to be tested in a randomized study. Feasibility deals with the usability of the system as well as the likelihood that patients and therapists will use and benefit from the system. To examine the treatment, at least 10 patients and 5 clinicians from the Psychiatry in the Region of Southern Denmark will be invited to participate in the testing of the VR8 system. Patients and clinicians will be interviewed for their user experience.
The feasibility study will take place in close collaboration with the development work in work package 2. This will allow the experience of testing the equipment to contribute to the development process.
The goal of the feasibility study is to ensure a satisfactory product for the subsequent RCT study, so that the development work will not have to be done in parallel with the real test of the treatment effect.
3.2. Randomized controlled trial
The randomized controlled trial (RCT) intends to measure the treatment effect using the VR8 system once it has been tested and developed through the feasibility study.
The treatment will take place as a 10-week course of treatment based on cognitive behavioral therapy, but with the exposure exercises delivered through VR. 180 people with social phobia will be divided into 3 groups:
- Case Group: Will be offered the treatment program.
- VR Placebo: Will receive a neutral VR simulation for 10 weeks.
- Waiting list: Will be on waiting list for 10 weeks and then be randomized to one of the other groups.
The goal of the RCT study is to investigate the effect of using VR-based exposure with biofeedback to treat social phobia. Through the study we hope to be able to demonstrate a similar or better treatment effect than traditional exposure therapy.
Robin Niels Kok
Manager of work package 'Clinical trials'
Assistant professor at the Department of Psychology,
member of INSIDE and senior researcher at CIMT –
Center for Innovative Medical Technology.
Psychologist and PhD.
Mathias Torp Ernst
Researcher in the 'Feasibility study'
Psychologist at Centre for Telepsychiatry,
Internet Psychiatry and the Telepsychiatric Research Unit.