The company Gaia AG is commencing recruitment for the clinical trial of the Effect of a Single Virtual Reality Exposure on Depressive Symptoms (Veovita-VR): Randomized Controlled Trial.
The trial officially began on the September 1, 2022 and is planned to complete on April 30, 2023.
The trial aims to evaluate the effectiveness of a novel virtual reality (VR) intervention (Veovita-VR) designed to expose people with at least moderate depressive symptoms to positive emotional stimuli and positive behavioral activation, thereby reducing depressive symptoms.
Therefore, 128 people with at least moderate depressive symptoms (operationalized as a Patient Health Questionnaire (PHQ-9) score ≥ 10) will be recruited and randomized into two groups:
(1) a control group that may undergo depression treatment (Care-as-Usual, CAU) and receive access to Veovita-VR 5 weeks post-baseline (i.e., CAU control group), or
(2) to an intervention group that receives one Veovita-VR session immediately after randomization and may also use CAU.
The primary endpoint is depressive symptom level as assessed with the Patient Health Questionnaire (PHQ-9) 4 weeks post-baseline. Additionally, depressive symptoms (PHQ-9) will be assessed 1 week post-baseline.
The complete study profile, including the investigator's contact details, can be found here: https://ichgcp.net/clinical-trials-registry/NCT05529797.