NCT05529797

Effect of a Single Virtual Reality Exposure on Depressive Symptoms (Veovita-VR)

Effect of a Single Virtual Reality Exposure on Depressive Symptoms (Veovita-VR): Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Gaia AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 adults 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.

Conditions

• Depression

Interventions

Type	Name	Description
OTHER	Veovita-VR	Veovita-VR is a VR intervention with positive emotional stimuli and positive behavioral activation designed to reduce depressive symptoms in people with at least moderate depressive symptoms. In the VR session, the participants stay in a beautiful environment (island, sandy beach, beautiful scenery). They can engage in activities that are perceived as positive (climbing, treasure hunting, listening to music, building sandcastles). The session has a length of approx. 30 minutes. Participants are free to continue to engage with any treatment they require during the duration of the study.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-05-25
• Completion: 2023-05-25
• First posted: 2022-09-07
• Last updated: 2023-06-15

Locations

1 site across 1 country: Germany