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

Gaia AG

Status: Completed

Conditions: Depression

Treatments: Other: Veovita-VR

Study type: Interventional

Funder types: Industry

Identifiers

NCT05529797

Veovita-VR

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18 years or older
• PHQ-9 score ≥ 10

Exclusion criteria

• apparent mental health problems other than depression (e.g., diagnosis of substance use disorder, psychotic disorder or bipolar disorder)
• acute suicidality

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Veovita-VR

Experimental group

Description:

Participants receive one VR session with positive emotional stimuli and positive behavioral activation.

Treatment:

Other: Veovita-VR

Care as Usual

No Intervention group

Description:

Participants receive CAU.