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

NCT05529797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2023-06-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Gaia AG

    lead INDUSTRY

Principal Investigators

  • Gitta Jacob, PD Dr. · Gaia AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-05-25
Completion
2023-05-25

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05529797 on ClinicalTrials.gov