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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05529797
• Other study ID #: Veovita-VR
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: May 25, 2023

Study information

• Verified date: June 2023
• Source: Gaia AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 25, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

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.

Locations

Country	Name	City	State
Germany	Gaia AG	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Gaia AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a well-validated nine-item self-report questionnaire developed to score each of the nine DSM-IV criteria for major depressive disorder on a 4-point Likert scale, from "0" (not at all) to "3" (nearly every day).	4 weeks after baseline
Secondary	Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a well-validated nine-item self-report questionnaire developed to score each of the nine DSM-IV criteria for major depressive disorder on a 4-point Likert scale, from "0" (not at all) to "3" (nearly every day).	1 week after baseline