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

Not Applicable

Completed

• Conditions: Depression
• Interventions: Other: Veovita-VR

• Registration Number: NCT05529797
• Lead Sponsor: Gaia AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Primary Completion: 2023-05-25
• Study Completion: 2023-05-25
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Veovita-VR	Veovita-VR	Participants receive one VR session with positive emotional stimuli and positive behavioral activation.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)	4 weeks after baseline	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).

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)	1 week after baseline	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).

Trial Locations

Locations (1)

Gaia AG; 🇩🇪 Hamburg, Germany