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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Other: Veovita-VR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Veovita-VR<br>Participants receive one VR session with positive emotional stimuli and positive behavioral activation. | Other: Veovita-VR<br>* 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.<br>|
| No Intervention: Care as Usual<br>Participants receive CAU. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Depression