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

NCT05529797 | Completed

• 1 other identifier: Veovita-VR
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Virtual Reality; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Health Questionnaire (PHQ-9)

  1 week after baseline

Study Arms (2)

Veovita-VR

EXPERIMENTAL

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

Other: Veovita-VR

Care as Usual

NO INTERVENTION

Participants receive CAU.

Interventions

Veovita-VR OTHER

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.

Veovita-VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gaia AG: lead

Study Sites (1)

Gaia AG

Hamburg, 22085, Germany

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Gitta Jacob, PD Dr.

  Gaia AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: September 1, 2022
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)