EVEN - Effects of VR on Empathy for Nature in Patients with Psychosis and Depressive Disorders (EVEN)

EVEN - Effects of VR on Empathy for Nature in Patients with Psychosis and Depressive Disorders / Effekte Von Virtueller Realität (VR) Auf Naturverbundenheit Und Empathie in Patient:innen Mit Psychotischen Und Depressiven Erkrankungen

Study group: Experimental study to evaluate empathy, compassion, and nature connectedness before and after an immersive virtual reality experience in patients with depressive disorder, patients with psychotic disorder and healthy control subjects (subjects between 18 and 65 years of age).

Primary hypothesis: The increase in nature connectedness explored by virtual body ownership of a tree in VR differs depending on the health condition (schizophrenia, depression, healthy controls).

Study Overview

• Status: Completed
• Conditions: Depressive Disorder; Schizophrenia; Healthy Control
• Intervention / Treatment: Device: VR application

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Psychiatric University Hospital Charité at St. Hedwig Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with depressive or psychotic disorder treated in the inpatient or outpatient psychiatric clinics or day clinics of the Psychiatric University Hospital Charité at St. Hedwig-Hospital

Description

Inclusion Criteria:

• age: 18-65 years
• Inpatients and outpatients treated at the Psychiatric University Clinic of the Charité at St.

Hedwig Hospital

• diagnosis of depressive disorder (ICD-10: F32.X, F33.X) or diagnosis of schizophrenia (F20.X) or healthy controls without psychiatric diagnosis
• able to provide written informed consent

Exclusion Criteria:

• Acute suicidality or danger to others
• Primarily treatment-requiring eating disorder
• Acute dermatological condition affecting the hands that can distort skin conductivity measurements
• Control group: psychiatric or psychosomatic pre-diagnoses (except for the psychiatric active control group), other exclusion diagnoses corresponding to the patient group

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VR study group; 20 patients with depressive disorder	Device: VR application; The VR application consists of a software ("Tree") developed as part of a research project at MIT and legally acquired via the HTC store Viveport. Duration of the VR application: approx. 5 min.
VR active control group; 20 patients with psychotic disorder.	Device: VR application; The VR application consists of a software ("Tree") developed as part of a research project at MIT and legally acquired via the HTC store Viveport. Duration of the VR application: approx. 5 min.
VR healthy control group; 20 patients with no psychiatric disorder	Device: VR application; The VR application consists of a software ("Tree") developed as part of a research project at MIT and legally acquired via the HTC store Viveport. Duration of the VR application: approx. 5 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nature Connectedness	Measurement of Nature Connectedness as a state with the "Inclusion of Nature in Self" (INS)-Questionnaire (Kleespies et al., 2021), pre and post VR exposure.	For all groups pre and directly post VR exposure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Empathy	Evaluation of empathy with the Multifaceted Empathy Test (MET; (Dziobek et al., 2008) pre and post VR exposure	For all groups pre and directly post VR exposure (within the same session of 1 hour)
Compassion	Evaluation of Compassion (state compassion) pre and post VR exposure with the Positive and Negative Affect Schedule (PANAS) and five integrated items measuring compassion based on Pfattheicher et al., 2015.	For all groups pre and directly post VR exposure (within the same session of 1 hour)
symptom burden	Measured with the PANAS (see above) and with the Visual Analogue Scale (0-10) measuring the burden of the 3 main symptoms, previously specified during assessment of symptom severity (PANSS; (Kay et al., 1987) and Beck Depression Inventory (BDI, Beck et al., 1961))	For the VR study group (patients with depressive disorder) and VR active control group (patients with psychotic disorder) pre and post VR exposure (within the same session of 1 hour)
Embodiment - Feeling of virtual body ownership	Evaluation with a subscale of the Embodiment scale by Ahn et al. (2016) adapted from Slater et al. (2010)	post VR exposure for all groups (within the same session of 1 hour)
Spirituality	Evaluation of spirituality using the 4-item short version of the questionnaire "Transpersonales Vertrauen" (Hampel et al., 2019) pre VR exposure.	pre VR exposure for all groups
Presence in VR	Scale according to Ahn et al. (Ahn et al., 2016), adapted from the "Spatial Presence scale" by Bailenson et al. (2005) - own German translation adapted to the virtual Amazon forest area (Spangenberger et al., 2024)	post VR exposure for all groups (within the same session of 1 hour)
Virtual Reality Simulator Sickness	Cyber Sickness as a potential side effect of VR, measured with the Virtual Reality Sickness Questionnaire (Kim et al., 2018)	post VR exposure for all groups (within the same session of 1 hour)
Explorative evaluation of electrodermal activity (EDA)	Explorative evaluation of electrodermal activity (EDA), e.g., skin conductance level (SCL) and skin conductance responses (SCR) in micro siemens during VR exposure	during (approx. 5 minutes) VR exposure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
demographic variables	acquisition of demographic data	pre VR exposure for all groups
comorbidities	acquisition of psychiatric comorbidities and physical illnesses	pre VR exposure for all groups
symptom severity - psychotic symptoms	Assessment of symptom severity with the Positive and Negative Syndrome Scale (PANSS; Kay et al., 1987)	For the VR study group (patients with depressive disorder) and VR active control group (patients with psychotic disorder) pre VR exposure (within the same session of 1 hour)
symptom severity - depressive symptoms	Assessment of symptom severity with the Beck Depression Inventory (BDI; Beck et al., 1961)	For the VR study group (patients with depressive disorder) and VR active control group (patients with psychotic disorder) pre VR exposure (within the same session of 1 hour)

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Universität Potsdam, Department Erziehungswissenschaft, Arbeitsbereich Schulbezogene Medienbildung

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: May 25, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Depression; Depressive Disorder; Schizophrenia
• Other Study ID Numbers: EA2/046/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No