EVEN - Effects of VR on Empathy for Nature in Patients With Psychosis and Depressive Disorders

Schizophrenia Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06446856
• Other study ID #: EA2/046/24
• Status: Recruiting
• Start date: May 27, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Charite University, Berlin, Germany
• Contact: Alva Lütt, Dr. med.
• Phone: 03023110
• Email: alva.luett[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Healthy Control
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Germany	Psychiatric University Hospital Charité at St. Hedwig Hospital	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Universität Potsdam, Department Erziehungswissenschaft, Arbeitsbereich Schulbezogene Medienbildung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	demographic variables	acquisition of demographic data	pre VR exposure for all groups
Other	comorbidities	acquisition of psychiatric comorbidities and physical illnesses	pre VR exposure for all groups
Other	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)
Other	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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