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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06446856
Other study ID # EA2/046/24
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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