Clinical trial NCT06446856: EVEN - Effects of VR on Empathy for Nature in Patients with Psychosis and Depressive Disorders
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder
Schizophrenia
Healthy Control
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Universität Potsdam, Department Erziehungswissenschaft, Arbeitsbereich Schulbezogene Medienbildung
First posted: 2024-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Nature Connectedness
timeFrame: For all groups pre and directly post VR exposure
Secondary outcomes:
measure: Empathy
timeFrame: For all groups pre and directly post VR exposure (within the same session of 1 hour)
measure: Compassion
timeFrame: For all groups pre and directly post VR exposure (within the same session of 1 hour)
measure: symptom burden
timeFrame: 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)
measure: Embodiment - Feeling of virtual body ownership
timeFrame: post VR exposure for all groups (within the same session of 1 hour)
measure: Spirituality
timeFrame: pre VR exposure for all groups
measure: Presence in VR
timeFrame: post VR exposure for all groups (within the same session of 1 hour)
measure: Virtual Reality Simulator Sickness
timeFrame: post VR exposure for all groups (within the same session of 1 hour)
measure: Explorative evaluation of electrodermal activity (EDA)
timeFrame: during (approx. 5 minutes) VR exposure
Other outcomes:
measure: demographic variables
timeFrame: pre VR exposure for all groups
measure: comorbidities
timeFrame: pre VR exposure for all groups
measure: symptom severity - psychotic symptoms
timeFrame: 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)
measure: symptom severity - depressive symptoms
timeFrame: 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)
Locations:
city: Berlin
country: Germany
facility: Psychiatric University Hospital Charité at St. Hedwig Hospital
Study officials:
References: