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Completed

NCT Number: NCT06446856

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

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).

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Key information

Conditions

Depressive Disorder Healthy Control Mental Disorders Mood Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Psychiatric University Hospital Charité at St. Hedwig Hospital

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR application

Device

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.

Primary outcomes

  1. Nature Connectedness

    Time frame: For all groups pre and directly post VR exposure

    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.

Secondary outcomes

  1. Empathy

    Time frame: For all groups pre and directly post VR exposure (within the same session of 1 hour)

    Evaluation of empathy with the Multifaceted Empathy Test (MET; (Dziobek et al., 2008) pre and post VR exposure

  2. Compassion

    Time frame: For all groups pre and directly post VR exposure (within the same session of 1 hour)

    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.

  3. symptom burden

    Time frame: 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)

    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))

  4. Embodiment - Feeling of virtual body ownership

    Time frame: post VR exposure for all groups (within the same session of 1 hour)

    Evaluation with a subscale of the Embodiment scale by Ahn et al. (2016) adapted from Slater et al. (2010)

  5. Spirituality

    Time frame: pre VR exposure for all groups

    Evaluation of spirituality using the 4-item short version of the questionnaire "Transpersonales Vertrauen" (Hampel et al., 2019) pre VR exposure.

  6. Presence in VR

    Time frame: post VR exposure for all groups (within the same session of 1 hour)

    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)

  7. Virtual Reality Simulator Sickness

    Time frame: post VR exposure for all groups (within the same session of 1 hour)

    Cyber Sickness as a potential side effect of VR, measured with the Virtual Reality Sickness Questionnaire (Kim et al., 2018)

  8. Explorative evaluation of electrodermal activity (EDA)

    Time frame: during (approx. 5 minutes) VR exposure

    Explorative evaluation of electrodermal activity (EDA), e.g., skin conductance level (SCL) and skin conductance responses (SCR) in micro siemens during VR exposure

Other outcomes

  1. demographic variables

    Time frame: pre VR exposure for all groups

    acquisition of demographic data

  2. comorbidities

    Time frame: pre VR exposure for all groups

    acquisition of psychiatric comorbidities and physical illnesses

  3. symptom severity - psychotic symptoms

    Time frame: 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)

    Assessment of symptom severity with the Positive and Negative Syndrome Scale (PANSS; Kay et al., 1987)

  4. symptom severity - depressive symptoms

    Time frame: 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)

    Assessment of symptom severity with the Beck Depression Inventory (BDI; Beck et al., 1961)

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Universität Potsdam, Department Erziehungswissenschaft, Arbeitsbereich Schulbezogene Medienbildung

Registry information

Official study 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

Acronym: EVEN

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 6, 2024
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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