Depressive DisorderEVENNCT06446856
EVEN - Effects of VR on Empathy for Nature in Patients with Psychosis and Depressive Disorders
An observational study of Depressive Disorder and Schizophrenia, run by Charite University, Berlin, Germany at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Schizophrenia, Healthy Control
- What is being tested?
- VR application
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 27 May 2024to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Psychiatric University Hospital Charité at St. Hedwig Hospital
Berlin
About this study
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 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).
- Conditions
- Depressive Disorder, Schizophrenia, Healthy Control
- Being tested
- VR application
- Medical subject headings
- Depressive Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR applicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| VR study group | 20 patients with depressive disorder Receives: Device: VR application | |
| VR active control group | 20 patients with psychotic disorder. Receives: Device: VR application | |
| VR healthy control group | 20 patients with no psychiatric disorder Receives: Device: VR application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For all groups pre and directly post VR exposure
Secondary outcomes (8)
Empathy
Evaluation of empathy with the Multifaceted Empathy Test (MET; (Dziobek et al., 2008) pre and post VR exposure
Measured: 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.
Measured: 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))
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: during (approx. 5 minutes) VR exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start27 May 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Potsdam, Department Erziehungswissenschaft, Arbeitsbereich Schulbezogene Medienbildung
- Responsible party
- Principal investigator, Alva Lütt, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446856
- Sponsor's protocol ID
- EA2/046/24
- Acronym
- EVEN
- Status last verified
- Sep 2024
- First submitted
- 25 May 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lutt A, Lutgens K, Montag C, Gutwinski S, Reuth GF, Nebel S, Bermpohl F, Spangenberger P. Effects of Virtual Nature Embodiment on Compassion, Empathy, Nature Connectedness, and Symptom Burden in Patients With Psychosis or Depression: An Explorative Clinical Study. JMIR Serious Games. 2026 Mar 24;14:e74337. doi: 10.2196/74337.
PubMed 41874554
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06446856
- Acronym / sponsor ID
- EVEN / EA2/046/24
- Conditions
- Depressive Disorder, Schizophrenia, Healthy Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Universität Potsdam, Department Erziehungswissenschaft, Arbeitsbereich Schulbezogene Medienbildung
- Study start
- 27 May 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VR study group | – | Device: VR application20 patients with depressive disorder |
| VR active control group | – | Device: VR application20 patients with psychotic disorder. |
| VR healthy control group | – | Device: VR application20 patients with no psychiatric disorder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR applicationThe 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. | Device | VR active control group, VR healthy control group, VR study group |
Primary outcome
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.
8 secondary outcomes
Empathy
Time frame: For all groups pre and directly post VR exposure (within the same session of 1 hour)
Compassion
Time frame: For all groups pre and directly post VR exposure (within the same session of 1 hour)
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)
Embodiment - Feeling of virtual body ownership
Time frame: post VR exposure for all groups (within the same session of 1 hour)
Spirituality
Time frame: pre VR exposure for all groups
Presence in VR
Time frame: post VR exposure for all groups (within the same session of 1 hour)
Virtual Reality Simulator Sickness
Time frame: post VR exposure for all groups (within the same session of 1 hour)
Explorative evaluation of electrodermal activity (EDA)
Time frame: during (approx. 5 minutes) VR exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Derived from this study: PubMed 41874554Lutt A, Lutgens K, Montag C, Gutwinski S, Reuth GF, Nebel S, Bermpohl F, Spangenberger P. Effects of Virtual Nature Embodiment on Compassion, Empathy, Nature Connectedness, and Symptom Burden in Patients With Psychosis or Depression: An Explorative Clinical Study. JMIR Serious Games. 2026 Mar 24;14:e74337. doi: 10.2196/74337.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder and Schizophrenia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nature Connectedness (time frame: For all groups pre and directly post VR exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06446856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.