Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-02 @ 8:12 AM
Study NCT ID:
NCT06446856
Status:
COMPLETED
Last Update Posted:
2024-09-20
First Post:
2024-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EVEN - Effects of VR on Empathy for Nature in Patients with Psychosis and Depressive Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2024-05-25', 'studyFirstSubmitQcDate': '2024-05-31', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'demographic variables', 'timeFrame': 'pre VR exposure for all groups', 'description': 'acquisition of demographic data'}, {'measure': 'comorbidities', 'timeFrame': 'pre VR exposure for all groups', 'description': 'acquisition of psychiatric comorbidities and physical illnesses'}, {'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)', 'description': 'Assessment of symptom severity with the Positive and Negative Syndrome Scale (PANSS; Kay et al., 1987)'}, {'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)', 'description': 'Assessment of symptom severity with the Beck Depression Inventory (BDI; Beck et al., 1961)'}], 'primaryOutcomes': [{'measure': 'Nature Connectedness', 'timeFrame': 'For all groups pre and directly post VR exposure', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Empathy', 'timeFrame': 'For all groups pre and directly post VR exposure (within the same session of 1 hour)', 'description': 'Evaluation of empathy with the Multifaceted Empathy Test (MET; (Dziobek et al., 2008) pre and post VR exposure'}, {'measure': 'Compassion', 'timeFrame': 'For all groups pre and directly post VR exposure (within the same session of 1 hour)', 'description': '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.'}, {'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)', 'description': '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))'}, {'measure': 'Embodiment - Feeling of virtual body ownership', 'timeFrame': 'post VR exposure for all groups (within the same session of 1 hour)', 'description': 'Evaluation with a subscale of the Embodiment scale by Ahn et al. (2016) adapted from Slater et al. (2010)'}, {'measure': 'Spirituality', 'timeFrame': 'pre VR exposure for all groups', 'description': 'Evaluation of spirituality using the 4-item short version of the questionnaire "Transpersonales Vertrauen" (Hampel et al., 2019) pre VR exposure.'}, {'measure': 'Presence in VR', 'timeFrame': 'post VR exposure for all groups (within the same session of 1 hour)', 'description': '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)'}, {'measure': 'Virtual Reality Simulator Sickness', 'timeFrame': 'post VR exposure for all groups (within the same session of 1 hour)', 'description': 'Cyber Sickness as a potential side effect of VR, measured with the Virtual Reality Sickness Questionnaire (Kim et al., 2018)'}, {'measure': 'Explorative evaluation of electrodermal activity (EDA)', 'timeFrame': 'during (approx. 5 minutes) VR exposure', 'description': 'Explorative evaluation of electrodermal activity (EDA), e.g., skin conductance level (SCL) and skin conductance responses (SCR) in micro siemens during VR exposure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depressive Disorder', 'Schizophrenia', 'Healthy Control']}, 'descriptionModule': {'briefSummary': '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).\n\nPrimary 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 18-65 years\n* Inpatients and outpatients treated at the Psychiatric University Clinic of the Charité at St.\n\nHedwig Hospital\n\n* diagnosis of depressive disorder (ICD-10: F32.X, F33.X) or diagnosis of schizophrenia (F20.X) or healthy controls without psychiatric diagnosis\n* able to provide written informed consent\n\nExclusion Criteria:\n\n* Acute suicidality or danger to others\n* Primarily treatment-requiring eating disorder\n* Acute dermatological condition affecting the hands that can distort skin conductivity measurements\n* Control group: psychiatric or psychosomatic pre-diagnoses (except for the psychiatric active control group), other exclusion diagnoses corresponding to the patient group'}, 'identificationModule': {'nctId': 'NCT06446856', 'acronym': 'EVEN', 'briefTitle': 'EVEN - Effects of VR on Empathy for Nature in Patients with Psychosis and Depressive Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EA2/046/24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VR study group', 'description': '20 patients with depressive disorder', 'interventionNames': ['Device: VR application']}, {'label': 'VR active control group', 'description': '20 patients with psychotic disorder.', 'interventionNames': ['Device: VR application']}, {'label': 'VR healthy control group', 'description': '20 patients with no psychiatric disorder', 'interventionNames': ['Device: VR application']}], 'interventions': [{'name': 'VR application', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['VR active control group', 'VR healthy control group', 'VR study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Psychiatric University Hospital Charité at St. Hedwig Hospital', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universität Potsdam, Department Erziehungswissenschaft, Arbeitsbereich Schulbezogene Medienbildung', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. Alva Lütt, MD', 'investigatorFullName': 'Alva Lütt', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}