NCT06446856

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

May 27, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

1 month

First QC Date

May 25, 2024

Last Update Submit

September 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Empathy

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

  • Compassion

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

  • symptom burden

    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

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

  • Spirituality

    pre VR exposure for all groups

  • +3 more secondary outcomes

Other Outcomes (4)

  • demographic variables

    pre VR exposure for all groups

  • comorbidities

    pre VR exposure for all groups

  • symptom severity - psychotic symptoms

    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)

  • +1 more other outcomes

Study Arms (3)

VR study group

20 patients with depressive disorder

Device: VR application

VR active control group

20 patients with psychotic disorder.

Device: VR application

VR healthy control group

20 patients with no psychiatric disorder

Device: VR application

Interventions

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.

VR active control groupVR healthy control groupVR study group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Acute suicidality or danger to others
  • Primarily treatment-requiring eating disorder
  • Acute dermatological condition affecting the hands that can distort skin conductivity measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric University Hospital Charité at St. Hedwig Hospital

Berlin, Germany

Location

MeSH Terms

Conditions

Depressive DisorderSchizophrenia

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Alva Lütt, MD

Study Record Dates

First Submitted

May 25, 2024

First Posted

June 6, 2024

Study Start

May 27, 2024

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

September 20, 2024

Record last verified: 2024-09

Locations