Effect of Psychedelic VR-augmented Therapy on Patients With Clinical Depression
NCT ID: NCT06174285
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2023-11-06
2026-06-30
Brief Summary
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The primary objective of this research is to examine the influence of psychedelic-like phenomenology, as simulated through VR, on depressive symptoms. The study is structured into two distinct arms: the experimental condition features 'Psyrreal,' a VR experience designed to emulate psychedelic effects and the control condition which includes 'Routine Realms,' an analogous VR experience devoid of psychedelic elements. A third waiting list condition may be included, dependent on the availability of sufficient participants and resources. Additionally, the study seeks to identify and analyze various potential mediators that might underpin the therapeutic outcomes observed.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Psyrreal
Psychedelic virtual reality experience.
Therapeutic Intervention with Psychedelic Virtual Reality
A 55-minute immersive psychedelic virtual reality experience is incorporated into a therapeutic intervention, comprising a preparatory phase and a subsequent integration session based on the individual's experience.
Routine Realms
A non-psychedelic virtual reality experience that is largely analogous to Psyrreal.
Therapeutic Intervention with Non-Psychedelic Virtual Reality
A 55-minute immersive virtual reality experience is incorporated into a therapeutic intervention, comprising a preparatory phase and a subsequent integration session based on the individual's experience.
No intervention
A conditional waiting list condition. This condition may be included, dependent on the availability of sufficient participants and resources.
No interventions assigned to this group
Interventions
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Therapeutic Intervention with Psychedelic Virtual Reality
A 55-minute immersive psychedelic virtual reality experience is incorporated into a therapeutic intervention, comprising a preparatory phase and a subsequent integration session based on the individual's experience.
Therapeutic Intervention with Non-Psychedelic Virtual Reality
A 55-minute immersive virtual reality experience is incorporated into a therapeutic intervention, comprising a preparatory phase and a subsequent integration session based on the individual's experience.
Eligibility Criteria
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Inclusion Criteria
* Provision of written informed consent by the participant.
* Fluent in Estonian as a native language.
Exclusion Criteria
* Active suicidal ideation or current engagement in self-harm behaviors. Note: Individuals meeting this criterion will be directed to suitable crisis intervention services.
* Established diagnosis of bipolar disorder.
* Manifestation of psychotic symptoms.
* History of schizophrenia, either personally or within two generations of the family lineage.
* Ongoing diagnosis of epilepsy, dementia, or any other neurological condition that could interfere with the effective utilization of virtual reality (VR) technology.
* Susceptibility to motion sickness.
18 Years
65 Years
ALL
No
Sponsors
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Confido Medical Centre
UNKNOWN
University of Tartu
OTHER
Responsible Party
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Karl Kristjan Kaup
Junior Research Fellow
Principal Investigators
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Jaan Aru, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Tartu
Locations
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Confido Medical Centre
Tallinn, Harju, Estonia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DB-RCT-PSYRREAL
Identifier Type: -
Identifier Source: org_study_id
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