Effect of Psychedelic VR-augmented Therapy on Patients With Clinical Depression

University of Tartu

Status: Enrolling

Conditions: Depression

Treatments: Other: Therapeutic Intervention with Psychedelic Virtual Reality; Other: Therapeutic Intervention with Non-Psychedelic Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT06174285

DB-RCT-PSYRREAL

Details and patient eligibility

About

Research has demonstrated that psychedelic compounds possess significant therapeutic potential for a variety of disorders, including depression. Despite these findings, the underlying mechanisms driving the therapeutic efficacy of psychedelics remain elusive. Furthermore, there exists a debate over the contribution of the subjective psychedelic experience to their therapeutic benefits. In this study, virtual reality (VR) is utilized as a tool to replicate the subjective experiences induced by psychedelics, aiming to explore their impact on depressive symptoms within a clinical sample.

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Persistent depressive symptoms observed during the initial screening and confirmed at baseline, as determined through a comprehensive psychiatric evaluation.
• Provision of written informed consent by the participant.
• Fluent in Estonian as a native language.

Exclusion criteria

• Presence of significant impairments in vision, hearing, or balance.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Psyrreal

Experimental group

Description:

Psychedelic virtual reality experience.

Treatment:

Other: Therapeutic Intervention with Psychedelic Virtual Reality

Routine Realms

Sham Comparator group

Description:

A non-psychedelic virtual reality experience that is largely analogous to Psyrreal.

Treatment:

Other: Therapeutic Intervention with Non-Psychedelic Virtual Reality

No intervention

No Intervention group

Description:

A conditional waiting list condition. This condition may be included, dependent on the availability of sufficient participants and resources.