Effect of Psychedelic VR-augmented Therapy on Patients With Clinical Depression
Recruiting · NCT06174285 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
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.
Where it is running
1 location listed.
- Confido Medical Centre - Tallinn, Harju, Estonia