Clinical trial NCT06174285: Effect of Psychedelic VR-augmented Therapy on Patients With Clinical Depression
Official title: Effect of Psychedelic VR-augmented Therapy on Patients With Clinical Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: University of Tartu
Sponsor class: OTHER
Collaborators: name: Confido Medical Centre
First posted: 2023-12-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Emotional State Questionnaire 2 depression subscale score from baseline to follow-up
timeFrame: Measured at 3 time-points - on the day 1 of intervention, and two weeks and two months after intervention.
Secondary outcomes:
measure: Short mood questionnaire
timeFrame: Measured at two time-points - baseline and on the day 1 of the intervention..
measure: Emotional State Questionnaire 2 other subscales
timeFrame: Measured at 3 time-points - on the day 1 of intervention and two weeks and two months after intervention.
measure: State Mindfulness Scale
timeFrame: Measured at two time-points -baseline and on the day 1 of the intervention
measure: Adapted short version of the questionnaire for the assessment of altered states of consciousness (11D-ASC)
timeFrame: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
measure: Psychological Insight Questionnaire
timeFrame: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
measure: Ego-Dissolution Inventory
timeFrame: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
measure: Avoidance/Acceptance-Promoting Experience Questionnaire
timeFrame: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
measure: Awe Experience Scale
timeFrame: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
Other outcomes:
measure: Custom background questionnaire part I
timeFrame: Measured at one time-point - before the virtual reality experience on the day 1 of the intervention.
measure: Custom background questionnaire part II
timeFrame: Measured at one time-point - at the two month follow-up.
measure: Semi-structured interview transcriptions
timeFrame: Measured at one time-point - immediately after the virtual reality experience on the day 1 of the intervention.
Locations:
city: Tallinn
country: Estonia
facility: Confido Medical Centre
state: Harjumaa
Study officials:
affiliation: University of Tartu
name: Jaan Aru, PhD
role: PRINCIPAL_INVESTIGATOR
References: