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

Not Applicable

Recruiting

• Conditions: Depression

• Registration Number: NCT06174285
• Lead Sponsor: University of Tartu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-06
• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-12-15
• Study First Posted: 2023-12-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Emotional State Questionnaire 2 depression subscale score from baseline to follow-up	Measured at 3 time-points - on the day 1 of intervention, and two weeks and two months after intervention.	Measurement of the intensity of depressive symptoms during a specified period (suitable for periods longer than a week).

Secondary Outcome Measures

Name	Time	Method
Short mood questionnaire	Measured at two time-points - baseline and on the day 1 of the intervention..	A short questionnaire based on the Emotional State Questionnaire 2 to evaluate changes in mood on a short time-scale.
Avoidance/Acceptance-Promoting Experience Questionnaire	Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.	Questionnaire for measuring changes in acceptance- and avoidance-related beliefs due to virtual reality experiences.
Emotional State Questionnaire 2 other subscales	Measured at 3 time-points - on the day 1 of intervention and two weeks and two months after intervention.	These subscales measure symptoms of panic disorder, agoraphobia, generalized anxiety disorder, asthenia and sleeping disorder.
Psychological Insight Questionnaire	Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.	Questionnaire for measuring psychological insight during acute (psychedelic) experiences.
Adapted short version of the questionnaire for the assessment of altered states of consciousness (11D-ASC)	Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.	Questionnaire to evaluate alterations in consciousness during the virtual reality experience. Some items are adapted for implementation in virtual reality and a subset of questions are omitted from the original 11D-ASC questionnaire.
Ego-Dissolution Inventory	Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.	Questionnaire for measuring the experience of ego-dissolution during the virtual reality experience.
Awe Experience Scale	Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.	Questionnaire for measuring the experience of awe during the virtual reality experience.
State Mindfulness Scale	Measured at two time-points -baseline and on the day 1 of the intervention	Questionnaire for evaluating change in state mindfulness due to virtual reality experience.

Trial Locations

Locations (1)

Confido Medical Centre; 🇪🇪 Tallinn, Harjumaa, Estonia