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

NCT06174285 | Recruiting

• 1 other identifier: DB-RCT-PSYRREAL
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Change in Emotional State Questionnaire 2 depression subscale score from baseline to follow-up

  Measurement of the intensity of depressive symptoms during a specified period (suitable for periods longer than a week).

  Measured at 3 time-points - on the day 1 of intervention, and two weeks and two months after intervention.

Secondary Outcomes (8)

• Short mood questionnaire

  Measured at two time-points - baseline and on the day 1 of the intervention..

• 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.

• State Mindfulness Scale

  Measured at two time-points -baseline and on the day 1 of the intervention

• 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.

• Psychological Insight Questionnaire

  Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.

Other Outcomes (3)

• Custom background questionnaire part I

  Measured at one time-point - before the virtual reality experience on the day 1 of the intervention.

• Custom background questionnaire part II

  Measured at one time-point - at the two month follow-up.

• Semi-structured interview transcriptions

  Measured at one time-point - immediately after the virtual reality experience on the day 1 of the intervention.

Study Arms (3)

Psyrreal

EXPERIMENTAL

Psychedelic virtual reality experience.

Other: Therapeutic Intervention with Psychedelic Virtual Reality

Routine Realms

SHAM COMPARATOR

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

Other: Therapeutic Intervention with Non-Psychedelic Virtual Reality

No intervention

NO INTERVENTION

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

Interventions

Therapeutic Intervention with Psychedelic Virtual Reality OTHER

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.

Psyrreal

Therapeutic Intervention with Non-Psychedelic Virtual Reality OTHER

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.

Routine Realms

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tartu: lead
• Confido Medical Centre: collaborator

Study Sites (1)

Confido Medical Centre

Tallinn, Harju, 10138, Estonia

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jaan Aru, PhD

  University of Tartu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl Kristjan Kaup, MSc

CONTACT

+372 5342 8489; kaup.kristjan@gmail.com

Kadi Tulver, PhD

CONTACT

+372 522 9245; kadi.tulver@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Research Fellow

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 18, 2023
• Study Start: November 6, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

ES (1)