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NCT Number: NCT06174285

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Confido Medical Centre

Tallinn, Harju, 10138, Estonia

Location status: Recruiting

Location contact

Helen Kadastik, Dr

CONTACT

[email protected]

+372 528 6278

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Short mood questionnaire

    Time frame: 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.

  2. Emotional State Questionnaire 2 other subscales

    Time frame: 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.

  3. State Mindfulness Scale

    Time frame: 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.

  4. Adapted short version of the questionnaire for the assessment of altered states of consciousness (11D-ASC)

    Time frame: 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.

  5. Psychological Insight Questionnaire

    Time frame: 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.

  6. Ego-Dissolution Inventory

    Time frame: 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.

  7. Avoidance/Acceptance-Promoting Experience Questionnaire

    Time frame: 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.

  8. Awe Experience Scale

    Time frame: 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.

Other outcomes

  1. Custom background questionnaire part I

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

    Contains items regarding demographic information and prior experiences with virtual reality.

  2. Custom background questionnaire part II

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

    Contains items on prior experiences with psychedelics and spiritual practices, and the subjective impression of the intervention.

  3. Semi-structured interview transcriptions

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

    If the participant agrees, the post-experience integration session will be recorded and transcribed.

Study contacts

Contact information is provided by the study sponsor or research team.

Kadi Tulver, PhD

CONTACT

[email protected]

+372 522 9245

Karl Kristjan Kaup, MSc

CONTACT

[email protected]

+372 5342 8489

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Collaborators

  • Confido Medical Centre

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2023
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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