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

ConditionDepression

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity of Tartu

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Therapeutic Intervention with Psychedelic Virtual Reality
Other intervention
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 intervention
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.

Treatment groups

45 Participants

are divided into 3 treatment groups

Group A: PsyrrealExperimental treatment 1 intervention

Group B: Routine RealmsSham comparator 1 intervention

Group C: No interventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

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).

Time frame

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

Secondary outcomes

Short mood questionnaire

A short questionnaire based on the Emotional State Questionnaire 2 to evaluate changes in mood on a short time-scale.

Time frame

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

Emotional State Questionnaire 2 other subscales

These subscales measure symptoms of panic disorder, agoraphobia, generalized anxiety disorder, asthenia and sleeping disorder.

Time frame

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

State Mindfulness Scale

Questionnaire for evaluating change in state mindfulness due to virtual reality experience.

Time frame

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)

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.

Time frame

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

Other outcomes

Custom background questionnaire part I

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

Time frame

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

Custom background questionnaire part II

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

Time frame

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

Semi-structured interview transcriptions

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

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Tartu

Lead sponsor

Confido Medical Centre

Collaborator

Source ClinicalTrials.gov

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