DepressionNCT06174285
Effect of Psychedelic VR-augmented Therapy on Patients With Clinical Depression
A study testing Therapeutic Intervention with Psychedelic Virtual Reality and Therapeutic Intervention with Non-Psychedelic Virtual Reality in people with Depression, run by University of Tartu at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Therapeutic Intervention with Psychedelic Virtual Reality and Therapeutic Intervention with Non-Psychedelic Virtual Reality
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEstonia
- Study dates
- 6 Nov 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Estonia1 site, 1 recruiting
- Recruiting
Confido Medical Centre
Tallinn, Harju, 10138
Helen Kadastik, Dr, +372 528 6278, Helen.Kadastik@confido.ee
About this study
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
- Being tested
- Therapeutic Intervention with Psychedelic Virtual Reality, Therapeutic Intervention with Non-Psychedelic Virtual Reality
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Intervention with Psychedelic Virtual RealityOther
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 RealityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Psyrreal | Experimental | Psychedelic virtual reality experience. Receives: Other: Therapeutic Intervention with Psychedelic Virtual Reality |
| Routine Realms | Sham comparator | A non-psychedelic virtual reality experience that is largely analogous to Psyrreal. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
A short questionnaire based on the Emotional State Questionnaire 2 to evaluate changes in mood on a short time-scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
Psychological Insight Questionnaire
Questionnaire for measuring psychological insight during acute (psychedelic) experiences.
Measured: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
Ego-Dissolution Inventory
Questionnaire for measuring the experience of ego-dissolution during the virtual reality experience.
Measured: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
Avoidance/Acceptance-Promoting Experience Questionnaire
Questionnaire for measuring changes in acceptance- and avoidance-related beliefs due to virtual reality experiences.
Measured: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
Awe Experience Scale
Questionnaire for measuring the experience of awe during the virtual reality experience.
Measured: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start6 Nov 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Collaborators
- Confido Medical Centre
- Responsible party
- Principal investigator, Karl Kristjan Kaup, University of Tartu
- Investigators
- Jaan Aru, PhD, Principal investigator, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174285
- Sponsor's protocol ID
- DB-RCT-PSYRREAL
- Status last verified
- Mar 2025
- First submitted
- 22 Nov 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psychedelic VR-augmented Therapy on Patients With Clinical Depression
- ClinicalTrials.gov ID
- NCT06174285
- Acronym / sponsor ID
- DB-RCT-PSYRREAL
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Collaborators
- Confido Medical Centre
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psyrreal | Experimental | Other: Therapeutic Intervention with Psychedelic Virtual RealityPsychedelic virtual reality experience. |
| Routine Realms | Sham comparator | Other: Therapeutic Intervention with Non-Psychedelic Virtual RealityA non-psychedelic virtual reality experience that is largely analogous to Psyrreal. |
| No intervention | No intervention | –A conditional waiting list condition. This condition may be included, dependent on the availability of sufficient participants and resources. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Intervention with Psychedelic Virtual RealityA 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. | Other | Psyrreal |
| Therapeutic Intervention with Non-Psychedelic Virtual RealityA 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. | Other | Routine Realms |
Primary outcome
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).
8 secondary outcomes
Short mood questionnaire
Time frame: Measured at two time-points - baseline and on the day 1 of the intervention..
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.
State Mindfulness Scale
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)
Time frame: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
Psychological Insight Questionnaire
Time frame: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
Ego-Dissolution Inventory
Time frame: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
Avoidance/Acceptance-Promoting Experience Questionnaire
Time frame: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
Awe Experience Scale
Time frame: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaan Aru, PhD principal investigator
University of Tartu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Intervention with Psychedelic Virtual Reality and Therapeutic Intervention with Non-Psychedelic Virtual Reality in people with Depression, run by University of Tartu at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karl Kristjan Kaup, MSc (+372 5342 8489, kaup.kristjan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.