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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174285
• Other study ID #: DB-RCT-PSYRREAL
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: December 2023
• Source: University of Tartu
• Contact: Karl Kristjan Kaup, MSc
• Phone: +372 5342 8489
• Email: kaup.kristjan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Therapeutic Intervention with Psychedelic Virtual Reality
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
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.

Locations

Country	Name	City	State
Estonia	Confido Medical Centre	Tallinn	Harjumaa

Sponsors (2)

Lead Sponsor	Collaborator
University of Tartu	Confido Medical Centre

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Custom background questionnaire part I	Contains items regarding demographic information and prior experiences with virtual reality.	Measured at one time-point - before the virtual reality experience on the day 1 of the intervention.
Other	Custom background questionnaire part II	Contains items on prior experiences with psychedelics and spiritual practices, and the subjective impression of the intervention.	Measured at one time-point - at the two month follow-up.
Other	Semi-structured interview transcriptions	If the participant agrees, the post-experience integration session will be recorded and transcribed.	Measured at one time-point - immediately after the virtual reality experience on the day 1 of the intervention.
Primary	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	Short mood questionnaire	A short questionnaire based on the Emotional State Questionnaire 2 to evaluate changes in mood on a short time-scale.	Measured at two time-points - baseline and on the day 1 of the intervention..
Secondary	Emotional State Questionnaire 2 other subscales	These subscales measure symptoms of panic disorder, agoraphobia, generalized anxiety disorder, asthenia and sleeping disorder.	Measured at 3 time-points - on the day 1 of intervention and two weeks and two months after intervention.
Secondary	State Mindfulness Scale	Questionnaire for evaluating change in state mindfulness due to virtual reality experience.	Measured at two time-points -baseline and on the day 1 of the intervention
Secondary	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 at one time-point - after the virtual reality experience on the day 1 of the intervention.
Secondary	Psychological Insight Questionnaire	Questionnaire for measuring psychological insight during acute (psychedelic) experiences.	Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
Secondary	Ego-Dissolution Inventory	Questionnaire for measuring the experience of ego-dissolution during the virtual reality experience.	Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
Secondary	Avoidance/Acceptance-Promoting Experience Questionnaire	Questionnaire for measuring changes in acceptance- and avoidance-related beliefs due to virtual reality experiences.	Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.
Secondary	Awe Experience Scale	Questionnaire for measuring the experience of awe during the virtual reality experience.	Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.