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

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Change in Emotional State Questionnaire 2 depression subscale score from baseline to follow-up [Срок оценки: Measured at 3 time-points - on the day 1 of intervention, and two weeks and two months after intervention.]

Вторичные конечные точки (8)

• Short mood questionnaire [Срок оценки: Measured at two time-points - baseline and on the day 1 of the intervention..]
• Emotional State Questionnaire 2 other subscales [Срок оценки: Measured at 3 time-points - on the day 1 of intervention and two weeks and two months after intervention.]
• State Mindfulness Scale [Срок оценки: 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) [Срок оценки: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.]
• Psychological Insight Questionnaire [Срок оценки: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.]
• Ego-Dissolution Inventory [Срок оценки: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.]
• Avoidance/Acceptance-Promoting Experience Questionnaire [Срок оценки: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.]
• Awe Experience Scale [Срок оценки: Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Эстония · 1 центр

• Confido Medical Centre — Tallinn

Идентификаторы

NCT: NCT06174285 · DB-RCT-PSYRREAL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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