Effect of Psychedelic VR-augmented Therapy on Patients With Clinical Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in Emotional State Questionnaire 2 depression subscale score from baseline to follow-up
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Emotional State Questionnaire 2 depression subscale score from baseline to follow-up
时间窗: 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).
次要结局
- Short mood questionnaire(Measured at two time-points - baseline and on the day 1 of the intervention..)
- Avoidance/Acceptance-Promoting Experience Questionnaire(Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.)
- Emotional State Questionnaire 2 other subscales(Measured at 3 time-points - on the day 1 of intervention and two weeks and two months after intervention.)
- Psychological Insight Questionnaire(Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.)
- Adapted short version of the questionnaire for the assessment of altered states of consciousness (11D-ASC)(Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.)
- Ego-Dissolution Inventory(Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.)
- Awe Experience Scale(Measured at one time-point - after the virtual reality experience on the day 1 of the intervention.)
- State Mindfulness Scale(Measured at two time-points -baseline and on the day 1 of the intervention)
研究者
Karl Kristjan Kaup
Junior Research Fellow
University of Tartu