Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Tolerability of VR Treatment Assessed by Qualitative Report
研究概览
简要总结
Investigators aim to examine the role of audiovisual inputs during treatment with ketamine/esketamine in affecting tolerability and effectiveness of treatment of depressive episodes, by providing patients with a relaxing environment using virtual reality goggles and noise cancelling headphones, and assessing whether these tools can improve the tolerability and effectiveness of treatment with ketamine/esketamine
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be at least 18 years old
- •Patients must have completed the acute series of treatment and weekly optimization phases of ketamine/esketamine treatment, and currently receiving continuation/maintenance treatment Written consent for the study procedures
- •Ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements.
排除标准
- •Hearing or visual impairment to the degree that would interfere with ability to see or hear VR content.
- •Difficulty in understanding spoken or written English
- •Unable to provide informed consent
- •Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the study procedure (per investigator judgment)
- •Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study.
- •Was previously enrolled/randomized into the study
研究组 & 干预措施
Treatment group
This single arm will include all participants of the study, who will all receive the intervention
干预措施: Virtual reality (Device)
结局指标
主要结局
Tolerability of VR Treatment Assessed by Qualitative Report
时间窗: Immediately post-VR treatment
Tolerability of VR treatment will be assessed by qualitative report, an open-ended question where the participant is allowed to describe any concerns not covered by SAFTEE assessment. Data presented here is the number of participants that stated the treatment was Tolerated.
Safety of VR Treatment Assessed by Systematic Assessment of Treatment Emergent Events (SAFTEE) Assessment
时间窗: baseline up to Immediately post-VR treatment
The SAFTEE assessment will be used to assess adverse events during the trial by the number of participants that had any adverse events while on study.
Change in Overall Treatment Experience Satisfaction
时间窗: Baseline, during and immediately post VR treatment session
Efficacy will be assessed by the difference in overall treatment experience satisfaction (via Likert scale) between the pre-VR and VR treatment sessions. Total scores range from 0 to 10 with higher scores indicating higher satisfaction with the treatment experience.
次要结局
- Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores(baseline, during VR treatment and Immediately post-VR treatment)
- Change in 5D-ASC Total Score(baseline, during VR treatment and Immediately post-VR treatment)
- Change in The Clinician-Administered Dissociative States Scale (CADSS)(baseline, during VR and immediately post VR treatment)
- Change in Participant Experience(baseline, during VR treatment and Immediately post-VR treatment)
- Change in Level of Relaxation(baseline, during VR treatment and Immediately post-VR treatment)