VR Mind™ and VR Mind +™ Intervention - Randomized, Open Label, Single Masking, Parallel Group Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Efficacy: Liebowitz Social Anxiety Scale - Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987)
研究概览
简要总结
The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions.
详细描述
In this study, investigators will test the software developed by Tomorrow Sp. z o. o., named VR Mind and VR Mind+. The software utilizes the concept of virtual reality exposure therapy to treat social anxiety disorder. The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions.
The research consists of fourteen sessions. The first and the last session will be dedicated to participant assessment. Subsequent sessions 2-13 will be performed according to the therapy protocol for each arm. Control group of participants (active comparative arm) will receive standard treatment for social anxiety disorder - cognitive behavioral therapy based on the protocol developed by the Principal Investigator [protocol adapted from the approach of Clark and Wells (Mayo-Wilson, Dias, Mavranezouli, 2014)]. Experimental group 1 will receive cognitive behavioral therapy with exposure in virtual environment. Experimental group 1 and control group were designed to be as similar as possible, with the exception of the modality for the delivery of exposure. All treatment session will be led by licensed therapist.
Participants of the experimental group 2 will independently conducts the self-therapy process. The intervention will consist of 12 therapeutic sessions. At each of the 12 sessions, the participant will selects a specific scenario of social situations that arouse fear (e.g. public speaking, job interview or other situations from everyday life).
Because of the risk of simulator sickness (e.g., headaches, nausea), exposure trials will last no longer than 20 minutes for each session.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD).
- •Signing informed consent
- •Unchanged doses of psychotropic medications within 3 months prior to baseline assessment and no change is anticipated
排除标准
- •occurrence of SAD symptoms inconsistent with DSM-IV-TR criteria and with psychiatric interview (SCID-I; Structured Clinical Interview)
- •psychosis,
- •bipolar disorder,
- •mental retardation
- •pregnancy,
- •drug addiction,
- •alcohol addiction,
- •psychoactive substances addiction,
- •participating in the experimental session while intoxicated
- •(current) neurological treatment of chronic disease of central nervous system,
- •epilepsy,
- •paroxysmal vertigo,
- •presence of suicidal thoughts, tendencies or attempts,
- •participant is taking drugs from benzodiazepine group, other sedatives, narcotic drugs
- •current CBT treatment for Social Anxiety Disorder
结局指标
主要结局
Efficacy: Liebowitz Social Anxiety Scale - Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987)
时间窗: change from baseline: Pre-treatment at session 1, to session 9 (5 weeks) and to post-treatment at session 14 (7 weeks)
The scale is composed of 24 items, depicting various social situations. For each item, participants assess their fear (from 1 - "No fear" to 4 - "Severe") and avoidance (from 1 - "Never" to 4 - "Usually"). LSAS has 3 scores, summing the results for particular items - fear (0-72), avoidance (0-72) and total score (0-144).
Safety: Occurrence and severity of Simulator Sickness - Simulator Sickness Questionnaire (SSQ; Kennedy, Lane, Berbaum, Lilienthal, 1993)
时间窗: Change from session to session with virtual reality exposure: at session 1, session 7 (4 weeks), session 8 (4 weeks), session 10 (5 weeks), session 11 (6 weeks) and session 12 (6 weeks)
Simulator sickness is expected adverse effect of the VR.Total SSQ score equal to or higher than 10 will be used as a preliminary cut-off for simulator sickness (Balk et al., 2013). Individual scores will be corrected for baseline (pre-VR) symptom severity. Only items with a pre-VR - post-VR increase will contribute to a final SSQ score. All post-intervention SSQ scores \>10 will be analyzed further for its association with study drop-outs and other intervention required. The adverse effect will be classified as: * mild (no intervention required), * moderate (any intervention needed, e.g. session termination), * severe (hospitalization required), * life-threatening / death. Some of the symptoms of anxiety may produce similar side effects as a simulator sickness. The results obtained in this case will be false positive. Therefore assessment of side effects for each case will be verified if the increase in SSQ score was triggered by rapid relapse of phobia symptoms.
次要结局
- Clinical Global Impression(Pre-treatment at session 1)
- Clinician Global Impressions of Improvement(Post-treatment, approximately 7 weeks after initial session)
- Patient Global Impression(Pre-treatment at session 1)
- Patient Global Impressions of Improvement(Post-treatment, approximately 7 weeks after initial session)
- Beck Depression Inventory(Pre-treatment at session 1 to post-treatment at session 14 (7 weeks))