NCT05895721Unknown不适用
A Randomized Control Trial of the Use of Virtual Reality as an Adjunct in the Treatment for Generalized Anxiety Disorders
Clinical Research Centre, Malaysia10 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年2月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 10
- 主要终点
- To determine the efficacy of VR modules as an adjunct therapy in improving GAD-7 scores among patients with generalized anxiety disorders.
研究概览
简要总结
The goal of this clinical trial is to apply Virtual Reality as an adjunct treatment for Generalized Anxiety Disorder. The main question it aims to answer are:
- Determination of the efficacy of VR modules as an adjunct therapy in improving GAD-7 scores
- Assessment of the acceptability of VR modules as an adjunct therapy to the standard of care
Participants will randomized into two arms:
- Control Arm: Standard of Care only
- Intervention Arm: Standard of Care + VR Modules
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-59
- •The primary diagnosis is a generalized anxiety disorder
- •Agree to participate and consented as per study protocol.
- •There is no change in the standard of care within the past two months prior to enrollment into the study. If a patient is on any psychotherapy, then there is no change in the type of current psychotherapy intervention.
- •GAD- 7 more than or equal to
- •Able to come for the session as per scheduled.
排除标准
- •Documented or known case of permanent hearing/visual impairment e.g., vestibular abnormalities that represent significant contraindications for the use of VR or visual impairment e.g., cataract.
- •Documented Disorder as listed:
- •A. Psychosis
- •B. Psychosis disorder - previous case, known case of
- •C. Claustrophobia
- •D. Substance use
- •E. Personality disorder
- •F. Visual impairment that might hinder usage of virtual reality equipment
- •G. Intellectual disabilities
- •H. All types of seizures including febrile seizure
- •The patient is under more than 1 center during follow up (e.g., patient is also receiving treatment from a private hospital for GAD).
结局指标
主要结局
To determine the efficacy of VR modules as an adjunct therapy in improving GAD-7 scores among patients with generalized anxiety disorders.
时间窗: Week 0 - Week 4
Patient will be access with GAD-7 questionnaire repeatedly at different time interval (3 Times - Week 0, Week 2, Week 4) .
次要结局
- To assess the acceptability of VR modules as an adjunct therapy to the standard of care among patients with generalized anxiety disorders.(Week 0 - Week 4)
研究者
研究点 (10)
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