【ChiCTR2500107057】Effectiveness of an immersive virtual reality (VR)-based mindfulness intervention (MI) to reduce depressive symptoms in patients with autoimmune arthritis (AA): a randomized control trial (RCT)

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基本信息

登记号

ChiCTR2500107057

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2025-08-01

临床申请受理号

靶点

适应症

Autoimmune arthritis

试验通俗题目

Effectiveness of an immersive virtual reality (VR)-based mindfulness intervention (MI) to reduce depressive symptoms in patients with autoimmune arthritis (AA): a randomized control trial (RCT)

试验专业题目

Effectiveness of an immersive virtual reality (VR)-based mindfulness intervention (MI) to reduce depressive symptoms in patients with autoimmune arthritis (AA): a randomized control trial (RCT)

申办单位信息

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临床试验信息

试验目的

To evaluate the effectiveness of an immersive VR-based mindfulness intervention program in reducing depressive symptoms among patients with autoimmune arthritis.

试验分类

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试验类型

随机平行对照

试验分期

治疗新技术

随机化

Eligible subjects will be individually randomized to the intervention or control group (1:1) using sequentially numbered, opaque, sealed envelopes (SNOSE), and block randomization. A statistician who is not part of the research team will generate the random numbers and assignment and prepare 198 identical opaque sealed A5-sized envelopes. The block randomization list will be created with a 1:1 allocation ratio and block size of 4, 8 and 12 in random order to ensure that a similar number of participants will be allocated to both groups.

盲法

Given the apparent nature of the intervention, it is unlikely to blind participants and intervention providers.

试验项目经费来源

The Kadoorie Charitable Foundation Grant & Hong Kong Metropolitan University

试验范围

目标入组人数

实际入组人数

第一例入组时间

2025-01-01

试验终止时间

2027-02-28

是否属于一致性

入选标准

Patients with AA aged 18 or above will be eligible. The inclusion criteria are: 1. being able to communicate in Cantonese, 2. presenting with depressive symptoms over the past two weeks based on the established criteria (DSM V) with a Patient Health Questionniare-9 score of at least five or above, 3. being able to commit to six consecutive weekly VR-based mindfulness sessions, and 4. on a stable medication regimen.；

排除标准

1. Severe visual or auditory deficits. 2. Severe organic disease or malignant tumour. 3. A history of motion or simulator sickness. 4. History of epilepsy. 5. A recent mental disorder in the past 12 months or current psychiatric disorder that are potentially life threatening (i.e. psychosis, suicidal ideation). 6. Meditation and yoga practice within the past 6 months or will plan to start mindfulness intervention.；

研究者信息

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试验机构

School of Nursing and Health Sciences, Hong Kong Metropolitan University

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