ChiCTR2500107057尚未招募Unknown
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)
The Kadoorie Charitable Foundation Grant & Hong Kong Metropolitan University1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2025年1月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Symptoms of depression
研究概览
简要总结
To evaluate the effectiveness of an immersive VR-based mindfulness intervention program in reducing depressive symptoms among patients with autoimmune arthritis.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- Given the apparent nature of the intervention, it is unlikely to blind participants and intervention providers.
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •Patients with AA aged 18 or above will be eligible. The inclusion criteria are:
- •being able to communicate in Cantonese,
- •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,
- •being able to commit to six consecutive weekly VR-based mindfulness sessions, and
- •on a stable medication regimen.
排除标准
- •Severe visual or auditory deficits.
- •Severe organic disease or malignant tumour.
- •A history of motion or simulator sickness.
- •History of epilepsy.
- •A recent mental disorder in the past 12 months or current psychiatric disorder that are potentially life threatening (i.e. psychosis, suicidal ideation).
- •Meditation and yoga practice within the past 6 months or will plan to start mindfulness intervention.
研究组 & 干预措施
Intervention group
The intervention group in this study will receive six sessions of immersive VR-based MIs in addition to usual care.
Control group
Participants in the control group will receive usual care without immersive VR-based MI program.
结局指标
主要结局
Symptoms of depression
次要结局
- Symptoms of anxiety and stress
- Pain intensity
- Pain self-efficacy
- Mindfulness level
- Patient satisfaction
- Adverse reactions
研究者
研究点 (1)
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