Mental Health Treatment in Caregivers of Psychiatric Patients: Application of Virtual Reality-Mediated Mindfulness
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- State-Trait Anxiety Inventory (STAI)
研究概览
简要总结
This clinical investigation aims to compare the mental health status of caregivers of psychiatric patients before and after virtual reality-based mindfulness. The study's primary objectives are to:
- Does immersive audio-based mindfulness have a greater positive impact on psychological well-being than virtual reality-mediated mindfulness?
- When compared to a single session, do four sessions lead to more improvements in psychological well-being? To assess the additional impact of virtual reality-mediated mindfulness, participants in the control group will receive mindfulness via immersive audio.
Those who voluntarily sign up for the study will participate in four sessions, one each week, on the same day and at the same time. Prior to and following the mindfulness intervention, self-administered psychometric assessment batteries will be completed.
While the control group will use ears to complete the mindfulness session using immersive audio, the experimental group will get a virtual reality-mediated mindfulness intervention. BECOME is the company that provides the audio and video content.
详细描述
In a sample of caregivers who visit the Department of Psychiatry at the "Renato Dulbecco" University Hospital in Catanzaro, the effects of the combined VR plus immersive audio treatment will be compared with the effects of immersive audio stimulation alone using a randomized controlled trial (RCT) design.
The main goal is to evaluate how much the experimental group's caregivers' mental health has improved both before and after therapy. The following self-report measures will be used for assessment: The World Health Organization Well-Being Index (WHO-5), the Zarit Burden Interview (ZBI), the Perceived Stress Scale (PSS-10), the Italian Mental Health Continuum-Short Form (MHC-SF), the Scale of Positive and Negative Experiences (SPANE), the Beck Depression Inventory-II (BDI-II), the State-Trait Anxiety Inventory (STAI), and the Pittsburgh Sleep Quality Index (PSQI).
Assessing variations in treatment effectiveness between the experimental and control groups is the secondary goal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Age ≥ 18 years.
- •Being the primary caregiver of a psychiatric patient with a clinically confirmed diagnosis for at least 6 months.
- •Willingness to participate for the entire duration of the study.
- •Signed informed consent.
排除标准
- •Active psychiatric diagnosis in the acute phase.
- •Previous regular use of mindfulness techniques or other relaxation techniques at any point in life.
- •Current use of psychotropic medications by the caregiver.
- •Photosensitive epilepsy (due to VR headset use).
- •Severe cognitive or sensory impairment.
- •Binocular vision abnormalities.
- •Hearing aids.
研究组 & 干预措施
Mindfulness and virtual reality
To examine changes in psychological factors, the same psychometric tests will be administered to both groups before and after each intervention. This group participate in a 10-minute virtual reality-mediated mindfulness protocol.
干预措施: VR (VR-Control) (Device)
Mindfulness and audio
To examine changes in psychological factors, the same psychometric tests will be administered to both groups before and after each intervention. This group participate in a 10-minute immersive audio-mediated mindfulness protocol.
干预措施: Audio immersivo (Device)
结局指标
主要结局
State-Trait Anxiety Inventory (STAI)
时间窗: From enrollment to the end of treatment at 4 weeks
Beck Depression Inventory (BDI-II)
时间窗: From enrollment to the end of treatment at 4 weeks
Italian Mental Health Continuum - Short Form (MHC-SF)
时间窗: From enrollment to the end of treatment at 4 weeks
Perceived Stress Scale (PSS-10)
时间窗: From enrollment to the end of treatment at 4 weeks
WHO-5
时间窗: From enrollment to the end of treatment at 4 weeks
Mindful Attention Awareness Scale (MAAS)
时间窗: From enrollment to the end of treatment at 4 weeks
Zarit Burden Interview (ZBI)
时间窗: From enrollment to the end of treatment at 4 weeks
Scale of Positive and Negative Experiences (SPANE)
时间窗: From enrollment to the end of treatment at 4 weeks
次要结局
未报告次要终点