Mindfulness-based Intervention for People Affected by Parkinson's Disease: A Distant-delivered Randomised Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline Hospital Anxiety and Depression Scale (HADS) at 4, 8 and 20 weeks
研究概览
简要总结
Psychological difficulties, especially depression and anxiety are the most prevalent non-motor symptoms in Parkinson's Disease (PD). Pharmacological treatments are not as effective in PD. Mindfulness courses have received increased popularity and recognition as an effective way to manage emotional states, and there is ever growing findings of the effectiveness of mindfulness courses for people with long-term medical conditions. Two small pilot studies have indicated that mindfulness courses can be helpful for people with PD in improving symptoms of depression, language functioning and motor symptoms. The investigators propose to deliver these courses remotely, through Skype video conferences, to make it more accessible for people with mobility limitations and people who live in rural areas.
详细描述
This study will employ a mixed-methods design, with an experimental randomised control trial followed by a qualitative design. Sixty participants will be randomly assigned to the 8-week mindfulness course (n=30) or a wait-list control group (n=30). Block randomisation will be used and the randomisation scheme will be generated using the randomisation.com website. One-hour sessions will be delivered to groups of 5 people using Skype video-conferencing. As this is a pilot study analyses will largely be descriptive. Further, inferential analyses using mixed modelling will be conducted by intention-to-treat. At the end of the intervention, the investigators will interview the participants of the mindfulness group about their experiences of the course.
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
- 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
- 否
入选标准
- •be diagnosed with PD according to PD Brain Bank criteria by a neurologist or geriatrician
- •have a computer and internet access at home, since the course will be delivered via Skype
- •be able to communicate in English fluently
- •be stabilised on mood altering medication and/or Parkinson's medication for a month
排除标准
- •have severe cognitive impairment that would make participation in the mindfulness sessions and home practice of mindful meditation problematic or distressing. This will be assessed using the Telephone Interview for Cognitive Status-Modified (TICS-M, Brandt et al., 1993).
- •have severe psychiatric conditions (e.g. psychosis, drug/ alcohol addiction) that can potentially risk failure in the treatment or limit participation in the course
- •have severe hearing impairment
- •are currently participating in other psychological therapies
- •have prior formal training in mindfulness methods or current meditation practice
结局指标
主要结局
Change from baseline Hospital Anxiety and Depression Scale (HADS) at 4, 8 and 20 weeks
时间窗: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20).
HADS also assessed at Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20) time points.
次要结局
- Parkinson's Disease Activities of Daily Living Scale (PADLS)(Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20))
- Fatigue Severity Scale (FSS)(Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20))
- Insomnia Severity Index (ISI)(Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20))
- Brief Pain Inventory (BPI)(Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20))
研究者
Angeliki Bogosian
Lecturer in Psychology
City, University of London