Anxiety, Stress and Sleep Problems in People With Early Onset Dementia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- KU Leuven
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- anxiety (GAD7 validated questionnaire)
研究概览
简要总结
The aim of this study is to
- detect and assess needs of people with early onset dementia regarding anxiety, stress and sleep
- implement a 6 week intervention pilot study in wich weekly (hourly) sessions are implemented in day care settings in order to decrease anxiety, stress and sleep problems in people with early onset dementia
详细描述
- needs detection by means of survey and interviews
- implementation of a 6 week program in day care facilities
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosed with early onset dementia before age of 65Y
排除标准
- •severe dementia
研究组 & 干预措施
Intervention group (pilot study)
- needs detection by means of survey and interviews (mixed-methods)
- 6 week program (1 hour) on a weekly basis including cognitive behavioural therapy, sleep/stress hygiene education, heart coherence exercises, mindfulness and relaxation exercises
干预措施: young-D program (Behavioral)
结局指标
主要结局
anxiety (GAD7 validated questionnaire)
时间窗: 6 weeks
this is a subjective survey that measures the level of anxiety in daily life. It is a score of 7 items with a min of 0 and a max of 21. A higher score indicates a higher anxiety.
stress (perceived stress scale, PSS, validated questionnaire)
时间窗: 6 weeks
this is a subjective survey that measures the level of stress in daily life. It is a score of 10 items with a min of 0 and a max of 40. A higher score indicates a higher stress level.
sleep (Insomnia severity index, ISI, validated questionnaire)
时间窗: 6 weeks
this is a subjective survey that measures the level of insomnia. It is a score of 7 items with a min of 0 and a max of 28. A higher score indicates a worse level of insomnia
sleep (actigraph)
时间窗: 6 weeks
this is an objective measurement that measures the sleep quantity
次要结局
- emotional well being (WEMWBS, Warwick emotional mental wellbeing scale)(6 weeks)
- quality of life (QoL) (quality of life in dementia, QUALIDEM)(6 weeks)
- heart rate variance (HRV)(6 weeks)
- Depression (Patient Health Questionnaire PHQ-9, validated questionnaire)(6 weeks)
研究者
Julie Vanderlinden
Principal investigator
KU Leuven