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临床试验/NCT03195985
NCT03195985已完成不适用

Managing Stress and Cognitive Difficulties With a Short Mindfulness-based Intervention in Old Adults With Subjective Cognitive Complaints

Chelsea and Westminster NHS Foundation Trust4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
4
主要终点
Changes in cortisol levels between the two MCI groups over time

研究概览

简要总结

The study will focus on measuring stress, rumination and cognitive function across three time points in old adults with subjective cognitive complaints via a 4-week short mindfulness intervention, as compare to an active control condition (psycho-education course "ge Well").

This is a pilot study.

详细描述

20 old adults with subjective cognitive complaints will be recruited from adult day centres and the Chelsea Westminster Hospital in London. All patients will be aged 65 and above. Each participant will be randomly allocated to either a mindfulness intervention or the active control condition (psychoeducation) with 10 participants in each intervention.

A short mindfulness intervention of 4 weeks will be delivered by a trained mindfulness teacher across four 2 hour sessions that focus on the breath, links between mind and body, sensory and metacognitive awareness, emotion regulation, movement and compassion using visually engaging materials that will enhance understanding, encoding and recollection.

There will be one session per week. The proposed study will evaluate the effects of a short mindfulness intervention in old adults with subjective cognitive complaints. Management of emotional difficulties associated with anxiety and stress can improve psychological well-being in sufferers, and in turn can enhance cognitive capacity to maximise function. Mindfulness interventions are gentle, non-invasive and cost effective techniques that have been designed for stress reduction, that have been associated with improvements in mood, stress, pain management and overall well-being in a range of clinical and healthy populations. In addition mindfulness interventions have also been shown to improve cognitive function and emotion regulation by enhancing attentional awareness, attentional flexibility and attentional capacity. However, very few studies to date focus on elderly participants and no study to date has tried to shorten the current 8-week Mindfulness-Based Stress Reduction training in older adult populations.

The psycho-education course will also take 4 consecutive weeks, with one session each week.

All participants will be screened (see Appendix 6 of protocol) prior to the beginning of the study and recruited if they fulfil the criteria required as highlighted within the 'participants' section. The screening session will take approximately 20minutes. Written informed consent will be obtained from the participant prior to performing any study related evaluations or procedures. Informed consent (see Appendix 4 of protocol) will be taken during all assessment sessions and also during the screening assessment.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • All willing and consenting patients over the age of 65
  • Patients who have been admitted to the hospital and who have been formally diagnosed with MCI at the Memory Clinic
  • Patients with hair at the posterior vertex
  • Patients with fluent English
  • Patients who can commit to the entire length of the study
  • Patients with interest in mindfulness

排除标准

  • Being under 65 years of age
  • Presence of any psychiatric disorders,
  • Presence of myopathy
  • Presence of atherosclerosis
  • Use of steroids
  • Having undergone chemotherapy
  • heart disorder
  • head injury
  • advanced neurodegenerative disease
  • any patient having had dyed their hair less than one week prior to the first cortisol sampling

研究组 & 干预措施

Mindfulness-based Intervention

Experimental

Mindfulness intervention of 4 weeks

干预措施: Mindfulness-based intervention (Other)

"Age Well" psycho-education course

Active Comparator

4-week active control condition

干预措施: Age Well psycho-education (Other)

结局指标

主要结局

Changes in cortisol levels between the two MCI groups over time

时间窗: One month

assessed by collecting hair from the vertex posterior for stress hormone analysis

次要结局

  • Changes in anxiety over time(One month)
  • Changes in verbal learning and memory over time(One month)

研究者

发起方
Chelsea and Westminster NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcela P. Vizcaychipi

Consultant in Anaesthesia and Intensive Care

Chelsea and Westminster NHS Foundation Trust

研究点 (4)

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