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临床试验/NCT02902692
NCT02902692Unknown不适用

Examining the Effects of a Brief Mindfulness Based Intervention (BMBI) on Mood and Cognitive Functioning in an Older Adult Population

King's College London2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
Test of Everyday Attention

研究概览

简要总结

The current study will examine the effects of a brief mindfulness based intervention (BMBI) on mood, memory and attention in comparison to a wait-list control (WLC) group. Participants for the study will be 90 adults aged 50 years and above who have presented at a memory clinic within SLaM NHS Trust with subjective cognitive concerns and/or those who have received a diagnosis of mild cognitive impairment (MCI) from their memory clinic.

详细描述

Participants will be randomly assigned to either the BMBI group or the WLC group. Those assigned to the BMBI group will complete a number of cognitive assessments and questionnaires at Time 1. They will then receive a 45 minute mindfulness intervention. Following this, they will be asked to practice mindfulness for 30 minutes per day for 7 days a week in their own homes. After 7 days, participants in the BMBI group will be invited to complete a paired set of cognitive assessments and questionnaires (Time 2). Participants in the WLC group will complete the same number of cognitive assessments and questionnaires as the BMBI group at Time 1. However, they will not receive the 45 minute mindfulness intervention nor will they be asked to practice it at home for 7 days. After 7 days, participants in the WLC group will be invited to complete a paired set of cognitive assessments and questionnaires (Time 2). After completion of the measures at Time 2, the WLC participants will then receive the 45 minute mindfulness intervention. All assessments, questionnaires and the intervention will be carried out either in a SLaM memory clinic or at participants own homes depending on level of mobility.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People aged 50 years and older with subjective memory concerns (SMC) and/or those who meet criteria for amnestic mild cognitive impairment (MCI) who have been seen by one of the three SLAM memory services (i.e. Croydon Memory Service; Southwark and Lambeth Memory Service; and Lewisham Memory Service) in the past three months. Participants must be able to give informed consent to participate.

排除标准

  • Diagnosis of dementia or multi-domain mild cognitive impairment, intellectual disability, current substance misuse, a current diagnosis of epilepsy or another neurodegenerative disorder (such as Parkinson's), a history of brain injury or stroke, a severe and enduring mental health disorder (e.g. severe depression or anxiety, personality disorder, schizophrenia, schizoaffective disorder, bipolar affective disorder), active suicidal ideation, severe sensory impairment that would significantly impair a person's ability to engage in the intervention.

结局指标

主要结局

Test of Everyday Attention

时间窗: Change in attention from Baseline to 1 Week

The Test of Everyday Attention (TEA): Two subtests from the TEA (Robertson et al., 1994) will be used in the current study. Specifically, the Elevator Test will be used to measure sustained attention and the Visual Elevator Test will be used as a measure of attentional switching, and hence of cognitive flexibility. The TEA subtests are based on everyday life scenarios offering greater ecological validity. It has parallel forms which allow for repeat administration within short time periods reducing the impact of practice effects.

次要结局

  • The Five Facet Mindfulness Questionnaire (FFMQ)(Change in mindfulness from Baseline to 1 Week)
  • The Trail Making Test Parts A&B(Change in executive functioning from Baseline to 1 Week)
  • The Cognitive Failures Questionnaire(Change in subjective cognitive concerns from Baseline to 1 Week)
  • Hospital Anxiety Depression Scale (HADS)(Change in anxiety and depression from Baseline to 1 Week)
  • Penn State Worry Questionnaire(Change in worry from Baseline to 1 Week)
  • Short Form Health Survey(Change in quality of life from Baseline to 1 Week)
  • Digit Span Task(Change in working memory from Baseline to 1 Week)
  • CORE-10(Change in general psychological functioning from Baseline to 1 Week)
  • Letter-Number Sequencing Task(Change in working memory from Baseline to 1 Week)
  • Discharge Satisfaction Questionnaire(Post-treatment)
  • Ruminative Response Scale of the Response Styles Questionnaire(Change in rumination from Baseline to 1 Week)
  • Self-Compassion Scale Short-Form(Change in self-compassion from Baseline to 1 Week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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