Mindfulness for Older Adults With Cognitive Concerns
2016年9月12日 更新者：King's College London
Examining the Effects of a Brief Mindfulness Based Intervention (BMBI) on Mood and Cognitive Functioning in an Older Adult Population
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
90
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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London、英国、SE5 8AF
- 招聘中
- South London and Maudsely NHS Memory Services
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接触：
- Rebecca Gould, PHD
- 电话号码：02078480346
- 邮箱：rebecca.gould@kcl.ac.uk
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接触：
- David Matthews, PHD
- 电话号码：02032289500
- 邮箱：david.matthews@slam.nhs.uk
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria: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.
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Exclusion Criteria: 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.
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学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Brief Mindfulness
45 minute brief mindfulness intervention (lead by study investigator) on day 1 followed by 7 days of 30 minute mindfulness practice at home (without study investigator)
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15 minutes psycho-education about mindfulness and a small experiential exercise using a raisin.
Following this, participants listen to a 30minute pre-recorded sitting meditation which encourages them to focus on their breath and the sounds around them.
Participants will be randomly assigned to either receive the brief mindfulness intervention immediately or will be asked to wait one week before receiving the intervention.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Test of Everyday Attention
大体时间：Change in attention from Baseline to 1 Week
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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.
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Change in attention from Baseline to 1 Week
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hospital Anxiety Depression Scale (HADS)
大体时间：Change in anxiety and depression from Baseline to 1 Week
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The HADS consists of two subscales measuring depression and anxiety respectively.
Each subscale consists of seven items and responses on the items are based on the relative frequency of symptoms over the past week using a four point Likert scale ranging from 0 (not at all) to 3 (very often indeed).
Higher scores indicate higher levels of depression and anxiety, and scores of about 10 on each subscale indicate clinical significance.
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Change in anxiety and depression from Baseline to 1 Week
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Penn State Worry Questionnaire
大体时间：Change in worry from Baseline to 1 Week
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Penn State Worry Questionnaire: The PSWQ is a 16-item measure of worry that has shown adequate internal consistency and convergent validity in elderly patients with GAD and controls( Beck et al., 1995 and Stanley et al., 2001).
It uses a Likert rating from 1 (not at all typical of me) to 5 (very typical of me).
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Change in worry from Baseline to 1 Week
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Short Form Health Survey
大体时间：Change in quality of life from Baseline to 1 Week
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Short-Form Health Survey (SF-36): The physical and mental summary scores of the Short Form Health Survey (SF-36) (Van de Zee et al., 1993) are used to measure quality of life related to physical and mental aspects.
The SF-36 is composed of 36 items measuring health across eight dimensions: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, pain, mental health, vitality, and general health perception.
These eight subscales can be summarized into one physical and one mental component summary score.
Each dimension score ranges from 0-100.
Higher scores indicate better health-related quality of life.
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Change in quality of life from Baseline to 1 Week
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The Trail Making Test Parts A&B
大体时间：Change in executive functioning from Baseline to 1 Week
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The Trail Making Test (TMT; Army Individual Test Battery, 1944) is a commonly used neuropsychological test of visual attention and task switching.
It consists of 2 parts: part A asks participants to connect a series of numbers in ascending order on a page, while part B requires participants to draw a line alternating between ascending numbers and letters.
Part A is used primarily to capture processing speed whereas Part B requires more complex attention shifting, planning, and concentration, and is, thus, considered a valid index of executive control.
The time taken to complete the task is the primary performance outcome
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Change in executive functioning from Baseline to 1 Week
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Digit Span Task
大体时间：Change in working memory from Baseline to 1 Week
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Digit Span is a core working memory sub-test of the WAIS-IV (Wechsler, 2008).
It requires participants to repeat a series of digits forwards and backwards with series ranging in length from 2 to 9 digits.
This test also measures auditory sequential processing as the individual must recall auditory information and repeat it back aloud.
The Digit Span subtest has revealed an average test-retest reliability of .82
(Wechsler, 2008b).
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Change in working memory from Baseline to 1 Week
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Letter-Number Sequencing Task
大体时间：Change in working memory from Baseline to 1 Week
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Letter Number Sequencing is a subtest of the WAIS-IV (Wechsler, 2008) and is a measure of attention and short-term memory.
Lemay et al. (2004) report test-retest reliability data of between .73 and .75 in a two-week interval in middle aged to elderly subjects suggesting it can be reliably used in repeated neuropsychological assessments.
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Change in working memory from Baseline to 1 Week
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The Cognitive Failures Questionnaire
大体时间：Change in subjective cognitive concerns from Baseline to 1 Week
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The Cognitive Failures Questionnaire (Broadbent et al., 1982) will be used as a measure of subjective cognitive complaints.
The CFQ has been shown to have acceptable internal consistency and retest reliability, and good face validity in a sample of older adults (Knight et al., 2004).
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Change in subjective cognitive concerns from Baseline to 1 Week
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The Five Facet Mindfulness Questionnaire (FFMQ)
大体时间：Change in mindfulness from Baseline to 1 Week
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The Five Facet Mindfulness Questionnaire (FFMQ): The FFMQ (Baer et al., 2006) assesses five components of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
It has been shown to have good internal consistency (Baer et al., 2006) and adequate construct validity (Baer et al., 2008).
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Change in mindfulness from Baseline to 1 Week
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Ruminative Response Scale of the Response Styles Questionnaire
大体时间：Change in rumination from Baseline to 1 Week
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Ruminative Response Scale of the Response Styles Questionnaire (RRS of RSQ; Nolen-Hoeksema & Morrow, 1991).
The RRS will be administered to assess participants' tendencies to ruminate in response to their symptoms of negative emotion.
The RRS includes 22 items in response to depressed mood that are self-focused (e.g., "I think why do I always react this way?"), symptom focused (e.g., "I think about how hard it is to concentrate"), and focused on the possible consequences and causes of mood (e.g., "I think I won't be able to do my job if I don't snap out of this"), which participants rate on a scale from 1 (never) to 4 (always).
Total scores range from 22 to 88 with higher scores indicating greater rumination.
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Change in rumination from Baseline to 1 Week
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Self-Compassion Scale Short-Form
大体时间：Change in self-compassion from Baseline to 1 Week
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Self-Compassion Scale Short-Form (SCS-SF): The SCS-SF (Raes, Pommier, Neff, & Van Gucht, 2011) measures self-compassion and it has the following sub-scales: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification.
Participants have to rate how often they behave in a stated manner (e.g., "When I'm going through a very hard time, I give myself the caring and tenderness I need") in a scale from 1 (almost never) to 5 (almost always).
Total scores range from 12 to 60 with higher scores indicating greater self-compassion
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Change in self-compassion from Baseline to 1 Week
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CORE-10
大体时间：Change in general psychological functioning from Baseline to 1 Week
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CORE-10.
The CORE-10 is a short, 10 item version of the CORE-OM, a standard measure of psychological distress
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Change in general psychological functioning from Baseline to 1 Week
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Discharge Satisfaction Questionnaire
大体时间：Post-treatment
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The Discharge Satisfaction Questionnaire, (a standard service measure used within the MHOA CAG) will be completed by both the mindfulness and WLC group at post-intervention only to evaluate service satisfaction and the acceptability of the mindfulness intervention
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Post-treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Rebecca Gould, PhD,DClinPsy、King's College London
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年4月1日
初级完成 (预期的)
2017年3月1日
研究完成 (预期的)
2017年5月1日
研究注册日期
首次提交
2016年8月31日
首先提交符合 QC 标准的
2016年9月12日
首次发布 (估计)
2016年9月16日
研究记录更新
最后更新发布 (估计)
2016年9月16日
上次提交的符合 QC 标准的更新
2016年9月12日
最后验证
2016年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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