跳至主要内容
临床试验/NCT03432754
NCT03432754已完成不适用

Health Education and Lifestyle Training in Older Adults

Ohio State University0 个研究点目标入组 74 人开始时间: 2014年10月20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
入组人数
74
主要终点
Change in Global Performance on Computerized Attentional Control Tasks

研究概览

简要总结

The investigators conducted a mindfulness training intervention in older adults aimed at examining the effects of brief mindfulness training on mind wandering as well as the cognitive and affective functioning of older adults. Individuals completed pre- and post-assessments of mind wandering and cognitive functioning. Additionally, all participants completed neuropsychological measures and self-report questionnaires.

详细描述

Age-related differences in sustained attention may be related to the prevalence and content of task unrelated thought or mind-wandering. Older adults report less mind-wandering in sustained tasks than younger adults, something that is surprising due to the reduced performance on tasks. It is clear that both cognitive and emotional processes underlie comprehension and sustained attention and relate to prevalence of task unrelated thought and performance. A complex process such as reading comprehension presents a challenge for improvement because of the wide range of changes that occur with age. Pharmacological therapies can target only a limited number of the many changes believed to underlie functional decline. One way that may mitigate these declines in performance in a broad way is mindfulness training. Thus, the investigators conducted a randomized study to assess the effects of mindfulness training relative to an active health education control group on mind wandering and controlled processing abilities in older adults. All individuals that contact the Clinical Neuroscience Laboratory (CNLab) with interest underwent a phone screening assessing inclusion/exclusion criteria.Those participants meeting I/E criteria were invited to participate in the study. During the first assessment session, written informed consent was obtained; additional inclusion/exclusion measures were administered; and self-report questionnaires and assessment measures were completed. Following the first assessment session, four training sessions took place. Participants were randomized into either the a mindfulness training intervention or a health education intervention. Subsequently, all participants were invited back for post-assessment session.

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
Double (Participant, Outcomes Assessor)

盲法说明

Randomization was conducted by the principle investigator (PI) and study coordinator using a computerized random number generator program (randomization.com). All experimenters (except the PI and study coordinator) were blinded to group assignments until study conclusion. To further reduce demand characteristics, participants were unaware of which group was considered the experimental intervention until debriefed by an experimenter after completing the study. Study binders were created to blind group assignment, and participants in each group were asked not to discuss the sessions with members of the other group or with the experimenter at their post-intervention assessment.

入排标准

年龄范围
60 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 60 to 74 years of age
  • No prior exposure to mindfulness training
  • No significant meditation experience
  • Have never engaged in regular practices of yoga
  • Capable of attending both assessment and training sessions
  • Corrected (near and far) visual acuity of 20/40 or better
  • Normal color vision
  • No self-reported history of psychiatric, neurological, or chronic inflammatory conditions
  • Absence of psychiatric medication use
  • Native English Speaker
  • Adequate performance on the Mini-Mental Status Examination (MMSE; >23)
  • Depression score on the Geriatric Depression Scale (GDS) below clinical level (<10)

排除标准

  • Below 60 years of age or above 74 years of age
  • Have exposure to or experience with any type of meditation or yoga regularly (one hour a week for at least 12 months)
  • Any physical or pragmatic limitation that prohibits attendance at both sessions
  • Corrected (near or far) visual acuity worse than 20/40
  • All types of color blindness
  • Presence of diagnosed neurological disorders (such as: Alzheimer's disease, Parkinson's disease or multiple sclerosis) or chronic inflammatory conditions
  • Presence of any diagnosed psychiatric disorder such as depression, attention deficit hyperactivity disorder (ADHD), substance abuse
  • Presence of psychiatric medication use such as Xanax, Wellbutrin, or Vivance
  • Non-Native English Speaker or no fluency in English
  • Inadequate performance on the Mini-Mental Status Examination (MMSE; <23)
  • Depression score on GDS indicative of clinical depression (>10)

研究组 & 干预措施

Mindfulness-Based Attention Training

Experimental

Four weekly group mindfulness attention training sessions of a 1.5-hour duration. Participants provided with audio recordings, readings, and homework assignments consisting of various mindfulness practices.

干预措施: Mindfulness-Based Attention Training (Behavioral)

Lifestyle Education Group

Active Comparator

Four weekly group lifestyle education sessions of a 1.5-hour duration. Homework consisting of reading, diet monitoring, stretching/toning exercises, and brainstorming new healthy living techniques/ideas.

干预措施: Lifestyle Education (Behavioral)

结局指标

主要结局

Change in Global Performance on Computerized Attentional Control Tasks

时间窗: Baseline and after the 4-week intervention

Signal detection scores on two computerized tasks of attentional control calculated for each task using the formula for logistic distributions: dL = ln{\[H(1-FA)\]/\[(1-H)FA\]}, where H refers to hit rates and FA refers to false alarms.

Change in Mind-Wandering During Attentional Control Tasks

时间窗: Baseline and after the 4-week intervention

Frequency with which thoughts categorized as evaluating performance or off-task in response to quasi-random mind-wandering probes collected during two computerized tasks of attentional control.

次要结局

  • Change in Self-report Mindful Attention Awareness Scale (MAAS)(Baseline and after the 4-week intervention)
  • Change on Self-Report Measure of Emotion Dysregulation(Baseline and after the 4-week intervention)
  • Change in Local Metrics of Attentional Control During Go/No-Go Task(Baseline and after the 4-week intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruchika Prakash

Associate Professor

Ohio State University

相似试验