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临床试验/NCT03511300
NCT03511300已完成不适用

Ready Set Goal: A Randomized Controlled Trial Examining Motivation and Cognition in Stroke Patients

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年6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
入组人数
72
试验地点
2
主要终点
Controlled Oral Word Association Task

研究概览

简要总结

Apathy is a syndrome of reduced motivation, characterized by diminished goal-directed behaviours (e.g., lack of effort), decreased goal-oriented cognitions (e.g., lack of interest) and blunted affect. Apathy is present in 20-50% of individuals after experiencing a stroke. Despite the detrimental impact of reduced goal-directed behaviours and cognitions on activities of daily living and cognition in stroke patients, interventions for increasing motivation (reducing apathy) have yet to be examined in this population. This study will examine the effect of goal-setting instructions on cognitive performance in stroke patients. The investigators hypothesize that in stroke patients, goal-setting instructions will improve cognitive performance relative to standard instructions. If goal-setting instructions are effective in improving cognitive performance, it may indicate that treatments targeting apathy could serve as a novel way to improve cognitive outcomes and enhance patient quality of life post-stroke.

详细描述

The study is a single-blind randomized controlled trial. It employs a mixed design, with a between-subjects variable (goal-setting instructions versus standardized instructions) and a within-subjects variable (pre-post instructional manipulation). It is a one-time intervention lasting 1-2 hours. Investigators plan to enroll 72 patients in this study. All participants will complete neuropsychological measures to assess their baseline performance. The baseline measures include Trial 1 of the CVLT-II Alternate Form, the Digit Span Test, Center for Epidemiologic Studies Depression Scale, Controlled Oral Word Association Test, Semantic Fluency Test, Apathy Evaluation Scale and Trail Making Test. After the baseline measures are completed, all participants will rate their level of motivation on a scale from 1 (extremely unmotivated) to 100 (extremely motivated), which will act as a pre-manipulation check measure, their level of fatigue on a scale from 1 (extremely not fatigued) to 100 (extremely fatigued), and their level of anxiety from 1 (extremely not anxious) to 100 (extremely anxious; 1 minute).

After completing the baseline measures and rating scales, half (n = 36) of the participants will be randomly assigned to the goal-setting instruction group ("goal-setting group"). Motivation will be enhanced by asking participants to perform 20% better than their previous performance on a similar task, and translating that into a number (e.g., "On this task, you generated 10 words when I asked you to name as many words as you could that start with the letter "F." Now, for the next letter, I want you to generate 12 words."). The remainder of the participants (n = 36) will be assigned to the "standard instruction group," where they will only receive the standardized instructions for completing the tests.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants will not be told which group they are assigned to.

入排标准

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

入选标准

  • Patient attending Secondary Stroke Prevention Clinic
  • Ischemic Stroke
  • Presenting at least 3 months after stroke
  • Modified Rankin Scale Score of at least 4
  • Fluent in English

排除标准

  • Marked aphasia
  • Marked neglect
  • Severe visual impairment
  • Inability to complete 1 hour of cognitive testing in English.

研究组 & 干预措施

Standard Instructions

Placebo Comparator

Participants will receive standard instructions for cognitive tasks.

干预措施: Standard Instructions (Behavioral)

Goal Setting Instructions

Experimental

Participants will receive goal-setting instructions for cognitive tasks.

干预措施: Goal-Setting Instructions (Behavioral)

Goal Setting Instructions

Experimental

Participants will receive goal-setting instructions for cognitive tasks.

干预措施: Standard Instructions (Behavioral)

结局指标

主要结局

Controlled Oral Word Association Task

时间窗: 10 minutes

Participant performance on Controlled Oral Word Association Task in goal setting instructions group compared to standard instruction group.

次要结局

  • Motivation Level(2 minutes)
  • Cognitive Performance on Semantic Fluency Test(10 minutes)
  • Digit Span Test(10 minutes)
  • California Verbal Learning Test-II(10 minutes)
  • Trail Making Test(10 minutes)

研究者

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

Dr. Richard H. Swartz

Principal Investigator

Sunnybrook Health Sciences Centre

研究点 (2)

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