Ready, Set, Goal: Motivation and Cognition in Stroke Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Behavioral: Goal-Setting Instructions
* Behavioral: Standard Instructions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Marked aphasia Marked neglect Severe visual impairment Inability to complete 1 hour of cognitive testing in English.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study is a single-blind randomized controlled trial. It employs a mixed design, with a between-subjects (instruction type: goal-setting or standard instructions) and a within subjects (pre- and post-instruction manipulation) variable. Seventy-two stroke patients will undergo baseline cognitive testing to assess their verbal ability, learning, memory, attention, visuospatial ability, and exective functioning, with standardized instructions. After completing baseline testing and ratings of apathy (AES), depression (CES-D), anxiety, motivation, and fatigue, participants (N = 72) will either be assigned to the standardized instruction condition (n = 30) or the goal-setting instruction condition (n = 30).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard Instructions<br>Participants will receive standard instructions for cognitive tasks. | Behavioral: Standard Instructions<br>* Participants in this group will receive the standardized instructions for completing the tests, as outlined in the test appendices.<br>|
| Experimental: Goal Setting Instructions<br>Participants will receive goal-setting instructions for cognitive tasks. | Behavioral: Goal-Setting Instructions<br>* In the goal-setting instruction condition, participants will be asked to increase their performance by 20% from the previous similar test (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, I want you to aim to generate at least 12 words for the letter 'F'.)<br>Behavioral: Standard Instructions<br>* Participants in this group will receive the standardized instructions for completing the tests, as outlined in the test appendices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Controlled Oral Word Association Task | Participant performance on Controlled Oral Word Association Task in goal setting instructions group compared to standard instruction group. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation Level | Participant self-reported motivation level in goal setting instruction group versus standard instruction group. | 2 minutes | 
| Cognitive Performance on Semantic Fluency Test | Participant performance on Semantic Fluency Test in goal setting instructions group compared to standard instruction group. | 10 minutes | 
| Digit Span Test | Participant performance on Digit Span Test in goal setting instructions group compared to standard instruction group. | 10 minutes | 
| California Verbal Learning Test-II | Participant performance on California Verbal Learning Test-II in goal setting instructions group compared to standard instruction group. | 10 minutes | 
| Trail Making Test | Participant performance on Trail Making Test in goal setting instructions group compared to standard instruction group. | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition, Apathy