Ready, Set, Goal: Motivation and Cognition in Stroke Patients (ACE)
Ready Set Goal: A Randomized Controlled Trial Examining Motivation and Cognition in Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Standard Instructions
Participants will receive standard instructions for cognitive tasks.
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Participants in this group will receive the standardized instructions for completing the tests, as outlined in the test appendices.
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Experimental: Goal Setting Instructions
Participants will receive goal-setting instructions for cognitive tasks.
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Participants in this group will receive the standardized instructions for completing the tests, as outlined in the test appendices.
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'.")
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Controlled Oral Word Association Task
Time Frame: 10 minutes
|
Participant performance on Controlled Oral Word Association Task in goal setting instructions group compared to standard instruction group.
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10 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motivation Level
Time Frame: 2 minutes
|
Participant self-reported motivation level in goal setting instruction group versus standard instruction group.
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2 minutes
|
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Cognitive Performance on Semantic Fluency Test
Time Frame: 10 minutes
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Participant performance on Semantic Fluency Test in goal setting instructions group compared to standard instruction group.
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10 minutes
|
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Digit Span Test
Time Frame: 10 minutes
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Participant performance on Digit Span Test in goal setting instructions group compared to standard instruction group.
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10 minutes
|
|
California Verbal Learning Test-II
Time Frame: 10 minutes
|
Participant performance on California Verbal Learning Test-II in goal setting instructions group compared to standard instruction group.
|
10 minutes
|
|
Trail Making Test
Time Frame: 10 minutes
|
Participant performance on Trail Making Test in goal setting instructions group compared to standard instruction group.
|
10 minutes
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Keera Fishman, B.Sc, Sunnybrook Health Sciences Centre/ University of Ottawa
Publications and helpful links
General Publications
- REITAN RM. The relation of the trail making test to organic brain damage. J Consult Psychol. 1955 Oct;19(5):393-4. doi: 10.1037/h0044509. No abstract available.
- Marin RS. Apathy: a neuropsychiatric syndrome. J Neuropsychiatry Clin Neurosci. 1991 Summer;3(3):243-54. doi: 10.1176/jnp.3.3.243.
- Scheurich A, Fellgiebel A, Schermuly I, Bauer S, Wolfges R, Muller MJ. Experimental evidence for a motivational origin of cognitive impairment in major depression. Psychol Med. 2008 Feb;38(2):237-46. doi: 10.1017/S0033291707002206. Epub 2007 Nov 16.
- Darvesh S, Leach L, Black SE, Kaplan E, Freedman M. The behavioural neurology assessment. Can J Neurol Sci. 2005 May;32(2):167-77. doi: 10.1017/s0317167100003930.
- Delis, D. C., Kramer, J. H, Kaplan, E., & Ober, B. A. (2000). California Verbal Learning Test - Second edition. Adult version: Manual. San Antonio: Psychological Corporation.
- Benton, A. L., & Hamsher, K. (1976). Multilingual Aphasia Examination. Iowa City, Iowa: University of Iowa.
- Wechsler, D. (2008). Wechsler Adult Intelligence Scale-Fourth Edition. San Antonio, TX: Pearson.
- Fishman KN, Ashbaugh AR, Swartz RH. Goal Setting Improves Cognitive Performance in a Randomized Trial of Chronic Stroke Survivors. Stroke. 2021 Jan;52(2):458-470. doi: 10.1161/STROKEAHA.120.032131. Epub 2021 Jan 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (Marta Eliza Miller Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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