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

Stroke, Ischemic Clinical Trial

— ACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03511300
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: October 25, 2019

Study information

• Verified date: October 2019
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 25, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke, Ischemic

Intervention

Behavioral:
• Goal-Setting Instructions
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'.")
• Standard Instructions
Participants in this group will receive the standardized instructions for completing the tests, as outlined in the test appendices.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	University of Ottawa

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Benton, A. L., & Hamsher, K. (1976). Multilingual Aphasia Examination. Iowa City, Iowa: University of Iowa.

Darvesh S, Leach L, Black SE, Kaplan E, Freedman M. The behavioural neurology assessment. Can J Neurol Sci. 2005 May;32(2):167-77. — View Citation

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.

Marin RS. Apathy: a neuropsychiatric syndrome. J Neuropsychiatry Clin Neurosci. 1991 Summer;3(3):243-54. Review. — View Citation

REITAN RM. The relation of the trail making test to organic brain damage. J Consult Psychol. 1955 Oct;19(5):393-4. — View Citation

Scheurich A, Fellgiebel A, Schermuly I, Bauer S, Wölfges R, Müller MJ. Experimental evidence for a motivational origin of cognitive impairment in major depression. Psychol Med. 2008 Feb;38(2):237-46. Epub 2007 Nov 16. — View Citation

Wechsler, D. (2008). Wechsler Adult Intelligence Scale-Fourth Edition. San Antonio, TX: Pearson.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Motivation Level	Participant self-reported motivation level in goal setting instruction group versus standard instruction group.	2 minutes
Secondary	Cognitive Performance on Semantic Fluency Test	Participant performance on Semantic Fluency Test in goal setting instructions group compared to standard instruction group.	10 minutes
Secondary	Digit Span Test	Participant performance on Digit Span Test in goal setting instructions group compared to standard instruction group.	10 minutes
Secondary	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
Secondary	Trail Making Test	Participant performance on Trail Making Test in goal setting instructions group compared to standard instruction group.	10 minutes