Clinical trial NCT03511300: Ready, Set, Goal: Motivation and Cognition in Stroke Patients
Official title: Ready Set Goal: A Randomized Controlled Trial Examining Motivation and Cognition in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Keywords: Cognition
Apathy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: University of Ottawa
First posted: 2018-04-27
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Controlled Oral Word Association Task
timeFrame: 10 minutes
Secondary outcomes:
measure: Motivation Level
timeFrame: 2 minutes
measure: Cognitive Performance on Semantic Fluency Test
timeFrame: 10 minutes
measure: Digit Span Test
timeFrame: 10 minutes
measure: California Verbal Learning Test-II
timeFrame: 10 minutes
measure: Trail Making Test
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre/ University of Ottawa
name: Keera Fishman, B.Sc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
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.
citation: Benton, A. L., & Hamsher, K. (1976). Multilingual Aphasia Examination. Iowa City, Iowa: University of Iowa.
citation: Wechsler, D. (2008). Wechsler Adult Intelligence Scale-Fourth Edition. San Antonio, TX: Pearson.
citation: Marin RS. Apathy: a neuropsychiatric syndrome. J Neuropsychiatry Clin Neurosci. 1991 Summer;3(3):243-54. doi: 10.1176/jnp.3.3.243.
citation: 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.