Ready, Set, Goal: Motivation and Cognition in Stroke Patients (ACE)

S

Sunnybrook Health Sciences Centre

Status

Completed

Conditions

Stroke, Ischemic

Treatments

Behavioral: Standard Instructions
Behavioral: Goal-Setting Instructions

Study type

Interventional

Funder types

Other

Identifiers

NCT03511300
001

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

72 participants in 2 patient groups, including a placebo group

Standard Instructions
Placebo Comparator group
Description:
Participants will receive standard instructions for cognitive tasks.
Treatment:
Behavioral: Standard Instructions
Goal Setting Instructions
Experimental group
Description:
Participants will receive goal-setting instructions for cognitive tasks.
Treatment:
Behavioral: Goal-Setting Instructions
Behavioral: Standard Instructions

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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