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

NCT03511300 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Keywords

Cognition; Apathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Motivation Level

  2 minutes

• Cognitive Performance on Semantic Fluency Test

  10 minutes

• Digit Span Test

  10 minutes

• California Verbal Learning Test-II

  10 minutes

• Trail Making Test

  10 minutes

Study Arms (2)

Standard Instructions

PLACEBO COMPARATOR

Participants will receive standard instructions for cognitive tasks.

Behavioral: Standard Instructions

Goal Setting Instructions

EXPERIMENTAL

Participants will receive goal-setting instructions for cognitive tasks.

Behavioral: Goal-Setting Instructions; Behavioral: Standard Instructions

Interventions

Goal-Setting Instructions BEHAVIORAL

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'.")

Goal Setting Instructions

Standard Instructions BEHAVIORAL

Participants in this group will receive the standardized instructions for completing the tests, as outlined in the test appendices.

Goal Setting Instructions; Standard Instructions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Marked aphasia
• Marked neglect
• Severe visual impairment
• Inability to complete 1 hour of cognitive testing in English.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• University of Ottawa: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (8)

• 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.

  PMID: 18005498 BACKGROUND

• 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.

  PMID: 13263471 BACKGROUND

• 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.

  PMID: 16018151 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• Marin RS. Apathy: a neuropsychiatric syndrome. J Neuropsychiatry Clin Neurosci. 1991 Summer;3(3):243-54. doi: 10.1176/jnp.3.3.243.

  PMID: 1821241 BACKGROUND

• 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.

  PMID: 33467876 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Lethargy

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Keera Fishman, B.Sc

  Sunnybrook Health Sciences Centre/ University of Ottawa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be told which group they are assigned to.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: April 27, 2018
• Study Start: June 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 25, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)