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Dissociating Components of Anhedonia: A Pilot fMRI Study

Primary Purpose

Anhedonia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional Magnetic Resonance Imaging
Effort-Expenditure for Rewards Task
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anhedonia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-38 or 60-80 years
  • Able to provide verbal and written consent
  • Right-handed
  • Native English speaker
  • At least 12 years of formal education

Exclusion Criteria:

  • Significant cognitive disturbance
  • Self-report of current or past history of psychiatric disturbance other than major depression (e.g., bipolar disorder, schizophrenia, alcohol and/or substance abuse)
  • Self-report of neurological disturbance (stroke, dementia, traumatic brain injury), chronic medical illness (HIV, metastatic cancer), or unstable medical conditions (cardiac or pulmonary disease)
  • Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks
  • Current anticholinergic, psychotropic (stimulants or dopamine agonists), or anti-epileptic use
  • Visual acuity difficulties that would interfere with task performance
  • Motor deficits that may interfere with the use of the dominant hand for performance of button press associated with the EEfRT task
  • MRI contraindications (e.g., ferrous metal in the body, claustrophobia, pregnancy)

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Young Adults

Older Adults

Arm Description

These participants will perform the Effort-Expenditure for Rewards Task (EEfRT) while an functional magnetic resonance imaging (fMRI) is performed. They will also complete a battery of both cognitive and anhedonia questionnaires.

These participants will perform the Effort-Expenditure for Rewards Task (EEfRT) while an functional magnetic resonance imaging (fMRI) is performed. They will also complete a battery of both cognitive and anhedonia questionnaires.

Outcomes

Primary Outcome Measures

fMRI Activity
To quantify brain activity associated with reward "wanting," the investigators will contrast fMRI activation while participants view information about reward probability and choose to perform the easy or hard task with activity during fixation. The investigators will contrast activation during performance feedback and presentation of reward magnitude with activation during fixation to capture brain activity associated with reward "liking." Parameter estimates (ß) will be generated, which indicated relative strength of covariance between the data and the hemodynamic response function (HRF). The investigators will use a three-dimensional spatial contiguity threshold of 20 voxels and a statistical significance threshold of p ≤ .005 to decrease the likelihood of spurious findings.
EEfRT Task Test
The EEfRT is a computerized task in which participants are presented with a series of repeated trials during which they choose between performing a ''hard-task'' or an ''easy-task'' in order to earn varying amounts of monetary rewards.

Secondary Outcome Measures

Montreal Cognitive Assessment (MoCA)
Cognitive screening instrument. The highest possible score is 30. 18 - 26 = mild cognitive impairment, 10 - 17 = moderate cognitive impairment and less than 10 = severe cognitive impairment.
Dementia Rating Scale-2 (DRS-2)
The scale includes 36 tasks which are grouped into five subscales assessing different cognitive domains, namely: Attention, Initiation/Perseveration (I/P), Construction, Conceptualization and Memory.
Card Stroop Task
Participants must 1) read color words (red, green and blue) aloud, 2) name the ink color of a string of X's presented in rows on a page, and 3) name the ink color of color words (red, green, blue) written in either the same or a different color as the word meaning.
Letter-Number Sequencing (Wechsler Adult Intelligence Scale, 4th Edition)
Subjects hear a string a numbers and letters and must repeat them with the numbers first, in order, followed by the letters in alphabetical order.
Trail Making Test Parts A and B
The task requires a subject to 'connect-the-dots' of 25 consecutive targets on a sheet of paper or computer screen. There are two parts to the test: A, in which the targets are all numbers (1,2,3..) and the test taker needs to connect them in sequential order, and B, in which the subject alternates between numbers and letters (1, A, 2, B, etc.). The test should be finished as quickly as possible within 5 minutes. The poorer the performance the higher the impairment.
Wisconsin Card Sorting Test
A number of stimulus cards are to be match within 20 minutes. Participants must figure out the sorting rule based on feedback from the examiner.
Controlled Oral Word Association/Category Fluency
Subjects are asked to name as many words as they can in 60 seconds based on either a letter (F, A, and S) or a category (animals) rule.
Digit Span (Wechsler Adult Intelligence Scale, 4th Edition)
Subjects repeat a string of numbers in either the same order (digits forward) or in reverse order (digits backward).
California Verbal Learning Test II (CVLT-II)
Subjects are asked to learn and remember a 16-item word list.
Brief Visuospatial Memory Test-Revised (BVMT-R)
Subjects are asked to learn and remember the identity and location of 6 simple figures displayed on a page.
Temporal Experience of Pleasure scale (TEPS)
18-item self-report questionnaire assessing anticipatory pleasure and consummatory pleasure
Snaith-Hamilton Pleasure Scale (SHAPS)
The SHAPS measures hedonic capacity. A higher total SHAPS score will indicate a higher level of anhedonia or the inability to experience pleasure.
Positive Affect Negative Affect Scale (PANAS)
Subjects are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).
Beck Depression Inventory, 2nd Edition (BDI-II)
21-item self-report questionnaire assessing symptoms of depression.
Geriatric Depression Scale (GDS)
Subjects answer 30 yes/no questions assessing symptoms of depression.
Center for Epidemiologic Studies Depression Scale (CES-D)
This is a 20-item measure of depression severity.
State-Trait Anxiety Inventory (STAI)
The STAI measures two extremes of anxiety affect, labeled state anxiety (A-State), and trait anxiety (A-Trait). Higher scores suggest higher levels of anxiety.
Apathy Scale (AS)
14-item self-report questionnaire assessing symptoms of apathy over the previous 2-4 weeks
Lille Apathy Rating Scale (LARS)
33 queries belonging to nine domains, each corresponding to a clinical manifestation of apathy

Full Information

First Posted
October 2, 2015
Last Updated
November 9, 2018
Sponsor
University of Florida
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02569034
Brief Title
Dissociating Components of Anhedonia: A Pilot fMRI Study
Official Title
Dissociating Components of Anhedonia: Pilot Behavioral and fMRI Data for the Effort Expenditure for Rewards Task
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
May 8, 2018 (Actual)
Study Completion Date
May 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Anhedonia, decreased motivation for and sensitivity to rewarding experiences, is present in at least 1/3 of community dwelling older adults and is a feature of various psychiatric and neurological disorders, including late-life depression and Parkinson's disease. Anhedonia is associated with cognitive deficits, as well as poor clinical outcomes and increased mortality. Recent research suggests that anhedonia comprises motivational (reward "wanting") and consummatory (reward "liking") aspects. However, previous research on anhedonia has failed to dissociate these components, which may explain the contradictory findings in the literature. Recently, the Effort-Expenditure for Rewards Task (EEfRT) was developed in an effort to dissociate reward components in anhedonia. The EEfRT is an effort-based decision-making task that measures reward "wanting", in contrast to commonly used anhedonia questionnaires, which focus on reward "liking." This novel task may provide a useful measure of components of anhedonia in older adults and in different patient populations. Thus far no data is available on this task in elderly individuals, and the cognitive and neural correlates of components of the task have not been investigated. Given the paucity of research on the neurobiology of anhedonia, cognitive neuroscience studies using this task could fill a gap in the literature. The investigators are developing a line of cognitive neuroscience studies examining anhedonia in community-dwelling older adults and in late-life depression and Parkinson's disease. This study will involve gathering pilot behavioral and functional magnetic resonance imaging (fMRI) data in young and older adults performing the EEfRT task. Understanding the brain mechanisms underlying anhedonia in older adults and in different patient populations will have a translational impact by elucidating biological targets for treatment.
Detailed Description
Twenty young adults (aged 18-38) and 20 older adults (aged 60-80) will perform the EEfRT while fMRI data are acquired. To quantify brain activity associated with reward "wanting," the fMRI activation will be measured while participants view information about reward probability and choose to perform the easy or hard task, with greater reward associated with the hard task. The investigators will measure activation during presentation of reward magnitude to capture brain activity associated with reward "liking." Participants will also complete a brief cognitive battery and anhedonia questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anhedonia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Young Adults
Arm Type
Active Comparator
Arm Description
These participants will perform the Effort-Expenditure for Rewards Task (EEfRT) while an functional magnetic resonance imaging (fMRI) is performed. They will also complete a battery of both cognitive and anhedonia questionnaires.
Arm Title
Older Adults
Arm Type
Experimental
Arm Description
These participants will perform the Effort-Expenditure for Rewards Task (EEfRT) while an functional magnetic resonance imaging (fMRI) is performed. They will also complete a battery of both cognitive and anhedonia questionnaires.
Intervention Type
Other
Intervention Name(s)
Functional Magnetic Resonance Imaging
Other Intervention Name(s)
fMRI
Intervention Description
Both groups will have the fMRI performed once. The fMRI will be use to to dissociate activity associated with both reward "wanting" and reward "liking" using the EEfRT. Learning more about the brain basis of components of anhedonia in both young and older adults is important in the context of previous research showing that risk-taking behavior and reward sensitivity changes with age, enhancing the knowledge of anhedonia.
Intervention Type
Other
Intervention Name(s)
Effort-Expenditure for Rewards Task
Other Intervention Name(s)
EEfRT
Intervention Description
Both groups with have the EEfRT performed once. The EEfRT is an effort-based decision-making task that measures reward "wanting", in contrast to commonly used anhedonia questionnaires, which focus on reward "liking." This novel task may provide a useful measure of components of anhedonia in older adults and in different patient populations.
Primary Outcome Measure Information:
Title
fMRI Activity
Description
To quantify brain activity associated with reward "wanting," the investigators will contrast fMRI activation while participants view information about reward probability and choose to perform the easy or hard task with activity during fixation. The investigators will contrast activation during performance feedback and presentation of reward magnitude with activation during fixation to capture brain activity associated with reward "liking." Parameter estimates (ß) will be generated, which indicated relative strength of covariance between the data and the hemodynamic response function (HRF). The investigators will use a three-dimensional spatial contiguity threshold of 20 voxels and a statistical significance threshold of p ≤ .005 to decrease the likelihood of spurious findings.
Time Frame
Approximately Day 14 (Visit 2)
Title
EEfRT Task Test
Description
The EEfRT is a computerized task in which participants are presented with a series of repeated trials during which they choose between performing a ''hard-task'' or an ''easy-task'' in order to earn varying amounts of monetary rewards.
Time Frame
Approximately Day 14 (Visit 2)
Secondary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MoCA)
Description
Cognitive screening instrument. The highest possible score is 30. 18 - 26 = mild cognitive impairment, 10 - 17 = moderate cognitive impairment and less than 10 = severe cognitive impairment.
Time Frame
Baseline (Visit 1)
Title
Dementia Rating Scale-2 (DRS-2)
Description
The scale includes 36 tasks which are grouped into five subscales assessing different cognitive domains, namely: Attention, Initiation/Perseveration (I/P), Construction, Conceptualization and Memory.
Time Frame
Baseline (Visit 1)
Title
Card Stroop Task
Description
Participants must 1) read color words (red, green and blue) aloud, 2) name the ink color of a string of X's presented in rows on a page, and 3) name the ink color of color words (red, green, blue) written in either the same or a different color as the word meaning.
Time Frame
Baseline (Visit 1)
Title
Letter-Number Sequencing (Wechsler Adult Intelligence Scale, 4th Edition)
Description
Subjects hear a string a numbers and letters and must repeat them with the numbers first, in order, followed by the letters in alphabetical order.
Time Frame
Baseline (Visit 1)
Title
Trail Making Test Parts A and B
Description
The task requires a subject to 'connect-the-dots' of 25 consecutive targets on a sheet of paper or computer screen. There are two parts to the test: A, in which the targets are all numbers (1,2,3..) and the test taker needs to connect them in sequential order, and B, in which the subject alternates between numbers and letters (1, A, 2, B, etc.). The test should be finished as quickly as possible within 5 minutes. The poorer the performance the higher the impairment.
Time Frame
Baseline (Visit 1)
Title
Wisconsin Card Sorting Test
Description
A number of stimulus cards are to be match within 20 minutes. Participants must figure out the sorting rule based on feedback from the examiner.
Time Frame
Baseline (Visit 1)
Title
Controlled Oral Word Association/Category Fluency
Description
Subjects are asked to name as many words as they can in 60 seconds based on either a letter (F, A, and S) or a category (animals) rule.
Time Frame
Baseline (Visit 1)
Title
Digit Span (Wechsler Adult Intelligence Scale, 4th Edition)
Description
Subjects repeat a string of numbers in either the same order (digits forward) or in reverse order (digits backward).
Time Frame
Baseline (Visit 1)
Title
California Verbal Learning Test II (CVLT-II)
Description
Subjects are asked to learn and remember a 16-item word list.
Time Frame
Baseline (Visit 1)
Title
Brief Visuospatial Memory Test-Revised (BVMT-R)
Description
Subjects are asked to learn and remember the identity and location of 6 simple figures displayed on a page.
Time Frame
Baseline (Visit 1)
Title
Temporal Experience of Pleasure scale (TEPS)
Description
18-item self-report questionnaire assessing anticipatory pleasure and consummatory pleasure
Time Frame
Baseline (Visit 1)
Title
Snaith-Hamilton Pleasure Scale (SHAPS)
Description
The SHAPS measures hedonic capacity. A higher total SHAPS score will indicate a higher level of anhedonia or the inability to experience pleasure.
Time Frame
Baseline (Visit 1)
Title
Positive Affect Negative Affect Scale (PANAS)
Description
Subjects are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).
Time Frame
Baseline (Visit 1)
Title
Beck Depression Inventory, 2nd Edition (BDI-II)
Description
21-item self-report questionnaire assessing symptoms of depression.
Time Frame
Baseline (Visit 1)
Title
Geriatric Depression Scale (GDS)
Description
Subjects answer 30 yes/no questions assessing symptoms of depression.
Time Frame
Baseline (Visit 1)
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
This is a 20-item measure of depression severity.
Time Frame
Baseline (Visit 1)
Title
State-Trait Anxiety Inventory (STAI)
Description
The STAI measures two extremes of anxiety affect, labeled state anxiety (A-State), and trait anxiety (A-Trait). Higher scores suggest higher levels of anxiety.
Time Frame
Baseline (Visit 1)
Title
Apathy Scale (AS)
Description
14-item self-report questionnaire assessing symptoms of apathy over the previous 2-4 weeks
Time Frame
Baseline (Visit 1)
Title
Lille Apathy Rating Scale (LARS)
Description
33 queries belonging to nine domains, each corresponding to a clinical manifestation of apathy
Time Frame
Baseline (Visit 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-38 or 60-80 years Able to provide verbal and written consent Right-handed Native English speaker At least 12 years of formal education Exclusion Criteria: Significant cognitive disturbance Self-report of current or past history of psychiatric disturbance other than major depression (e.g., bipolar disorder, schizophrenia, alcohol and/or substance abuse) Self-report of neurological disturbance (stroke, dementia, traumatic brain injury), chronic medical illness (HIV, metastatic cancer), or unstable medical conditions (cardiac or pulmonary disease) Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks Current anticholinergic, psychotropic (stimulants or dopamine agonists), or anti-epileptic use Visual acuity difficulties that would interfere with task performance Motor deficits that may interfere with the use of the dominant hand for performance of button press associated with the EEfRT task MRI contraindications (e.g., ferrous metal in the body, claustrophobia, pregnancy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam J Woods, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

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Dissociating Components of Anhedonia: A Pilot fMRI Study

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