Dissociating Components of Anhedonia: A Pilot fMRI Study

November 9, 2018 updated by: University of Florida

Dissociating Components of Anhedonia: Pilot Behavioral and fMRI Data for the Effort Expenditure for Rewards Task

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Young Adults
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.
Other: Functional Magnetic Resonance Imaging
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.
Other Names:
  • fMRI
Other: Effort-Expenditure for Rewards Task
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.
Other Names:
  • EEfRT
Experimental: Older Adults
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.
Other: Functional Magnetic Resonance Imaging
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.
Other Names:
  • fMRI
Other: Effort-Expenditure for Rewards Task
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.
Other Names:
  • EEfRT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
fMRI Activity
Time Frame: Approximately Day 14 (Visit 2)
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.
Approximately Day 14 (Visit 2)
EEfRT Task Test
Time Frame: Approximately Day 14 (Visit 2)
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.
Approximately Day 14 (Visit 2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline (Visit 1)
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.
Baseline (Visit 1)
Dementia Rating Scale-2 (DRS-2)
Time Frame: Baseline (Visit 1)
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.
Baseline (Visit 1)
Card Stroop Task
Time Frame: Baseline (Visit 1)
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.
Baseline (Visit 1)
Letter-Number Sequencing (Wechsler Adult Intelligence Scale, 4th Edition)
Time Frame: Baseline (Visit 1)
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.
Baseline (Visit 1)
Trail Making Test Parts A and B
Time Frame: Baseline (Visit 1)
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.
Baseline (Visit 1)
Wisconsin Card Sorting Test
Time Frame: Baseline (Visit 1)
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.
Baseline (Visit 1)
Controlled Oral Word Association/Category Fluency
Time Frame: Baseline (Visit 1)
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.
Baseline (Visit 1)
Digit Span (Wechsler Adult Intelligence Scale, 4th Edition)
Time Frame: Baseline (Visit 1)
Subjects repeat a string of numbers in either the same order (digits forward) or in reverse order (digits backward).
Baseline (Visit 1)
California Verbal Learning Test II (CVLT-II)
Time Frame: Baseline (Visit 1)
Subjects are asked to learn and remember a 16-item word list.
Baseline (Visit 1)
Brief Visuospatial Memory Test-Revised (BVMT-R)
Time Frame: Baseline (Visit 1)
Subjects are asked to learn and remember the identity and location of 6 simple figures displayed on a page.
Baseline (Visit 1)
Temporal Experience of Pleasure scale (TEPS)
Time Frame: Baseline (Visit 1)
18-item self-report questionnaire assessing anticipatory pleasure and consummatory pleasure
Baseline (Visit 1)
Snaith-Hamilton Pleasure Scale (SHAPS)
Time Frame: Baseline (Visit 1)
The SHAPS measures hedonic capacity. A higher total SHAPS score will indicate a higher level of anhedonia or the inability to experience pleasure.
Baseline (Visit 1)
Positive Affect Negative Affect Scale (PANAS)
Time Frame: Baseline (Visit 1)
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).
Baseline (Visit 1)
Beck Depression Inventory, 2nd Edition (BDI-II)
Time Frame: Baseline (Visit 1)
21-item self-report questionnaire assessing symptoms of depression.
Baseline (Visit 1)
Geriatric Depression Scale (GDS)
Time Frame: Baseline (Visit 1)
Subjects answer 30 yes/no questions assessing symptoms of depression.
Baseline (Visit 1)
Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: Baseline (Visit 1)
This is a 20-item measure of depression severity.
Baseline (Visit 1)
State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline (Visit 1)
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.
Baseline (Visit 1)
Apathy Scale (AS)
Time Frame: Baseline (Visit 1)
14-item self-report questionnaire assessing symptoms of apathy over the previous 2-4 weeks
Baseline (Visit 1)
Lille Apathy Rating Scale (LARS)
Time Frame: Baseline (Visit 1)
33 queries belonging to nine domains, each corresponding to a clinical manifestation of apathy
Baseline (Visit 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB201400639-N
  • 5R03MH109336-02 (U.S. NIH Grant/Contract)
  • R03MH109336-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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