AnhedoniaNCT02569034
Dissociating Components of Anhedonia: A Pilot fMRI Study
A study testing Functional Magnetic Resonance Imaging and Effort-Expenditure for Rewards Task in people with Anhedonia, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anhedonia
- What is being tested?
- Functional Magnetic Resonance Imaging and Effort-Expenditure for Rewards Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 8 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anhedonia
- Being tested
- Functional Magnetic Resonance Imaging, Effort-Expenditure for Rewards Task
- Medical subject headings
- Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Magnetic Resonance ImagingOther
Also called fMRI
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.
Effort-Expenditure for Rewards TaskOther
Also called EEfRT
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.
| Study group | Role | What they receive |
|---|---|---|
| Young Adults | Active comparator | 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. Receives: Other: Functional Magnetic Resonance Imaging; Other: Effort-Expenditure for Rewards Task |
| Older Adults | Experimental | 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. Receives: Other: Functional Magnetic Resonance Imaging; Other: Effort-Expenditure for Rewards Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately Day 14 (Visit 2)
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.
Measured: Approximately Day 14 (Visit 2)
Secondary outcomes (19)
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.
Measured: Baseline (Visit 1)
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.
Measured: Baseline (Visit 1)
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.
Measured: Baseline (Visit 1)
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.
Measured: Baseline (Visit 1)
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.
Measured: Baseline (Visit 1)
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.
Measured: Baseline (Visit 1)
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.
Measured: Baseline (Visit 1)
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).
Measured: Baseline (Visit 1)
California Verbal Learning Test II (CVLT-II)
Subjects are asked to learn and remember a 16-item word list.
Measured: Baseline (Visit 1)
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.
Measured: Baseline (Visit 1)
Temporal Experience of Pleasure scale (TEPS)
18-item self-report questionnaire assessing anticipatory pleasure and consummatory pleasure
Measured: Baseline (Visit 1)
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.
Measured: Baseline (Visit 1)
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).
Measured: Baseline (Visit 1)
Beck Depression Inventory, 2nd Edition (BDI-II)
21-item self-report questionnaire assessing symptoms of depression.
Measured: Baseline (Visit 1)
Geriatric Depression Scale (GDS)
Subjects answer 30 yes/no questions assessing symptoms of depression.
Measured: Baseline (Visit 1)
Center for Epidemiologic Studies Depression Scale (CES-D)
This is a 20-item measure of depression severity.
Measured: Baseline (Visit 1)
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.
Measured: Baseline (Visit 1)
Apathy Scale (AS)
14-item self-report questionnaire assessing symptoms of apathy over the previous 2-4 weeks
Measured: Baseline (Visit 1)
Lille Apathy Rating Scale (LARS)
33 queries belonging to nine domains, each corresponding to a clinical manifestation of apathy
Measured: Baseline (Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completion8 May 2018
- Study completion8 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnhedoniaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Adam J Woods, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569034
- Sponsor's protocol ID
- IRB201400639-N
- Other IDs
- 5R03MH109336-02, R03MH109336-01A1
- Status last verified
- Nov 2018
- First submitted
- 2 Oct 2015
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissociating Components of Anhedonia: Pilot Behavioral and fMRI Data for the Effort Expenditure for Rewards Task
- ClinicalTrials.gov ID
- NCT02569034
- Acronym / sponsor ID
- IRB201400639-N
- Conditions
- Anhedonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2016 (actual)
- Primary completion
- 8 May 2018 (actual)
- Study completion
- 8 May 2018 (actual)
- First posted
- 6 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young Adults | Active comparator | Other: Functional Magnetic Resonance Imaging, Other: Effort-Expenditure for Rewards TaskThese 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. |
| Older Adults | Experimental | Other: Functional Magnetic Resonance Imaging, Other: Effort-Expenditure for Rewards TaskThese 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Magnetic Resonance ImagingAlso: fMRIBoth 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 | Older Adults, Young Adults |
| Effort-Expenditure for Rewards TaskAlso: EEfRTBoth 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 | Older Adults, Young Adults |
Primary outcome
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.
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.
19 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline (Visit 1)
Dementia Rating Scale-2 (DRS-2)
Time frame: Baseline (Visit 1)
Card Stroop Task
Time frame: Baseline (Visit 1)
Letter-Number Sequencing (Wechsler Adult Intelligence Scale, 4th Edition)
Time frame: Baseline (Visit 1)
Trail Making Test Parts A and B
Time frame: Baseline (Visit 1)
Wisconsin Card Sorting Test
Time frame: Baseline (Visit 1)
Controlled Oral Word Association/Category Fluency
Time frame: Baseline (Visit 1)
Digit Span (Wechsler Adult Intelligence Scale, 4th Edition)
Time frame: Baseline (Visit 1)
California Verbal Learning Test II (CVLT-II)
Time frame: Baseline (Visit 1)
Brief Visuospatial Memory Test-Revised (BVMT-R)
Time frame: Baseline (Visit 1)
Temporal Experience of Pleasure scale (TEPS)
Time frame: Baseline (Visit 1)
Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: Baseline (Visit 1)
Positive Affect Negative Affect Scale (PANAS)
Time frame: Baseline (Visit 1)
Beck Depression Inventory, 2nd Edition (BDI-II)
Time frame: Baseline (Visit 1)
Geriatric Depression Scale (GDS)
Time frame: Baseline (Visit 1)
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Baseline (Visit 1)
State-Trait Anxiety Inventory (STAI)
Time frame: Baseline (Visit 1)
Apathy Scale (AS)
Time frame: Baseline (Visit 1)
Lille Apathy Rating Scale (LARS)
Time frame: Baseline (Visit 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam J Woods, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Magnetic Resonance Imaging and Effort-Expenditure for Rewards Task in people with Anhedonia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI Activity (time frame: Approximately Day 14 (Visit 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.