- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04353947
Induction and Recognition of Emotions (IRE)
Induction and Recognition of Emotions in Healthy Older Adults, Alzheimer's Disease and Parkinson's Disease
Study Overview
Status
Intervention / Treatment
- Diagnostic test: Mini Cognitive Examination (MCE)
- Diagnostic test: Beck Depression Inventory-II (BDI-II)
- Diagnostic test: Global Deterioration Scale (GDS)
- Diagnostic test: Memory alteration test (M@T)
- Diagnostic test: Spanish-Complutense Verbal Learning Test (TAVEC)
- Diagnostic test: Barcelona test (BT)
- Diagnostic test: Rey-Osterrieth Complex Figure Test (ROCFT)
- Diagnostic test: Positive and Negative Affect Scale (PANAS)
- Diagnostic test: Auto-Assessment Manikins (SAM)
- Diagnostic test: Frontal assessment battery (FAB)
Detailed Description
Different neuropsychological tests will be used to assess the differences in cognitive function in the different groups, whose scores are expected to be lower in the group of older adults with Alzheimer's disease (AD) and older adults with Parkinson's disease (PD).
After studying the cognitive function in the different groups, we proceed to check through a task based on movie clips if there are also differences in the valence assessment (liking/disliking depending on the emotion induced by scenes from different films) and activation (excitement caused by each one of the movie scenes), hoping to find differences for the negative emotions taking into account the cognitive difficulties that both (the EA group and the EP group) may have for processing this type of cognitively more demanding information; instead, it is possible that the positivity effect continues to affect these patients so that for positive emotions there are no differences between the different groups.
Study Type
Contacts and Locations
Study Locations
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Valencia, Spain, 46010
- University of Valencia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Healthy older adults will be recruited from the Third Age Classrooms of the municipality of Quart de Poblet.
- The older adults with mild Alzheimer's disease will be recruited through the Neurology Department of the General Hospital of Valencia.
- The older adults with Parkinson's disease will be recruited through the Valencia Parkinson Association.
Description
Inclusion Criteria:
For the group of healthy older adults:
- MEC score greater than 26 points.
- GDS between 1 and 3.
For the mild EA group:
- MEC score between 18 and 23 points.
- GDS between 3 and 4.
For the EP group:
- MEC score greater than 23 points.
- GDS between 1 and 3.
- FAB score equal to or less than 11 points.
General Exclusion Criteria:
Participants cannot have:
- Significant asymptomatic neurovascular disease
- History of previous symptomatic stroke
- Alcohol or drug abuse/dependence
- Severe psychiatric symptoms
- Depressive symptoms higher than mild
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Healthy older adults
Healthy older adults with 65 years or older
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This test provides information on temporal and spatial orientation, fixation, concentration and calculation, memory and language and construction.
This test evaluates the absence or presence of depressive symptoms.
This scale measures the level of deterioration of the subject.
In this test different memory subtypes are evaluated.
This test is used to assess immediate memory, deferred memory and learning ability.
This test evaluates categorical evocation and verbal fluency.
The categorical recall subtest consists of recalling the maximum number of words linked to a specific category "animals" in 1 minute.
In the case of verbal fluency, the subject is asked to evoke the maximum number of words that begin with the letter "p" in 3 minutes.
In this test, the person must carefully copy a complex geometric drawing, which must be memorized later.
The first part evaluates multiple cognitive processes such as planning, motor skills, working memory, and visual-constructive and spatial skills.
In the second part, memory is evaluated.
It is a self-report questionnaire made up of 20 items (10 of positive affect and another 10 of negative affect) that the subject must answer, obtaining in this way a score in positive affectivity (AP subscale) and another in negative affectivity (AN subscale).
It is a self-report questionnaire that assesses the emotional response of the subject, in this case, through a mood induction task that plays different films scenes.
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Older adults with Alzheimer's disease
Older adults with Alzheimer's disease with 65 years or older
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This test provides information on temporal and spatial orientation, fixation, concentration and calculation, memory and language and construction.
This test evaluates the absence or presence of depressive symptoms.
This scale measures the level of deterioration of the subject.
In this test different memory subtypes are evaluated.
This test is used to assess immediate memory, deferred memory and learning ability.
This test evaluates categorical evocation and verbal fluency.
The categorical recall subtest consists of recalling the maximum number of words linked to a specific category "animals" in 1 minute.
In the case of verbal fluency, the subject is asked to evoke the maximum number of words that begin with the letter "p" in 3 minutes.
In this test, the person must carefully copy a complex geometric drawing, which must be memorized later.
The first part evaluates multiple cognitive processes such as planning, motor skills, working memory, and visual-constructive and spatial skills.
In the second part, memory is evaluated.
It is a self-report questionnaire made up of 20 items (10 of positive affect and another 10 of negative affect) that the subject must answer, obtaining in this way a score in positive affectivity (AP subscale) and another in negative affectivity (AN subscale).
It is a self-report questionnaire that assesses the emotional response of the subject, in this case, through a mood induction task that plays different films scenes.
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|
Older adults with Parkinson's disease
Older adults with Alzheimer's disease with 65 years or older
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This test provides information on temporal and spatial orientation, fixation, concentration and calculation, memory and language and construction.
This test evaluates the absence or presence of depressive symptoms.
This scale measures the level of deterioration of the subject.
In this test different memory subtypes are evaluated.
This test is used to assess immediate memory, deferred memory and learning ability.
This test evaluates categorical evocation and verbal fluency.
The categorical recall subtest consists of recalling the maximum number of words linked to a specific category "animals" in 1 minute.
In the case of verbal fluency, the subject is asked to evoke the maximum number of words that begin with the letter "p" in 3 minutes.
In this test, the person must carefully copy a complex geometric drawing, which must be memorized later.
The first part evaluates multiple cognitive processes such as planning, motor skills, working memory, and visual-constructive and spatial skills.
In the second part, memory is evaluated.
It is a self-report questionnaire made up of 20 items (10 of positive affect and another 10 of negative affect) that the subject must answer, obtaining in this way a score in positive affectivity (AP subscale) and another in negative affectivity (AN subscale).
It is a self-report questionnaire that assesses the emotional response of the subject, in this case, through a mood induction task that plays different films scenes.
This test is a composite tool for assessing executive functions related to the frontal lobe.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mini-Mental State Examination (MMSE)
Time Frame: 5-10 minutes
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This test is evaluated on a maximum of 30 points.
Participants with scores equal to or below 23 would be considered cognitively deficient.
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5-10 minutes
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Beck Depression Inventory-II (BDI-II)
Time Frame: 5-10 minutes
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In this test, a score of 0-13 indicates absence of depression, 14-19 mild depression, 20-28 moderate depression, and 29-63 severe depression.
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5-10 minutes
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Global Deterioration Scale (GDS)
Time Frame: 30 minutes
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This scale indicates seven possible stages: 1. Absence of Cognitive Deficit; 2. Very slight cognitive deficit; 3. Mild Cognitive Deficit; 4. Moderate cognitive deficit; 5. Moderately severe cognitive deficit; 6. Severe cognitive deficit; 7. Very severe cognitive deficit.
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30 minutes
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Memory alteration test (M@T)
Time Frame: 5-10 minutes
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This cognitive test is evaluated on a maximum of 50 points.
The optimal cut-off point for distinguishing mild cognitive impairment of the amnesiac type from subjective memory complaints is 37 points.
The optimal cut-off point for Alzheimer's disease is 31 points.
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5-10 minutes
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Spanish-Complutense Verbal Learning Test (TAVEC)
Time Frame: 30 minutes
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The evaluator reads a 16-word shopping list in five different essays and in each of them the evaluated person must mention those words that he or she remembers.
After 20 minutes, the subject is asked to remember them again.
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30 minutes
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Barcelona test (BT)
Time Frame: 5 minutes
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In this test, the subject is considered to have a good categorical evocation when he is able to evoke more than 16 animals in 1 minute and a good verbal fluency when he is able to evoke more than 19 words beginning with "p" in 3 minutes.
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5 minutes
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Rey-Osterrieth Complex Figure Test (ROCFT)
Time Frame: 10 minutes
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The direct score (PD) in the copy of the Rey figure that would leave 50% of the population below is 30 points, while in the reproduction of the Rey figure from memory the PD that would leave 50% below of the population is 21 points.
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10 minutes
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Frontal assessment battery (FAB)
Time Frame: 10 minutes
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The maximum score to be obtained in this test is 18 points.
To consider that the subject presents alterations in the frontal lobe and, therefore, altered executive functions, his score must be equal to or less than 11 points.
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10 minutes
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Positive and Negative Affect Scale (PANAS)
Time Frame: 10 minutes
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The final score of this scale is the sum of the 10 terms on the positive scale and the sum of the 10 terms on the negative scale, with the value assigned for the responses on the positive scale being positive and negative for the responses on the negative scale.
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10 minutes
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Auto-Assessment Manikins (SAM)
Time Frame: 5-10 minutes
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This questionnaire measures the valence (liking/disliking depending on the emotion induced by scenes from different movies), the arousal (excitement caused by each of the movie scenes) and mastery or emotional control (self-perception of the control exerted on the environment and the emotion itself).
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5-10 minutes
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Juan C Melendez, Psychology, University of Valencia
Publications and helpful links
General Publications
- Fernandez-Aguilar L, Ricarte J, Ros L, Latorre JM. Emotional Differences in Young and Older Adults: Films as Mood Induction Procedure. Front Psychol. 2018 Jul 3;9:1110. doi: 10.3389/fpsyg.2018.01110. eCollection 2018.
- Carvalho S, Leite J, Galdo-Alvarez S, Goncalves OF. The Emotional Movie Database (EMDB): a self-report and psychophysiological study. Appl Psychophysiol Biofeedback. 2012 Dec;37(4):279-94. doi: 10.1007/s10484-012-9201-6.
- Alves H, Koch A, Unkelbach C. Why Good Is More Alike Than Bad: Processing Implications. Trends Cogn Sci. 2017 Feb;21(2):69-79. doi: 10.1016/j.tics.2016.12.006. Epub 2017 Jan 4.
- Alves H, Koch A, Unkelbach C. The differential similarity of positive and negative information - an affect-induced processing outcome? Cogn Emot. 2019 Sep;33(6):1224-1238. doi: 10.1080/02699931.2018.1549022. Epub 2018 Nov 26.
- Reed AE, Carstensen LL. The theory behind the age-related positivity effect. Front Psychol. 2012 Sep 27;3:339. doi: 10.3389/fpsyg.2012.00339. eCollection 2012.
- Nashiro K, Mather M. Effects of emotional arousal on memory binding in normal aging and Alzheimer's disease. Am J Psychol. 2011 Fall;124(3):301-12. doi: 10.5406/amerjpsyc.124.3.0301.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UV-INV_ETICA-1217558
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
All the information of the study, as well as its results, will be shared in scientific publications and conferences related to the research area.
The information that is intended to be published in scientific journals includes: 1) Study Protocol, 2) Statistical Analysis, 3) Informed Consent Form, 4) Clinical Study Results.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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