Induction and Recognition of Emotions (IRE)

May 3, 2021 updated by: University of Valencia

Induction and Recognition of Emotions in Healthy Older Adults, Alzheimer's Disease and Parkinson's Disease

This study evaluates the differences in cognitive function between healthy older adults, older adults with mild Alzheimer's type dementia and older adults with Parkinson's disease and if there are differences in valence assessment and activation that produce them a mood induction task. Subjects are assessed using neuropsychological tests and then a mood induction task based on movie clips is applied.

Study Overview

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

Observational

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

      • Valencia, Spain, 46010
        • University of Valencia

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

Ages Eligible for Study

65 years to 99 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy older adults
Healthy older adults with 65 years or older
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.
Older adults with Alzheimer's disease
Older adults with Alzheimer's disease with 65 years or older
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.
Older adults with Parkinson's disease
Older adults with Alzheimer's disease with 65 years or older
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-Mental State Examination (MMSE)
Time Frame: 5-10 minutes
This test is evaluated on a maximum of 30 points. Participants with scores equal to or below 23 would be considered cognitively deficient.
5-10 minutes
Beck Depression Inventory-II (BDI-II)
Time Frame: 5-10 minutes
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.
5-10 minutes
Global Deterioration Scale (GDS)
Time Frame: 30 minutes
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.
30 minutes
Memory alteration test (M@T)
Time Frame: 5-10 minutes
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.
5-10 minutes
Spanish-Complutense Verbal Learning Test (TAVEC)
Time Frame: 30 minutes
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.
30 minutes
Barcelona test (BT)
Time Frame: 5 minutes
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.
5 minutes
Rey-Osterrieth Complex Figure Test (ROCFT)
Time Frame: 10 minutes
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.
10 minutes
Frontal assessment battery (FAB)
Time Frame: 10 minutes
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.
10 minutes
Positive and Negative Affect Scale (PANAS)
Time Frame: 10 minutes
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.
10 minutes
Auto-Assessment Manikins (SAM)
Time Frame: 5-10 minutes
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).
5-10 minutes

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Juan C Melendez, Psychology, University of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

March 2, 2020

Primary Completion (ANTICIPATED)

October 30, 2020

Study Completion (ANTICIPATED)

November 30, 2020

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (ACTUAL)

April 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

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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