Induction and Recognition of Emotions

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 65 to 99 years
• All sexes
• Healthy volunteers accepted
• Older adult

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.

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Healthy Older Adults, Alzheimer's Disease, Parkinson's Disease

Being tested

Mini Cognitive Examination (MCE), Beck Depression Inventory-II (BDI-II), Global Deterioration Scale (GDS), Memory alteration test (M@T), Spanish-Complutense Verbal Learning Test (TAVEC)

Keywords

Healthy older adults, Alzheimer's disease, Parkinson's disease, Mood induction, Positive emotions, Negative emotions

Medical subject headings

Alzheimer Disease, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Mini Cognitive Examination (MCE)Diagnostic test

  This test provides information on temporal and spatial orientation, fixation, concentration and calculation, memory and language and construction.

• Beck Depression Inventory-II (BDI-II)Diagnostic test

  This test evaluates the absence or presence of depressive symptoms.

• Global Deterioration Scale (GDS)Diagnostic test

  This scale measures the level of deterioration of the subject.

• Memory alteration test (M@T)Diagnostic test

  In this test different memory subtypes are evaluated.

• Spanish-Complutense Verbal Learning Test (TAVEC)Diagnostic test

  This test is used to assess immediate memory, deferred memory and learning ability.

• Barcelona test (BT)Diagnostic test

  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.

• Rey-Osterrieth Complex Figure Test (ROCFT)Diagnostic test

  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.

• Frontal assessment battery (FAB)Diagnostic test

  This test is a composite tool for assessing executive functions related to the frontal lobe.

• Positive and Negative Affect Scale (PANAS)Diagnostic test

  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).

• Auto-Assessment Manikins (SAM)Diagnostic test

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Mini-Mental State Examination (MMSE)

   This test is evaluated on a maximum of 30 points. Participants with scores equal to or below 23 would be considered cognitively deficient.

   Measured: 5-10 minutes

2. Beck Depression Inventory-II (BDI-II)

   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.

   Measured: 5-10 minutes

3. Global Deterioration Scale (GDS)

   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.

   Measured: 30 minutes

4. Memory alteration test (M@T)

   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.

   Measured: 5-10 minutes

5. Spanish-Complutense Verbal Learning Test (TAVEC)

   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.

   Measured: 30 minutes

6. Barcelona test (BT)

   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.

   Measured: 5 minutes

7. Rey-Osterrieth Complex Figure Test (ROCFT)

   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.

   Measured: 10 minutes

8. Frontal assessment battery (FAB)

   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.

   Measured: 10 minutes

9. Positive and Negative Affect Scale (PANAS)

   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.

   Measured: 10 minutes

10. Auto-Assessment Manikins (SAM)

    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).

    Measured: 5-10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted21 Apr 2020
2. Study start2 Mar 2020
3. Primary completion30 Oct 2020 (estimated)
4. Study completion30 Nov 2020 (estimated)

Why it stopped: COVID 19

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (6)Papers the sponsor has linked to this study.
• Other trials for Healthy Older AdultsStudies of the same condition, open and under way.
• More trials run by University of ValenciaThe 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.