- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05143983
Perception of Music and Facial and Vocal Emotions in a Population With and Without Depression (MusInDep)
Depressed subjects display a cognitive bias of information processing and emotional self-regulation, which reinforces negative experiences more than positive ones, known as the negativity bias. The link between depressive disorder and negativity bias has been much studied in terms of genetic, neurobiology, structural and functional neuroanatomy and cognitive sciences. It has been admitted that depressed subjects show impairment of facial expressions and prosody recognition, and of implicit memory.
Induction of depressive or elated mood with musical excerpts listening in healthy subjects influences facial emotions perception, respectively by reducing or enhancing recognition skills. However, no study to date already explored the interest of music-induced positive mood for alleviating negativity bias in depressed elderly population.
Main objective : to assess the impact of exposure to positive valence musical excerpts, on evaluation of facial emotions intensity, in a population of elderly patients hospitalized for depression, compared to neutral valence music listening.
Secondary objectives : to assess the impact of exposure to positive valence musical excerpts, on facial and vocal emotions recognition, and on implicit memory of faces, compared to neutral valence music listening.
The same methodology is also applied in a sample of control participants over 65 years to study the mood induction effect by music in elderlies.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The duration of the study, from first to last included subject, is estimated at 6 months, from January to June 2022. Each subject will participate for a period of 5 to 10 days.
Depressed group subjects will be pre-selected from all consecutive patients hospitalized or seen in consultation in geronto-psychiatric ward at Centre Hospitalier Le Vinatier, who agreed to participate in research. Patients will pass a basic cognitive task (MMSE) during the inclusion visit.
Healthy controls will be selected from relatives of patients admitted in Centre Hospitalier Le Vinatier, who agreed to participate in research.
Once included, subjects will be randomized, and will remain blind to study hypotheses until the study end.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lydie SARTELET
- Phone Number: +33437915531
- Email: lydie.sartelet@ch-le-vinatier.fr
Study Contact Backup
- Name: Jean-Michel DOREY, MD,PHD
- Phone Number: +33 0437915531
- Email: jean-michel.dorey@ch-le-vinatier.fr
Study Locations
-
-
-
Bron Cedex, France, 69678
- Recruiting
- Centre Hospitalier le Vinatier
-
Contact:
- Jean-Michel DOREY, MD, PHD
- Phone Number: 04 37 91 51 00
- Email: jean-michel.dorey@ch-le-vinatier.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and Women between the ages of 18 and 60 years old
- Major depressive episode of moderate to strong intensity, according to DSM-5 criteria, diagnosed by a Psychiatrist for subjects with depression ; GDS < 5 for healthy subjects
- Being fluent in French
Exclusion Criteria:
- - Neurodegenerative disorder
- Cognitive impairments (MMSE<26)
- Sensory loss not sufficiently corrected, compromising the perception of oral instructions or visual or auditory stimuli
- Impairment of awareness or attentional abilities restricting completion of cognitive tasks lasting 40 minutes.
And for Patients with depressive episode:
- Psychotic or catatonic features of current depressive episode
- Comorbid psychiatric disorder other than major unipolar depressive or anxiety disorders
- Current treatment by electroconvulsive therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: depressed subjects, positive valence music listening at first
patients with major depressive disorder will be recruited and will complete 3 cognitive tasks after listening to positive musical excepts (3 minutes)
|
Subjects will have to listen to 3 minutes of unfamiliar musical excerpts, with positive valence characteristics (fast tempo, major key).
They will be told to listen carefully in order to then answer a short questionnaire.
The listening will be followed by an liking scale (from 1 : not liked at all, to 5 : liked a lot) and a familiarity scale (from 1 : not familiar at all, to 5 : very familiar).
|
|
Other: depressed subjects, neutral valence music listening
patients with major depressive disorder will be recruited and will complete 3 cognitive tasks after listening to neutral valence musical excepts (3 minutes)
|
Subjects will have to listen to 3 minutes of unfamiliar musical excepts with neutral valence.
They will be told to listen carefully in order to then answer to a short questionnaire.
The listening will be followed by a liking scale (from 1 : not liked at all, to 5 : liked a lot) and a familiarity scale (from 1 : not familiar at all, to 5 : very familiar).
|
|
Other: healthy controls, positive valence music listening
healthy individuals will be recruited and will complete 3 cognitive task after listening to positive valence musical excepts (3 minutes)
|
Subjects will have to listen to 3 minutes of unfamiliar musical excerpts, with positive valence characteristics (fast tempo, major key).
They will be told to listen carefully in order to then answer a short questionnaire.
The listening will be followed by an liking scale (from 1 : not liked at all, to 5 : liked a lot) and a familiarity scale (from 1 : not familiar at all, to 5 : very familiar).
|
|
Other: healthy controls, neutral valence music listening
healthy individuals will be recruited and will complete 3 cognitive task after listening to neutral valence musical excepts (3 minutes)
|
Subjects will have to listen to 3 minutes of unfamiliar musical excepts with neutral valence.
They will be told to listen carefully in order to then answer to a short questionnaire.
The listening will be followed by a liking scale (from 1 : not liked at all, to 5 : liked a lot) and a familiarity scale (from 1 : not familiar at all, to 5 : very familiar).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional intensity score of facial expressions, rated by participants
Time Frame: up to 9 days
|
This intensity score will be calculated for a subject as the mean of intensity scores (from 1 to 5) attributed to negative faces and reverse intensity scores attributed to positive faces.
This will give a "negativity score".
The higher this score, the more negative emotions are judged as intense and the less positive emotions are judged as intense.
This measurement will be collected by a computerized interface in two different sessions, one for each experimental condition.
|
up to 9 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotions recognition
Time Frame: up to 7 days
|
Percentage of correct answers to facial and vocal emotion recognition
|
up to 7 days
|
|
Implicit memory
Time Frame: 1 day
|
Percentage of identification of previously presented faces with positive expression
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Michel DOREY, MD, PHD, CH le Vinatier
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
- 2021-A01916-35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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