search
Back to results

Perception of Music and Facial and Vocal Emotions in a Population With and Without Depression (MusInDep)

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Positive valence music
Neutral valence music
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression focused on measuring music, depression, elderly, Emotion perception

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Hospitalier Le VinatierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Other

Other

Other

Arm Label

depressed subjects, positive valence music listening at first

depressed subjects, neutral valence music listening

healthy controls, positive valence music listening

healthy controls, neutral valence music listening

Arm Description

patients with major depressive disorder will be recruited and will complete 3 cognitive tasks after listening to positive musical excepts (3 minutes)

patients with major depressive disorder will be recruited and will complete 3 cognitive tasks after listening to neutral valence musical excepts (3 minutes)

healthy individuals will be recruited and will complete 3 cognitive task after listening to positive valence musical excepts (3 minutes)

healthy individuals will be recruited and will complete 3 cognitive task after listening to neutral valence musical excepts (3 minutes)

Outcomes

Primary Outcome Measures

Emotional intensity score of facial expressions, rated by participants
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.

Secondary Outcome Measures

Emotions recognition
Percentage of correct answers to facial and vocal emotion recognition
Implicit memory
Percentage of identification of previously presented faces with positive expression

Full Information

First Posted
November 19, 2021
Last Updated
March 23, 2022
Sponsor
Hôpital le Vinatier
search

1. Study Identification

Unique Protocol Identification Number
NCT05143983
Brief Title
Perception of Music and Facial and Vocal Emotions in a Population With and Without Depression
Acronym
MusInDep
Official Title
Perception of Music and Facial and Vocal Emotions in a Population With and Without Depression
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
music, depression, elderly, Emotion perception

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Two groups of participants will be recruited: depressed patients and healthy controls. Each of these groups will be divided in two arms: one group listening to positive music at the first testing visit and neutral music at the second one, and the other group being exposed to positive and neutral conditions in the reverse order.
Masking
Participant
Masking Description
Subjects masked from the study hypothesis.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
depressed subjects, positive valence music listening at first
Arm Type
Active Comparator
Arm Description
patients with major depressive disorder will be recruited and will complete 3 cognitive tasks after listening to positive musical excepts (3 minutes)
Arm Title
depressed subjects, neutral valence music listening
Arm Type
Other
Arm Description
patients with major depressive disorder will be recruited and will complete 3 cognitive tasks after listening to neutral valence musical excepts (3 minutes)
Arm Title
healthy controls, positive valence music listening
Arm Type
Other
Arm Description
healthy individuals will be recruited and will complete 3 cognitive task after listening to positive valence musical excepts (3 minutes)
Arm Title
healthy controls, neutral valence music listening
Arm Type
Other
Arm Description
healthy individuals will be recruited and will complete 3 cognitive task after listening to neutral valence musical excepts (3 minutes)
Intervention Type
Behavioral
Intervention Name(s)
Positive valence music
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Neutral valence music
Intervention Description
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).
Primary Outcome Measure Information:
Title
Emotional intensity score of facial expressions, rated by participants
Description
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.
Time Frame
up to 9 days
Secondary Outcome Measure Information:
Title
Emotions recognition
Description
Percentage of correct answers to facial and vocal emotion recognition
Time Frame
up to 7 days
Title
Implicit memory
Description
Percentage of identification of previously presented faces with positive expression
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Michel DOREY, MD,PHD
Phone
0437915531
Ext
+33
Email
jean-michel.dorey@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Lydie SARTELET
Phone
+33437915531
Email
lydie.sartelet@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel DOREY, MD, PHD
Organizational Affiliation
CH le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Le Vinatier
City
Bron Cedex
ZIP/Postal Code
69678
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Michel DOREY, MD, PHD
Phone
04 37 91 51 00
Email
jean-michel.dorey@ch-le-vinatier.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Perception of Music and Facial and Vocal Emotions in a Population With and Without Depression

We'll reach out to this number within 24 hrs