Clinical trial NCT05143983: Perception of Music and Facial and Vocal Emotions in a Population With and Without Depression
Official title: Perception of Music and Facial and Vocal Emotions in a Population With and Without Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: music
depression
elderly
Emotion perception
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Emotional intensity score of facial expressions, rated by participants
timeFrame: up to 9 days
Secondary outcomes:
measure: Emotions recognition
timeFrame: up to 7 days
measure: Implicit memory
timeFrame: 1 day
Other outcomes:
Locations:
city: Bron Cedex
country: France
facility: Centre Hospitalier Le Vinatier
Study officials:
affiliation: CH le Vinatier
name: Jean-Michel DOREY, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: