NCT05143983

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 7, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 24, 2022

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

November 19, 2021

Last Update Submit

March 23, 2022

Conditions

Keywords

musicdepressionelderlyEmotion perception

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 9 days

Secondary Outcomes (2)

  • Emotions recognition

    up to 7 days

  • Implicit memory

    1 day

Study Arms (4)

depressed subjects, positive valence music listening at first

ACTIVE COMPARATOR

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

Behavioral: Positive valence music

depressed subjects, neutral valence music listening

OTHER

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

Behavioral: Neutral valence music

healthy controls, positive valence music listening

OTHER

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

Behavioral: Positive valence music

healthy controls, neutral valence music listening

OTHER

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

Behavioral: Neutral valence music

Interventions

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).

depressed subjects, positive valence music listening at firsthealthy controls, positive valence music listening

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).

depressed subjects, neutral valence music listeninghealthy controls, neutral valence music listening

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, 69678, France

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jean-Michel DOREY, MD, PHD

    CH le Vinatier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Subjects masked from the study hypothesis.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2021

First Posted

December 3, 2021

Study Start

February 7, 2022

Primary Completion

June 1, 2022

Study Completion

September 1, 2022

Last Updated

March 24, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations