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临床试验/NCT05143983
NCT05143983已完成不适用

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

Hôpital le Vinatier2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2022年2月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
2
主要终点
Emotional intensity score of facial expressions, rated by participants

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Subjects masked from the study hypothesis.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • - 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

研究组 & 干预措施

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)

干预措施: Positive valence music (Behavioral)

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)

干预措施: Neutral valence music (Behavioral)

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)

干预措施: Positive valence music (Behavioral)

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)

干预措施: Neutral valence music (Behavioral)

结局指标

主要结局

Emotional intensity score of facial expressions, rated by participants

时间窗: 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.

次要结局

  • Emotions recognition(up to 7 days)
  • Implicit memory(1 day)

研究者

发起方
Hôpital le Vinatier
申办方类型
Other
责任方
Sponsor

研究点 (2)

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