NCT04903522

Brief Summary

Major depressive disorder, or characterized depressive episode, is a common illness that limits psychosocial functioning and impairs quality of life. The initial goal of treatment for a major depressive episode is complete remission of depressive symptoms. The most commonly used treatments are antidepressants, psychotherapy or a combination of medication and psychotherapy. Music therapy can be considered as one of the complementary therapies in the treatment of the characterized depressive episode and many studies have shown a beneficial effect of musical interventions, even of short duration, on depression and anxiety. In depressive disorders, therapies such as hypnosis or phenomenological psychotherapies lead to modifications of consciousness during which the subject finds the means, notably non-reflexive and in the realm of the imaginary, to overcome anxiety. Generally speaking, in the field of musical cognition, it is considered that music affects the emotions. Unfortunately this approach is often insufficiently refined in cognitive psychology since it is most generally interested in the 6 fundamental emotions: joy, anger, fear, sadness, surprise, disgust. However, during the Baroque period (end of the 16th and 17th centuries), various philosophers and musicians analyzed with great finesse not these fundamental emotions, but more precisely the passions, or "shocks of the soul", that is to say the affects in their great diversity. These affects or passions are thus at the center of Baroque musical composition. In the Barhepsy project, it is suggested that listening to Baroque music, thanks to the rhetoric of the passions included in it, would allow the mobilization of the patients' affects and thus reduce their state of anxiety. During a follow-up consultation, the effects of a 30-minute "musical path" of baroque pieces will be evaluated, exemplifying the reduction of anxiety and the subsequent appeasement, on the conscious experience of subjects suffering from a characterized depressive state associated with anxious symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

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

May 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

May 28, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2022

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

May 19, 2021

Last Update Submit

April 10, 2026

Conditions

Keywords

Major depressive disorderMusical interventionAnxiety

Outcome Measures

Primary Outcomes (1)

  • Anxiety assessed by State Trait Anxiety Inventory questionnaire

    the minimum value is 20 and the maximum value is 80. Higher scores mean a worse outcome, high level of anxiety.

    1 day

Secondary Outcomes (3)

  • Qualitative assessment scale of the fluency of consciousness (EQFC)

    1 day

  • Experiential phenomenological interviews (EPE)

    1 day

  • Depression assessed by Beck Depression Inventory-Second Edition (BDI-II) questionnaire

    1 day

Study Arms (1)

Depressive patients

EXPERIMENTAL

Patients suffering from major depressive disorder with anxiety symptoms

Behavioral: Baroque music listening

Interventions

Patients will listen to a 30-minute "musical path" of baroque pieces. Before and after this, anxiety, depression and consciousness fluidity will be evaluated thanks to different questionnaires

Depressive patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female over the age of 18
  • Depressive state characterized by the DSM-V criteria
  • Able to express his/her consent prior to participation in the study
  • Affiliated to or beneficiary of a social security regimen

You may not qualify if:

  • Deafness
  • Suspected or diagnosed neurodegenerative disorder or other associated neurological pathology
  • Comorbid psychotic disorder
  • Pregnant women
  • Patient under judicial protection (guardianship, curatorship...) or safeguard of justice
  • Any other reason that, in the opinion of the investigator, would interfere with the evaluation of the study objectives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83100, France

Location

MeSH Terms

Conditions

Depressive Disorder, MajorAnxiety Disorders

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Manuel Dias Alves, MD

    Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 26, 2021

Study Start

May 28, 2021

Primary Completion

February 17, 2022

Study Completion

February 17, 2022

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations