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Can the Affects Conveyed by Baroque Music Reduce Anxiety in Patients With Major Depressive Disorder ? (BARHEPSY)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Baroque music listening
Sponsored by
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder focused on measuring Major depressive disorder, Musical intervention, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Depressive patients

Arm Description

Patients suffering from major depressive disorder with anxiety symptoms

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Qualitative assessment scale of the fluency of consciousness (EQFC)
For State EQFC : the minimum value is 17 and the maximum value is 68. Higher scores mean a better outcome, high level of fluency. For "Trait" EQFC : the minimum value is 17 and the maximum value is 102. Higher scores mean a better outcome, high level of fluency.
Experiential phenomenological interviews (EPE)
based on guided introspection and allow the description of background experiences of consciousness
Depression assessed by Beck Depression Inventory-Second Edition (BDI-II) questionnaire
the minimum value is 0 and the maximum value is 63. Higher scores mean a worse outcome, high level of depression.

Full Information

First Posted
May 19, 2021
Last Updated
October 23, 2023
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
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1. Study Identification

Unique Protocol Identification Number
NCT04903522
Brief Title
Can the Affects Conveyed by Baroque Music Reduce Anxiety in Patients With Major Depressive Disorder ?
Acronym
BARHEPSY
Official Title
Can the Affects Conveyed by Baroque Music and Its Rhetoric Reduce Anxiety in Patients With Major Depressive Disorder Associated With Anxiety Symptoms?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 28, 2021 (Actual)
Primary Completion Date
February 17, 2022 (Actual)
Study Completion Date
February 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

4. Oversight

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

5. Study Description

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.
Detailed Description
Major depressive disorder or characterized depressive episode is a common illness that limits psychosocial functioning and impairs quality of life. In 2008, the WHO ranked major depression as the third leading cause of disease burden worldwide and predicts that the disease will become the leading cause by 2030. The 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) defines a depressive episode as the presence of a sad mood and/or anhedonia (loss of interest or pleasure) lasting at least 15 days, variably associated with other symptoms (appetite disturbance, sleep disturbance, feelings of guilt and worthlessness...). It also defines as an additional characteristic of this illness, anxiety and more precisely anxiety distress, i.e. the presence of the feeling of being tense, the feeling of unusual agitation and the difficulty to concentrate due to worry or fear. When treating a major depressive episode, the initial goal is complete remission of depressive symptoms. The most commonly used treatments are antidepressants, psychotherapy or a combination of medication and psychotherapy. Although these treatments are effective, some studies show a high rate of discontinuation and poor remission and the use of complementary and alternative medicine is increasing. 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. However, the nature of the effects of music remains mysterious, and even if psychometric scales are used, the body of research lacks explanations of what happens in these improvement processes. To seek an explanation, there are two strategies: either one focuses on using a psychophysiological approach (with physiological or biological measures), or one tries to approach the problem through the changes in mental processes (i.e., the content and structure of consciousness) associated with this enhancement. This is the choice made in the Barhepsy protocol. The Barhepsy project is part of the research program "Sounds, Music, Therapies: SoMuThé" developed at the CNRS (UMR 7061 PRISM, Marseille). It is part of the current trend of non-medicinal therapies by focusing on the beneficial effects of music and sound therapy. SoMuThé is a project inspired by a philosophical current called phenomenology. It is interested in the general problematic of the therapeutic effects of sound and music, not from the point of view of neurophysiological or cognitive processes evaluated by means of brain imaging or cognitive psychology experiments, but in what happens in the structure and contents of the consciousness of the subjects who benefit from such therapies. It is therefore more of a comprehension approach than an explanatory one, aiming at describing the conscious experience of these subjects in its reflexive and pre-reflexive component, and thus at understanding how their flow of consciousness is reconfigured. In depressive pathologies, therapies such as hypnosis or phenomenological psychotherapies lead to modifications of consciousness during which the subject finds means, notably non-reflexive and in the domain 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 to mobilize 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. To study the structure and metamorphoses of consciousness during the experience of listening to music, will be assessed in these patients : anxiety by means of the STAI (State-Trait Anxiety Inventory) scale of Spielberger et al., 1983 , and depression by the BDI (Beck Depression Inventory-II) scale of Beck et al., 1996. These two questionnaires will make it possible to qualify (and quantify) these two clinical signs; the fluidity of consciousness by means of the EQFC scale. Indeed, consciousness is made more "fluid", less rigid after certain psychotherapies such as hypnosis. the reflexive and pre-reflexive contents of consciousness that can be obtained through experiential phenomenological interviews (EPE), which are based on guided introspection and allow the description of background experiences of consciousness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depressive disorder, Musical intervention, Anxiety

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Depressive patients
Arm Type
Experimental
Arm Description
Patients suffering from major depressive disorder with anxiety symptoms
Intervention Type
Behavioral
Intervention Name(s)
Baroque music listening
Intervention Description
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
Primary Outcome Measure Information:
Title
Anxiety assessed by State Trait Anxiety Inventory questionnaire
Description
the minimum value is 20 and the maximum value is 80. Higher scores mean a worse outcome, high level of anxiety.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Qualitative assessment scale of the fluency of consciousness (EQFC)
Description
For State EQFC : the minimum value is 17 and the maximum value is 68. Higher scores mean a better outcome, high level of fluency. For "Trait" EQFC : the minimum value is 17 and the maximum value is 102. Higher scores mean a better outcome, high level of fluency.
Time Frame
1 day
Title
Experiential phenomenological interviews (EPE)
Description
based on guided introspection and allow the description of background experiences of consciousness
Time Frame
1 day
Title
Depression assessed by Beck Depression Inventory-Second Edition (BDI-II) questionnaire
Description
the minimum value is 0 and the maximum value is 63. Higher scores mean a worse outcome, high level of depression.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Dias Alves, MD
Organizational Affiliation
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
City
Toulon
State/Province
Var
ZIP/Postal Code
83100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Can the Affects Conveyed by Baroque Music Reduce Anxiety in Patients With Major Depressive Disorder ?

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