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

Can the Affects Conveyed by Baroque Music and Its Rhetoric Reduce Anxiety in Patients With Major Depressive Disorder Associated With Anxiety Symptoms?

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Var
      • Toulon, Var, France, 83100
        • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Depressive patients
Patients suffering from major depressive disorder with anxiety symptoms
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety assessed by State Trait Anxiety Inventory questionnaire
Time Frame: 1 day
the minimum value is 20 and the maximum value is 80. Higher scores mean a worse outcome, high level of anxiety.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative assessment scale of the fluency of consciousness (EQFC)
Time Frame: 1 day
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.
1 day
Experiential phenomenological interviews (EPE)
Time Frame: 1 day
based on guided introspection and allow the description of background experiences of consciousness
1 day
Depression assessed by Beck Depression Inventory-Second Edition (BDI-II) questionnaire
Time Frame: 1 day
the minimum value is 0 and the maximum value is 63. Higher scores mean a worse outcome, high level of depression.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Manuel DIAS ALVES, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2021

Primary Completion (Actual)

February 17, 2022

Study Completion (Actual)

February 17, 2022

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-CHITS-002
  • 2021-A00216-35 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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