Major Depressive DisorderBARHEPSYNCT04903522
Can the Affects Conveyed by Baroque Music Reduce Anxiety in Patients With Major Depressive Disorder ?
A study testing Baroque music listening in people with Major Depressive Disorder, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Baroque music listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2021to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83100
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Baroque music listening
- Keywords
- Major depressive disorder, Musical intervention, Anxiety
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baroque music listeningBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Depressive patients | Experimental | Patients suffering from major depressive disorder with anxiety symptoms Receives: Behavioral: Baroque music listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (3)
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.
Measured: 1 day
Experiential phenomenological interviews (EPE)
based on guided introspection and allow the description of background experiences of consciousness
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start28 May 2021
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Dias Alves, MD, Study director, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903522
- Sponsor's protocol ID
- 2021-CHITS-002
- Other IDs
- 2021-A00216-35
- Acronym
- BARHEPSY
- Status last verified
- Jul 2026
- First submitted
- 19 May 2021
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Affects Conveyed by Baroque Music and Its Rhetoric Reduce Anxiety in Patients With Major Depressive Disorder Associated With Anxiety Symptoms?
- ClinicalTrials.gov ID
- NCT04903522
- Acronym / sponsor ID
- BARHEPSY / 2021-CHITS-002
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, Musical intervention, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depressive patients | Experimental | Behavioral: Baroque music listeningPatients suffering from major depressive disorder with anxiety symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baroque music listeningPatients 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 | Behavioural | Depressive patients |
Primary outcome
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.
3 secondary outcomes
Qualitative assessment scale of the fluency of consciousness (EQFC)
Time frame: 1 day
Experiential phenomenological interviews (EPE)
Time frame: 1 day
Depression assessed by Beck Depression Inventory-Second Edition (BDI-II) questionnaire
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Dias Alves, MD study director
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baroque music listening in people with Major Depressive Disorder, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety assessed by State Trait Anxiety Inventory questionnaire (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.