Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04903522 |
| Other study ID # |
2021-CHITS-002 |
| Secondary ID |
2021-A00216-35 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 28, 2021 |
| Est. completion date |
February 17, 2022 |
Study information
| Verified date |
March 2024 |
| Source |
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
