Cognitive Remediation Method Using Rhythmic, Vocal and Corporal Musical Learning for Schizophrenia

NCT ID: NCT07055204

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-04
• Study Completion Date: 2028-12-31

Brief Summary

Schizophrenia, affecting 1% of the population, is a persistent disorder characterized by varied symptoms. Antipsychotic medications effectively address positive symptoms (delusions, hallucinations) and relapse but have limited impact on negative symptoms (e.g., blunted affect, anhedonia) and cognitive impairment. These dimensions significantly influence social functioning and quality of life. Combining non-pharmacological approaches like Cognitive Remediation (CR) and psychosocial rehabilitation alongside antipsychotic drugs is recommended to enhance overall functioning and quality of life. Current CR programs show moderate effectiveness due to patient commitment issues. However, completed programs demonstrate higher efficacy. Real-life applicability of these programs lacks sufficient data. We propose musical learning for cognitive remediation due to its established cognitive benefits in the general population, targeting executive functions, working memory, attention, and inhibition. These functions are specifically impaired in schizophrenia and thus are relevant for remediation. Though unexplored in schizophrenia, music learning seems promising due to its motivational and pleasurable aspects for long-term commitment and its transferability through embodied and situated dimensions. A pilot study (ARCoS-1) on CR by musical learning demonstrated feasibility and preliminary positive results on cognitive and negative symptoms. This project aims to assess this method's effectiveness on a larger scale. Our hypothesis posits that musical learning offers an efficient and well-received medium for CR in patients with schizophrenia.

Detailed Description

This study will be a national, multicenter, randomized, open label, comparative study evaluating the impact of 6-month collective embodied musical learning program on attentional deficits, in comparison with a control group receiving standard care.

Patients will be randomized in each center in 2 groups: one group will participate in weekly musical learning sessions, the other one will beneficit of standard care.

The study will be conducted in 2 phases:

• Phase 1 (six months of collective rhythmic, vocal and corporal musical training): 6 groups of 10 patients will participate in 6-month collective musical training provided by a professional music teacher. Sessions will start no later than 3 months after the inclusion, at the rate of one session per week for a period of 6 months (24 sessions in all, as part of a pedagogical project). Each session lasts one hour.
• Phase 2: a post-remediation follow-up period of 3 months (after the musical training sessions have stopped) to evaluate the potential lasting effect of group musical training on cognitive disorders and negative symptoms in patients.

For each patient, the duration of the protocol is 9 months, with assessment visits scheduled at regular 3-month intervals (Inclusion, M3, M6 and M9) for a total of 4 visits. Before the inclusions begin, 6 music teachers will be trained in the musical learning method developed for this project (one teacher in each participating town : Bayonne, Lyon, Marseille, Paris, Toulouse).

Conditions

Schizophrenia Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

"Diapason & Metronome" musical learning arm

The "Diapason \& Metronome" musical learning method was developed specifically by the authors of the study. Participants will make music with the two instruments we all have in common: the voice and the body.

Group Type: EXPERIMENTAL

"Diapason & Metronome" musical learning

Intervention Type: OTHER

Participants will make music with the two instruments we all have in common: the voice and the body. The method is three-dimensional built on: rhythm, simple sound and harmony. The music sessions will take place in the same place and on the same day of the week, at a fixed time to establish a regularity that is suitable to this population. The courses will be taught in a cultural location, both to give meaning to the approach on a contextual level and to allow patients to be in the city and not in the hospital. A training of the music teachers will be planned before the beginning of the study. This training combined with regular debriefings during the music sessions, should ensure that the teachers' practices are consistent across the different groups.

standard of care arm

Patients randomly assigned in the control group will receive standard regular outpatient psychiatric care with at least one therapeutic or social activity (except musical or rhythmic activities).

The "standard of care" is defined by regular psychiatric follow-up by a doctor specialised in psychiatry, and the use of antipsychotic medication. Care may be provided by a private psychiatrist, a Centre Médico-Psychologique (CMP) or a psychiatric day hospital. The frequency of treatment can vary from weekly to monthly, depending on the patient's state of stability. In addition, patients must be enrolled in at least one social or therapeutic activity during the week (therapeutic workshop in a day hospital or CATTP (Centre Accueil Thérapeutique à Temps Partiel), workshop in a GEM (Groupe d'Entraide Mutuelle), voluntary activity, club sport, or professional activity).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

"Diapason & Metronome" musical learning

Participants will make music with the two instruments we all have in common: the voice and the body. The method is three-dimensional built on: rhythm, simple sound and harmony. The music sessions will take place in the same place and on the same day of the week, at a fixed time to establish a regularity that is suitable to this population. The courses will be taught in a cultural location, both to give meaning to the approach on a contextual level and to allow patients to be in the city and not in the hospital. A training of the music teachers will be planned before the beginning of the study. This training combined with regular debriefings during the music sessions, should ensure that the teachers' practices are consistent across the different groups.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient with a diagnosis of schizophrenia or schizoaffective disorder (DSM-5 TR criteria)
• Clinically stable (no full-time hospitalization related to schizophrenia for 3 months)
• Regular psychiatric follow-up
• Enrolled in at least 1 therapeutic or social out-of-home activity
• No change in the antipsychotic treatment for 3 months (medication and/or dosage)
• Have given free, informed and written consent to participate in the study.
• Patient affiliated or beneficiary of a social security scheme

Exclusion Criteria

• Patient with moderate to severe intellectual disability (clinical criteria)
• Engaged in a Social rythmic or musical activity
• Presenting an addictive comorbidity (excluding tobacco addiction and behavioural addictions)
• Presenting a neurological pathology with cognitive impact
• Involved in a neurocognitive remediation program

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CH de la Côte Basque

Bayonne, , France

CH Le Vinatier

Bron, , France

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Association route nouvelle

Toulouse, , France

Centre de Santé MGEN

Toulouse, , France

CH Gérard Marchant

Toulouse, , France

Countries

France

Central Contacts

Soukaina Chouiba

Role: CONTACT

soukaina.chouiba@ferrepsy.fr

05 61 43 78 63

Tudi Gozé, MD

Role: CONTACT

Facility Contacts

Dr Sophie Athéna Chapron, MD

Role: primary

sachapron@ch-cotebasque.fr

+33 (0)5 61 43 78 63

Pr Frédéric Haesebaert, MD PHD

Role: primary

frederic.haesebaert@ch-le-vinatier.fr

+33 (0)5 61 43 78 63

Pr Michel Cermolacce, MD PHD

Role: primary

michel.cermolacce@ap-hm.fr

+33 (0)5 61 43 78 63

Dr Rafaele Combaud, MD

Role: primary

rafaele.combaud@routenouvelle.fr

+33 (0)5 61 43 78 63

Dr Florent Amadei, MD

Role: primary

FAMADEI@mgen.fr

+33 (0)5 61 43 78 63

Emmanuel Gallet, MD

Role: primary

emmanuel.gallet@ch-marchant.fr

+33 (0)5 61 43 78 63

Other Identifiers

RC31/24/0332

Identifier Type: -

Identifier Source: org_study_id