Cognitive Remediation Method Using Rhythmic, Vocal and Corporal Musical Learning for Schizophrenia (ARCoS-2)

Toulouse University Hospital

Status: Not yet enrolling

Conditions: Schizophrenia Disorders

Treatments: Other: "Diapason & Metronome" musical learning

Study type: Interventional

Funder types: Other

Identifiers

NCT07055204

RC31/24/0332

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

"Diapason & Metronome" musical learning arm

Experimental group

Description:

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.

Treatment:

Other: "Diapason & Metronome" musical learning

standard of care arm

No Intervention group

Description:

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).