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Recruiting Not applicable

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

NCT07055204 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-10-21
Last updated
2026-10-23

Condition(s) studied

Schizophrenia Disorders

Investigational drug(s) / intervention(s)

"Diapason & Metronome" musical learning

"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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • attention capacity — Baseline = Day 0 ; Month 6
    The primary endpoint will be to compare treated and control groups on the change from baseline to M6 (evaluation at the end of the remediation phase) of the D2-R scale score. D2-R scale (Brickenkamp, R. et al, 2015) is a paper-and-pencil test that provides a fine-tuned measure of selective and sustained attention. The test requires the subject to identify and cross out target characters (d with 2 dashes) from a large number of distractor characters. It therefore requires concentrated and sustained visual attention, and mobilises inhibitory control. There are three indicators of the strategy employed and the evolution of concentration: * CC - concentration capacity or concentration performance * CCT - work rhythm or processing speed * E% - processing precision --\> the higher the score for each category, the better the attention capacity is

Trial sites (6)

FacilityCityRegionStatus
CH de la Côte Basque Bayonne France Recruiting
CH Le Vinatier Bron France Recruiting
Assistance Publique Hôpitaux de Marseille Marseille France Not Yet Recruiting
Association route nouvelle Toulouse France Recruiting
Centre de Santé MGEN Toulouse France Recruiting
CH Gérard Marchant Toulouse France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07055204 on ClinicalTrials.gov ↗ ← All trials in France