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

NCT07055204 | Not Yet Recruiting

• 1 other identifier: RC31/24/0332
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

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.

Conditions

Schizophrenia Disorders

Keywords

cognitive remediation; music; rythmic; vocal; corporal; musical learning

Outcome Measures

Primary Outcomes (1)

• attention capacity

  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

  Baseline = Day 0 ; Month 6

Secondary Outcomes (2)

• Attentional deficits at 3 months after the start of the remediation (M3) and at 3 months post-remediation (M9)

  Baseline = Day 0 ; Month 6 and Month 9 (evaluation at 3 month of the remediation phase)

• Attentional phasic alert at 3 months after the start of remediation (M3), at the end of the remediation phase (M6) and at 3 months post-remediation (M9).

  Baseline = Day 0 ; Month 6 and Month 9

Study Arms (2)

"Diapason & Metronome" musical learning arm

EXPERIMENTAL

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.

Other: "Diapason & Metronome" musical learning

standard of care arm

NO INTERVENTION

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).

Interventions

"Diapason & Metronome" musical learning 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.

"Diapason & Metronome" musical learning arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (6)

CH de la Côte Basque

Bayonne, France

Location

CH Le Vinatier

Bron, France

Location

Assistance Publique Hôpitaux de Marseille

Marseille, France

Location

Association route nouvelle

Toulouse, France

Location

Centre de Santé MGEN

Toulouse, France

Location

CH Gérard Marchant

Toulouse, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Soukaina Chouiba

CONTACT

05 61 43 78 63; soukaina.chouiba@ferrepsy.fr

Tudi Gozé, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: national, multicenter, randomized, open label, comparative study

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 8, 2025
• Study Start: January 4, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)