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

Not Applicable

Not yet recruiting

• Conditions: Schizophrenia Disorders

• Registration Number: NCT07055204
• Lead Sponsor: University Hospital, Toulouse

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).

Study Timeline

• Study First Submitted: 2025-06-12
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-03
• Last Update Submitted: 2025-07-03
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Study Start: 2026-01-04
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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)	Change from baseline to M3 and M9 (evaluation at 3 month 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
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	Change in attention abilities evaluated by the results obtained in the phasic alert test of the TAP, from baseline to M3, M6 and M9.; TAP = Test of Attentional Performance is a computer-based battery for assessing attention. The phasic alert test : refers to a state of general arousal that allows for quick and appropriate responses to stimuli. It is an indispensable condition for effective behavior and constitutes, from this point of view, a basis for all attentional performances. Reaction times (RT) are examined under two conditions. The first concerns the evaluation of simple RT: a cross appears in the center of the screen after randomly varying inter-stimulus intervals, and the subject must react as quickly as possible by pressing a response key. In this condition, intrinsic alertness is measured. In the second condition, RTs are measured as responses to the same cross but this time preceded by a (auditory) stimulus.; --\> The lowest the RT, the better is the attention ability

Trial Locations

Locations (6)

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