Schizophrenia Clinical Trials

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Multicenter Study Evaluating the Efficacy of a Cognitive Remediation Method Using Rhythmic, Vocal and Corporal Musical Learning for Schizophrenia Patients

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CH de la Côte Basque
RECRUITING
Bayonne
CH Le Vinatier
RECRUITING
Bron
Assistance Publique Hôpitaux de Marseille
NOT_YET_RECRUITING
Marseille
Association route nouvelle
RECRUITING
Toulouse
Centre de Santé MGEN
RECRUITING
Toulouse
CH Gérard Marchant
RECRUITING
Toulouse
Contact Information
Primary
Soukaina Chouiba
soukaina.chouiba@ferrepsy.fr
05 61 43 78 63
Backup
Tudi Gozé, MD
Time Frame
Start Date: 2026-09-04
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 120
Treatments
Experimental: 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.
No_intervention: 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).
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov