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

Official title

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

Overview

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).

Interventions

• Other "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

Primary outcome measures

• attention capacity [Time frame: Baseline = Day 0 ; Month 6]

Secondary outcome measures (2)

• Attentional deficits at 3 months after the start of the remediation (M3) and at 3 months post-remediation (M9) [Time frame: 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). [Time frame: Baseline = Day 0 ; Month 6 and Month 9]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 6 centers

• CH de la Côte Basque — Bayonne
• CH Le Vinatier — Bron
• Assistance Publique Hôpitaux de Marseille — Marseille
• Association route nouvelle — Toulouse
• Centre de Santé MGEN — Toulouse
• CH Gérard Marchant — Toulouse

Identifiers

NCT: NCT07055204 · RC31/24/0332

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗