Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID07055204

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

Led by University Hospital, Toulouse · Updated on 2026-05-12

120

Participants Needed

6

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Schizophrenia is a persistent disorder affecting about 1% of the population. It involves positive symptoms like delusions and hallucinations and negative symptoms such as blunted affect and reduced motivation, which greatly affect social functioning and quality of life. This research evaluates a cognitive remediation method using rhythmic, vocal, and corporal musical learning to improve attention and cognitive function in people with schizophrenia, building on promising preliminary results from a pilot study and addressing challenges of current programs' patient commitment. The study is a national, multicenter, randomized, open-label trial comparing a 6-month collective musical training program to standard psychiatric care. Participants are randomly assigned to either attend weekly one-hour musical sessions led by trained professional music teachers or receive standard care including psychiatric follow-up and participation in non-musical therapeutic or social activities. After the 6-month intervention phase, there is a 3-month follow-up period to assess lasting effects. Participants will be involved for 9 months with evaluations at the start, 3 months, 6 months, and 9 months. The study measures attention capacity primarily and also examines attentional deficits and alertness over time. Assessments include regular visits and monitoring of symptom changes. The study aims to understand if musical learning can be a motivating and effective approach to improve cognitive and negative symptoms in schizophrenia.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of schizophrenia or schizoaffective disorder according to DSM-5 TR criteria
  • Clinically stable with no full-time hospitalization for schizophrenia in the past 3 months
  • Regular psychiatric follow-up
  • Enrolled in at least one therapeutic or social out-of-home activity
  • No change in antipsychotic medication or dosage for 3 months
  • Provided free, informed, and written consent to participate
  • Affiliated with or beneficiary of a social security scheme
Not Eligible

You will not qualify if you...

  • Moderate to severe intellectual disability
  • Currently engaged in social rhythmic or musical activities
  • Presence of an addictive comorbidity excluding tobacco and behavioral addictions
  • Presence of neurological disease affecting cognition
  • Currently involved in a neurocognitive remediation program

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants in the experimental group attend weekly collective rhythmic, vocal and corporal musical learning sessions for 6 months. Participants in the control group receive standard psychiatric care and continue their usual therapeutic or social activities.

Weekly sessions for 6 months (24 sessions total)

Follow-up

Duration - 3 months

After completing the musical learning sessions or standard care, participants are monitored for 3 months to evaluate the lasting effects on cognitive and negative symptoms.

Visits at 3-month intervals including at 3 months and 9 months after inclusion

Trial Site Locations

Total: 6 locations

1

CH de la Côte Basque

Bayonne, France

Actively Recruiting

2

CH Le Vinatier

Bron, France

Actively Recruiting

3

Assistance Publique Hôpitaux de Marseille

Marseille, France

Not Yet Recruiting

4

Association route nouvelle

Toulouse, France

Actively Recruiting

5

Centre de Santé MGEN

Toulouse, France

Actively Recruiting

6

CH Gérard Marchant

Toulouse, France

Actively Recruiting

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Research Team

S

Soukaina Chouiba

T

Tudi Gozé, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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