Rhythmic, vocal and body-based musical training to support thinking and social skills in schizophrenia

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

This trial tests whether a 6-month group musical program using rhythm, singing and movement can help adults with schizophrenia improve attention and negative symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: University Hospital, Toulouse (other)
• Locations: 6 sites (Bayonne and 5 other locations)
• Trial ID: NCT07055204 on ClinicalTrials.gov

What this trial studies

This is a national, multicenter, randomized open-label trial comparing a 6-month collective embodied musical learning program to standard care for people with schizophrenia. Participants are randomized to weekly one-hour group sessions (24 sessions total) led by trained music teachers or to continue standard care, with groups of about 10 patients per site. Outcomes focus on attentional deficits, cognitive domains such as working memory and executive function, and negative symptoms, with visits at baseline, 3, 6 and 9 months. A 3-month post-intervention follow-up evaluates whether any benefits persist after the sessions end.

Who should consider this trial

Good fit: Adults diagnosed with schizophrenia or schizoaffective disorder who are clinically stable, in regular psychiatric follow-up, enrolled in at least one out-of-home therapeutic or social activity, on no medication changes for 3 months, and able to give informed consent are eligible.

Not a fit: Patients with moderate to severe intellectual disability, active addictive comorbidity (excluding tobacco and behavioral addictions), neurological disorders with cognitive impact, those already engaged in rhythmic or musical activities, or those currently in a neurocognitive remediation program are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the program could improve attention, working memory and negative symptoms, which may translate into better daily functioning and social participation.

How similar studies have performed: Music-based interventions have shown cognitive and social benefits in general populations and some clinical samples, but few randomized trials have tested this specific collective embodied musical learning approach in schizophrenia.

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

Where this trial is running

Bayonne and 5 other locations

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

Study contacts

• Study coordinator: Soukaina Chouiba

Conditions: Schizophrenia Disorders, cognitive remediation, music, rythmic, vocal, corporal, musical learning