NCT05124470

Cognitive Remediation Method by Rhythmic, Vocal and Embodied Musical Learning for Stabilized Schizophrenic Patients

Pilot Study Evaluating the Feasibility and the Preliminary Effects of a Cognitive Remediation Method by Rhythmic, Vocal and Embodied Musical Learning for Stabilized Schizophrenic Patients.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

ARCoS is a pilot study evaluating the feasibility and preliminary effects of a method of cognitive remediation by a Rhythmic, Vocal and Embodied Musical Learning for a population of stabilized schizophrenic patients. 20 stabilized schizophrenics patients will participate in the study for 9 months, i) 6 months of Musical learning (24 sessions over the 6 months) ; ii) and 3 months of follow-up post cognitive remediation. Assessments of attention deficits, inhibitory abilities, negative symptoms and anxiety, will carried out at baseline (V1, M0), third month (M3), sixth month (M6) after the start of the intervention and third months after the end of the intervention (M9). The primary endpoint will be the proportion of patients who have attended at least 80% of the musical training sessions over the 6 months (participation in at least 19/24 sessions).

Detailed description

Schizophrenia is a chronic psychiatric condition affecting 1% of the population. Antipsychotic medications are effective on positive symptoms (delusions, hallucinations). However, they do not have a significant effect on negative symptoms (apragmatism, social withdrawal, blunting of affect, etc.) and cognitive impairment. These last two dimensions are the most impacting in terms of social functioning and quality of life, and antipsychotics can potentially aggravate them. In addition to pharmacological treatments it is recommended to combine non-pharmacological approaches including cognitive remediation and psychosocial rehabilitation. The latter are best able to improve the personal and interpersonal functioning of patients and improve their quality of life which makes a recovery trajectory possible. Do date very few studies conduct cognitive remediation using musical learning. We have created an original teaching method based on the embodied dimension of cognition. The objective is to conduct a first pilot study to validate the feasibility of this music learning with schizophrenic patients. It will allow a preliminary evaluation of the effects of this new approach on cognitive disorders and negative symptoms of stabilized schizophrenic patients. 20 stabilized schizophrenics patients will participate in the study for 9 months, i) Rhythmic, Vocal and Embodied Musical Learning to two groups of 10 patients during 6 months each. (24 sessions over the 6 months) ; ii) and 3 months of follow-up post cognitive remediation. Each patient will have 4 evaluation visits during the study.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
OTHER	cognitive remediation by musical training sessions	The musical learning method "Diapason \& Metronome" is unprecedented. It was specially created by Florent Cholat. It aims an apprenticeship of a musical practice adapted to subjects with schizophrenia. The method does not require the handling of a musical instrument; it is based on the voice and the body. It is built on the three essential dimensions of music, which are rhythm, single sound and harmony. "Rhythm" concerns the division and management of time. The "single sound" allows work on the representation of a sound object as a singularity. "Harmony" allows you to work on the positioning of a sound in the globality of the chord to which it belongs and in the collective polyphony exercises.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-10-21
• Completion: 2022-10-21
• First posted: 2021-11-18
• Last updated: 2023-03-31

Locations

2 sites across 1 country: France