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

NCT05124470 | Completed

• 1 other identifier: RC31/20/0448
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Schizophrenia

Keywords

Psychiatric Rehabilitation; Music Therapy; Cognitive Remediation

Outcome Measures

Primary Outcomes (1)

• proportion of patients who have attended at least 80% of the musical training sessions over the 6 months

  The primary outcomes 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).

  6 months

Secondary Outcomes (10)

• list of factors of no adherence to musical learning

  6 months

• Reduce of attention deficits at 6 month

  6 months

• Reduce of attention deficits at 9 month

  9 months

• Improving inhibitory abilities at 6 month

  6 months

• Improving inhibitory abilities at 9 month

  9 months

Study Arms (1)

musical training sessions

EXPERIMENTAL

24 musical training sessions over the 6 months + 3 months of follow-up post cognitive remediation.

Other: cognitive remediation by musical training sessions

Interventions

cognitive remediation by musical training sessions OTHER

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.

musical training sessions

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Established schizophrenia or with schizoaffective disorder as per Diagnostic and Statistical Manual (DSM 5)
• Clinically stable (with no full-time hospitalization within the last 6 months)
• Regular follow-up (followed in a day Hospital of Psychiatric)
• Patient must be on stable background antipsychotic treatment (with no modification within the last 6 month)
• \. Male or female patients who are 18-60 years of age 5. Signed and dated written consent 6. Patient having a health Insurance coverage

You may not qualify if:

• Patient with moderate to severe intellectual disabilities (clinical criteria)
• Addictive comorbidity (excluding tobacco and behavioral addictions)
• Previous neurologic pathology with cognitive impact
• Patient who are following a cognitive rehabilitation program

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (2)

CH Marchant

Toulouse, France

Location

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• TUDI L GOZE, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 18, 2021
• Study Start: December 1, 2021
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)