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

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Other: cognitive remediation by musical training sessions

• Registration Number: NCT05124470
• Lead Sponsor: University Hospital, Toulouse

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).

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.

Study Timeline

• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-18
• Study Start: 2021-12-01
• Primary Completion: 2022-10-21
• Study Completion: 2022-10-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
proportion of patients who have attended at least 80% of the musical training sessions over the 6 months	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).

Secondary Outcome Measures

Name	Time	Method
Improving inhibitory abilities at 6 month	6 months	change of score of attention deficit (Go-no-Go) between inclusion and the end of the program (M6)
Reduce of attention deficits at 6 month	6 months	change of score of attention deficit (d2-R : Revised Focused Attention Test) between inclusion and the end of the program (M6)
Reduce of attention deficits at 9 month	9 months	change of score of attention deficit (d2-R : Revised Focused Attention Test) between inclusion and 3 months after (M9)
The state of anxiety at 6 month	6 months	change of scores of State-Trait Anxiety Inventory (STAI) between inclusion and the end of the program (M6)
list of factors of no adherence to musical learning	6 months	Describe the causes of no adherence to the project and the difficulties encountered during the study.
Improving inhibitory abilities at 9 month	9 months	change of score of attention deficit (Go-no-Go) between inclusion and 3 months after (M9)
Decrease on Negative symptoms	6 months	change of score the Self evaluation of negative symptoms (SNS) between inclusion and the end of the program (M6), and between inclusion and 3 months after (M9)
The state of anxiety at 9 month	6 months	change of scores of State-Trait Anxiety Inventory (STAI) between inclusion and 3 months after (M9)
modification of psychotropic medication	9 months	The modification of psychotropic medication at 3 months after (post cognitive remediation phase) compared to inclusion

Trial Locations

Locations (2)

CH Marchant; 🇫🇷 Toulouse, France

CHU Toulouse; 🇫🇷 Toulouse, France