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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cognitive remediation by musical training sessions
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring Psychiatric Rehabilitation, Music Therapy, Cognitive Remediation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers
  • Inclusion criteria:

    1. Established schizophrenia or with schizoaffective disorder (as per DSM-5)
    2. Clinically stable (with no full-time hospitalization within the last 6 months)
    3. Regular follow-up (followed in a day Hospital of Psychiatric)
    4. Patient must be on stable background antipsychotic treatment (with no modification within the last 6 month)

    4. Male or female patients who are 18-60 years of age 5. Signed and dated written consent 6. Patient having a health Insurance coverage

  • Exclusion criteria:

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

Sites / Locations

  • CH Marchant
  • CHU Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

musical training sessions

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
October 27, 2021
Last Updated
March 29, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05124470
Brief Title
Cognitive Remediation Method by Rhythmic, Vocal and Embodied Musical Learning for Stabilized Schizophrenic Patients
Acronym
ARCoS
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
October 21, 2022 (Actual)
Study Completion Date
October 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Psychiatric Rehabilitation, Music Therapy, Cognitive Remediation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
musical training sessions
Arm Type
Experimental
Arm Description
24 musical training sessions over the 6 months + 3 months of follow-up post cognitive remediation.
Intervention Type
Other
Intervention Name(s)
cognitive remediation by musical training sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
proportion of patients who have attended at least 80% of the musical training sessions over the 6 months
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
list of factors of no adherence to musical learning
Description
Describe the causes of no adherence to the project and the difficulties encountered during the study.
Time Frame
6 months
Title
Reduce of attention deficits at 6 month
Description
change of score of attention deficit (d2-R : Revised Focused Attention Test) between inclusion and the end of the program (M6)
Time Frame
6 months
Title
Reduce of attention deficits at 9 month
Description
change of score of attention deficit (d2-R : Revised Focused Attention Test) between inclusion and 3 months after (M9)
Time Frame
9 months
Title
Improving inhibitory abilities at 6 month
Description
change of score of attention deficit (Go-no-Go) between inclusion and the end of the program (M6)
Time Frame
6 months
Title
Improving inhibitory abilities at 9 month
Description
change of score of attention deficit (Go-no-Go) between inclusion and 3 months after (M9)
Time Frame
9 months
Title
Decrease on Negative symptoms
Description
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)
Time Frame
6 months
Title
The state of anxiety at 6 month
Description
change of scores of State-Trait Anxiety Inventory (STAI) between inclusion and the end of the program (M6)
Time Frame
6 months
Title
The state of anxiety at 9 month
Description
change of scores of State-Trait Anxiety Inventory (STAI) between inclusion and 3 months after (M9)
Time Frame
6 months
Title
modification of psychotropic medication
Description
The modification of psychotropic medication at the end of the program compared to inclusion
Time Frame
6 months
Title
modification of psychotropic medication
Description
The modification of psychotropic medication at 3 months after (post cognitive remediation phase) compared to inclusion
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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) 4. Male or female patients who are 18-60 years of age 5. Signed and dated written consent 6. Patient having a health Insurance coverage Exclusion criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TUDI L GOZE, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Marchant
City
Toulouse
Country
France
Facility Name
CHU Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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