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

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.

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).

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Other: cognitive remediation by musical training 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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • CHU Toulouse
  • Toulouse, France
    • CH Marchant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• Inclusion criteria:

  1. Established schizophrenia or with schizoaffective disorder as per Diagnostic and Statistical Manual (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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)	6 months
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)	9 months
Improving inhibitory abilities at 6 month	change of score of attention deficit (Go-no-Go) between inclusion and the end of the program (M6)	6 months
Improving inhibitory abilities at 9 month	change of score of attention deficit (Go-no-Go) between inclusion and 3 months after (M9)	9 months
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)	6 months
modification of psychotropic medication	The modification of psychotropic medication at the end of the program compared to inclusion	6 months
modification of psychotropic medication	The modification of psychotropic medication at 3 months after (post cognitive remediation phase) compared to inclusion	9 months
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)	6 months
The state of anxiety at 9 month	change of scores of State-Trait Anxiety Inventory (STAI) between inclusion and 3 months after (M9)	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: TUDI L GOZE, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): October 21, 2022
• Study Completion (Actual): October 21, 2022

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Cognitive Remediation; Music Therapy; Psychiatric Rehabilitation
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: RC31/20/0448

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No