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Completed

NCT Number: NCT05124470

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).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Marchant, Toulouse, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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)
  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. list of factors of no adherence to musical learning

    Time frame: 6 months

    Describe the causes of no adherence to the project and the difficulties encountered during the study.

  2. Reduce of attention deficits at 6 month

    Time frame: 6 months

    change of score of attention deficit (d2-R : Revised Focused Attention Test) between inclusion and the end of the program (M6)

  3. Reduce of attention deficits at 9 month

    Time frame: 9 months

    change of score of attention deficit (d2-R : Revised Focused Attention Test) between inclusion and 3 months after (M9)

  4. Improving inhibitory abilities at 6 month

    Time frame: 6 months

    change of score of attention deficit (Go-no-Go) between inclusion and the end of the program (M6)

  5. Improving inhibitory abilities at 9 month

    Time frame: 9 months

    change of score of attention deficit (Go-no-Go) between inclusion and 3 months after (M9)

  6. Decrease on Negative symptoms

    Time frame: 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)

  7. The state of anxiety at 6 month

    Time frame: 6 months

    change of scores of State-Trait Anxiety Inventory (STAI) between inclusion and the end of the program (M6)

  8. The state of anxiety at 9 month

    Time frame: 6 months

    change of scores of State-Trait Anxiety Inventory (STAI) between inclusion and 3 months after (M9)

  9. modification of psychotropic medication

    Time frame: 6 months

    The modification of psychotropic medication at the end of the program compared to inclusion

  10. modification of psychotropic medication

    Time frame: 9 months

    The modification of psychotropic medication at 3 months after (post cognitive remediation phase) compared to inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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.

Acronym: ARCoS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2021
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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