Clinical trial NCT05124470: Cognitive Remediation Method by Rhythmic, Vocal and Embodied Musical Learning for Stabilized Schizophrenic Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Psychiatric Rehabilitation
Music Therapy
Cognitive Remediation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: * 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

Primary outcomes:
measure: proportion of patients who have attended at least 80% of the musical training sessions over the 6 months
timeFrame: 6 months
Secondary outcomes:
measure: list of factors of no adherence to musical learning
timeFrame: 6 months
measure: Reduce of attention deficits at 6 month
timeFrame: 6 months
measure: Reduce of attention deficits at 9 month
timeFrame: 9 months
measure: Improving inhibitory abilities at 6 month
timeFrame: 6 months
measure: Improving inhibitory abilities at 9 month
timeFrame: 9 months
measure: Decrease on Negative symptoms
timeFrame: 6 months
measure: The state of anxiety at 6 month
timeFrame: 6 months
measure: The state of anxiety at 9 month
timeFrame: 6 months
measure: modification of psychotropic medication
timeFrame: 6 months
measure: modification of psychotropic medication
timeFrame: 9 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CH Marchant
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: TUDI L GOZE, MD
role: PRINCIPAL_INVESTIGATOR
References: