Schizophrenia Clinical Trial
— ARCoSOfficial 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.
Verified date | March 2023 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 20 |
Est. completion date | October 21, 2022 |
Est. primary completion date | October 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | - 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 |
Country | Name | City | State |
---|---|---|---|
France | CH Marchant | Toulouse | |
France | CHU Toulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Improving inhibitory abilities at 9 month | change of score of attention deficit (Go-no-Go) between inclusion and 3 months after (M9) | 9 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | modification of psychotropic medication | The modification of psychotropic medication at the end of the program compared to inclusion | 6 months | |
Secondary | modification of psychotropic medication | The modification of psychotropic medication at 3 months after (post cognitive remediation phase) compared to inclusion | 9 months |
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