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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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Primary Objective:
Efficacy of Occupational Therapy (OT) based Occupational Goal Intervention (OGI) in improving executive functions in patients with refractory schizophrenia as measured by the BADS.
Secondary Objectives: improvement of functional aspects,basic and instrumental activities of daily living,negative symptoms and cognitive functions improvement
Hypothesis: OT is more effective than control group to improve executive functions in patients with refractory schizophrenia.
A single-center, randomized, single blind, controlled study, lasting one year, including the follow-up.
The study is conducted in two groups:the experimental group is based on the OGI method (N=30 patients) and the control group receives craft activities (N = 30 patients).
Psychiatric, neuropsychological and functional aspects are assessed at the beginning, after 30 sessions and 6 months after the intervention. The scale PANSS (Positive and Negative Syndrome Scale) is used for monitoring psychopathological symptoms during the study.
Scales BADS, DAFS-R, ILSS-BR respectively assess executive functions, functionality and basic and instrumental activities of daily living. The neuropsychological evaluation includes a battery to measure attention, executive functions, memory and estimated intellectual efficiency.
Statistical analysis to be used: ANOVA (Analysis of Variance)for repeated measures; data are also calculated to messure clinical efficacy, effect size and needed number to treat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OGI Method | Active Comparator | - experimental group: use the OGI method to improve the executive functioning of patients with refractory schizophrenia. |
|
| craft activities | Placebo Comparator | - control group: use of craft activities, attend the same-number of sessions, but without the intervention of therapists. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Craft Activities | Other | There is no intervention method used to perform the task. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| BADS (Behavioral Assessment of Functional Status) | It is a battery which measures neuropsychological executive functions. | up to 6 months follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| DAFS-BR ( Direct Assessment of Functional Status), ILSS-BR (Habilities of Daily Living-Brazilian validated version). | DAFS-BR - Evaluates functional aspects of daily living such as dealing with money, shopping, social comunication ILSS-BR- similar to DAFS. | at baseline, after 30 sessions of treatment and follow-up 6 months. |
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Inclusion Criteria:
Pacients with diagnosis of schizophrenia for DMS IV-R.
Pacients that signed the consent in writing and receive explanations about the nature of the study.
Patients who carefully counted another responsible person to provide reliable support to the patient and ensure adherence to the same study treatment.
Patients with minimum education: five years (elementary school).
Patients with stable clozapine and which have not been recently admitted (3 months).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helio Elkis, MD PhD | Contact | +55 11 26617581 | helkis@usp.br | |
| Adriana Vizzotto, BSc | Contact | +55 11 26618043 | adrivizzotto@usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Helio Elkis, MD PhD | Departamento de Psiquiatria da FMUSP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Psiquiatria do HCFMUSP | Recruiting | São Paulo | São Paulo | 05403000 | Brazil |
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| ID | Term |
|---|---|
| D000090663 | Schizophrenia, Treatment-Resistant |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| OGI Method |
| Behavioral |
metacognitive approach to assess executive functions. |
|
| Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory. |
Neuropsychological Battery (Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test,Rey Complex Figure, Fluência Verbal, Tapping Visual and Memória Logica)which measure cognitive functions. |
| at baseline, after 30 sessions of treatment and 6 months follo-up. |
| Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory. | Neuropsychological Battery (Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test,Rey Complex Figure, Verbal Fluency, Tapping Visual and Memória Logica)which measure cognitive functions. | at baseline, after 30 sessions of treatment and 6 months follo-up. |