Occupational Therapy in the Rehabilitation of Executive Functions in Patients With Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial for the Evaluation of the Efficacy of Occupational Therapy in the Rehabilitation of Executive Functions in Patients With Refractory Schizophrenia

Conditions
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Refractory Schizophrenia

Intervention / Treatment
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* Other: Craft Activities
* Behavioral: OGI Method


Participation Criteria
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Eligibility Criteria
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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 who present rates below those expected for their age group in at least 3 of the executive functions assessed on neuropsychological tests, and evaluation of executive functions. Patients with stable clozapine and which have not been recently admitted (3 months). Exclusion Criteria: Comorbid diagnosis of substance dependence or other psychiatric Axis I; History of head trauma and / or other neurological problems; Medical problems that compromise somehow the central nervous system; History of mental retardation; Patients treated with medication other than clozapine; Patients who are suffering other psychosocial treatments.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OGI Method<br>- experimental group: use the OGI method to improve the executive functioning of patients with refractory schizophrenia. | Behavioral: OGI Method<br>* metacognitive approach to assess executive functions.<br>|
| Placebo Comparator: craft activities<br>- control group: use of craft activities, attend the same-number of sessions, but without the intervention of therapists. | Other: Craft Activities<br>* There is no intervention method used to perform the task.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Executive Functions, Schizophrenia, Occupational Therapy