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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
There is no intervention method used to perform the task.
metacognitive approach to assess executive functions.
Instituto de Psiquiatria do HCFMUSP
São Paulo, São Paulo, Brazil
RECRUITINGBADS (Behavioral Assessment of Functional Status)
It is a battery which measures neuropsychological executive functions.
Time frame: up to 6 months follow-up.
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.
Time frame: 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.
Time frame: 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.
Time frame: at baseline, after 30 sessions of treatment and 6 months follo-up.
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