Refractory Schizophrenia
Conditions
Keywords
Executive Functions, Schizophrenia, Occupational Therapy
Brief summary
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
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.
Interventions
OTHERCraft Activities
There is no intervention method used to perform the task.
BEHAVIORALOGI Method
metacognitive approach to assess executive functions.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BADS (Behavioral Assessment of Functional Status) | up to 6 months follow-up. | It is a battery which measures neuropsychological executive functions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DAFS-BR ( Direct Assessment of Functional Status), ILSS-BR (Habilities of Daily Living-Brazilian validated version). | at baseline, after 30 sessions of treatment and follow-up 6 months. | DAFS-BR - Evaluates functional aspects of daily living such as dealing with money, shopping, social comunication ILSS-BR- similar to DAFS. |
| Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory. | at baseline, after 30 sessions of treatment and 6 months follo-up. | 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. |
Countries
Brazil
Contacts
Primary ContactHelio Elkis, MD PhD
Backup ContactAdriana Vizzotto, BSc
Outcome results
None listed