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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-09-30

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.

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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.

Conditions

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Refractory Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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OGI Method

\- experimental group: use the OGI method to improve the executive functioning of patients with refractory schizophrenia.

Group Type ACTIVE_COMPARATOR

OGI Method

Intervention Type BEHAVIORAL

metacognitive approach to assess executive functions.

craft activities

\- control group: use of craft activities, attend the same-number of sessions, but without the intervention of therapists.

Group Type PLACEBO_COMPARATOR

Craft Activities

Intervention Type OTHER

There is no intervention method used to perform the task.

Interventions

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Craft Activities

There is no intervention method used to perform the task.

Intervention Type OTHER

OGI Method

metacognitive approach to assess executive functions.

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No