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

Not Applicable

• Conditions: Refractory Schizophrenia

• Registration Number: NCT01879956
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-05-29
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-17
• Last Update Submitted: 2013-06-17
• Study First Posted: 2013-06-18
• Last Update Posted: 2013-06-18
• Primary Completion: 2013-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
BADS (Behavioral Assessment of Functional Status)	up to 6 months follow-up.	It is a battery which measures neuropsychological executive functions.

Secondary Outcome Measures

Name	Time	Method
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, Verbal Fluency, Tapping Visual and Memória Logica)which measure cognitive functions.

Trial Locations

Locations (1)

Instituto de Psiquiatria do HCFMUSP; 🇧🇷 São Paulo, Brazil