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

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

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.

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.