Occupational Therapy in the Rehabilitation of Executive Functions in Patients With Schizophrenia (OTSchizo)

University of Sao Paulo

Status: Unknown

Conditions: Refractory Schizophrenia

Treatments: Behavioral: OGI Method; Other: Craft Activities

Study type: Interventional

Funder types: Other

Identifiers

NCT01879956

OT Schizophrenia_1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

OGI Method

Active Comparator group

Description:

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

Treatment:

Behavioral: OGI Method

craft activities

Placebo Comparator group

Description:

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

Treatment:

Other: Craft Activities