NCT01879956

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Refractory Schizophrenia

Interventions

Type	Name	Description
OTHER	Craft Activities	There is no intervention method used to perform the task.
BEHAVIORAL	OGI Method	metacognitive approach to assess executive functions.

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-09-01
• Completion: 2014-09-01
• First posted: 2013-06-18
• Last updated: 2013-06-18

Locations

1 site across 1 country: Brazil