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

Refractory Schizophrenia Clinical Trial

— OTSchizo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01879956
• Other study ID #: OT Schizophrenia_1
• Status: Recruiting
• Phase: N/A
• First received: May 29, 2013
• Last updated: June 17, 2013
• Start date: February 2012
• Est. completion date: September 2014

Study information

• Verified date: June 2013
• Source: University of Sao Paulo
• Contact: Helio Elkis, MD PhD
• Phone: +55 11 26617581
• Email: helkis[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Refractory Schizophrenia
• Schizophrenia

Intervention

Other:
• Craft Activities
There is no intervention method used to perform the task.

Behavioral:
• OGI Method
metacognitive approach to assess executive functions.

Locations

Country	Name	City	State
Brazil	Instituto de Psiquiatria do HCFMUSP	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BADS (Behavioral Assessment of Functional Status)	It is a battery which measures neuropsychological executive functions.	up to 6 months follow-up.	No
Secondary	DAFS-BR ( Direct Assessment of Functional Status), ILSS-BR (Habilities of Daily Living-Brazilian validated version).	DAFS-BR - Evaluates functional aspects of daily living such as dealing with money, shopping, social comunication ILSS-BR- similar to DAFS.	at baseline, after 30 sessions of treatment and follow-up 6 months.	No
Secondary	Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory.	Neuropsychological Battery (Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test,Rey Complex Figure, Fluência Verbal, Tapping Visual and Memória Logica)which measure cognitive functions.	at baseline, after 30 sessions of treatment and 6 months follo-up.	No
Secondary	Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory.	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.	at baseline, after 30 sessions of treatment and 6 months follo-up.	No