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

June 17, 2013 updated by: Helio Elkis, University of Sao Paulo

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403000
        • Recruiting
        • Instituto de Psiquiatria do HCFMUSP
        • Principal Investigator:
          • Helio Elkis, PhD MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OGI Method
- experimental group: use the OGI method to improve the executive functioning of patients with refractory schizophrenia.
Behavioral: OGI Method
metacognitive approach to assess executive functions.
Placebo Comparator: craft activities
- control group: use of craft activities, attend the same-number of sessions, but without the intervention of therapists.
Other: Craft Activities
There is no intervention method used to perform the task.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BADS (Behavioral Assessment of Functional Status)
Time Frame: up to 6 months follow-up.
It is a battery which measures neuropsychological executive functions.
up to 6 months follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DAFS-BR ( Direct Assessment of Functional Status), ILSS-BR (Habilities of Daily Living-Brazilian validated version).
Time Frame: 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.
at baseline, after 30 sessions of treatment and follow-up 6 months.
Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory.
Time Frame: 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, Fluência Verbal, Tapping Visual and Memória Logica)which measure cognitive functions.
at baseline, after 30 sessions of treatment and 6 months follo-up.
Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory.
Time Frame: 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.
at baseline, after 30 sessions of treatment and 6 months follo-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Helio Elkis, MD PhD, Departamento de Psiquiatria da FMUSP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimate)

June 18, 2013

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OT Schizophrenia_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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