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

This study is currently recruiting participants.
Verified June 2013 by University of Sao Paulo
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Helio Elkis, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01879956
First received: May 29, 2013
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Refractory Schizophrenia
Other: Craft Activities
Behavioral: OGI Method

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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • BADS (Behavioral Assessment of Functional Status) [ Time Frame: up to 6 months follow-up. ] [ Designated as safety issue: No ]
    It is a battery which measures neuropsychological executive functions.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    DAFS-BR - Evaluates functional aspects of daily living such as dealing with money, shopping, social comunication ILSS-BR- similar to DAFS.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: February 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01879956

Contacts
Contact: Helio Elkis, MD PhD +55 11 26617581 helkis@usp.br
Contact: Adriana Vizzotto, BSc +55 11 26618043 adrivizzotto@usp.br

Locations
Brazil
Instituto de Psiquiatria do HCFMUSP Recruiting
São Paulo, Brazil, 05403000
Contact: Adriana Vizzotto, BSc    +55 11 26618043    adrivizzotto@usp.br   
Contact: Helio Elkis, MD PhD       helkis@usp.br   
Principal Investigator: Helio Elkis, PhD MD         
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Helio Elkis, MD PhD Departamento de Psiquiatria da FMUSP
  More Information

No publications provided

Responsible Party: Helio Elkis, Associate Professor of the Department of Psychiatry, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01879956     History of Changes
Other Study ID Numbers: OT Schizophrenia_1
Study First Received: May 29, 2013
Last Updated: June 17, 2013
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Executive Functions
Schizophrenia
Occupational Therapy

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 21, 2014