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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014