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

Primary Purpose

Refractory Schizophrenia

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Craft Activities

OGI Method

About this trial

This is an interventional treatment trial for Refractory Schizophrenia focused on measuring Executive Functions, Schizophrenia, Occupational Therapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Instituto de Psiquiatria do HCFMUSPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

OGI Method

craft activities

Arm Description

- experimental group: use the OGI method to improve the executive functioning of patients with refractory schizophrenia.

- control group: use of craft activities, attend the same-number of sessions, but without the intervention of therapists.

Outcomes

Primary Outcome Measures

BADS (Behavioral Assessment of Functional Status)

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).

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.

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.

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.

Full Information

NCT ID

NCT01879956

First Posted

May 29, 2013

Last Updated

June 17, 2013

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01879956

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Unknown status

Study Start Date

February 2012 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Schizophrenia

Keywords

Executive Functions, Schizophrenia, Occupational Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

OGI Method

Arm Type

Active Comparator

Arm Description

- experimental group: use the OGI method to improve the executive functioning of patients with refractory schizophrenia.

Arm Title

craft activities

Arm Type

Placebo Comparator

Arm Description

- control group: use of craft activities, attend the same-number of sessions, but without the intervention of therapists.

Intervention Type

Other

Intervention Name(s)

Craft Activities

Intervention Description

There is no intervention method used to perform the task.

Intervention Type

Behavioral

Intervention Name(s)

OGI Method

Intervention Description

metacognitive approach to assess executive functions.

Primary Outcome Measure Information:

Title

BADS (Behavioral Assessment of Functional Status)

Description

It is a battery which measures neuropsychological executive functions.

Time Frame

up to 6 months follow-up.

Secondary Outcome Measure Information:

Title

DAFS-BR ( Direct Assessment of Functional Status), ILSS-BR (Habilities of Daily Living-Brazilian validated version).

Description

DAFS-BR - Evaluates functional aspects of daily living such as dealing with money, shopping, social comunication ILSS-BR- similar to DAFS.

Time Frame

at baseline, after 30 sessions of treatment and follow-up 6 months.

Title

Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory.

Description

Time Frame

at baseline, after 30 sessions of treatment and 6 months follo-up.

Title

Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory.

Description

Time Frame

at baseline, after 30 sessions of treatment and 6 months follo-up.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Helio Elkis, MD PhD

Phone

+55 11 26617581

helkis@usp.br

First Name & Middle Initial & Last Name or Official Title & Degree

Adriana Vizzotto, BSc

Phone

+55 11 26618043

adrivizzotto@usp.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helio Elkis, MD PhD

Organizational Affiliation

Departamento de Psiquiatria da FMUSP

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto de Psiquiatria do HCFMUSP

City

São Paulo

ZIP/Postal Code

05403000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Adriana Vizzotto, BSc

Phone

+55 11 26618043

adrivizzotto@usp.br

First Name & Middle Initial & Last Name & Degree

Helio Elkis, MD PhD

helkis@usp.br

First Name & Middle Initial & Last Name & Degree

Helio Elkis, PhD MD

12. IPD Sharing Statement

Learn more about this trial

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

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