NCT01879956

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

1.6 years

First QC Date

May 29, 2013

Last Update Submit

June 17, 2013

Conditions

Refractory Schizophrenia

Keywords

Executive FunctionsSchizophreniaOccupational Therapy

Outcome Measures

Primary Outcomes (1)

  • BADS (Behavioral Assessment of Functional Status)

    It is a battery which measures neuropsychological executive functions.

    up to 6 months follow-up.

Secondary Outcomes (3)

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

    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.

    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.

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

Study Arms (2)

OGI Method

ACTIVE COMPARATOR

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

Behavioral: OGI Method

craft activities

PLACEBO COMPARATOR

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

Other: Craft Activities

Interventions

Craft ActivitiesOTHER

There is no intervention method used to perform the task.

craft activities
OGI MethodBEHAVIORAL

metacognitive approach to assess executive functions.

OGI Method

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Psiquiatria do HCFMUSP

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

Schizophrenia, Treatment-ResistantSchizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Helio Elkis, MD PhD

    Departamento de Psiquiatria da FMUSP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helio Elkis, MD PhD

CONTACT

+55 11 26617581helkis@usp.br

Adriana Vizzotto, BSc

CONTACT

+55 11 26618043adrivizzotto@usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of the Department of Psychiatry

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 18, 2013

Study Start

February 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2014

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

BR(1)