Clinical trial NCT01879956: Occupational Therapy in the Rehabilitation of Executive Functions in Patients With Schizophrenia
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
Overall status: UNKNOWN
Phase: NA
Conditions: Refractory Schizophrenia
Keywords: Executive Functions
Schizophrenia
Occupational Therapy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: BADS (Behavioral Assessment of Functional Status)
timeFrame: up to 6 months follow-up.
Secondary outcomes:
measure: DAFS-BR ( Direct Assessment of Functional Status), ILSS-BR (Habilities of Daily Living-Brazilian validated version).
timeFrame: at baseline, after 30 sessions of treatment and follow-up 6 months.
measure: Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory.
timeFrame: at baseline, after 30 sessions of treatment and 6 months follo-up.
measure: Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory.
timeFrame: at baseline, after 30 sessions of treatment and 6 months follo-up.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Psiquiatria do HCFMUSP
Study officials:
affiliation: Departamento de Psiquiatria da FMUSP
name: Helio Elkis, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: