Occupational Therapy in the Rehabilitation of Executive Functions in Patients With Schizophrenia (OTSchizo)
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|ClinicalTrials.gov Identifier: NCT01879956|
Recruitment Status : Unknown
Verified June 2013 by Helio Elkis, University of Sao Paulo.
Recruitment status was: Recruiting
First Posted : June 18, 2013
Last Update Posted : June 18, 2013
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 or disease||Intervention/treatment||Phase|
|Refractory Schizophrenia||Other: Craft Activities Behavioral: OGI Method||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||February 2012|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2014|
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.
- BADS (Behavioral Assessment of Functional Status) [ Time Frame: up to 6 months follow-up. ]It is a battery which measures neuropsychological executive functions.
- 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. ]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. ]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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879956
|Contact: Helio Elkis, MD PhD||+55 11 email@example.com|
|Contact: Adriana Vizzotto, BSc||+55 11 firstname.lastname@example.org|
|Instituto de Psiquiatria do HCFMUSP||Recruiting|
|São Paulo, Brazil, 05403000|
|Contact: Adriana Vizzotto, BSc +55 11 26618043 email@example.com|
|Contact: Helio Elkis, MD PhD firstname.lastname@example.org|
|Principal Investigator: Helio Elkis, PhD MD|
|Principal Investigator:||Helio Elkis, MD PhD||Departamento de Psiquiatria da FMUSP|