Randomized Controlled Trial for the Evaluation of the Efficacy of Occupational Therapy in the Rehabilitation of Executive Functions in Patients With Refractory Schizophrenia
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- BADS (Behavioral Assessment of Functional Status)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
BADS (Behavioral Assessment of Functional Status)
时间窗: up to 6 months follow-up.
It is a battery which measures neuropsychological executive functions.
次要结局
- 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.)
研究者
Helio Elkis
Associate Professor of the Department of Psychiatry
University of Sao Paulo