Assessing the Effect of Compensatory Cognitive Intervention for Functional Capacity, Cognitive Functions and Severity of Symptoms Among People With Severe Mental Illness
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline functional capacity at 12 weeks : The Observed Tasks of Daily Living-Revised (OTDL-R)
研究概览
简要总结
The aim of this study is to assess the efficacy of a short term compensatory cognitive group intervention - the Compensatory Cognitive Training (CCT) among people with severe mental illnesses, receiving ambulatory treatment
详细描述
This study includes two experimental arms to research cognitive compensatory group treatment in severe mental illness population. The study consists of 4 primary phases: recruitment, assessment, intervention and post-intervention assessment. Two arms involve an ambulatory participants. participants are assigned to an intervention or control group according to the order of recruitment. Assessment and post-assessment phases include assessments of functional capacity, cognitive functions and severity of symptoms.
Intervention includes 12 group sessions in a small group of five participants, focusing on learning compensatory strategies aimed to improve attention, concentration, learning, memory, organization, and problem-solving in order to improve everyday functioning. Interventions will be performed in addition to standard ambulatory treatment. The control group will receive standard ambulatory treatment only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •basic knowledge in Hebrew
- •diagnosed according to the ICD -10 with severe mental illness: schizophrenia, bipolar disease, schizoaffective disorder or major depression
- •Patients are treated with neuroleptic medication for at least four weeks.
排除标准
- •acquired neurological disorders including dementia and brain injury.
- •Developmental neurological disorders including developmental intellectual disability and autistic spectrum disorders.
- •Regular Electro convulsive therapy treatment with frequency of twice a month or more.
- •People to whom a guardian has been appointed
- •Current addiction
结局指标
主要结局
Change from baseline functional capacity at 12 weeks : The Observed Tasks of Daily Living-Revised (OTDL-R)
时间窗: 30 min duration at week 0 ; week 12
OTDL-R is an objective, performance-based evaluation of the subjects' ability to perform daily life activities in the following areas: Medication management, communication and finances management. The final score ranges from 0 (not independent) to 28 (independent).
次要结局
- Change from baseline cognitive functions at 12 weeks: The Neurobehavioral Cognitive Status Examination (COGNISTAT)(20 min at week 0 ; week 12)
- Change from baseline cognitive functions at 12 weeks: The Cognitive Problems and Strategies Assessment (CPSA)(10 min at week 0 ; week 12)
- Change from baseline severity of clinical symptoms at 12 weeks: Clinical Global Impression (CGI)(week 0 ; week 12)
- Change from baseline cognitive functions at 12 weeks: Rey- Ostereich Complex Figure(20 min at week 0 ; week 12)
- Change from baseline cognitive functions at 12 weeks: Trail Making Test A & B (TMT)(3 min at week 0 ; week 12)
- Change from baseline cognitive functions at 12 weeks: Behavioral Assessment of the Dysexecutive Syndrome (BADS): key searching test(1 min at week 0 ; week 12)
- Change from baseline cognitive functions at 12 weeks: Category Fluency Test (CFT)(1 min at week 0 ; week 12)
研究者
ido lurie
Director of adult clinic
Shalvata Mental Health Center