Evaluation of Cognitive Stimulation on Dysexecutive Residual Symptoms in Bipolar Patients Over 65 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Score at the Frontal Assessment Battery (FAB)
研究概览
简要总结
Age is a major risk factor for the development of cognitive disorders and neurodegenerative pathologies. Cognitive disorders during the phases of bipolar disease are known to exist, and alterations increase significantly after the age of 65. Drug treatments seem to have only a limited effect. A cognitive stimulation program has proven his benefit to patients over 65 with neurodegenerative diseases (Israel, 2004). We propose to evaluate this cognitive stimulation program that we have adapted to bipolar disease.
详细描述
Bipolar disorders, which belong to the category of mood disorders, are the 6th leading cause of disability in the world. Cognitive disorders are known to exist during the phases of bipolar disease, and alterations increase significantly after the age of 65. Recent studies have shown that attention, memory and executive function impairments are the main causes of cognitive disorders. Residual symptoms have a significant impact on the risk of relapse into bipolar disorder and on quality of life. Cognitive stimulation (CS) is a pedagogical approach based on the idea that cognitive skills contribute to personal development in the same way as psychological and social factors. This study aims at assessing a cognitive stimulation program initially developed for patients with neurodegenerative diseases, and adapted to bipolar disease. This program will be compared to the usual practice consisting in consultation with psychiatrist and sometimes in intervention of home nurses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-Inclusion Criteria:
- •age > 65 years old
- •Diagnosis of bipolar illness for more than 10 years
- •Euthymic phase
- •Understands and speaks French
- •Free, informed and express consent
- •Inclusion Criteria:
- •Mild to moderate neuro-cognitive impairments (MMS Test : 16 ≤ score < 26)
排除标准
- •Illiteracy
- •Patient participating in other therapeutic workshops (e. g. psycho-geriatric day hospital care, etc.)
- •Persons deprived of their liberty by a judicial or administrative decision
- •Persons of full age who are subject to a legal protection measure
- •Persons unable to consent
- •Persons who are not members of or beneficiaries of a social security scheme
- •Patient's refusal to participate in the study
结局指标
主要结局
Score at the Frontal Assessment Battery (FAB)
时间窗: at 3 months after inclusion
The FAB assesses conceptualization (category responses, such as "in what way are a banana and an orange are alike?"), lexical fluency, programming or motor series (Luria), sensitivity to interference (conflicting instructions, such as "tap twice when I tap once"), inhibitory control (Go/No-Go), and environmental autonomy (prehension behavior, such as "do not take my hands")
次要结局
- Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF)(at 6 months after inclusion)
- Score at DMS48(at 3 months after inclusion)
- Score at the Hamilton Depression Rating Scale(at 6 months after inclusion)
- Interference score at the Stroop test(at 6 months after inclusion)
- Number of hospitalization due to relapse(at 6 months after inclusion)
- Score at Zarit scale (caregiver)(at 6 months after inclusion)
- Time in minutes at the Trail Making Test A (TMTA)(at inclusion)
- Score at Montreal Cognitive Assessment (MMS)(at 6 months after inclusion)
- Score at FAB(at 6 months after inclusion)
- Score at delayed matching-to-sample (DMS48)(at inclusion)
- Time in minutes at the Trail Making Test A(at 3 months after inclusion)
- Number of errors at Trail Making Test B (TMTB)(at 3 months after inclusion)
- Score at ISAAC test(at 3 months after inclusion)