Меню
Идёт набор NCT04184375

Cognitive Stimulation for Elderly Bipolar Patients

Без фазы С лечением Bipolar Disorder Cognitive Impairment Age-related Cognitive Decline

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: cognitive stimulation.
Кому может быть актуально
Состояния в реестре: Bipolar Disorder, Cognitive Impairment, Age-related Cognitive Decline. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Evaluation of Cognitive Stimulation on Dysexecutive Residual Symptoms in Bipolar Patients Over 65 Years of Age

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое cognitive stimulation
    Patients participate in one session per week according to the following schedule: * 2 sensory stimulation sessions: identify sensations, emotions, how to manage them. * 2 sessions on association, verbal fluency, and imagination: language as a tool for expression in the face of illness. * 2 voluntary attention sessions: improve daily attention. * 2 sessions of intellectual structuring: stimulating and maintaining memory, carrying out external activities. * 2 sessions of structuring through langu

Первичные конечные точки

  • Score at the Frontal Assessment Battery (FAB) [Срок оценки: at 3 months after inclusion]
Вторичные конечные точки (12)
  • Score at FAB [Срок оценки: at 6 months after inclusion]
  • Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF) [Срок оценки: at inclusion]
  • Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF) [Срок оценки: at 6 months after inclusion]
  • Score at delayed matching-to-sample (DMS48) [Срок оценки: at inclusion]
  • Score at DMS48 [Срок оценки: at 3 months after inclusion]
  • Time in minutes at the Trail Making Test A (TMTA) [Срок оценки: at inclusion]
  • Time in minutes at the Trail Making Test A [Срок оценки: at 3 months after inclusion]
  • Number of errors at Trail Making Test B (TMTB) [Срок оценки: at inclusion]
  • Number of errors at Trail Making Test B (TMTB) [Срок оценки: at 3 months after inclusion]
  • Score at ISAAC test [Срок оценки: at inclusion]
  • Score at ISAAC test [Срок оценки: at 3 months after inclusion]
  • Score at Montreal Cognitive Assessment (MMS) [Срок оценки: at inclusion]

Критерии участия

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

Критерии включения

  • Mild to moderate neuro-cognitive impairments (MMS Test : 16 ≤ score < 26)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Франция · 1 центр
  • Groupe Hospitalier de la Rochelle Ré Aunis — La Rochelle

Идентификаторы

NCT: NCT04184375 · 2015/P05/095

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗