Cognitive Stimulation for Elderly Bipolar Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cognitive stimulation.
- Who it may be relevant to
- Registry conditions: Bipolar Disorder, Cognitive Impairment, Age-related Cognitive Decline. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Cognitive Stimulation on Dysexecutive Residual Symptoms in Bipolar Patients Over 65 Years of Age
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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
Primary outcome measures
- Score at the Frontal Assessment Battery (FAB) [Time frame: at 3 months after inclusion]
Secondary outcome measures (12)
- Score at FAB [Time frame: at 6 months after inclusion]
- Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF) [Time frame: at inclusion]
- Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF) [Time frame: at 6 months after inclusion]
- Score at delayed matching-to-sample (DMS48) [Time frame: at inclusion]
- Score at DMS48 [Time frame: at 3 months after inclusion]
- Time in minutes at the Trail Making Test A (TMTA) [Time frame: at inclusion]
- Time in minutes at the Trail Making Test A [Time frame: at 3 months after inclusion]
- Number of errors at Trail Making Test B (TMTB) [Time frame: at inclusion]
- Number of errors at Trail Making Test B (TMTB) [Time frame: at 3 months after inclusion]
- Score at ISAAC test [Time frame: at inclusion]
- Score at ISAAC test [Time frame: at 3 months after inclusion]
- Score at Montreal Cognitive Assessment (MMS) [Time frame: at inclusion]
Eligibility criteria
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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Groupe Hospitalier de la Rochelle Ré Aunis — La Rochelle
Identifiers
NCT: NCT04184375 · 2015/P05/095