Cognitive Stimulation for Elderly Bipolar Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bipolar Disorder, Cognitive Impairment, Age-related Cognitive Decline

Intervention / Treatment
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* Behavioral: cognitive stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TONIC<br>The cognitive stimulation sessions are carried out using Liliane Israël's TRAIN YOUR MEMORY software, and are divided into two parts: the first part is essentially cognitive and the second relates to the daily life of the Bipolar patient. This training method consists of combining two means of intervention, pedagogical action and psychotherapeutic effect. It aims to stimulate, develop and strengthen the basic mechanisms underlying memory phenomena (sensory acuity, attention, associations, structuring, executive functions, spatial and temporal landmarks, associative recruitment). It is presented in the form of exercises divided into eight modules. | Behavioral: cognitive stimulation<br>* 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 language: impact on social life. 2 sessions stimulating the temporal and spatial landmarks: agenda, daily trips.<br>|
| No Intervention: Control<br>The usual practice consists of interviews with the psychiatrist with the possibility of home visits by the nurse. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score at the Frontal Assessment Battery (FAB) | 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) | at 3 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score at FAB | Scores between the 3-month and 6-month evaluation will determine whether executive analysis functions have been maintained | at 6 months after inclusion | 
| Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF) | The QAF allows to quickly assess a patient's functional capacity and to identify a functional decline in the patient with a mild neurocognitive disorder, Alzheimer's disease or other neurocognitive disorder. | at inclusion | 
| Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF) | A positive difference in scores reflects an improvement in patient autonomy | at 6 months after inclusion | 
| Score at delayed matching-to-sample (DMS48) | The DMS48 is a test of visual recognition memory test | at inclusion | 
| Score at DMS48 | The DMS48 is a test of visual recognition memory test | at 3 months after inclusion | 
| Time in minutes at the Trail Making Test A (TMTA) | Evaluation of speed of processing. | at inclusion | 
| Time in minutes at the Trail Making Test A | Evaluation of speed of processing. | at 3 months after inclusion | 
| Number of errors at Trail Making Test B (TMTB) | Evaluation of mental flexibility | at inclusion | 
| Number of errors at Trail Making Test B (TMTB) | Evaluation of mental flexibility | at 3 months after inclusion | 
| Score at ISAAC test | Measures fluence | at inclusion | 
| Score at ISAAC test | Measures fluence | at 3 months after inclusion | 
| Score at Montreal Cognitive Assessment (MMS) | Assessment for detecting cognitive impairment | at inclusion | 
| Score at Montreal Cognitive Assessment (MMS) | Assessment for detecting cognitive impairment | at 6 months after inclusion | 
| Score at the Hamilton Depression Rating Scale | Evaluation of patient thymic state | at inclusion | 
| Score at the Hamilton Depression Rating Scale | Evaluation of patient thymic state | at 6 months after inclusion | 
| Interference score at the Stroop test | Evaluation of selective attention | at inclusion | 
| Interference score at the Stroop test | Evaluation of selective attention | at 6 months after inclusion | 
| Number of hospitalization due to relapse | hospitalization due to relapse | at 6 months after inclusion | 
| Score at Zarit scale (caregiver) | Identification of suffering or exhaustion, anxiety and/or depressive disorder(s), sleep disorder(s), etc. in the caregiver | at inclusion | 
| Score at Zarit scale (caregiver) | Identification of suffering or exhaustion, anxiety and/or depressive disorder(s), sleep disorder(s), etc. in the caregiver | at 6 months after inclusion |