Cognitive Stimulation for Elderly Bipolar Patients

Not Applicable

Recruiting

• Conditions: Bipolar Disorder; Cognitive Impairment; Age-related Cognitive Decline

• Registration Number: NCT04184375
• Lead Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

Brief Summary

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.

Study Timeline

• Study First Submitted: 2019-11-29
• Study First Submitted QC: 2019-11-29
• Study First Posted: 2019-12-03
• Study Start: 2021-03-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-03-03
• Study Completion: 2026-09-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Score at the Frontal Assessment Battery (FAB)	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")

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Groupe Hospitalier de la Rochelle Ré Aunis; 🇫🇷 La Rochelle, France