Cognitive Stimulation for Elderly Bipolar Patients

Bipolar Disorder Clinical Trial

— TONIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04184375
• Other study ID #: 2015/P05/095
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2021
• Est. completion date: September 3, 2025

Study information

• Verified date: February 2024
• Source: Groupe Hospitalier de la Rochelle Ré Aunis
• Contact: Caroline ALLIX-BEGUEC, Ph.D.
• Phone: +33 (0) 516 49 42 46
• Email: caroline.allix-beguec[@]ght-atlantique17.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 3, 2025
• Est. primary completion date: March 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Bipolar Disorder
• Cognitive Dysfunction
• Cognitive Impairment

Intervention

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 language: impact on social life. 2 sessions stimulating the temporal and spatial landmarks: agenda, daily trips.

Locations

Country	Name	City	State
France	Groupe Hospitalier de la Rochelle Ré Aunis	La Rochelle

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Rochelle Ré Aunis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Score at delayed matching-to-sample (DMS48)	The DMS48 is a test of visual recognition memory test	at inclusion
Secondary	Score at DMS48	The DMS48 is a test of visual recognition memory test	at 3 months after inclusion
Secondary	Time in minutes at the Trail Making Test A (TMTA)	Evaluation of speed of processing.	at inclusion
Secondary	Time in minutes at the Trail Making Test A	Evaluation of speed of processing.	at 3 months after inclusion
Secondary	Number of errors at Trail Making Test B (TMTB)	Evaluation of mental flexibility	at inclusion
Secondary	Number of errors at Trail Making Test B (TMTB)	Evaluation of mental flexibility	at 3 months after inclusion
Secondary	Score at ISAAC test	Measures fluence	at inclusion
Secondary	Score at ISAAC test	Measures fluence	at 3 months after inclusion
Secondary	Score at Montreal Cognitive Assessment (MMS)	Assessment for detecting cognitive impairment	at inclusion
Secondary	Score at Montreal Cognitive Assessment (MMS)	Assessment for detecting cognitive impairment	at 6 months after inclusion
Secondary	Score at the Hamilton Depression Rating Scale	Evaluation of patient thymic state	at inclusion
Secondary	Score at the Hamilton Depression Rating Scale	Evaluation of patient thymic state	at 6 months after inclusion
Secondary	Interference score at the Stroop test	Evaluation of selective attention	at inclusion
Secondary	Interference score at the Stroop test	Evaluation of selective attention	at 6 months after inclusion
Secondary	Number of hospitalization due to relapse	hospitalization due to relapse	at 6 months after inclusion
Secondary	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
Secondary	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