Cognitive Stimulation for Elderly Bipolar Patients (TONIC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Bipolar Disorder; Age-related Cognitive Decline
• Intervention / Treatment: Behavioral: cognitive stimulation

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline ALLIX-BEGUEC, Ph.D.; Phone Number: +33 (0) 516 49 42 46; Email: caroline.allix-beguec@ght-atlantique17.fr

Study Locations

• France
  • La Rochelle, France
    • Recruiting
    • Groupe Hospitalier de la Rochelle Ré Aunis
    • Contact: Pascale Puzos, MD
    • Principal Investigator: Cécile DUFRESNE
    • Principal Investigator: Damien CLUS
    • Principal Investigator: Edouard BARUCQ
    • Principal Investigator: Louise LARROQUE
    • Principal Investigator: Marion COULON
    • Principal Investigator: Emmanuelle TEYSSEDRE
    • Principal Investigator: Sophie DEVAUCHELLE
    • Principal Investigator: Caroline DURAND

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TONIC; 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; 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.
No Intervention: Control; The usual practice consists of interviews with the psychiatrist with the possibility of home visits by the nurse.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
• Investigators: Study Director: Pascale Puzos, MD, Groupe Hospitalier de la Rochelle Ré Aunis

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Estimated): March 3, 2025
• Study Completion (Estimated): September 3, 2025

Study Registration Dates

• First Submitted: November 29, 2019
• First Submitted That Met QC Criteria: November 29, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Neurocognitive Disorders; Cognition Disorders; Bipolar and Related Disorders; Cognitive Dysfunction; Bipolar Disorder
• Other Study ID Numbers: 2015/P05/095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data will be made available with publication. A Digital Object Identifier will be used.

Keyword are bipolar disorder, aged, cognitive dysfunction, cognitive Remediation.

The only available version will be the locked database. With the exception of dates, all data will be made available. Dates will only be collected to verify the quality of the clinical trial execution. They do not add to the clinical question, and may be a means of indirectly identifying patients. The database will be made available through Mendeley Data.

Medical Subject Headings (MESH) terms will be used to describe clinical data. Psychological test references will be provided in the publication. International standard unit will be used. The data will be made available to the community of scientists and clinicians interested in bipolar disorder.

Data will be made available with the free access to the publication for 15 years.

• IPD Sharing Time Frame: Data will be made available with publication and up to 15 years after the end of the study
• IPD Sharing Access Criteria: On Mendeley repository A Digital Object Identifier will be provided
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No