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Cognitive Stimulation for Elderly Bipolar Patients (TONIC)

Primary Purpose

Bipolar Disorder, Cognitive Impairment, Age-related Cognitive Decline

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cognitive stimulation
Sponsored by
Groupe Hospitalier de la Rochelle Ré Aunis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bipolar Disorder

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Groupe Hospitalier de la Rochelle Ré AunisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TONIC

Control

Arm Description

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.

The usual practice consists of interviews with the psychiatrist with the possibility of home visits by the nurse.

Outcomes

Primary Outcome Measures

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")

Secondary Outcome Measures

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

Full Information

First Posted
November 29, 2019
Last Updated
February 17, 2023
Sponsor
Groupe Hospitalier de la Rochelle Ré Aunis
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1. Study Identification

Unique Protocol Identification Number
NCT04184375
Brief Title
Cognitive Stimulation for Elderly Bipolar Patients
Acronym
TONIC
Official Title
Evaluation of Cognitive Stimulation on Dysexecutive Residual Symptoms in Bipolar Patients Over 65 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
March 3, 2025 (Anticipated)
Study Completion Date
September 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier de la Rochelle Ré Aunis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Cognitive Impairment, Age-related Cognitive Decline

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TONIC
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The usual practice consists of interviews with the psychiatrist with the possibility of home visits by the nurse.
Intervention Type
Behavioral
Intervention Name(s)
cognitive stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Score at the Frontal Assessment Battery (FAB)
Description
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")
Time Frame
at 3 months after inclusion
Secondary Outcome Measure Information:
Title
Score at FAB
Description
Scores between the 3-month and 6-month evaluation will determine whether executive analysis functions have been maintained
Time Frame
at 6 months after inclusion
Title
Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF)
Description
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.
Time Frame
at inclusion
Title
Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF)
Description
A positive difference in scores reflects an improvement in patient autonomy
Time Frame
at 6 months after inclusion
Title
Score at delayed matching-to-sample (DMS48)
Description
The DMS48 is a test of visual recognition memory test
Time Frame
at inclusion
Title
Score at DMS48
Description
The DMS48 is a test of visual recognition memory test
Time Frame
at 3 months after inclusion
Title
Time in minutes at the Trail Making Test A (TMTA)
Description
Evaluation of speed of processing.
Time Frame
at inclusion
Title
Time in minutes at the Trail Making Test A
Description
Evaluation of speed of processing.
Time Frame
at 3 months after inclusion
Title
Number of errors at Trail Making Test B (TMTB)
Description
Evaluation of mental flexibility
Time Frame
at inclusion
Title
Number of errors at Trail Making Test B (TMTB)
Description
Evaluation of mental flexibility
Time Frame
at 3 months after inclusion
Title
Score at ISAAC test
Description
Measures fluence
Time Frame
at inclusion
Title
Score at ISAAC test
Description
Measures fluence
Time Frame
at 3 months after inclusion
Title
Score at Montreal Cognitive Assessment (MMS)
Description
Assessment for detecting cognitive impairment
Time Frame
at inclusion
Title
Score at Montreal Cognitive Assessment (MMS)
Description
Assessment for detecting cognitive impairment
Time Frame
at 6 months after inclusion
Title
Score at the Hamilton Depression Rating Scale
Description
Evaluation of patient thymic state
Time Frame
at inclusion
Title
Score at the Hamilton Depression Rating Scale
Description
Evaluation of patient thymic state
Time Frame
at 6 months after inclusion
Title
Interference score at the Stroop test
Description
Evaluation of selective attention
Time Frame
at inclusion
Title
Interference score at the Stroop test
Description
Evaluation of selective attention
Time Frame
at 6 months after inclusion
Title
Number of hospitalization due to relapse
Description
hospitalization due to relapse
Time Frame
at 6 months after inclusion
Title
Score at Zarit scale (caregiver)
Description
Identification of suffering or exhaustion, anxiety and/or depressive disorder(s), sleep disorder(s), etc. in the caregiver
Time Frame
at inclusion
Title
Score at Zarit scale (caregiver)
Description
Identification of suffering or exhaustion, anxiety and/or depressive disorder(s), sleep disorder(s), etc. in the caregiver
Time Frame
at 6 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline ALLIX-BEGUEC, Ph.D.
Phone
+33 (0) 516 49 42 46
Email
caroline.allix-beguec@ght-atlantique17.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascale Puzos, MD
Organizational Affiliation
Groupe Hospitalier de la Rochelle Ré Aunis
Official's Role
Study Director
Facility Information:
Facility Name
Groupe Hospitalier de la Rochelle Ré Aunis
City
La Rochelle
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascale Puzos, MD
First Name & Middle Initial & Last Name & Degree
Cécile DUFRESNE
First Name & Middle Initial & Last Name & Degree
Damien CLUS
First Name & Middle Initial & Last Name & Degree
Edouard BARUCQ
First Name & Middle Initial & Last Name & Degree
Louise LARROQUE
First Name & Middle Initial & Last Name & Degree
Marion COULON
First Name & Middle Initial & Last Name & Degree
Emmanuelle TEYSSEDRE
First Name & Middle Initial & Last Name & Degree
Sophie DEVAUCHELLE
First Name & Middle Initial & Last Name & Degree
Caroline DURAND

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Cognitive Stimulation for Elderly Bipolar Patients

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