An interventional study of cognitive stimulation in Bipolar Disorder, Cognitive Impairment and Age-related Cognitive Decline, sponsored by Groupe Hospitalier de la Rochelle Ré Aunis. Recruiting at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Groupe Hospitalier de la Rochelle Ré Aunis · Not applicable, Interventional, and Supportive care
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.
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.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 40 is below the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Groupe Hospitalier de la Rochelle Ré Aunis is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pre-Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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
The usual practice consists of interviews with the psychiatrist with the possibility of home visits by the nurse.
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.
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")
Time frame: at 3 months after inclusion
Score at FAB
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
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.
Time frame: 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
Time frame: at 6 months after inclusion
Score at delayed matching-to-sample (DMS48)
The DMS48 is a test of visual recognition memory test
Time frame: at inclusion
Score at DMS48
The DMS48 is a test of visual recognition memory test
Time frame: at 3 months after inclusion
Time in minutes at the Trail Making Test A (TMTA)
Evaluation of speed of processing.
Time frame: at inclusion
Time in minutes at the Trail Making Test A
Evaluation of speed of processing.
Time frame: at 3 months after inclusion
Number of errors at Trail Making Test B (TMTB)
Evaluation of mental flexibility
Time frame: at inclusion
Number of errors at Trail Making Test B (TMTB)
Evaluation of mental flexibility
Time frame: at 3 months after inclusion
Score at ISAAC test
Measures fluence
Time frame: at inclusion
Score at ISAAC test
Measures fluence
Time frame: at 3 months after inclusion
Score at Montreal Cognitive Assessment (MMS)
Assessment for detecting cognitive impairment
Time frame: at inclusion
Score at Montreal Cognitive Assessment (MMS)
Assessment for detecting cognitive impairment
Time frame: at 6 months after inclusion
Score at the Hamilton Depression Rating Scale
Evaluation of patient thymic state
Time frame: at inclusion
Score at the Hamilton Depression Rating Scale
Evaluation of patient thymic state
Time frame: at 6 months after inclusion
Interference score at the Stroop test
Evaluation of selective attention
Time frame: at inclusion
Interference score at the Stroop test
Evaluation of selective attention
Time frame: at 6 months after inclusion
Number of hospitalization due to relapse
hospitalization due to relapse
Time frame: 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
Time frame: 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
Time frame: at 6 months after inclusion
Plan to share: Yes — 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.
Supporting information: Clinical study report
Time frame: Data will be made available with publication and up to 15 years after the end of the study
Access criteria: On Mendeley repository A Digital Object Identifier will be provided
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for Mar 2026, 59 months after the start.
Of 352 non-industry interventional studies with no phase under Bipolar Disorder, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 58. This study's planned 59 months is above that.
Counting every sponsor, half of 354 studies reached it within 37 months; a quarter within 23 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
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Groupe Hospitalier de la Rochelle Ré Aunis