Clinical trial NCT04184375: Cognitive Stimulation for Elderly Bipolar Patients
Official title: Evaluation of Cognitive Stimulation on Dysexecutive Residual Symptoms in Bipolar Patients Over 65 Years of Age
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Cognitive Impairment
Age-related Cognitive Decline
Lead sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Score at the Frontal Assessment Battery (FAB)
timeFrame: at 3 months after inclusion
Secondary outcomes:
measure: Score at FAB
timeFrame: at 6 months after inclusion
measure: Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF)
timeFrame: at inclusion
measure: Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF)
timeFrame: at 6 months after inclusion
measure: Score at delayed matching-to-sample (DMS48)
timeFrame: at inclusion
measure: Score at DMS48
timeFrame: at 3 months after inclusion
measure: Time in minutes at the Trail Making Test A (TMTA)
timeFrame: at inclusion
measure: Time in minutes at the Trail Making Test A
timeFrame: at 3 months after inclusion
measure: Number of errors at Trail Making Test B (TMTB)
timeFrame: at inclusion
measure: Number of errors at Trail Making Test B (TMTB)
timeFrame: at 3 months after inclusion
measure: Score at ISAAC test
timeFrame: at inclusion
measure: Score at ISAAC test
timeFrame: at 3 months after inclusion
measure: Score at Montreal Cognitive Assessment (MMS)
timeFrame: at inclusion
measure: Score at Montreal Cognitive Assessment (MMS)
timeFrame: at 6 months after inclusion
measure: Score at the Hamilton Depression Rating Scale
timeFrame: at inclusion
measure: Score at the Hamilton Depression Rating Scale
timeFrame: at 6 months after inclusion
measure: Interference score at the Stroop test
timeFrame: at inclusion
measure: Interference score at the Stroop test
timeFrame: at 6 months after inclusion
measure: Number of hospitalization due to relapse
timeFrame: at 6 months after inclusion
measure: Score at Zarit scale (caregiver)
timeFrame: at inclusion
measure: Score at Zarit scale (caregiver)
timeFrame: at 6 months after inclusion
Other outcomes:
Locations:
city: La Rochelle
country: France
facility: Groupe Hospitalier de la Rochelle Ré Aunis
Study officials:
affiliation: Groupe Hospitalier de la Rochelle Ré Aunis
name: Pascale Puzos, MD
role: STUDY_DIRECTOR
References: