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Clinical Trials/NCT04184375
NCT04184375
Recruiting
N/A

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

Groupe Hospitalier de la Rochelle Ré Aunis1 site in 1 country40 target enrollmentMarch 4, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Bipolar Disorder
Sponsor
Groupe Hospitalier de la Rochelle Ré Aunis
Enrollment
40
Locations
1
Primary Endpoint
Score at the Frontal Assessment Battery (FAB)
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 4, 2021
End Date
September 3, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Groupe Hospitalier de la Rochelle Ré Aunis
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Score at the Frontal Assessment Battery (FAB)

Time Frame: at 3 months after inclusion

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 Outcomes

  • Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF)(at 6 months after inclusion)
  • Score at DMS48(at 3 months after inclusion)
  • Score at the Hamilton Depression Rating Scale(at 6 months after inclusion)
  • Interference score at the Stroop test(at 6 months after inclusion)
  • Number of hospitalization due to relapse(at 6 months after inclusion)
  • Score at Zarit scale (caregiver)(at 6 months after inclusion)
  • Time in minutes at the Trail Making Test A (TMTA)(at inclusion)
  • Score at Montreal Cognitive Assessment (MMS)(at 6 months after inclusion)
  • Score at FAB(at 6 months after inclusion)
  • Score at delayed matching-to-sample (DMS48)(at inclusion)
  • Time in minutes at the Trail Making Test A(at 3 months after inclusion)
  • Number of errors at Trail Making Test B (TMTB)(at 3 months after inclusion)
  • Score at ISAAC test(at 3 months after inclusion)

Study Sites (1)

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