Cognitive Stimulation for Elderly Bipolar Patients (TONIC)

Groupe Hospitalier de la Rochelle Ré Aunis

Status: Enrolling

Conditions: Cognitive Impairment; Bipolar Disorder; Age-related Cognitive Decline

Treatments: Behavioral: cognitive stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04184375

2015/P05/095

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

TONIC

Experimental group

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.

Treatment:

Behavioral: cognitive stimulation

Control

No Intervention group

Description:

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