Cognitive Stimulation for Elderly Bipolar Patients

NCT ID: NCT04184375

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-04
• Study Completion Date: 2026-09-03

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.

Conditions

Bipolar Disorder; Cognitive Impairment; Age-related Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

TONIC

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.

Group Type: EXPERIMENTAL

cognitive stimulation

Intervention Type: BEHAVIORAL

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

cognitive stimulation

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.

Intervention Type: BEHAVIORAL

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

• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier de la Rochelle Ré Aunis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascale Puzos, MD

Role: STUDY_DIRECTOR

Groupe Hospitalier de la Rochelle Ré Aunis

Locations

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Caroline ALLIX-BEGUEC, Ph.D.

Role: CONTACT

caroline.allix-beguec@ght-atlantique17.fr

+33 (0) 516 49 42 46

Facility Contacts

Pascale Puzos, MD

Role: primary

Other Identifiers

2015/P05/095

Identifier Type: -

Identifier Source: org_study_id