Cognitive Remediation on Patients With Bipolar Disorder and Memory Complaints
NCT ID: NCT02988518
Last Updated: 2016-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
41 participants
INTERVENTIONAL
2014-07-31
2017-11-30
Brief Summary
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The impact of this program on compliance, quality of life, and memory complaints will be evaluated.
The investigator will measure whether there is a correlation between working memory and overall performances.
Finally, the investigator will try to achieve a profile of bipolar patients in whom the Cogmed program is particularly effective on a plan of overall performance.
Detailed Description
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Two visits :
1. at baseline (V0) : the investigator evaluate bipolar disorder, treatment, mood, quality of life, global functioning, and memory complaints. Patients also have a neuropsychological assessment. The COGMED program is proposed to patients with memory complaints and explain by the investigator
2. 4-6 weeks after the end of the program (11-13 weeks after V1) : the same evaluation is realized to compare score before and after the program of cognitive remediation.
Between the two visits the patient will benefit of COGMED program, at home, during 5 weeks.
COGMED is a remediation cognitive program, based on working memory, consisting on daily exercises at home on a computer.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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COGMED program
Cognitive remediation using COGMED program on bipolar euthymic patients with memory complaints
COGMED program
Patient should connect on his computer at home, 5 times a week, for 5 weeks. Every day, the patient has to do 8 exercises for a total duration of 30 to 45 minutes.
In total, the patient will have to complete 25 sessions. The difficulty level of the proposed items adjust automatically to the patient's maximum capacity to compel him to provide a cognitive effort. A progression index assesses the progress made by the patient.
Every week, the investigator will call the patient for 10 minutes in order to gather the patient's feelings, his difficulties, provide some advice and encourage him.
The investigator will have to analyze the results of curves available for each event, as well as the patient's progress index.
Interventions
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COGMED program
Patient should connect on his computer at home, 5 times a week, for 5 weeks. Every day, the patient has to do 8 exercises for a total duration of 30 to 45 minutes.
In total, the patient will have to complete 25 sessions. The difficulty level of the proposed items adjust automatically to the patient's maximum capacity to compel him to provide a cognitive effort. A progression index assesses the progress made by the patient.
Every week, the investigator will call the patient for 10 minutes in order to gather the patient's feelings, his difficulties, provide some advice and encourage him.
The investigator will have to analyze the results of curves available for each event, as well as the patient's progress index.
Eligibility Criteria
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Inclusion Criteria
* Memory complaints or overall performance alterations according to the memory scale (MEM III Wechsler memory scale - third edition)
* Being euthymic at the inclusion according to Montgomery-Asberg Depression Rating Scale (MADRS \< 12) and Young Mania Rating Scale (YMRS \< 6)
* Not being treated with electroconvulsive therapy for the last year
* Not having drug-dependance or drug-abuse for the last six months
* Having a computer with internet and a cellphone at home
* Having signed informed consent
* Able to understand nature, aims and methodology of the study
Exclusion Criteria
* Deprived of liberty subject (judicial or administrative decision)
18 Months
65 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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Montpellier University Hospital
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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Catherine GENTY, MD
Role: primary
Other Identifiers
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2014-A00825-42
Identifier Type: OTHER
Identifier Source: secondary_id
UF 9418
Identifier Type: -
Identifier Source: org_study_id