Clinical trial NCT02988518: Cognitive Remediation on Patients With Bipolar Disorder and Memory Complaints
Official title: Evaluation of a Cognitive Remediation Program on Patients With Bipolar Disorders, With Memory Complaints
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient With Bipolar Disorder
Euthymic Status
Wirh Memory Complaints
Keywords: Psychiatry
Bipolar disorder
Memory complaints
Global functioning
Cognitive remediation
Working memory
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Bipolar disorder is a major health concern. Intercritical periods are marked with residual symptoms, both thymic and cognitive, which affects quality of life of patients, but also the quality of observance. The implementation of cognitive remediation programs could be interesting. The aim of this study is to evaluate the overall performance on euthymic bipolar patients with memory complaints included in the program named "COGMED", targeting the working memory.

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: Patients with bipolar disorder and memory complaints will be recruited.

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.

Eligibility criteria: Inclusion criteria:

* Being diagnosed bipolar according to the Diagnostic and Statistical Manual of Mental Disorders - IV (DSM-IV) 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:

* Patient on protective measures (guardianship or trusteeship)
* Deprived of liberty subject (judicial or administrative decision)

Primary outcomes:
measure: Evolution of the global functioning between the inclusion and the end of the program
timeFrame: At 4 weeks
measure: Evolution of the global functioning between the inclusion and the end of the program
timeFrame: At 6 weeks
Secondary outcomes:
measure: Observance
timeFrame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
measure: Quality of life
timeFrame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
measure: Correlation between working memory and global functioning
timeFrame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
measure: Memory complaints
timeFrame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
References: