Back to resultsCognitive Remediation on Patients With Bipolar Disorder and Memory Complaints (COGMED)
Primary Purpose
Patient With Bipolar Disorder, Euthymic Status, Wirh Memory Complaints
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
COGMED program
Sponsored by
About this trial
This is an interventional supportive care trial for Patient With Bipolar Disorder focused on measuring Psychiatry, Bipolar disorder, Memory complaints, Global functioning, Cognitive remediation, Working memory
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)
Sites / Locations
- Montpellier University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COGMED program
Arm Description
Cognitive remediation using COGMED program on bipolar euthymic patients with memory complaints
Outcomes
Primary Outcome Measures
Evolution of the global functioning between the inclusion and the end of the program
evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program.
Evolution of the global functioning between the inclusion and the end of the program
evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program
Secondary Outcome Measures
Observance
Evaluation of variation of patient's compliance by Medication Adherence Rating Scale (MARS) score after COGMED program.
Quality of life
Evaluation of variation of quality of life by Short Form (36) Health Survey (SF-36) score after COGMED program.
Correlation between working memory and global functioning
Searching a statistical correlation between global functioning (using FAST) and working memory (using neuropsychological tests)
Memory complaints
Variations on memory complaints will be evaluated by Mac Nair Scale score before and after COGMED program.
Full Information
NCT ID
NCT02988518
First Posted
August 1, 2016
Last Updated
December 6, 2016
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02988518
Brief Title
Cognitive Remediation on Patients With Bipolar Disorder and Memory Complaints
Acronym
COGMED
Official Title
Evaluation of a Cognitive Remediation Program on Patients With Bipolar Disorders, With Memory Complaints
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 :
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient With Bipolar Disorder, Euthymic Status, Wirh Memory Complaints
Keywords
Psychiatry, Bipolar disorder, Memory complaints, Global functioning, Cognitive remediation, Working memory
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
COGMED program
Arm Type
Experimental
Arm Description
Cognitive remediation using COGMED program on bipolar euthymic patients with memory complaints
Intervention Type
Behavioral
Intervention Name(s)
COGMED program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evolution of the global functioning between the inclusion and the end of the program
Description
evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program.
Time Frame
At 4 weeks
Title
Evolution of the global functioning between the inclusion and the end of the program
Description
evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program
Time Frame
At 6 weeks
Secondary Outcome Measure Information:
Title
Observance
Description
Evaluation of variation of patient's compliance by Medication Adherence Rating Scale (MARS) score after COGMED program.
Time Frame
At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Title
Quality of life
Description
Evaluation of variation of quality of life by Short Form (36) Health Survey (SF-36) score after COGMED program.
Time Frame
At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Title
Correlation between working memory and global functioning
Description
Searching a statistical correlation between global functioning (using FAST) and working memory (using neuropsychological tests)
Time Frame
At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Title
Memory complaints
Description
Variations on memory complaints will be evaluated by Mac Nair Scale score before and after COGMED program.
Time Frame
At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie OLIE, MD PhD
Phone
+33 4 67 33 85 81
Email
e-olie@chu-montpellier.fr
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine GENTY, MD
Phone
+33 4 67 99 61 45 75
Email
c-genty@chu-montpellier.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive Remediation on Patients With Bipolar Disorder and Memory Complaints
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