Cognitive Remediation on Patients With Bipolar Disorder and Memory Complaints (COGMED)

December 6, 2016 updated by: University Hospital, Montpellier

Evaluation of a Cognitive Remediation Program on Patients With Bipolar Disorders, With Memory Complaints

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Recruiting
        • Montpellier University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COGMED program
Cognitive remediation using COGMED program on bipolar euthymic patients with memory complaints
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of the global functioning between the inclusion and the end of the program
Time Frame: At 4 weeks
evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program.
At 4 weeks
Evolution of the global functioning between the inclusion and the end of the program
Time Frame: At 6 weeks
evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program
At 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observance
Time Frame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Evaluation of variation of patient's compliance by Medication Adherence Rating Scale (MARS) score after COGMED program.
At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Quality of life
Time Frame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Evaluation of variation of quality of life by Short Form (36) Health Survey (SF-36) score after COGMED program.
At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Correlation between working memory and global functioning
Time Frame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Searching a statistical correlation between global functioning (using FAST) and working memory (using neuropsychological tests)
At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Memory complaints
Time Frame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Variations on memory complaints will be evaluated by Mac Nair Scale score before and after COGMED program.
At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimate)

December 9, 2016

Study Record Updates

Last Update Posted (Estimate)

December 9, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF 9418
  • 2014-A00825-42 (Other Identifier: Agence nationale de Sécurité des Médicaments)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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