Cognitive Remediation on Patients With Bipolar Disorder and Memory Complaints

NCT02988518 | Unknown

• 2 other identifiers: UF 94182014-A00825-42
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient With Bipolar Disorder; Euthymic Status; Wirh Memory Complaints

Keywords

Psychiatry; Bipolar disorder; Memory complaints; Global functioning; Cognitive remediation; Working memory

Outcome Measures

Primary Outcomes (2)

• 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.

  At 4 weeks

• 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

  At 6 weeks

Secondary Outcomes (4)

• Observance

  At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)

• Quality of life

  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

  At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)

• Memory complaints

  At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)

Study Arms (1)

COGMED program

EXPERIMENTAL

Cognitive remediation using COGMED program on bipolar euthymic patients with memory complaints

Behavioral: COGMED program

Interventions

COGMED program BEHAVIORAL

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.

COGMED program

Eligibility Criteria

• Age: 18 Months - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

Emilie OLIE, MD PhD

CONTACT

+33 4 67 33 85 81; e-olie@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: December 9, 2016
• Study Start: July 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 9, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)