Cognitive Remediation on Patients With Bipolar Disorder and Memory Complaints

Not Applicable

• Conditions: Euthymic Status; Patient With Bipolar Disorder; Wirh Memory Complaints
• Interventions: Behavioral: COGMED program

• Registration Number: NCT02988518
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2014-07
• Status Verified: 2016-07
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-12-06
• Last Update Submitted: 2016-12-06
• Study First Posted: 2016-12-09
• Last Update Posted: 2016-12-09
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Evolution of the global functioning between the inclusion and the end of the program	At 6 weeks	evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program

Secondary Outcome Measures

Name	Time	Method
Observance	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.
Quality of life	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.
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)	Searching a statistical correlation between global functioning (using FAST) and working memory (using neuropsychological tests)
Memory complaints	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.

Trial Locations

Locations (1)

Montpellier University Hospital; 🇫🇷 Montpellier, France