Validation of a Cognitive Remediation Program for Bipolar Disorders

Study Overview
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Brief Summary
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This study evaluates the effect of a new cognitive remediation program designed for patients suffering from a bipolar disorder, on cognitive functions, psychosocial functioning and neural processes. In this double-blind (patient, outcomes assessor) controlled randomized trial the investigators compare patients receiving the ECo program for bipolar disorders, to patients benefiting from the broadly used cognitive remediation program CRT and to patients receiving supportive psychotherapy. Patients are treated for 3 months and monitored for 9 months.

Official Title
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Validation of a Cognitive Remediation Program for Bipolar Disorders

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Other: ECo program
* Other: CRT program
* Other: Supportive psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type I or type II Bipolar Disorder diagnosis, according to DSM-IV-TR criteria No Manic or Major Depressive episode during the last three months No or few residual depressive symptoms (HDRS-17 ≤ 12) No or few residual manic symptoms (YMRS ≤ 8) Stable dose of medication for the last two months Cognitive complaint expressed by the patient and impairment observed by the patient's regular psychiatrist Informed consent form read, initialed and signed Patient registered on the social welfare system Exclusion Criteria: Other diagnosis than Bipolar Disorder on axis I of the DSM-IV-TR Rapid Cycling Bipolar Disorder diagnosis Addiction or substance abuse (except tobacco) during the twelve last months Physical or neurological disorder that can lead to cognitive impairment Engagement in a research protocol either currently or over the last month Neuropsychological assessment or Rorschach Inkblot Test evaluation during the last six months Ineligibility for Magnetic Resonance Imaging [MRI] (e.g. claustrophobia, metallic implants, pace-maker, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECo program<br>Objective: to inform the patient about cognitive impairments and their repercussions; to train the patient in problem-solving skills through exercises; to implement strategies in daily life Duration: three months Frequency: two one-hour individual sessions and one hour of at-home training per week Modalities: pen and paper exercises, tools (tokens, cards, maps, chessboard) Modules: Psychoeducation, Attention, Memory, Executive Functions, Functional Impairments | Other: ECo program<br> <br> |
| Experimental: CRT program<br>Objective: problem-solving skills training through exercises, in order to use strategies in daily life Duration: three months Frequency: two one-hour individual sessions and one hour of at-home training per week Modalities: pen and paper exercises Modules: Cognitive Flexibility, Working Memory, Planning | Other: CRT program<br> <br> |
| Active Comparator: Supportive psychotherapy<br>Individual psychotherapy sessions focussing on autonomy in daily life, management of mood disorders' cognitive and functional impact, social skills, and the regulation of sleep and daily activities. | Other: Supportive psychotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Perceptual Reasoning Index at 3 months | Composite score of the Wechsler Adult Intelligence Scale - fourth edition | baseline and 3 months | 
| Change from 3-months Perceptual Reasoning Index at 9 months | Composite score of the Wechsler Adult Intelligence Scale - fourth edition | 3 months and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Working Memory Index | Composite score of the Wechsler Adult Intelligence Scale - fourth edition | baseline, 3 months and 9 months | 
| Processing Speed Index | Composite score of the Wechsler Adult Intelligence Scale - fourth edition | baseline, 3 months and 9 months | 
| Rey Auditory Verbal Learning Test | Neuropsychological test assessing verbal memory | baseline, 3 months and 9 months | 
| Cardebat's Verbal Fluencies | Neuropsychological test | baseline, 3 months and 9 months | 
| Emotion Hexagon | Task from the Facial Expressions of Emotion: Stimuli and Tests scale, assessing the recognition of emotions on faces | baseline, 3 months and 9 months | 
| Key Search Test | Task from the Behavioral Assessment of the Dysexecutive Syndrome scale, assessing planing abilities | baseline, 3 months and 9 months | 
| Stroop Color Word Test | Neuropsychological test assessing inhibition abilities | baseline, 3 months and 9 months | 
| Hamilton Depression Rating Scale |  | 15 days before baseline, 3 months and 9 months | 
| Young Mania Rating Scale |  | 15 days before baseline, 3 months and 9 months | 
| Functional Repercussions Scale | Self-assessment scale evaluating the consequences of cognitive impairments in daily life | baseline, 3 months and 9 months | 
| Social Desirability Scale | Self-assessment scale | baseline, 3 months and 9 months | 
| Social Relationships Scale | Self-assessment scale | baseline, 3 months and 9 months | 
| Self-Appraisal of Illness Questionnaire | Self-assessment scale | baseline, 3 months and 9 months | 
| Rorschach Inkblot Test |  | baseline, 3 months and 9 months | 
| Change from baseline Event-Related Potentials [ERP] P300 at 3 months during an Oddball task | Assessed for the first third of included patients | baseline and 3 months | 
| Change from baseline Event-Related Potentials [ERP] N2/P3 complex at 3 months during an emotional Stroop task | Assessed for the first third of included patients | baseline and 3 months | 
| Change from baseline serum Brain-Derived Neurotrophic Factor [BDNF] level (ng/mL) at 3 months | Assessed for the second third of included patients | baseline and 3 months | 
| Change from baseline functional Magnetic Resonance Imaging frontal activation at 3 months during an emotion recognition task | Assessed for the last third of included patients | baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Remediation, Mood disorders, Neuropsychology