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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECo program | Experimental | 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 |
|
| CRT program | Experimental | 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 |
|
| Supportive psychotherapy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECo program | Other |
| ||
| CRT program |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clémence Isaac, Psychologist | Contact | 0033143093232 | 3157 | clm.isaac@gmail.com |
| Dominique Januel, MD Phd | Contact | 0033143093424 | domjanuel@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Clémence Isaac, Psychologist | Unité de Recherche Clinique, EPS Ville Evrard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité de Recherche Clinique, EPS Ville Evrard | Recruiting | Neuilly-sur-Marne | 93332 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15476685 | Background | Altshuler LL, Ventura J, van Gorp WG, Green MF, Theberge DC, Mintz J. Neurocognitive function in clinically stable men with bipolar I disorder or schizophrenia and normal control subjects. Biol Psychiatry. 2004 Oct 15;56(8):560-9. doi: 10.1016/j.biopsych.2004.08.002. | |
| 19895584 | Result | Deckersbach T, Nierenberg AA, Kessler R, Lund HG, Ametrano RM, Sachs G, Rauch SL, Dougherty D. RESEARCH: Cognitive rehabilitation for bipolar disorder: An open trial for employed patients with residual depressive symptoms. CNS Neurosci Ther. 2010 Oct;16(5):298-307. doi: 10.1111/j.1755-5949.2009.00110.x. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D001523 | Mental Disorders |
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| Supportive psychotherapy | Other |
|
| 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 |
| 21687565 | Result | Martinez-Aran A, Torrent C, Sole B, Bonnin CM, Rosa AR, Sanchez-Moreno J, Vieta E. Functional remediation for bipolar disorder. Clin Pract Epidemiol Ment Health. 2011;7:112-6. doi: 10.2174/1745017901107010112. Epub 2011 Jun 6. |