Validation of a Cognitive Remediation Program for Bipolar Disorders

Centre hospitalier de Ville-Evrard, France60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Bipolar Disorder

Interventions

ECo program

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Type I or type II Bipolar Disorder diagnosis, according to DSM-IV-TR criteria 2. No Manic or Major Depressive episode during the last three months 3. No or few residual depressive symptoms (HDRS-17 ≤ 12) 4. No or few residual manic symptoms (YMRS ≤ 8) 5. Stable dose of medication for the last two months 6. Cognitive complaint expressed by the patient and impairment observed by the patient's regular psychiatrist 7. Informed consent form read, initialed and signed 8. Patient registered on the social welfare system Exclusion Criteria: 1. Other diagnosis than Bipolar Disorder on axis I of the DSM-IV-TR 2. Rapid Cycling Bipolar Disorder diagnosis 3. Addiction or substance abuse (except tobacco) during the twelve last months 4. Physical or neurological disorder that can lead to cognitive impairment 5. Engagement in a research protocol either currently or over the last month 6. Neuropsychological assessment or Rorschach Inkblot Test evaluation during the last six months 7. Ineligibility for Magnetic Resonance Imaging \[MRI\] (e.g. claustrophobia, metallic implants, pace-maker, etc.)

Outcomes

Primary Outcomes

Change from baseline Perceptual Reasoning Index at 3 months

Composite score of the Wechsler Adult Intelligence Scale - fourth edition

Time frame: baseline and 3 months

Change from 3-months Perceptual Reasoning Index at 9 months

Composite score of the Wechsler Adult Intelligence Scale - fourth edition

Time frame: 3 months and 9 months

Secondary Outcomes

Working Memory Index

Composite score of the Wechsler Adult Intelligence Scale - fourth edition

Time frame: baseline, 3 months and 9 months

Processing Speed Index

Composite score of the Wechsler Adult Intelligence Scale - fourth edition

Time frame: baseline, 3 months and 9 months

Rey Auditory Verbal Learning Test

Neuropsychological test assessing verbal memory

Time frame: baseline, 3 months and 9 months

Cardebat's Verbal Fluencies

Neuropsychological test

Time frame: 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

Time frame: baseline, 3 months and 9 months

Key Search Test

Task from the Behavioral Assessment of the Dysexecutive Syndrome scale, assessing planing abilities

Time frame: baseline, 3 months and 9 months

Stroop Color Word Test

Neuropsychological test assessing inhibition abilities

Time frame: baseline, 3 months and 9 months

Hamilton Depression Rating Scale

Time frame: 15 days before baseline, 3 months and 9 months

Young Mania Rating Scale

Time frame: 15 days before baseline, 3 months and 9 months

Functional Repercussions Scale

Self-assessment scale evaluating the consequences of cognitive impairments in daily life

Time frame: baseline, 3 months and 9 months

Social Desirability Scale

Self-assessment scale

Time frame: baseline, 3 months and 9 months

Social Relationships Scale

Self-assessment scale

Time frame: baseline, 3 months and 9 months

Self-Appraisal of Illness Questionnaire

Self-assessment scale

Time frame: baseline, 3 months and 9 months

Rorschach Inkblot Test

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: baseline and 3 months

Central Contacts

Clémence Isaac, Psychologist

CONTACT

0033143093232 clm.isaac@gmail.com

Dominique Januel, MD Phd

CONTACT

0033143093424 domjanuel@gmail.com

Validation of a Cognitive Remediation Program for Bipolar Disorders

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts