Validation of a Cognitive Remediation Program for Bipolar Disorders
- Conditions
- Bipolar Disorder
- Interventions
- Other: CRT programOther: ECo programOther: Supportive psychotherapy
- Registration Number
- NCT02698696
- Lead Sponsor
- Centre hospitalier de Ville-Evrard, France
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CRT program CRT program 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 ECo program ECo program 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 Supportive psychotherapy Supportive psychotherapy 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.
- Primary Outcome Measures
Name Time Method Change from baseline Perceptual Reasoning Index at 3 months baseline and 3 months Composite score of the Wechsler Adult Intelligence Scale - fourth edition
Change from 3-months Perceptual Reasoning Index at 9 months 3 months and 9 months Composite score of the Wechsler Adult Intelligence Scale - fourth edition
- Secondary Outcome Measures
Name Time Method Emotion Hexagon baseline, 3 months and 9 months Task from the Facial Expressions of Emotion: Stimuli and Tests scale, assessing the recognition of emotions on faces
Key Search Test baseline, 3 months and 9 months Task from the Behavioral Assessment of the Dysexecutive Syndrome scale, assessing planing abilities
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 baseline, 3 months and 9 months Self-assessment scale evaluating the consequences of cognitive impairments in daily life
Social Desirability Scale baseline, 3 months and 9 months Self-assessment scale
Social Relationships Scale baseline, 3 months and 9 months Self-assessment scale
Self-Appraisal of Illness Questionnaire baseline, 3 months and 9 months Self-assessment scale
Rorschach Inkblot Test baseline, 3 months and 9 months Change from baseline Event-Related Potentials [ERP] P300 at 3 months during an Oddball task baseline and 3 months Assessed for the first third of included patients
Change from baseline Event-Related Potentials [ERP] N2/P3 complex at 3 months during an emotional Stroop task baseline and 3 months Assessed for the first third of included patients
Change from baseline serum Brain-Derived Neurotrophic Factor [BDNF] level (ng/mL) at 3 months baseline and 3 months Assessed for the second third of included patients
Change from baseline functional Magnetic Resonance Imaging frontal activation at 3 months during an emotion recognition task baseline and 3 months Assessed for the last third of included patients
Processing Speed Index baseline, 3 months and 9 months Composite score of the Wechsler Adult Intelligence Scale - fourth edition
Working Memory Index baseline, 3 months and 9 months Composite score of the Wechsler Adult Intelligence Scale - fourth edition
Cardebat's Verbal Fluencies baseline, 3 months and 9 months Neuropsychological test
Rey Auditory Verbal Learning Test baseline, 3 months and 9 months Neuropsychological test assessing verbal memory
Stroop Color Word Test baseline, 3 months and 9 months Neuropsychological test assessing inhibition abilities
Trial Locations
- Locations (1)
Unité de Recherche Clinique, EPS Ville Evrard
🇫🇷Neuilly-sur-Marne, France