Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of a Cognitive Remediation Program for Bipolar Disorders (ECO-BIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02698696
Recruitment Status : Recruiting
First Posted : March 4, 2016
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Clémence ISAAC, 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Other: ECo program Other: CRT program Other: Supportive psychotherapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Validation of a Cognitive Remediation Program for Bipolar Disorders
Study Start Date : February 2014
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: 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
Other: ECo program
Experimental: 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
Other: CRT program
Active Comparator: 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.
Other: Supportive psychotherapy



Primary Outcome Measures :
  1. Change from baseline Perceptual Reasoning Index at 3 months [ Time Frame: baseline and 3 months ]
    Composite score of the Wechsler Adult Intelligence Scale - fourth edition

  2. Change from 3-months Perceptual Reasoning Index at 9 months [ Time Frame: 3 months and 9 months ]
    Composite score of the Wechsler Adult Intelligence Scale - fourth edition


Secondary Outcome Measures :
  1. Working Memory Index [ Time Frame: baseline, 3 months and 9 months ]
    Composite score of the Wechsler Adult Intelligence Scale - fourth edition

  2. Processing Speed Index [ Time Frame: baseline, 3 months and 9 months ]
    Composite score of the Wechsler Adult Intelligence Scale - fourth edition

  3. Rey Auditory Verbal Learning Test [ Time Frame: baseline, 3 months and 9 months ]
    Neuropsychological test assessing verbal memory

  4. Cardebat's Verbal Fluencies [ Time Frame: baseline, 3 months and 9 months ]
    Neuropsychological test

  5. Emotion Hexagon [ Time Frame: baseline, 3 months and 9 months ]
    Task from the Facial Expressions of Emotion: Stimuli and Tests scale, assessing the recognition of emotions on faces

  6. Key Search Test [ Time Frame: baseline, 3 months and 9 months ]
    Task from the Behavioral Assessment of the Dysexecutive Syndrome scale, assessing planing abilities

  7. Stroop Color Word Test [ Time Frame: baseline, 3 months and 9 months ]
    Neuropsychological test assessing inhibition abilities

  8. Hamilton Depression Rating Scale [ Time Frame: 15 days before baseline, 3 months and 9 months ]
  9. Young Mania Rating Scale [ Time Frame: 15 days before baseline, 3 months and 9 months ]
  10. Functional Repercussions Scale [ Time Frame: baseline, 3 months and 9 months ]
    Self-assessment scale evaluating the consequences of cognitive impairments in daily life

  11. Social Desirability Scale [ Time Frame: baseline, 3 months and 9 months ]
    Self-assessment scale

  12. Social Relationships Scale [ Time Frame: baseline, 3 months and 9 months ]
    Self-assessment scale

  13. Self-Appraisal of Illness Questionnaire [ Time Frame: baseline, 3 months and 9 months ]
    Self-assessment scale

  14. Rorschach Inkblot Test [ Time Frame: baseline, 3 months and 9 months ]
  15. Change from baseline Event-Related Potentials [ERP] P300 at 3 months during an Oddball task [ Time Frame: baseline and 3 months ]
    Assessed for the first third of included patients

  16. Change from baseline Event-Related Potentials [ERP] N2/P3 complex at 3 months during an emotional Stroop task [ Time Frame: baseline and 3 months ]
    Assessed for the first third of included patients

  17. Change from baseline serum Brain-Derived Neurotrophic Factor [BDNF] level (ng/mL) at 3 months [ Time Frame: baseline and 3 months ]
    Assessed for the second third of included patients

  18. Change from baseline functional Magnetic Resonance Imaging frontal activation at 3 months during an emotion recognition task [ Time Frame: baseline and 3 months ]
    Assessed for the last third of included patients



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698696


Contacts
Layout table for location contacts
Contact: Clémence Isaac, Psychologist 0033143093232 ext 3157 clm.isaac@gmail.com
Contact: Dominique Januel, MD Phd 0033143093424 domjanuel@gmail.com

Locations
Layout table for location information
France
Unité de Recherche Clinique, EPS Ville Evrard Recruiting
Neuilly-sur-Marne, France, 93332
Contact: Arezki Ourrad, CRA    +33143093232    arezkiourrad@yahoo.fr   
Contact: Joanna De araujo    0033143093232    urcve1@gmail.com   
Sponsors and Collaborators
Centre hospitalier de Ville-Evrard, France
Investigators
Layout table for investigator information
Principal Investigator: Clémence Isaac, Psychologist Unité de Recherche Clinique, EPS Ville Evrard
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Clémence ISAAC, Psychologist, Centre hospitalier de Ville-Evrard, France
ClinicalTrials.gov Identifier: NCT02698696    
Other Study ID Numbers: 10477M
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Keywords provided by Clémence ISAAC, Centre hospitalier de Ville-Evrard, France:
Cognitive Remediation
Mood disorders
Neuropsychology
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders