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

Primary Purpose

Bipolar Disorder

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ECo program
CRT program
Supportive psychotherapy
Sponsored by
Centre hospitalier de Ville-Evrard, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bipolar Disorder focused on measuring Cognitive Remediation, Mood disorders, Neuropsychology

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Unité de Recherche Clinique, EPS Ville EvrardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

ECo program

CRT program

Supportive psychotherapy

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Change from baseline Perceptual Reasoning Index at 3 months
Composite score of the Wechsler Adult Intelligence Scale - fourth edition
Change from 3-months Perceptual Reasoning Index at 9 months
Composite score of the Wechsler Adult Intelligence Scale - fourth edition

Secondary Outcome Measures

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

Full Information

First Posted
February 12, 2016
Last Updated
July 31, 2020
Sponsor
Centre hospitalier de Ville-Evrard, France
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1. Study Identification

Unique Protocol Identification Number
NCT02698696
Brief Title
Validation of a Cognitive Remediation Program for Bipolar Disorders
Acronym
ECO-BIP
Official Title
Validation of a Cognitive Remediation Program for Bipolar Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de Ville-Evrard, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Cognitive Remediation, Mood disorders, Neuropsychology

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clémence Isaac, Psychologist
Phone
0033143093232
Ext
3157
Email
clm.isaac@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Januel, MD Phd
Phone
0033143093424
Email
domjanuel@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clémence Isaac, Psychologist
Organizational Affiliation
Unité de Recherche Clinique, EPS Ville Evrard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unité de Recherche Clinique, EPS Ville Evrard
City
Neuilly-sur-Marne
ZIP/Postal Code
93332
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arezki Ourrad, CRA
Phone
+33143093232
Email
arezkiourrad@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Joanna De araujo
Phone
0033143093232
Email
urcve1@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
15476685
Citation
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.
Results Reference
background
PubMed Identifier
19895584
Citation
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.
Results Reference
result
PubMed Identifier
21687565
Citation
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.
Results Reference
result

Learn more about this trial

Validation of a Cognitive Remediation Program for Bipolar Disorders

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