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

February 7, 2024 updated by: Clémence ISAAC, Centre hospitalier de Ville-Evrard, France
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Clémence Isaac, Psychologist
  • Phone Number: 3157 0033143093232
  • Email: clm.isaac@gmail.com

Study Contact Backup

Study Locations

  • France
      • Neuilly-sur-Marne, France, 93332
        • Recruiting
        • Unité de Recherche Clinique, EPS Ville Evrard
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline and 3 months
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
3 months and 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Working Memory Index
Time Frame: baseline, 3 months and 9 months
Composite score of the Wechsler Adult Intelligence Scale - fourth edition
baseline, 3 months and 9 months
Processing Speed Index
Time Frame: baseline, 3 months and 9 months
Composite score of the Wechsler Adult Intelligence Scale - fourth edition
baseline, 3 months and 9 months
Rey Auditory Verbal Learning Test
Time Frame: baseline, 3 months and 9 months
Neuropsychological test assessing verbal memory
baseline, 3 months and 9 months
Cardebat's Verbal Fluencies
Time Frame: baseline, 3 months and 9 months
Neuropsychological test
baseline, 3 months and 9 months
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
baseline, 3 months and 9 months
Key Search Test
Time Frame: baseline, 3 months and 9 months
Task from the Behavioral Assessment of the Dysexecutive Syndrome scale, assessing planing abilities
baseline, 3 months and 9 months
Stroop Color Word Test
Time Frame: baseline, 3 months and 9 months
Neuropsychological test assessing inhibition abilities
baseline, 3 months and 9 months
Hamilton Depression Rating Scale
Time Frame: 15 days before baseline, 3 months and 9 months
15 days before baseline, 3 months and 9 months
Young Mania Rating Scale
Time Frame: 15 days before baseline, 3 months and 9 months
15 days before baseline, 3 months and 9 months
Functional Repercussions Scale
Time Frame: baseline, 3 months and 9 months
Self-assessment scale evaluating the consequences of cognitive impairments in daily life
baseline, 3 months and 9 months
Social Desirability Scale
Time Frame: baseline, 3 months and 9 months
Self-assessment scale
baseline, 3 months and 9 months
Social Relationships Scale
Time Frame: baseline, 3 months and 9 months
Self-assessment scale
baseline, 3 months and 9 months
Self-Appraisal of Illness Questionnaire
Time Frame: baseline, 3 months and 9 months
Self-assessment scale
baseline, 3 months and 9 months
Rorschach Inkblot Test
Time Frame: baseline, 3 months and 9 months
baseline, 3 months and 9 months
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
baseline and 3 months
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
baseline and 3 months
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
baseline and 3 months
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
baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre hospitalier de Ville-Evrard, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Clémence Isaac, Psychologist, Unité de Recherche Clinique, EPS Ville Evrard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10477M

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