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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • 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

  • 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

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
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

What is the study measuring?

Primary Outcome Measures

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

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

Centre hospitalier de Ville-Evrard, France

Investigators

  • 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

February 1, 2014

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 12, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimated)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10477M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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