NCT02698696

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

10.8 years

First QC Date

February 12, 2016

Last Update Submit

February 7, 2024

Conditions

Bipolar Disorder

Keywords

Cognitive RemediationMood disordersNeuropsychology

Outcome Measures

Primary Outcomes (2)

  • Change from baseline Perceptual Reasoning Index at 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

    Composite score of the Wechsler Adult Intelligence Scale - fourth edition

    3 months and 9 months

Secondary Outcomes (18)

  • Working Memory Index

    baseline, 3 months and 9 months

  • Processing Speed Index

    baseline, 3 months and 9 months

  • Rey Auditory Verbal Learning Test

    baseline, 3 months and 9 months

  • Cardebat's Verbal Fluencies

    baseline, 3 months and 9 months

  • Emotion Hexagon

    baseline, 3 months and 9 months

  • +13 more secondary outcomes

Study Arms (3)

ECo program

EXPERIMENTAL

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

CRT program

EXPERIMENTAL

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

Supportive psychotherapy

ACTIVE COMPARATOR

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

Interventions

ECo programOTHER
ECo program
CRT programOTHER
CRT program
Supportive psychotherapyOTHER
Supportive psychotherapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de Recherche Clinique, EPS Ville Evrard

Neuilly-sur-Marne, 93332, France

RECRUITING

Related Publications (3)

  • 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.

    PMID: 15476685BACKGROUND

  • 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.

    PMID: 19895584RESULT

  • 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.

    PMID: 21687565RESULT

MeSH Terms

Conditions

Bipolar DisorderMood Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMental Disorders

Study Officials

  • Clémence Isaac, Psychologist

    Unité de Recherche Clinique, EPS Ville Evrard

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clémence Isaac, Psychologist

CONTACT

0033143093232clm.isaac@gmail.com

Dominique Januel, MD Phd

CONTACT

0033143093424domjanuel@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

February 12, 2016

First Posted

March 4, 2016

Study Start

February 1, 2014

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

February 8, 2024

Record last verified: 2024-02

Locations

FR(1)