Bipolar DisorderECO-BIPNCT02698696
Validation of a Cognitive Remediation Program for Bipolar Disorders
A study testing ECo program, CRT program and Supportive psychotherapy in people with Bipolar Disorder, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- ECo program, CRT program and Supportive psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Unité de Recherche Clinique, EPS Ville Evrard
Neuilly-sur-Marne, 93332
Arezki Ourrad, CRA, +33143093232, arezkiourrad@yahoo.fr
Joanna De araujo, 0033143093232, urcve1@gmail.com
About this study
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.
- Conditions
- Bipolar Disorder
- Being tested
- ECo program, CRT program, Supportive psychotherapy
- Keywords
- Cognitive Remediation, Mood disorders, Neuropsychology
- Medical subject headings
- Bipolar Disorder, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECo programOther
CRT programOther
Supportive psychotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Other: Supportive psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Perceptual Reasoning Index at 3 months
Composite score of the Wechsler Adult Intelligence Scale - fourth edition
Measured: baseline and 3 months
Change from 3-months Perceptual Reasoning Index at 9 months
Composite score of the Wechsler Adult Intelligence Scale - fourth edition
Measured: 3 months and 9 months
Secondary outcomes (18)
Working Memory Index
Composite score of the Wechsler Adult Intelligence Scale - fourth edition
Measured: baseline, 3 months and 9 months
Processing Speed Index
Composite score of the Wechsler Adult Intelligence Scale - fourth edition
Measured: baseline, 3 months and 9 months
Rey Auditory Verbal Learning Test
Neuropsychological test assessing verbal memory
Measured: baseline, 3 months and 9 months
Cardebat's Verbal Fluencies
Neuropsychological test
Measured: baseline, 3 months and 9 months
Emotion Hexagon
Task from the Facial Expressions of Emotion: Stimuli and Tests scale, assessing the recognition of emotions on faces
Measured: baseline, 3 months and 9 months
Key Search Test
Task from the Behavioral Assessment of the Dysexecutive Syndrome scale, assessing planing abilities
Measured: baseline, 3 months and 9 months
Stroop Color Word Test
Neuropsychological test assessing inhibition abilities
Measured: baseline, 3 months and 9 months
Hamilton Depression Rating Scale
Measured: 15 days before baseline, 3 months and 9 months
Young Mania Rating Scale
Measured: 15 days before baseline, 3 months and 9 months
Functional Repercussions Scale
Self-assessment scale evaluating the consequences of cognitive impairments in daily life
Measured: baseline, 3 months and 9 months
Social Desirability Scale
Self-assessment scale
Measured: baseline, 3 months and 9 months
Social Relationships Scale
Self-assessment scale
Measured: baseline, 3 months and 9 months
Self-Appraisal of Illness Questionnaire
Self-assessment scale
Measured: baseline, 3 months and 9 months
Rorschach Inkblot Test
Measured: baseline, 3 months and 9 months
Change from baseline Event-Related Potentials [ERP] P300 at 3 months during an Oddball task
Assessed for the first third of included patients
Measured: baseline and 3 months
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
Measured: baseline and 3 months
Change from baseline serum Brain-Derived Neurotrophic Factor [BDNF] level (ng/mL) at 3 months
Assessed for the second third of included patients
Measured: baseline and 3 months
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
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startFeb 2014
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clémence ISAAC, Centre hospitalier de Ville-Evrard, France
- Investigators
- Clémence Isaac, Psychologist, Principal investigator, Unité de Recherche Clinique, EPS Ville Evrard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698696
- Sponsor's protocol ID
- 10477M
- Acronym
- ECO-BIP
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2016
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15476685Deckersbach 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.
PubMed 19895584Martinez-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.
PubMed 21687565
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Cognitive Remediation Program for Bipolar Disorders
- ClinicalTrials.gov ID
- NCT02698696
- Acronym / sponsor ID
- ECO-BIP / 10477M
- Conditions
- Bipolar Disorder
- Keywords
- Cognitive Remediation, Mood disorders, Neuropsychology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ECo program | Experimental | Other: ECo programObjective: 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 |
| CRT program | Experimental | Other: CRT programObjective: 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 |
| Supportive psychotherapy | Active comparator | Other: Supportive psychotherapyIndividual 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECo program | Other | ECo program |
| CRT program | Other | CRT program |
| Supportive psychotherapy | Other | Supportive psychotherapy |
Primary outcome
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
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
18 secondary outcomes
Working Memory Index
Time frame: baseline, 3 months and 9 months
Processing Speed Index
Time frame: baseline, 3 months and 9 months
Rey Auditory Verbal Learning Test
Time frame: baseline, 3 months and 9 months
Cardebat's Verbal Fluencies
Time frame: baseline, 3 months and 9 months
Emotion Hexagon
Time frame: baseline, 3 months and 9 months
Key Search Test
Time frame: baseline, 3 months and 9 months
Stroop Color Word Test
Time frame: baseline, 3 months and 9 months
Hamilton Depression Rating Scale
Time frame: 15 days before baseline, 3 months and 9 months
Young Mania Rating Scale
Time frame: 15 days before baseline, 3 months and 9 months
Functional Repercussions Scale
Time frame: baseline, 3 months and 9 months
Social Desirability Scale
Time frame: baseline, 3 months and 9 months
Social Relationships Scale
Time frame: baseline, 3 months and 9 months
Self-Appraisal of Illness Questionnaire
Time frame: baseline, 3 months and 9 months
Rorschach Inkblot Test
Time frame: 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
Change from baseline Event-Related Potentials [ERP] N2/P3 complex at 3 months during an emotional Stroop task
Time frame: 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
Change from baseline functional Magnetic Resonance Imaging frontal activation at 3 months during an emotion recognition task
Time frame: baseline and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 15476685Altshuler 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 publication: PubMed 19895584Deckersbach 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 publication: PubMed 21687565Martinez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clémence Isaac, Psychologist principal investigator
Unité de Recherche Clinique, EPS Ville Evrard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECo program, CRT program and Supportive psychotherapy in people with Bipolar Disorder, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clémence Isaac, Psychologist (0033143093232 ext. 3157, clm.isaac@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Perceptual Reasoning Index at 3 months (time frame: baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02698696, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.