Taking Charge of Cognitive Impairment in Patients With Mood DisordersECO-DBPNCT04354974
Evaluation of a Cognitive Remediation Program for Mood Disorders
A study testing Evaluation in people with Taking Charge of Cognitive Impairment in Patients With Mood Disorders, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
Trial summary
Psychotherapeutic management of cognitive disorders in patients suffering from a mood disorder Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Taking Charge of Cognitive Impairment in Patients With Mood Disorders
- What is being tested?
- Evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2019to 18 Feb 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years old
- The patient's previous diagnosis of Bipolar-Related Disorder or Depressive Disorder according to the DSM-5 criteria.
- Mood stabilized with respect to depressive symptomatology (absence or presence of residual mild depressive symptoms (HDRS-17 ≤ 18))
- Mood stabilized with respect to manic symptomatology (absence or presence of residual mild manic symptoms (YMRS ≤ 8))
- Stable and effective treatment at minimum dose for at least 2 months
- Cognitive complaint expressed by the patient, and detected by the patient's referring psychiatrist
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- Free and Informed Consent Form read, initialled and signed
- Patient affiliated to a social protection scheme or beneficiary of State Medical Aid
- Patient knowing how to speak French -
Who cannot join
- Presence of a DSM-5 disorder, other than a mood, anxiety or personality disorder
- Substance addiction or abuse (Alcohol, psychoactive substances) in the past 12 months
- Manic, hypomanic or major depressive episode in the last 2 months
- Somatic or neurological disorder which may lead to cognitive impairment
- Current or less than one month's commitment to another research protocol
- A neuropsychological assessment prior to 6 months.
- Patient under protective custody, guardianship or reinforced guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Youcef Bencherif
Neuilly-sur-Marne, 93330
Youcef BENCHERIF, 0782723674, bencherif.info@gmail.com
About this study
Psychotherapeutic management of cognitive disorders in patients suffering from a mood disorder
- Being tested
- Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationBehavioural
Evaluation of a cognitive remediation program for mood disorders
| Study group | Role | What they receive |
|---|---|---|
| Eco Program (Ecological Cognitive Training for Mood Disorders) | Active comparator | Duration: four months, 16 sessions
* Frequency: One one-hour session and one hour of personal work per week
* Modalities: Paper and pencil exercises and manipulable tools
* Objective: Learning problem-solving strategies for use in daily life
* Modules: Psychoeducation, Information Processing, Memory, Concept Formation, Functional Disorders Receives: Behavioral: Evaluation |
| ThOR Program (Remission Oriented Therapy) | Active comparator | Duration: four months, 16 sessions
* Frequency: One one-hour session and one hour of personal work per week
* Modalities: Paper tools and verbal exchange with the patient
* Objective: Improvement of the patient's quality of life
* Themes: Mood, social skills, autonomy, motivation, sleep Receives: Behavioral: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Perceptual Reasoning Index (PRI) the Wechsler Intelligence Scale.
Increase in the Perceptual Reasoning Index (PRI) of the Wechsler Adult Intelligence Scale - Fourth Edition [WAIS-IV] significantly different between the two study groups.
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start18 Oct 2019
- Primary completion18 Feb 2022 (estimated)
- Study completion18 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Taking Charge of Cognitive Impairment in Patients With Mood DisordersStudies 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
- Model description
- Evaluation of the specific therapeutic efficacy of Cognitive Training Therapy for Bipolar Patients on cognitive deficits in patients with bipolar disorder, treated over three months and followed up over nine months. Randomized, double-blind study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354974
- Sponsor's protocol ID
- 10477M-ECO-DBP-2019
- Acronym
- ECO-DBP
- Status last verified
- Jul 2020
- First submitted
- 16 Apr 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Cognitive Remediation Program for Mood Disorders
- ClinicalTrials.gov ID
- NCT04354974
- Acronym / sponsor ID
- ECO-DBP / 10477M-ECO-DBP-2019
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 18 Feb 2022 (estimated)
- Study completion
- 18 Feb 2023 (estimated)
- First posted
- 21 Apr 2020 (actual)
- 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.
Psychotherapeutic management of cognitive disorders in patients suffering from a mood disorder
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Evaluation of the specific therapeutic efficacy of Cognitive Training Therapy for Bipolar Patients on cognitive deficits in patients with bipolar disorder, treated over three months and followed up over nine months. Randomized, double-blind study.
| Arm | Type | Receives |
|---|---|---|
| Eco Program (Ecological Cognitive Training for Mood Disorders) | Active comparator | Behavioral: EvaluationDuration: four months, 16 sessions * Frequency: One one-hour session and one hour of personal work per week * Modalities: Paper and pencil exercises and manipulable tools * Objective: Learning problem-solving strategies for use in daily life * Modules: Psychoeducation, Information Processing, Memory, Concept Formation, Functional Disorders |
| ThOR Program (Remission Oriented Therapy) | Active comparator | Behavioral: EvaluationDuration: four months, 16 sessions * Frequency: One one-hour session and one hour of personal work per week * Modalities: Paper tools and verbal exchange with the patient * Objective: Improvement of the patient's quality of life * Themes: Mood, social skills, autonomy, motivation, sleep |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 65 years old
- The patient's previous diagnosis of Bipolar-Related Disorder or Depressive Disorder according to the DSM-5 criteria.
- Mood stabilized with respect to depressive symptomatology (absence or presence of residual mild depressive symptoms (HDRS-17 ≤ 18))
- Mood stabilized with respect to manic symptomatology (absence or presence of residual mild manic symptoms (YMRS ≤ 8))
- Stable and effective treatment at minimum dose for at least 2 months
Key exclusion criteria (7 listed)
- Presence of a DSM-5 disorder, other than a mood, anxiety or personality disorder
- Substance addiction or abuse (Alcohol, psychoactive substances) in the past 12 months
- Manic, hypomanic or major depressive episode in the last 2 months
- Somatic or neurological disorder which may lead to cognitive impairment
- Current or less than one month's commitment to another research protocol
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 |
|---|---|---|
| EvaluationEvaluation of a cognitive remediation program for mood disorders | Behavioural | Eco Program (Ecological Cognitive Training for Mood Disorders), ThOR Program (Remission Oriented Therapy) |
Primary outcome
the Perceptual Reasoning Index (PRI) the Wechsler Intelligence Scale.
Time frame: at 1 year
Increase in the Perceptual Reasoning Index (PRI) of the Wechsler Adult Intelligence Scale - Fourth Edition [WAIS-IV] significantly different between the two study groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Individual participant dataSharing planned: Yes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation in people with Taking Charge of Cognitive Impairment in Patients With Mood Disorders, 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 9 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 4 Aug 2020. 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 Youcef BENCHERIF (0782723674, youcef.bencherif@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Perceptual Reasoning Index (PRI) the Wechsler Intelligence Scale. (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2020.