Evaluation of a Cognitive Remediation Program for Mood Disorders

NCT ID: NCT04354974

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-18

Study Completion Date

2023-02-18

Brief Summary

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Psychotherapeutic management of cognitive disorders in patients suffering from a mood disorder

Detailed Description

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Conditions

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Taking Charge of Cognitive Impairment in Patients With Mood Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Eco Program (Ecological Cognitive Training for Mood Disorders)

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

Group Type ACTIVE_COMPARATOR

Evaluation

Intervention Type BEHAVIORAL

Evaluation of a cognitive remediation program for mood disorders

ThOR Program (Remission Oriented Therapy)

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

Group Type ACTIVE_COMPARATOR

Evaluation

Intervention Type BEHAVIORAL

Evaluation of a cognitive remediation program for mood disorders

Interventions

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Evaluation

Evaluation of a cognitive remediation program for mood disorders

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age between 18 and 65 years old
2. The patient's previous diagnosis of Bipolar-Related Disorder or Depressive Disorder according to the DSM-5 criteria.
3. Mood stabilized with respect to depressive symptomatology (absence or presence of residual mild depressive symptoms (HDRS-17 ≤ 18))
4. Mood stabilized with respect to manic symptomatology (absence or presence of residual mild manic symptoms (YMRS ≤ 8))
5. Stable and effective treatment at minimum dose for at least 2 months
6. Cognitive complaint expressed by the patient, and detected by the patient's referring psychiatrist
7. Free and Informed Consent Form read, initialled and signed
8. Patient affiliated to a social protection scheme or beneficiary of State Medical Aid
9. Patient knowing how to speak French -

Exclusion Criteria

1. Presence of a DSM-5 disorder, other than a mood, anxiety or personality disorder
2. Substance addiction or abuse (Alcohol, psychoactive substances) in the past 12 months
3. Manic, hypomanic or major depressive episode in the last 2 months
4. Somatic or neurological disorder which may lead to cognitive impairment
5. Current or less than one month's commitment to another research protocol
6. A neuropsychological assessment prior to 6 months.
7. Patient under protective custody, guardianship or reinforced guardianship
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre hospitalier de Ville-Evrard, France

OTHER

Sponsor Role lead

Responsible Party

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Clémence ISAAC

clinical research unit director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Youcef Bencherif

Neuilly-sur-Marne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Youcef BENCHERIF

Role: CONTACT

0782723674

Facility Contacts

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Youcef BENCHERIF

Role: primary

0782723674

Other Identifiers

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10477M-ECO-DBP-2019

Identifier Type: -

Identifier Source: org_study_id

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