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Evaluation of a Cognitive Remediation Program for Mood Disorders (ECO-DBP)

Primary Purpose

Taking Charge of Cognitive Impairment in Patients With Mood Disorders

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluation
Sponsored by
Centre hospitalier de Ville-Evrard, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Taking Charge of Cognitive Impairment in Patients With Mood Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Youcef BencherifRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Eco Program (Ecological Cognitive Training for Mood Disorders)

ThOR Program (Remission Oriented Therapy)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 16, 2020
Last Updated
July 31, 2020
Sponsor
Centre hospitalier de Ville-Evrard, France
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1. Study Identification

Unique Protocol Identification Number
NCT04354974
Brief Title
Evaluation of a Cognitive Remediation Program for Mood Disorders
Acronym
ECO-DBP
Official Title
Evaluation of a Cognitive Remediation Program for Mood Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
February 18, 2022 (Anticipated)
Study Completion Date
February 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de Ville-Evrard, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Taking Charge of Cognitive Impairment in Patients With Mood Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eco Program (Ecological Cognitive Training for Mood Disorders)
Arm Type
Active Comparator
Arm Description
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
Arm Title
ThOR Program (Remission Oriented Therapy)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Evaluation
Intervention Description
Evaluation of a cognitive remediation program for mood disorders
Primary Outcome Measure Information:
Title
the Perceptual Reasoning Index (PRI) the Wechsler Intelligence Scale.
Description
Increase in the Perceptual Reasoning Index (PRI) of the Wechsler Adult Intelligence Scale - Fourth Edition [WAIS-IV] significantly different between the two study groups.
Time Frame
at 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 - Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youcef BENCHERIF
Phone
0782723674
Email
youcef.bencherif@gmail.com
Facility Information:
Facility Name
Youcef Bencherif
City
Neuilly sur Marne
ZIP/Postal Code
93330
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youcef BENCHERIF
Phone
0782723674
Email
bencherif.info@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Evaluation of a Cognitive Remediation Program for Mood Disorders

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