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

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

Study Overview

• Status: Unknown
• Conditions: Taking Charge of Cognitive Impairment in Patients With Mood Disorders
• Intervention / Treatment: Behavioral: Evaluation

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youcef BENCHERIF; Phone Number: 0782723674; Email: youcef.bencherif@gmail.com

Study Locations

• France
  • Neuilly sur Marne, France, 93330
    • Recruiting
    • Youcef Bencherif

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Behavioral: Evaluation; Evaluation of a cognitive remediation program for mood disorders
Active Comparator: 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	Behavioral: Evaluation; Evaluation of a cognitive remediation program for mood disorders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 1 year

Collaborators and Investigators

• Sponsor: Centre hospitalier de Ville-Evrard, France

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2019
• Primary Completion (Anticipated): February 18, 2022
• Study Completion (Anticipated): February 18, 2023

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders
• Other Study ID Numbers: 10477M-ECO-DBP-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• 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