Evaluation of a Cognitive Remediation Program for Mood Disorders

Not Applicable

• Conditions: Taking Charge of Cognitive Impairment in Patients With Mood Disorders
• Interventions: Behavioral: Evaluation

• Registration Number: NCT04354974
• Lead Sponsor: Centre hospitalier de Ville-Evrard, France

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-18
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-21
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04
• Primary Completion: 2022-02-18
• Study Completion: 2023-02-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eco Program (Ecological Cognitive Training for Mood Disorders)	Evaluation	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
ThOR Program (Remission Oriented Therapy)	Evaluation	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

Primary Outcome Measures

Name	Time	Method
the Perceptual Reasoning Index (PRI) the Wechsler Intelligence Scale.	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.

Trial Locations

Locations (1)

Youcef Bencherif; 🇫🇷 Neuilly sur Marne, France