Evaluation of a Cognitive Remediation Program for Mood Disorders

NCT04354974 | Unknown DMC

• 1 other identifier: 10477M-ECO-DBP-2019
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Taking Charge of Cognitive Impairment in Patients With Mood Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Behavioral: Evaluation

Interventions

Evaluation BEHAVIORAL

Evaluation of a cognitive remediation program for mood disorders

Eco Program (Ecological Cognitive Training for Mood Disorders); ThOR Program (Remission Oriented Therapy)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de Ville-Evrard, France: lead

Study Sites (1)

Youcef Bencherif

Neuilly-sur-Marne, 93330, France

RECRUITING

Central Study Contacts

Youcef BENCHERIF

CONTACT

0782723674; youcef.bencherif@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical research unit director

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 21, 2020
• Study Start: October 18, 2019
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2023
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)