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Validation of a Cognitive Remediation Program for Bipolar Disorders

Validation of a Cognitive Remediation Program for Bipolar Disorders

Recruiting
18-60 years
All
Phase N/A

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Overview

This study evaluates the effect of a new cognitive remediation program designed for patients suffering from a bipolar disorder, on cognitive functions, psychosocial functioning and neural processes. In this double-blind (patient, outcomes assessor) controlled randomized trial the investigators compare patients receiving the ECo program for bipolar disorders, to patients benefiting from the broadly used cognitive remediation program CRT and to patients receiving supportive psychotherapy. Patients are treated for 3 months and monitored for 9 months.

Eligibility

Inclusion Criteria:

  1. Type I or type II Bipolar Disorder diagnosis, according to DSM-IV-TR criteria
  2. No Manic or Major Depressive episode during the last three months
  3. No or few residual depressive symptoms (HDRS-17 ≤ 12)
  4. No or few residual manic symptoms (YMRS ≤ 8)
  5. Stable dose of medication for the last two months
  6. Cognitive complaint expressed by the patient and impairment observed by the patient's regular psychiatrist
  7. Informed consent form read, initialed and signed
  8. Patient registered on the social welfare system

Exclusion Criteria:

  1. Other diagnosis than Bipolar Disorder on axis I of the DSM-IV-TR
  2. Rapid Cycling Bipolar Disorder diagnosis
  3. Addiction or substance abuse (except tobacco) during the twelve last months
  4. Physical or neurological disorder that can lead to cognitive impairment
  5. Engagement in a research protocol either currently or over the last month
  6. Neuropsychological assessment or Rorschach Inkblot Test evaluation during the last six months
  7. Ineligibility for Magnetic Resonance Imaging [MRI] (e.g. claustrophobia, metallic implants, pace-maker, etc.)

Study details
    Bipolar Disorder

NCT02698696

Centre hospitalier de Ville-Evrard, France

16 February 2024

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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