Cognitive remediation program for bipolar disorder
Validation of a Cognitive Remediation Program for Bipolar Disorders
This study tests a new program aimed at helping people with bipolar disorder improve their thinking skills and daily functioning compared to a standard treatment and supportive therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Centre hospitalier de Ville-Evrard, France Academic / other |
| Locations | 1 site (Neuilly-sur-Marne) |
| Trial ID | NCT02698696 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new cognitive remediation program specifically designed for patients with bipolar disorder, focusing on improving cognitive functions, psychosocial functioning, and neural processes. It is a double-blind, controlled, randomized trial comparing the new ECo program to an established cognitive remediation program (CRT) and supportive psychotherapy. Patients will undergo treatment for three months and will be monitored for nine months to assess the outcomes of each intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Type I or Type II Bipolar Disorder who have stable symptoms and cognitive complaints.
Not a fit: Patients with rapid cycling bipolar disorder or those with other significant psychiatric or neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance cognitive and psychosocial functioning in patients with bipolar disorder.
How similar studies have performed: Other studies have shown promise in cognitive remediation for mood disorders, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Neuilly-sur-Marne
- Unité de Recherche Clinique, EPS Ville Evrard — Neuilly-sur-Marne, France (Recruiting)
Study contacts
- Principal investigator: Clémence Isaac, Psychologist — Unité de Recherche Clinique, EPS Ville Evrard
- Study coordinator: Clémence Isaac, Psychologist
- Email: clm.isaac@gmail.com
- Phone: 0033143093232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.