Validation of a Cognitive Remediation Program for Bipolar Disorders

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Type I or type II Bipolar Disorder diagnosis, according to DSM-IV-TR criteria

• No Manic or Major Depressive episode during the last three months

• No or few residual depressive symptoms (HDRS-17 ≤ 12)

• No or few residual manic symptoms (YMRS ≤ 8)

• Stable dose of medication for the last two months

• Cognitive complaint expressed by the patient and impairment observed by the patient's regular psychiatrist

• Informed consent form read, initialed and signed

• Patient registered on the social welfare system

Locations
Other Locations
France
Unité de Recherche Clinique, EPS Ville Evrard
RECRUITING
Neuilly-sur-marne
Contact Information
Primary
Clémence Isaac, Psychologist
clm.isaac@gmail.com
0033143093232
Backup
Dominique Januel, MD Phd
domjanuel@gmail.com
0033143093424
Time Frame
Start Date: 2014-02
Estimated Completion Date: 2024-12
Participants
Target number of participants: 60
Treatments
Experimental: ECo program
Objective: to inform the patient about cognitive impairments and their repercussions; to train the patient in problem-solving skills through exercises; to implement strategies in daily life Duration: three months Frequency: two one-hour individual sessions and one hour of at-home training per week Modalities: pen and paper exercises, tools (tokens, cards, maps, chessboard) Modules: Psychoeducation, Attention, Memory, Executive Functions, Functional Impairments
Experimental: CRT program
Objective: problem-solving skills training through exercises, in order to use strategies in daily life Duration: three months Frequency: two one-hour individual sessions and one hour of at-home training per week Modalities: pen and paper exercises Modules: Cognitive Flexibility, Working Memory, Planning
Active_comparator: Supportive psychotherapy
Individual psychotherapy sessions focussing on autonomy in daily life, management of mood disorders' cognitive and functional impact, social skills, and the regulation of sleep and daily activities.
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de Ville-Evrard, France

This content was sourced from clinicaltrials.gov