Validation of a Cognitive Remediation Program for Bipolar Disorders (ECO-BIP)

Centre hospitalier de Ville-Evrard, France

Status: Enrolling

Conditions: Bipolar Disorder

Treatments: Other: ECo program; Other: Supportive psychotherapy; Other: CRT program

Study type: Interventional

Funder types: Other

Identifiers

NCT02698696

10477M

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

ECo program

Experimental group

Description:

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

Treatment:

Other: ECo program

CRT program

Experimental group

Description:

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

Treatment:

Other: CRT program

Supportive psychotherapy

Active Comparator group

Description:

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.

Treatment:

Other: Supportive psychotherapy