Efficacity of Cognitive Remediation Treatment Compared to a Controlled Group in Young Patient With Anorexia Nervosa

Study Overview
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Brief Summary
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The aim of research is to test in a randomized clinical trial with active sessions, the efficacy of cognitive remediation therapy in children anorexia nervosa compared to a controlled group. The investigators want to confirm the efficacy of cognitive remediation treatment in children's flexibility problems.

Detailed Description
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In this research, the investigators want to evaluate remediation cognitive therapy in anorexia nervosa compared to a controlled group (relaxation) based on different factors that testified the cognitive improvement of patients: one week after therapy, six months after and one year after. Those factors are: Weight, perfectionism and food symptomatology, temperament, therapeutic alliance and change motivation, clinical evolution of anorexia nervosa, self esteem, executive functions, neuropsychological performance (flexibility and central coherence).

Official Title
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Prospective Evaluation of Neuropsychological and Clinical Impact of Cognitive Remediation Program Among Children and Adolescents Treated for Anorexia Nervosa

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Behavioral: Cognitive remediation therapy
* Other: relaxation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathology DSM IV criteria of restrictive anorexia nervosa (AN- R), but not requiring amenorrhea or DSM V Accepting and their parents to participate in the study ( signed consents ) Topics Female supported for AN- R Aged 8 to 16 years Fluent French Inpatients or outpatients suffering of restrictive anorexia nervosa Treatments Supports standard load ( family psychotherapy , dietary management , medical monitoring ) In case of anxiety or depression , patients may receive additional psychotropic prescription which should be mentioned in the record Treatments previously followed by patients and treatments for other conditions should be described Exclusion Criteria: Pathology Mental Retardation Schizophrenia Organic brain disorder ( encephalitis , degenerative brain tumor , cerebral neuro- degenerative disease , multiple sclerosis , amyotrophic lateral sclerosis, epilepsy ) Metabolic Pathology interfere with feeding or its regulation Trouble consumption current substance Severe somatic pathology , progressive or likely to be life -threatening Topics The subjects are not mastering the French language will not be considered Subjects or parents do not have sufficient capacity for understanding instructions and consent No affiliation in social security ( beneficiary or legal )

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive remediation therapy<br>10 sessions of the cognitive remediation therapy program conducted during five weeks | Behavioral: Cognitive remediation therapy<br>* Our scheme comprises 10 biweekly sessions ( 5 in group and 5 single) . Each session last about 45 minutes. Individual sessions will be held with the patient and a therapist trained in the CRT; group sessions will be led by two therapists trained in CRT and regroup the maximum 5 patients.<br>|
| Placebo Comparator: relaxation therapy<br>10 relaxation sessions during 5 weeks | Other: relaxation therapy<br>* Our scheme comprises 10 biweekly sessions. Each session last about 45 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive flexibility | behavioral characteristics related to cognitive difficulties flexibility of anorexic patients, as measured in the medium term (6 months post treatment) by the score of the subscale shift BRIEF parent version of the scale (BRIEF-PR). | 6 months after therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight status | Assess the impact of cognitive remediation therapy on :Weight status by the Body Mass Index | 6 months and one year | 
| Food symptoms and perfectionism | Assess the impact of cognitive remediation therapy on :Food symptoms and perfectionism measured by the Eating Disorders Inventory auto questionnaire, EDI-2 | 6 months and one year | 
| Temperamental profile | Assess the impact of cognitive remediation therapy on :Temperamental profile measured by the Junior Temperament and Character Inventory questionnaire | 6 months after therapy | 
| Therapeutic alliance and motivation to change | Assess the impact of cognitive remediation therapy on : therapeutic alliance and motivation to change measured by self-reported scales Helping Alliance Questionnaire-11 and MOTIV | 6 months and one year | 
| Self-esteem | measured by the Rosenberg Self-Esteem Scale | 6 months and one year | 
| Executive functions | measured by the scale BRIEF-Parent Report | 6 months and one year | 
| Neuropsychological performance in particular flexibility and central coherence | measured by tests of WCST (Wisconsin Card Sorting Test), Geft (Group Embedded Figure Test) and tests the battery Ravello Profile (Tower, Verbal Fluency Test VFT, Trail Making Test TMT, Rey Complex Figure Test Osterreich ROCFT ) | 6 months and one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive remediation therapy, Anorexia nervosa