Clinical trial NCT02400541: Efficacity of Cognitive Remediation Treatment Compared to a Controlled Group in Young Patient With Anorexia Nervosa
Official title: Prospective Evaluation of Neuropsychological and Clinical Impact of Cognitive Remediation Program Among Children and Adolescents Treated for Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Anorexia nervosa
Cognitive remediation therapy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 65
Sex: FEMALE
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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 )

Primary outcomes:
measure: cognitive flexibility
timeFrame: 6 months after therapy
Secondary outcomes:
measure: Weight status
timeFrame: 6 months and one year
measure: Food symptoms and perfectionism
timeFrame: 6 months and one year
measure: Temperamental profile
timeFrame: 6 months after therapy
measure: Therapeutic alliance and motivation to change
timeFrame: 6 months and one year
measure: Self-esteem
timeFrame: 6 months and one year
measure: Executive functions
timeFrame: 6 months and one year
measure: Neuropsychological performance in particular flexibility and central coherence
timeFrame: 6 months and one year
Other outcomes:
Locations:
city: Paris
country: France
facility: Asch
Study officials:
affiliation: -Hôpital Robert Debré, Service de psychiatrie de l'enfant et de l'adolescent
name: Asch Muriel, PHD
role: PRINCIPAL_INVESTIGATOR
References: