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

Not Applicable

Completed

• Conditions: Anorexia Nervosa
• Interventions: Behavioral: Cognitive remediation therapy; Other: relaxation therapy

• Registration Number: NCT02400541
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Study Timeline

• Study First Submitted: 2015-01-27
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-27
• Primary Completion: 2019-12-22
• Study Completion: 2019-12-22
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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 )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive remediation therapy	Cognitive remediation therapy	10 sessions of the cognitive remediation therapy program conducted during five weeks
relaxation therapy	relaxation therapy	10 relaxation sessions during 5 weeks

Primary Outcome Measures

Name	Time	Method
cognitive flexibility	6 months after therapy	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).

Secondary Outcome Measures

Name	Time	Method
Weight status	6 months and one year	Assess the impact of cognitive remediation therapy on :Weight status by the Body Mass Index
Food symptoms and perfectionism	6 months and one year	Assess the impact of cognitive remediation therapy on :Food symptoms and perfectionism measured by the Eating Disorders Inventory auto questionnaire, EDI-2
Neuropsychological performance in particular flexibility and central coherence	6 months and one year	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 )
Temperamental profile	6 months after therapy	Assess the impact of cognitive remediation therapy on :Temperamental profile measured by the Junior Temperament and Character Inventory questionnaire
Self-esteem	6 months and one year	measured by the Rosenberg Self-Esteem Scale
Therapeutic alliance and motivation to change	6 months and one year	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
Executive functions	6 months and one year	measured by the scale BRIEF-Parent Report

Trial Locations

Locations (1)

Asch; 🇫🇷 Paris, France