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

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

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.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Behavioral: Cognitive remediation therapy; Other: relaxation therapy

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Asch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive remediation therapy; 10 sessions of the cognitive remediation therapy program conducted during five weeks	Behavioral: Cognitive remediation therapy; 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.
Placebo Comparator: relaxation therapy; 10 relaxation sessions during 5 weeks	Other: relaxation therapy; Our scheme comprises 10 biweekly sessions. Each session last about 45 minutes.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Asch Muriel, PHD, -Hôpital Robert Debré, Service de psychiatrie de l'enfant et de l'adolescent

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): December 22, 2019
• Study Completion (Actual): December 22, 2019

Study Registration Dates

• First Submitted: January 27, 2015
• First Submitted That Met QC Criteria: March 23, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Anorexia nervosa; Cognitive remediation therapy
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: P130905