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Completed

NCT Number: NCT02400541

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

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Key information

Age range

8 year–16 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Asch

Paris, 75019, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Cognitive Remediation Therapy

Behavioral

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.

relaxation therapy

Other

Our scheme comprises 10 biweekly sessions. Each session last about 45 minutes.

Primary outcomes

  1. cognitive flexibility

    Time frame: 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 outcomes

  1. Weight status

    Time frame: 6 months and one year

    Assess the impact of cognitive remediation therapy on :Weight status by the Body Mass Index

  2. Food symptoms and perfectionism

    Time frame: 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

  3. Temperamental profile

    Time frame: 6 months after therapy

    Assess the impact of cognitive remediation therapy on :Temperamental profile measured by the Junior Temperament and Character Inventory questionnaire

  4. Therapeutic alliance and motivation to change

    Time frame: 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

  5. Self-esteem

    Time frame: 6 months and one year

    measured by the Rosenberg Self-Esteem Scale

  6. Executive functions

    Time frame: 6 months and one year

    measured by the scale BRIEF-Parent Report

  7. Neuropsychological performance in particular flexibility and central coherence

    Time frame: 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 )

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: RECOGAMEA

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2015
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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