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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Anorexia Nervosa

Treatments: Behavioral: Cognitive remediation therapy; Other: relaxation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02400541

P130905

Details and patient eligibility

About

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.

Full 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).

Enrollment: 65 patients

Sex: Female

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

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 )

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups, including a placebo group

Cognitive remediation therapy

Experimental group

Description:

10 sessions of the cognitive remediation therapy program conducted during five weeks

Treatment:

Behavioral: Cognitive remediation therapy

relaxation therapy

Placebo Comparator group

Description:

10 relaxation sessions during 5 weeks

Treatment:

Other: relaxation therapy