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Clinical Trials/NCT02400541
NCT02400541
Completed
N/A

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country65 target enrollmentMarch 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anorexia Nervosa
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
65
Locations
1
Primary Endpoint
cognitive flexibility
Status
Completed
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
December 22, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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 )
  • 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

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 )

Outcomes

Primary Outcomes

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

  • Weight status(6 months and one year)
  • Food symptoms and perfectionism(6 months and one year)
  • Neuropsychological performance in particular flexibility and central coherence(6 months and one year)
  • Temperamental profile(6 months after therapy)
  • Self-esteem(6 months and one year)
  • Therapeutic alliance and motivation to change(6 months and one year)
  • Executive functions(6 months and one year)

Study Sites (1)

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