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

NCT ID: NCT02400541

Last Updated: 2020-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-12-22

Brief Summary

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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

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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).

Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Cognitive remediation therapy

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

Group Type EXPERIMENTAL

Cognitive remediation therapy

Intervention Type 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

10 relaxation sessions during 5 weeks

Group Type PLACEBO_COMPARATOR

relaxation therapy

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

relaxation therapy

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

Intervention Type OTHER

Eligibility Criteria

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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 )
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Asch Muriel, PHD

Role: PRINCIPAL_INVESTIGATOR

-Hôpital Robert Debré, Service de psychiatrie de l'enfant et de l'adolescent

Locations

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Asch

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P130905

Identifier Type: -

Identifier Source: org_study_id

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