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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02400541
Acronym
RECOGAMEA
Enrollment
65
Registered
2015-03-27
Start date
2015-03-31
Completion date
2019-12-22
Last updated
2020-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosa, Cognitive remediation therapy

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).

Interventions

BEHAVIORALCognitive 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.

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
8 Years to 16 Years
Healthy volunteers
No

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 )

Design outcomes

Primary

MeasureTime frameDescription
cognitive flexibility6 months after therapybehavioral 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

MeasureTime frameDescription
Food symptoms and perfectionism6 months and one yearAssess the impact of cognitive remediation therapy on :Food symptoms and perfectionism measured by the Eating Disorders Inventory auto questionnaire, EDI-2
Temperamental profile6 months after therapyAssess the impact of cognitive remediation therapy on :Temperamental profile measured by the Junior Temperament and Character Inventory questionnaire
Therapeutic alliance and motivation to change6 months and one yearAssess the impact of cognitive remediation therapy on : therapeutic alliance and motivation to change measured by self-reported scales Helping Alliance Questionnaire-11 and MOTIV
Weight status6 months and one yearAssess the impact of cognitive remediation therapy on :Weight status by the Body Mass Index
Executive functions6 months and one yearmeasured by the scale BRIEF-Parent Report
Neuropsychological performance in particular flexibility and central coherence6 months and one yearmeasured 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 )
Self-esteem6 months and one yearmeasured by the Rosenberg Self-Esteem Scale

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026