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

Anorexia Nervosa Clinical Trial

— RECOGAMEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400541
• Other study ID #: P130905
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 22, 2019

Study information

• Verified date: April 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 22, 2019
• Est. primary completion date: December 22, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 8 Years to 16 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Behavioral:
• 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.

Other:
• relaxation therapy
Our scheme comprises 10 biweekly sessions. Each session last about 45 minutes.

Locations

Country	Name	City	State
France	Asch	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive flexibility	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).	6 months after therapy
Secondary	Weight status	Assess the impact of cognitive remediation therapy on :Weight status by the Body Mass Index	6 months and one year
Secondary	Food symptoms and perfectionism	Assess the impact of cognitive remediation therapy on :Food symptoms and perfectionism measured by the Eating Disorders Inventory auto questionnaire, EDI-2	6 months and one year
Secondary	Temperamental profile	Assess the impact of cognitive remediation therapy on :Temperamental profile measured by the Junior Temperament and Character Inventory questionnaire	6 months after therapy
Secondary	Therapeutic alliance and motivation to change	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	6 months and one year
Secondary	Self-esteem	measured by the Rosenberg Self-Esteem Scale	6 months and one year
Secondary	Executive functions	measured by the scale BRIEF-Parent Report	6 months and one year
Secondary	Neuropsychological performance in particular flexibility and central coherence	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 )	6 months and one year