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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive remediation therapy
relaxation therapy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia nervosa, Cognitive remediation therapy

Eligibility Criteria

8 Years - 16 Years (Child)FemaleDoes not accept 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 )

Sites / Locations

  • Asch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cognitive remediation therapy

relaxation therapy

Arm Description

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

10 relaxation sessions during 5 weeks

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Weight status
Assess the impact of cognitive remediation therapy on :Weight status by the Body Mass Index
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
Temperamental profile
Assess the impact of cognitive remediation therapy on :Temperamental profile measured by the Junior Temperament and Character Inventory questionnaire
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
Self-esteem
measured by the Rosenberg Self-Esteem Scale
Executive functions
measured by the scale BRIEF-Parent Report
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 )

Full Information

First Posted
January 27, 2015
Last Updated
April 28, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02400541
Brief Title
Efficacity of Cognitive Remediation Treatment Compared to a Controlled Group in Young Patient With Anorexia Nervosa
Acronym
RECOGAMEA
Official Title
Prospective Evaluation of Neuropsychological and Clinical Impact of Cognitive Remediation Program Among Children and Adolescents Treated for Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 22, 2019 (Actual)
Study Completion Date
December 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Anorexia nervosa, Cognitive remediation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive remediation therapy
Arm Type
Experimental
Arm Description
10 sessions of the cognitive remediation therapy program conducted during five weeks
Arm Title
relaxation therapy
Arm Type
Placebo Comparator
Arm Description
10 relaxation sessions during 5 weeks
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation therapy
Intervention Description
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
Other
Intervention Name(s)
relaxation therapy
Intervention Description
Our scheme comprises 10 biweekly sessions. Each session last about 45 minutes.
Primary Outcome Measure Information:
Title
cognitive flexibility
Description
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).
Time Frame
6 months after therapy
Secondary Outcome Measure Information:
Title
Weight status
Description
Assess the impact of cognitive remediation therapy on :Weight status by the Body Mass Index
Time Frame
6 months and one year
Title
Food symptoms and perfectionism
Description
Assess the impact of cognitive remediation therapy on :Food symptoms and perfectionism measured by the Eating Disorders Inventory auto questionnaire, EDI-2
Time Frame
6 months and one year
Title
Temperamental profile
Description
Assess the impact of cognitive remediation therapy on :Temperamental profile measured by the Junior Temperament and Character Inventory questionnaire
Time Frame
6 months after therapy
Title
Therapeutic alliance and motivation to change
Description
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
Time Frame
6 months and one year
Title
Self-esteem
Description
measured by the Rosenberg Self-Esteem Scale
Time Frame
6 months and one year
Title
Executive functions
Description
measured by the scale BRIEF-Parent Report
Time Frame
6 months and one year
Title
Neuropsychological performance in particular flexibility and central coherence
Description
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 )
Time Frame
6 months and one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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 ) 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 )
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asch Muriel, PHD
Organizational Affiliation
-Hôpital Robert Debré, Service de psychiatrie de l'enfant et de l'adolescent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asch
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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