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Trial record 2 of 50 for:    Recruiting, Not yet recruiting, Available Studies | "Anorexia Nervosa"

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

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ClinicalTrials.gov Identifier: NCT02400541
Recruitment Status : Recruiting
First Posted : March 27, 2015
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Behavioral: Cognitive remediation therapy Other: relaxation therapy Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Neuropsychological and Clinical Impact of Cognitive Remediation Program Among Children and Adolescents Treated for Anorexia Nervosa
Actual Study Start Date : March 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Experimental: Cognitive remediation therapy
10 sessions of the cognitive remediation therapy program conducted during five weeks
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.


Placebo Comparator: relaxation therapy
10 relaxation sessions during 5 weeks
Other: relaxation therapy
Our scheme comprises 10 biweekly sessions. Each session last about 45 minutes.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Weight status [ Time Frame: 6 months and one year ]
    Assess the impact of cognitive remediation therapy on :Weight status by the Body Mass Index

  2. Food symptoms and perfectionism [ Time Frame: 6 months and one year ]
    Assess the impact of cognitive remediation therapy on :Food symptoms and perfectionism measured by the Eating Disorders Inventory auto questionnaire, EDI-2

  3. Temperamental profile [ Time Frame: 6 months after therapy ]
    Assess the impact of cognitive remediation therapy on :Temperamental profile measured by the Junior Temperament and Character Inventory questionnaire

  4. Therapeutic alliance and motivation to change [ Time Frame: 6 months and one year ]
    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

  5. Self-esteem [ Time Frame: 6 months and one year ]
    measured by the Rosenberg Self-Esteem Scale

  6. Executive functions [ Time Frame: 6 months and one year ]
    measured by the scale BRIEF-Parent Report

  7. Neuropsychological performance in particular flexibility and central coherence [ Time Frame: 6 months and one year ]
    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 )



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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400541


Contacts
Contact: Asch Muriel, PHD 0033140034092 muriel.asch@rdb.aphp.fr

Locations
France
Asch Recruiting
Paris, France, 75019
Contact: Asch Muriel, PHD    0033140034092      
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Asch Muriel, PHD -Hôpital Robert Debré, Service de psychiatrie de l'enfant et de l'adolescent

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02400541     History of Changes
Other Study ID Numbers: P130905
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: February 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Anorexia nervosa
Cognitive remediation therapy

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders