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
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa||Behavioral: Cognitive remediation therapy Other: relaxation therapy||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|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|
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.
- 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).
- Weight status [ Time Frame: 6 months and one year ]Assess the impact of cognitive remediation therapy on :Weight status by the Body Mass Index
- 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
- 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
- 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
- Self-esteem [ Time Frame: 6 months and one year ]measured by the Rosenberg Self-Esteem Scale
- Executive functions [ Time Frame: 6 months and one year ]measured by the scale BRIEF-Parent Report
- 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 )
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
|Contact: Asch Muriel, PHDfirstname.lastname@example.org|
|Paris, France, 75019|
|Contact: Asch Muriel, PHD 0033140034092|
|Principal Investigator:||Asch Muriel, PHD||-Hôpital Robert Debré, Service de psychiatrie de l'enfant et de l'adolescent|