Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-05 @ 8:51 AM
Study NCT ID:
NCT01772394
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2013-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Remediation Therapy in Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-13', 'studyFirstSubmitDate': '2013-01-17', 'studyFirstSubmitQcDate': '2013-01-17', 'lastUpdatePostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropsychological functioning:Wisconsin Sorting Card Test (WSCT)', 'timeFrame': '1 week post-therapy', 'description': 'The WSCT are two neuropsychological tests that have been consistently used to highlight poor set-shifting skills in Anorexia nervosa.'}, {'measure': 'Clinical status Evaluation:Morgan and Russell Global Outcome Assessment Scale (GOAS);', 'timeFrame': 'up to 1 year of follow-up', 'description': 'The Global Outcome Assessment Schedule (GOAS; Morgan \\& Hayward, 1998) is a standard measure of outcome in eating disorders; it includes 14 subscales evaluating five dimensions: (A) Food Intake and body weight ; (B) Menstrual status; (C) Mental state ; (D) Psychosexual state ; (E) Socioeconomic status and social functioning.'}], 'secondaryOutcomes': [{'measure': 'Central coherence', 'timeFrame': '1 week post-therapy', 'description': 'Central coherence: Rey figure;'}, {'measure': 'Nutritional status', 'timeFrame': '1 week post-therapy', 'description': 'body mass index'}, {'measure': 'Nutritional status', 'timeFrame': '6 months of follow-up', 'description': 'body mass index'}, {'measure': 'Nutritional status', 'timeFrame': '1 year of follow-up', 'description': 'body mass index'}, {'measure': 'Self-reported eating disorders symptoms', 'timeFrame': '1 week post-therapy', 'description': 'Eating Disorder Examination Questionnaire and Body Shape Questionnaire'}, {'measure': 'Self-reported eating disorders symptoms', 'timeFrame': '1 year of follow-up', 'description': 'Eating Disorder Examination Questionnaire and Body Shape Questionnaire'}, {'measure': 'Self-reported Cognitive style;', 'timeFrame': '1 week post-therapy', 'description': 'Detail and Flexibility Questionnaire'}, {'measure': 'Self-reported Cognitive style;', 'timeFrame': '1 year of follow-up', 'description': 'Detail and Flexibility Questionnaire'}, {'measure': 'Self-reported treatment satisfaction', 'timeFrame': '1 week post-therapy', 'description': 'Helping Alliance Questionnaire and Patient Satisfaction Questionnaire'}, {'measure': 'Self-reported motivation to change', 'timeFrame': '1 week post-therapy', 'description': 'the Maudsley motivation to change questionnaire'}, {'measure': 'Self-reported motivation to change', 'timeFrame': '6 months of follow-up', 'description': 'the Maudsley motivation to change questionnaire'}, {'measure': 'Self-reported motivation to change', 'timeFrame': '1 year of follow-up', 'description': 'the Maudsley motivation to change questionnaire'}, {'measure': 'Self-reported self-esteem', 'timeFrame': '1 week post-therapy', 'description': 'Rosenberg self-esteem Questionnaire'}, {'measure': 'Self-reported self-esteem', 'timeFrame': '1 year of follow-up', 'description': 'Rosenberg self-esteem Questionnaire'}, {'measure': 'Flexibility evolution : Trail Making Test (TMT)', 'timeFrame': '1 week post-therapy', 'description': 'Neuropsychological functioning'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anorexia Nervosa', 'Cognitive remediation therapy', 'Randomized clinical trial'], 'conditions': ['Teenager', 'Young Adult', 'Hospitalized', 'Anorexia Nervosa (DSM-IV Revised Criteria)']}, 'referencesModule': {'references': [{'pmid': '33274668', 'type': 'DERIVED', 'citation': 'Maria AS, Barry C, Ringuenet D, Falissard B, Group T, Berthoz S. Subjective cognitive rigidity and attention to detail: A cross-cultural validation of the Detail and Flexibility Questionnaire (DFlex) in a French clinical sample. J Clin Exp Neuropsychol. 2020 Dec;42(10):1059-1071. doi: 10.1080/13803395.2020.1842333. Epub 2020 Dec 4.'}, {'pmid': '27310229', 'type': 'DERIVED', 'citation': 'Maria AS, Bourdier L, Duclos J, Ringuenet D, Berthoz S. Psychometric properties of the French version of a scale measuring perceived emotional intelligence : the Trait Meta-Mood Scale (TMMS). Can J Psychiatry. 2016 Oct;61(10):652-62. doi: 10.1177/0706743716639936. Epub 2016 Mar 28.'}]}, 'descriptionModule': {'briefSummary': '"Clinicians from the Maudsley (IoP, London, UK) have specifically tailored a cognitive remediation therapy (CRT) for treating Anorexia Nervosa (AN). It is an intensive manualised training cognitive therapy which addresses the difficulties in flexibility and holistic processing that have been incriminated in AN. CRT has been found to improve AN\'s neuropsychological functioning and short term outcome. To our knowledge, no French speaking country has tested its effectiveness. Moreover, the question whether it is efficient for both anorexic restrictive and anorexic binge-purging patients remains unanswered.\n\nThe aim of the present study is to determine if CRT in AN adolescents and young adults has a favourable impact on cognitive functioning and clinical status. We will also explore whether the impact of CRT is similar in both anorexic restrictive and binge-purging subtypes. There will also be an Historical Control Group of patients, sixty, who received traditional medical interventions in a specialized inpatient unit for eating disorders (i.e., EVHAN study)."', 'detailedDescription': '"Several studies have documented that patients with Anorexia Nervosa (AN) display a trait of cognitive inflexibility (e;g., poor set-shifting performances on the Trail Making Task B), i.e. an inability to move flexibly back and forth between tasks, operations, or mental sets which allows for the adaptation of behaviour in response to changing demands within the environment. This cognitive inflexibility can be observed both during the acute phase of the illness and after weight restoration, and has been found to predict negative treatment outcomes. \'Weak central coherence\' is another skill which is particularly problematic in AN. It refers to a cognitive style in which information remains fragmented as opposed to integrated, with processing occurring at the level of \'detail\' as opposed to \'whole\'. AN patients exhibit this detail focussed information-processing style (e.g., as measured by the Embedded Figures Test). To treat these difficulties, clinicians from the Institute of Psychiatry (London, UK) have specifically tailored a treatment for AN. Cognitive remediation therapy (CRT) is an intensive training cognitive therapy that encourages people to reflect on and try to modify the way they think, with a particular focus on improving cognitive flexibility. It is a manualised therapist-led intervention consisting of multiple versions of a variety of tasks and mental exercises that address the difficulties in flexibility and holistic processing. CRT is a 10-sessions long program that has been found to improve AN\'s neuropsychological functioning and short term outcome. To our knowledge, no French speaking country has tested its effectiveness. Moreover, the question whether it is efficient for both anorexic restrictive and anorexic binge-purging patients remains unanswered.\n\nTo address these issues, we designed a multicenter randomized clinical trial on the effectiveness of CRT in AN adolescents and young adults.\n\nMain hypothesis: AN patients treated with CRT present a better clinical status than those treated by a control therapy.\n\nRecruitment and Procedure: 120 female adolescents or young adults \\[15-40 years old\\] AN (60 Anorexic Restrictive; 60 Anorexic Binge-Purging) will be recruited among the patients of specialized ED care units of three hospitals: PAUL BROUSSE, INSTITUT MUTUALISTE MONTSOURIS, COCHIN-MAISON DE SOLENN. In each group of AN subtype, the patients will be randomly allocated to one of the two treatment arms: CRT or Sham Therapy (ST). Each therapy is manualised and includes 10 sessions over a period of 5 weeks (2 sessions/week). All the patients will be assessed just prior the beginning and after the end of the CRT/ST, at 6 months and 1 year of follow-up."'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* female;\n* 15-40 years old;\n* hospitalised for a diagnosis of Anorexia Nervosa (DSM-IV Revised criteria) in one of the three departments participating in this research ;\n* fluent in French;\n* who provide their informed consent (or as far as possible their parents for those under 18).\n\nExclusion Criteria:\n\n* previous history of neurological disorders;\n* actual substance use disorder;\n* schizophrenia;\n* presenting a related somatic illness (diabetes, Crohn's disease, metabolic illness) or a life-threatening condition."}, 'identificationModule': {'nctId': 'NCT01772394', 'acronym': 'TreCogAM', 'briefTitle': 'Cognitive Remediation Therapy in Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Cognitive Remediation Therapy Effectiveness in Anorexia Nervosa: a Multicenter Randomized Clinical Study', 'orgStudyIdInfo': {'id': 'RCB-2011-A01280-41'}, 'secondaryIdInfos': [{'id': 'P091123', 'type': 'OTHER', 'domain': 'AP-HP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Remediation Therapy (CRT)', 'description': 'Active : CRT', 'interventionNames': ['Behavioral: Cognitive Remediation Therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Therapy (ST)', 'description': 'Sham : ST', 'interventionNames': ['Behavioral: Sham Therapy']}], 'interventions': [{'name': 'Cognitive Remediation Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['CRT'], 'description': 'Cognitive remediation therapy (CRT) is an intensive training cognitive therapy that encourages people to reflect on and try to modify the way they think, with a particular focus on improving cognitive flexibility. It is a manualised therapist-led intervention consisting of multiple versions of a variety of tasks and mental exercises that address the difficulties in flexibility and holistic processing. CRT is an individual 10-sessions long program (2 sessions per week).', 'armGroupLabels': ['Cognitive Remediation Therapy (CRT)']}, {'name': 'Sham Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['ST'], 'description': 'The Sham therapy (ST) has been designed to match the CRT format: an individual manualised therapist-led 10-sessions long program (2 sessions per week). ST sessions have been designed so as to avoid set-shifting and central coherence training. Rather, ST is a manualised sham intervention consisting of multiple exercises on 3 domains: soft physical activity, emotional expression recognition and interpersonal functioning.', 'armGroupLabels': ['Sham Therapy (ST)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Clinique Villa Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Mutualiste Monsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Maison de Solenn', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '94804', 'city': 'Villejuif', 'country': 'France', 'facility': 'Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Sylvie BERTHOZ, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut National de la Santé Et de la Recherche Médicale, France'}, {'name': 'Damien RINGUENET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}