Brief Summary

"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. The 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)."

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

120

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach

1 country

4 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.3 years study duration

Study Start

First participant enrolled

October 1, 2012

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2013

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed

3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed

Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

3.7 years

First QC Date

January 17, 2013

Last Update Submit

January 13, 2017

Conditions

Teenager Young Adult Hospitalized Anorexia Nervosa (DSM-IV Revised Criteria)

Keywords

Anorexia NervosaCognitive remediation therapyRandomized clinical trial

Outcome Measures

Primary Outcomes (2)

Neuropsychological functioning:Wisconsin Sorting Card Test (WSCT)
The WSCT are two neuropsychological tests that have been consistently used to highlight poor set-shifting skills in Anorexia nervosa.
1 week post-therapy
Clinical status Evaluation:Morgan and Russell Global Outcome Assessment Scale (GOAS);
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.
up to 1 year of follow-up

Secondary Outcomes (15)

Central coherence
1 week post-therapy
Nutritional status
1 week post-therapy
Nutritional status
6 months of follow-up
Nutritional status
1 year of follow-up
Self-reported eating disorders symptoms
1 week post-therapy
+10 more secondary outcomes

Study Arms (2)

Cognitive Remediation Therapy (CRT)

ACTIVE COMPARATOR

Active : CRT

Behavioral: Cognitive Remediation Therapy

Sham Therapy (ST)

SHAM COMPARATOR

Sham : ST

Behavioral: Sham Therapy

Interventions

Cognitive Remediation TherapyBEHAVIORAL

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).

Also known as: CRT

Cognitive Remediation Therapy (CRT)

Sham TherapyBEHAVIORAL

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.

Also known as: ST

Sham Therapy (ST)

Eligibility Criteria

Age15 Years - 40 Years

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

female;
years old;
hospitalised for a diagnosis of Anorexia Nervosa (DSM-IV Revised criteria) in one of the three departments participating in this research ;
fluent in French;
who provide their informed consent (or as far as possible their parents for those under 18).

You may not qualify if:

previous history of neurological disorders;
actual substance use disorder;
schizophrenia;
presenting a related somatic illness (diabetes, Crohn's disease, metabolic illness) or a life-threatening condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinique Villa Montsouris

Paris, 75013, France

Location

Institut Mutualiste Monsouris

Paris, 75014, France

Location

Maison de Solenn

Paris, 75014, France

Location

Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse

Villejuif, 94804, France

Location

Related Publications (2)

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: 33274668DERIVED
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.
PMID: 27310229DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

Sylvie BERTHOZ, PhD
Institut National de la Santé Et de la Recherche Médicale, France
STUDY DIRECTOR
Damien RINGUENET, MD
Assistance Publique - Hôpitaux de Paris
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 21, 2013

Study Start

October 1, 2012

Primary Completion

June 1, 2016

Study Completion

January 1, 2017

Last Updated

January 16, 2017

Record last verified: 2017-01

Locations

FR(4)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (15)

Study Arms (2)

Cognitive Remediation Therapy (CRT)

Sham Therapy (ST)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations