search
Back to results

Cognitive Remediation Therapy in Anorexia Nervosa (TreCogAM)

Primary Purpose

Teenager, Young Adult, Hospitalized

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive Remediation Therapy
Sham 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 Teenager focused on measuring Anorexia Nervosa, Cognitive remediation therapy, Randomized clinical trial

Eligibility Criteria

15 Years - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • female;
  • 15-40 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).

Exclusion Criteria:

  • 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.

Sites / Locations

  • Clinique Villa Montsouris
  • Institut Mutualiste Monsouris
  • Maison de Solenn
  • Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Cognitive Remediation Therapy (CRT)

Sham Therapy (ST)

Arm Description

Active : CRT

Sham : ST

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Central coherence
Central coherence: Rey figure;
Nutritional status
body mass index
Nutritional status
body mass index
Nutritional status
body mass index
Self-reported eating disorders symptoms
Eating Disorder Examination Questionnaire and Body Shape Questionnaire
Self-reported eating disorders symptoms
Eating Disorder Examination Questionnaire and Body Shape Questionnaire
Self-reported Cognitive style;
Detail and Flexibility Questionnaire
Self-reported Cognitive style;
Detail and Flexibility Questionnaire
Self-reported treatment satisfaction
Helping Alliance Questionnaire and Patient Satisfaction Questionnaire
Self-reported motivation to change
the Maudsley motivation to change questionnaire
Self-reported motivation to change
the Maudsley motivation to change questionnaire
Self-reported motivation to change
the Maudsley motivation to change questionnaire
Self-reported self-esteem
Rosenberg self-esteem Questionnaire
Self-reported self-esteem
Rosenberg self-esteem Questionnaire
Flexibility evolution : Trail Making Test (TMT)
Neuropsychological functioning

Full Information

First Posted
January 17, 2013
Last Updated
January 13, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
search

1. Study Identification

Unique Protocol Identification Number
NCT01772394
Brief Title
Cognitive Remediation Therapy in Anorexia Nervosa
Acronym
TreCogAM
Official Title
Cognitive Remediation Therapy Effectiveness in Anorexia Nervosa: a Multicenter Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)."
Detailed Description
"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. To address these issues, we designed a multicenter randomized clinical trial on the effectiveness of CRT in AN adolescents and young adults. Main hypothesis: AN patients treated with CRT present a better clinical status than those treated by a control therapy. Recruitment 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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Teenager, Young Adult, Hospitalized, Anorexia Nervosa (DSM-IV Revised Criteria)
Keywords
Anorexia Nervosa, Cognitive remediation therapy, Randomized clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Remediation Therapy (CRT)
Arm Type
Active Comparator
Arm Description
Active : CRT
Arm Title
Sham Therapy (ST)
Arm Type
Sham Comparator
Arm Description
Sham : ST
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation Therapy
Other Intervention Name(s)
CRT
Intervention 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).
Intervention Type
Behavioral
Intervention Name(s)
Sham Therapy
Other Intervention Name(s)
ST
Intervention 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.
Primary Outcome Measure Information:
Title
Neuropsychological functioning:Wisconsin Sorting Card Test (WSCT)
Description
The WSCT are two neuropsychological tests that have been consistently used to highlight poor set-shifting skills in Anorexia nervosa.
Time Frame
1 week post-therapy
Title
Clinical status Evaluation:Morgan and Russell Global Outcome Assessment Scale (GOAS);
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.
Time Frame
up to 1 year of follow-up
Secondary Outcome Measure Information:
Title
Central coherence
Description
Central coherence: Rey figure;
Time Frame
1 week post-therapy
Title
Nutritional status
Description
body mass index
Time Frame
1 week post-therapy
Title
Nutritional status
Description
body mass index
Time Frame
6 months of follow-up
Title
Nutritional status
Description
body mass index
Time Frame
1 year of follow-up
Title
Self-reported eating disorders symptoms
Description
Eating Disorder Examination Questionnaire and Body Shape Questionnaire
Time Frame
1 week post-therapy
Title
Self-reported eating disorders symptoms
Description
Eating Disorder Examination Questionnaire and Body Shape Questionnaire
Time Frame
1 year of follow-up
Title
Self-reported Cognitive style;
Description
Detail and Flexibility Questionnaire
Time Frame
1 week post-therapy
Title
Self-reported Cognitive style;
Description
Detail and Flexibility Questionnaire
Time Frame
1 year of follow-up
Title
Self-reported treatment satisfaction
Description
Helping Alliance Questionnaire and Patient Satisfaction Questionnaire
Time Frame
1 week post-therapy
Title
Self-reported motivation to change
Description
the Maudsley motivation to change questionnaire
Time Frame
1 week post-therapy
Title
Self-reported motivation to change
Description
the Maudsley motivation to change questionnaire
Time Frame
6 months of follow-up
Title
Self-reported motivation to change
Description
the Maudsley motivation to change questionnaire
Time Frame
1 year of follow-up
Title
Self-reported self-esteem
Description
Rosenberg self-esteem Questionnaire
Time Frame
1 week post-therapy
Title
Self-reported self-esteem
Description
Rosenberg self-esteem Questionnaire
Time Frame
1 year of follow-up
Title
Flexibility evolution : Trail Making Test (TMT)
Description
Neuropsychological functioning
Time Frame
1 week post-therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female; 15-40 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie BERTHOZ, PhD
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Damien RINGUENET, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Villa Montsouris
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Institut Mutualiste Monsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Maison de Solenn
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse
City
Villejuif
ZIP/Postal Code
94804
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33274668
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.
Results Reference
derived
PubMed Identifier
27310229
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.
Results Reference
derived

Learn more about this trial

Cognitive Remediation Therapy in Anorexia Nervosa

We'll reach out to this number within 24 hrs