Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    trecogam
Previous Study | Return to List | Next Study

Cognitive Remediation Therapy in Anorexia Nervosa (TreCogAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01772394
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : January 16, 2017
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE January 17, 2013
First Posted Date  ICMJE January 21, 2013
Last Update Posted Date January 16, 2017
Study Start Date  ICMJE October 2012
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2013)
  • Neuropsychological functioning:Wisconsin Sorting Card Test (WSCT) [ Time Frame: 1 week post-therapy ]
    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); [ Time Frame: up to 1 year of follow-up ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2013)
  • Neuropsychological functioning:Trail Making Test [TMT] B and Wisconsin Sorting Card Test [WSCT] [ Time Frame: 1 week post-therapy ]
    The TMT and 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); [ Time Frame: 1 week post-therapy; 6 months and 1 year of follow-up ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2013)
  • Central coherence [ Time Frame: 1 week post-therapy ]
    Central coherence: Rey figure;
  • Nutritional status [ Time Frame: 1 week post-therapy ]
    body mass index
  • Nutritional status [ Time Frame: 6 months of follow-up ]
    body mass index
  • Nutritional status [ Time Frame: 1 year of follow-up ]
    body mass index
  • Self-reported eating disorders symptoms [ Time Frame: 1 week post-therapy ]
    Eating Disorder Examination Questionnaire and Body Shape Questionnaire
  • Self-reported eating disorders symptoms [ Time Frame: 1 year of follow-up ]
    Eating Disorder Examination Questionnaire and Body Shape Questionnaire
  • Self-reported Cognitive style; [ Time Frame: 1 week post-therapy ]
    Detail and Flexibility Questionnaire
  • Self-reported Cognitive style; [ Time Frame: 1 year of follow-up ]
    Detail and Flexibility Questionnaire
  • Self-reported treatment satisfaction [ Time Frame: 1 week post-therapy ]
    Helping Alliance Questionnaire and Patient Satisfaction Questionnaire
  • Self-reported motivation to change [ Time Frame: 1 week post-therapy ]
    the Maudsley motivation to change questionnaire
  • Self-reported motivation to change [ Time Frame: 6 months of follow-up ]
    the Maudsley motivation to change questionnaire
  • Self-reported motivation to change [ Time Frame: 1 year of follow-up ]
    the Maudsley motivation to change questionnaire
  • Self-reported self-esteem [ Time Frame: 1 week post-therapy ]
    Rosenberg self-esteem Questionnaire
  • Self-reported self-esteem [ Time Frame: 1 year of follow-up ]
    Rosenberg self-esteem Questionnaire
  • Flexibility evolution : Trail Making Test (TMT) [ Time Frame: 1 week post-therapy ]
    Neuropsychological functioning
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2013)
  • Central coherence [ Time Frame: 1 week post-therapy ]
    Central coherence: Rey figure;
  • Nutritional status [ Time Frame: 1 week post-therapy ]
    body mass index
  • Nutritional status [ Time Frame: 6 months and 1 year of follow-up ]
    body mass index
  • Self-reported eating disorders symptoms [ Time Frame: 1 week post-therapy, 6 months and 1 year of follow-up ]
    Eating Disorder Examination Questionnaire and Body Shape Questionnaire
  • Self-reported Cognitive style; [ Time Frame: 1 year of follow-up ]
    Detail and Flexibility Questionnaire
  • Self-reported treatment satisfaction [ Time Frame: 1 week post-therapy ]
    Helping Alliance Questionnaire and Patient Satisfaction Questionnaire
  • Self-reported motivation to change [ Time Frame: 1 week post-therapy, 6 months ans 1 year of follow-up ]
    the Maudsley motivation to change questionnaire
  • self-esteem [ Time Frame: 1 week post-therapy, and 1 year of follow-up ]
    Rosenberg self-esteem Questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Remediation Therapy in Anorexia Nervosa
Official Title  ICMJE Cognitive Remediation Therapy Effectiveness in Anorexia Nervosa: a Multicenter Randomized Clinical Study
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."

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Teenager
  • Young Adult
  • Hospitalized
  • Anorexia Nervosa (DSM-IV Revised Criteria)
Intervention  ICMJE
  • Behavioral: Cognitive Remediation Therapy
    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).
    Other Name: CRT
  • Behavioral: Sham Therapy
    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.
    Other Name: ST
Study Arms  ICMJE
  • Active Comparator: Cognitive Remediation Therapy (CRT)
    Active : CRT
    Intervention: Behavioral: Cognitive Remediation Therapy
  • Sham Comparator: Sham Therapy (ST)
    Sham : ST
    Intervention: Behavioral: Sham Therapy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2013)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01772394
Other Study ID Numbers  ICMJE RCB-2011-A01280-41
P091123 ( Other Identifier: AP-HP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE
Study Director: Sylvie BERTHOZ, PhD Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Damien RINGUENET, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP