Cognitive Remediation Therapy in Anorexia Nervosa (TreCogAM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01772394
First received: January 17, 2013
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

"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)."


Condition Intervention
Adolescent
Young Adult
Hospitalised
Anorexia Nervosa (DSM-IV Revised Criteria)
Behavioral: Cognitive Remediation Therapy
Behavioral: Sham Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Cognitive Remediation Therapy Effectiveness in Anorexia Nervosa: a Multicenter Randomized Clinical Study

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Neuropsychological functioning:Wisconsin Sorting Card Test (WSCT) [ Time Frame: 1 week post-therapy ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 week post-therapy ] [ Designated as safety issue: No ]
    Central coherence: Rey figure;

  • Nutritional status [ Time Frame: 1 week post-therapy ] [ Designated as safety issue: No ]
    body mass index

  • Nutritional status [ Time Frame: 6 months of follow-up ] [ Designated as safety issue: No ]
    body mass index

  • Nutritional status [ Time Frame: 1 year of follow-up ] [ Designated as safety issue: No ]
    body mass index

  • Self-reported eating disorders symptoms [ Time Frame: 1 week post-therapy ] [ Designated as safety issue: No ]
    Eating Disorder Examination Questionnaire and Body Shape Questionnaire

  • Self-reported eating disorders symptoms [ Time Frame: 1 year of follow-up ] [ Designated as safety issue: No ]
    Eating Disorder Examination Questionnaire and Body Shape Questionnaire

  • Self-reported Cognitive style; [ Time Frame: 1 week post-therapy ] [ Designated as safety issue: No ]
    Detail and Flexibility Questionnaire

  • Self-reported Cognitive style; [ Time Frame: 1 year of follow-up ] [ Designated as safety issue: No ]
    Detail and Flexibility Questionnaire

  • Self-reported treatment satisfaction [ Time Frame: 1 week post-therapy ] [ Designated as safety issue: No ]
    Helping Alliance Questionnaire and Patient Satisfaction Questionnaire

  • Self-reported motivation to change [ Time Frame: 1 week post-therapy ] [ Designated as safety issue: No ]
    the Maudsley motivation to change questionnaire

  • Self-reported motivation to change [ Time Frame: 6 months of follow-up ] [ Designated as safety issue: No ]
    the Maudsley motivation to change questionnaire

  • Self-reported motivation to change [ Time Frame: 1 year of follow-up ] [ Designated as safety issue: No ]
    the Maudsley motivation to change questionnaire

  • Self-reported self-esteem [ Time Frame: 1 week post-therapy ] [ Designated as safety issue: No ]
    Rosenberg self-esteem Questionnaire

  • Self-reported self-esteem [ Time Frame: 1 year of follow-up ] [ Designated as safety issue: No ]
    Rosenberg self-esteem Questionnaire

  • Flexibility evolution : Trail Making Test (TMT) [ Time Frame: 1 week post-therapy ] [ Designated as safety issue: No ]
    Neuropsychological functioning


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cognitive Remediation Therapy (CRT)
Active : CRT
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
Sham Comparator: Sham Therapy (ST)
Sham : ST
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

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."

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772394

Contacts
Contact: Sylvie BERTHOZ, PhD +33(0)-156616911 sylvie.berthoz@imm.fr
Contact: Damien RINGUENET, MD +33(0)-145596601 damien.ringuenet@pbr.ap-hop-paris.fr

Locations
France
Institut Mutualiste Monsouris Recruiting
Paris, France, 75014
Principal Investigator: Nathalie GODART, MD         
Maison de Solenn Recruiting
Paris, France, 75014
Principal Investigator: Corinne BLANCHET, MD         
Clinique Villa Montsouris Recruiting
Paris, France, 75013
Contact: Christine Foulon, MD         
Principal Investigator: Christine Foulon, MD         
Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse Recruiting
Villejuif, France, 94804
Contact: Damien RINGUENET, MD    +33(0)-145596601    damien.ringuenet@pbr.ap-hop-paris.fr   
Principal Investigator: Damien RINGUENET, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Sylvie BERTHOZ, PhD Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Damien RINGUENET, MD AP-HP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01772394     History of Changes
Other Study ID Numbers: RCB-2011-A01280-41, P091123
Study First Received: January 17, 2013
Last Updated: April 28, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Anorexia Nervosa
Cognitive remediation therapy
Randomized clinical trial

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014