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NCT Number: NCT01772394

Cognitive Remediation Therapy in Anorexia Nervosa

"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)."

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Key information

Age range

15 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Villa Montsouris, Paris, France

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About this study

"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."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Remediation Therapy

Behavioral

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 names: CRT

Sham Therapy

Behavioral

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 names: ST

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Central coherence

    Time frame: 1 week post-therapy

    Central coherence: Rey figure;

  2. Nutritional status

    Time frame: 1 week post-therapy

    body mass index

  3. Nutritional status

    Time frame: 6 months of follow-up

    body mass index

  4. Nutritional status

    Time frame: 1 year of follow-up

    body mass index

  5. Self-reported eating disorders symptoms

    Time frame: 1 week post-therapy

    Eating Disorder Examination Questionnaire and Body Shape Questionnaire

  6. Self-reported eating disorders symptoms

    Time frame: 1 year of follow-up

    Eating Disorder Examination Questionnaire and Body Shape Questionnaire

  7. Self-reported Cognitive style;

    Time frame: 1 week post-therapy

    Detail and Flexibility Questionnaire

  8. Self-reported Cognitive style;

    Time frame: 1 year of follow-up

    Detail and Flexibility Questionnaire

  9. Self-reported treatment satisfaction

    Time frame: 1 week post-therapy

    Helping Alliance Questionnaire and Patient Satisfaction Questionnaire

  10. Self-reported motivation to change

    Time frame: 1 week post-therapy

    the Maudsley motivation to change questionnaire

  11. Self-reported motivation to change

    Time frame: 6 months of follow-up

    the Maudsley motivation to change questionnaire

  12. Self-reported motivation to change

    Time frame: 1 year of follow-up

    the Maudsley motivation to change questionnaire

  13. Self-reported self-esteem

    Time frame: 1 week post-therapy

    Rosenberg self-esteem Questionnaire

  14. Self-reported self-esteem

    Time frame: 1 year of follow-up

    Rosenberg self-esteem Questionnaire

  15. Flexibility evolution : Trail Making Test (TMT)

    Time frame: 1 week post-therapy

    Neuropsychological functioning

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Cognitive Remediation Therapy Effectiveness in Anorexia Nervosa: a Multicenter Randomized Clinical Study

Acronym: TreCogAM

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Jan 21, 2013
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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