Cognitive Remediation Therapy in Anorexia Nervosa

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Cognitive Remediation Therapy
* Behavioral: Sham Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Remediation Therapy (CRT)<br>Active : CRT | Behavioral: Cognitive Remediation Therapy<br>* 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).<br>* Other names: CRT;|
| Sham Comparator: Sham Therapy (ST)<br>Sham : ST | Behavioral: Sham Therapy<br>* 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.<br>* Other names: ST;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central coherence | Central coherence: Rey figure; | 1 week post-therapy | 
| Nutritional status | body mass index | 1 week post-therapy | 
| Nutritional status | body mass index | 6 months of follow-up | 
| Nutritional status | body mass index | 1 year of follow-up | 
| Self-reported eating disorders symptoms | Eating Disorder Examination Questionnaire and Body Shape Questionnaire | 1 week post-therapy | 
| Self-reported eating disorders symptoms | Eating Disorder Examination Questionnaire and Body Shape Questionnaire | 1 year of follow-up | 
| Self-reported Cognitive style; | Detail and Flexibility Questionnaire | 1 week post-therapy | 
| Self-reported Cognitive style; | Detail and Flexibility Questionnaire | 1 year of follow-up | 
| Self-reported treatment satisfaction | Helping Alliance Questionnaire and Patient Satisfaction Questionnaire | 1 week post-therapy | 
| Self-reported motivation to change | the Maudsley motivation to change questionnaire | 1 week post-therapy | 
| Self-reported motivation to change | the Maudsley motivation to change questionnaire | 6 months of follow-up | 
| Self-reported motivation to change | the Maudsley motivation to change questionnaire | 1 year of follow-up | 
| Self-reported self-esteem | Rosenberg self-esteem Questionnaire | 1 week post-therapy | 
| Self-reported self-esteem | Rosenberg self-esteem Questionnaire | 1 year of follow-up | 
| Flexibility evolution : Trail Making Test (TMT) | Neuropsychological functioning | 1 week post-therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anorexia Nervosa, Cognitive remediation therapy, Randomized clinical trial