Cognitive Remediation Therapy in Anorexia Nervosa

Not Applicable

Completed

• Conditions: Anorexia Nervosa (DSM-IV Revised Criteria); Young Adult; Teenager; Hospitalized
• Interventions: Behavioral: Cognitive Remediation Therapy; Behavioral: Sham Therapy

• Registration Number: NCT01772394
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-17
• Study First Posted: 2013-01-21
• Primary Completion: 2016-06
• Status Verified: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Remediation Therapy (CRT)	Cognitive Remediation Therapy	Active : CRT
Sham Therapy (ST)	Sham Therapy	Sham : ST

Primary Outcome Measures

Name	Time	Method
Neuropsychological functioning:Wisconsin Sorting Card Test (WSCT)	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);	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 Outcome Measures

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

Trial Locations

Locations (4)

Maison de Solenn; 🇫🇷 Paris, France

Clinique Villa Montsouris; 🇫🇷 Paris, France

Institut Mutualiste Monsouris; 🇫🇷 Paris, France

Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse; 🇫🇷 Villejuif, France