Clinical trial NCT01772394: Cognitive Remediation Therapy in Anorexia Nervosa
Official title: Cognitive Remediation Therapy Effectiveness in Anorexia Nervosa: a Multicenter Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teenager
Young Adult
Hospitalized
Anorexia Nervosa (DSM-IV Revised Criteria)
Keywords: Anorexia Nervosa
Cognitive remediation therapy
Randomized clinical trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2013-01-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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."

Eligibility 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.

Primary outcomes:
measure: Neuropsychological functioning:Wisconsin Sorting Card Test (WSCT)
timeFrame: 1 week post-therapy
measure: Clinical status Evaluation:Morgan and Russell Global Outcome Assessment Scale (GOAS);
timeFrame: up to 1 year of follow-up
Secondary outcomes:
measure: Central coherence
timeFrame: 1 week post-therapy
measure: Nutritional status
timeFrame: 1 week post-therapy
measure: Nutritional status
timeFrame: 6 months of follow-up
measure: Nutritional status
timeFrame: 1 year of follow-up
measure: Self-reported eating disorders symptoms
timeFrame: 1 week post-therapy
measure: Self-reported eating disorders symptoms
timeFrame: 1 year of follow-up
measure: Self-reported Cognitive style;
timeFrame: 1 week post-therapy
measure: Self-reported Cognitive style;
timeFrame: 1 year of follow-up
measure: Self-reported treatment satisfaction
timeFrame: 1 week post-therapy
measure: Self-reported motivation to change
timeFrame: 1 week post-therapy
measure: Self-reported motivation to change
timeFrame: 6 months of follow-up
measure: Self-reported motivation to change
timeFrame: 1 year of follow-up
measure: Self-reported self-esteem
timeFrame: 1 week post-therapy
measure: Self-reported self-esteem
timeFrame: 1 year of follow-up
measure: Flexibility evolution : Trail Making Test (TMT)
timeFrame: 1 week post-therapy
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Villa Montsouris
city: Paris
country: France
facility: Institut Mutualiste Monsouris
city: Paris
country: France
facility: Maison de Solenn
city: Villejuif
country: France
facility: Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Sylvie BERTHOZ, PhD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Damien RINGUENET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maria AS, Barry C, Ringuenet D, Falissard B, Group T, Berthoz S. Subjective cognitive rigidity and attention to detail: A cross-cultural validation of the Detail and Flexibility Questionnaire (DFlex) in a French clinical sample. J Clin Exp Neuropsychol. 2020 Dec;42(10):1059-1071. doi: 10.1080/13803395.2020.1842333. Epub 2020 Dec 4.
citation: 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.