Overview

This trial is active, not recruiting.

Conditions teenager, young adult, hospitalized, anorexia nervosa (dsm-iv revised criteria)
Treatments cognitive remediation therapy, sham therapy
Sponsor Assistance Publique - Hôpitaux de Paris
Collaborator Institut National de la Santé Et de la Recherche Médicale, France
Start date October 2012
End date June 2016
Trial size 120 participants
Trial identifier NCT01772394, P091123, RCB-2011-A01280-41

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)."

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Active : CRT
cognitive remediation therapy CRT
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).
(Sham Comparator)
Sham : ST
sham therapy ST
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.

Primary Outcomes

Measure
Neuropsychological functioning:Wisconsin Sorting Card Test (WSCT)
time frame: 1 week post-therapy
Clinical status Evaluation:Morgan and Russell Global Outcome Assessment Scale (GOAS);
time frame: up to 1 year of follow-up

Secondary Outcomes

Measure
Central coherence
time frame: 1 week post-therapy
Nutritional status
time frame: 1 week post-therapy
Nutritional status
time frame: 6 months of follow-up
Nutritional status
time frame: 1 year of follow-up
Self-reported eating disorders symptoms
time frame: 1 week post-therapy
Self-reported eating disorders symptoms
time frame: 1 year of follow-up
Self-reported Cognitive style;
time frame: 1 week post-therapy
Self-reported Cognitive style;
time frame: 1 year of follow-up
Self-reported treatment satisfaction
time frame: 1 week post-therapy
Self-reported motivation to change
time frame: 1 week post-therapy
Self-reported motivation to change
time frame: 6 months of follow-up
Self-reported motivation to change
time frame: 1 year of follow-up
Self-reported self-esteem
time frame: 1 week post-therapy
Self-reported self-esteem
time frame: 1 year of follow-up
Flexibility evolution : Trail Making Test (TMT)
time frame: 1 week post-therapy

Eligibility Criteria

Female participants from 15 years up to 40 years old.

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.

Additional Information

Official title Cognitive Remediation Therapy Effectiveness in Anorexia Nervosa: a Multicenter Randomized Clinical Study
Principal investigator Damien RINGUENET, MD
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."
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.