Cognitive Remediation Therapy in Anorexia Nervosa

Young Adult Clinical Trial

— TreCogAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772394
• Other study ID #: RCB-2011-A01280-41
• Secondary ID: P091123
• Status: Completed
• Phase: N/A
• First received: January 17, 2013
• Last updated: January 13, 2017
• Start date: October 2012
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)."

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Cognitive Remediation Therapy
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 Therapy
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.

Locations

Country	Name	City	State
France	Clinique Villa Montsouris	Paris
France	Institut Mutualiste Monsouris	Paris
France	Maison de Solenn	Paris
France	Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

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