The ANTOP study: focal psychodynamic psychotherapy, cognitive-behavioural therapy, and treatment-as-usual in outpatients with anorexia nervosa - a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Anorexia nervosa is a serious eating disorder leading to high morbidity and mortality as a result of both malnutrition and suicide. The seriousness of the disorder requires extensive knowledge of effective treatment options. However,...

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Main Authors: Schauenburg Henning, de Zwaan Martina, Giel Katrin E, Herzog Wolfgang, Teufel Martin, Gross Gaby, Friederich Hans-Christoph, Wild Beate, Schade-Brittinger Carmen, Schäfer Helmut, Zipfel Stephan
Format: Article
Language:English
Published: BMC 2009-04-01
Series:Trials
Online Access:http://www.trialsjournal.com/content/10/1/23
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author Schauenburg Henning
de Zwaan Martina
Giel Katrin E
Herzog Wolfgang
Teufel Martin
Gross Gaby
Friederich Hans-Christoph
Wild Beate
Schade-Brittinger Carmen
Schäfer Helmut
Zipfel Stephan
author_facet Schauenburg Henning
de Zwaan Martina
Giel Katrin E
Herzog Wolfgang
Teufel Martin
Gross Gaby
Friederich Hans-Christoph
Wild Beate
Schade-Brittinger Carmen
Schäfer Helmut
Zipfel Stephan
author_sort Schauenburg Henning
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>Anorexia nervosa is a serious eating disorder leading to high morbidity and mortality as a result of both malnutrition and suicide. The seriousness of the disorder requires extensive knowledge of effective treatment options. However, evidence for treatment efficacy in this area is remarkably weak. A recent Cochrane review states that there is an urgent need for large, well-designed treatment studies for patients with anorexia nervosa. The aim of this particular multi-centre study is to evaluate the efficacy of two standardized outpatient treatments for patients with anorexia nervosa: focal psychodynamic (FPT) and cognitive behavioural therapy (CBT). Each therapeutic approach is compared to a "treatment-as-usual" control group.</p> <p>Methods/Design</p> <p>237 patients meeting eligibility criteria are randomly and evenly assigned to the three groups – two intervention groups (CBT and FPT) and one control group. The treatment period for each intervention group is 10 months, consisting of 40 sessions respectively. Body weight, eating disorder related symptoms, and variables of therapeutic alliance are measured during the course of treatment. Psychotherapy sessions are audiotaped for adherence monitoring. The treatment in the control group, both the dosage and type of therapy, is not regulated in the study protocol, but rather reflects the current practice of established outpatient care. The primary outcome measure is the body mass index (BMI) at the end of the treatment (10 months after randomization).</p> <p>Discussion</p> <p>The study design surmounts the disadvantages of previous studies in that it provides a randomized controlled design, a large sample size, adequate inclusion criteria, an adequate treatment protocol, and a clear separation of the treatment conditions in order to avoid contamination. Nevertheless, the study has to deal with difficulties specific to the psychopathology of anorexia nervosa. The treatment protocol allows for dealing with the typically occurring medical complications without dropping patients from the protocol. However, because patients are difficult to recruit and often ambivalent about treatment, a drop-out rate of 30% is assumed for sample size calculation. Due to the ethical problem of denying active treatment to patients with anorexia nervosa, the control group is defined as "treatment-as-usual".</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN72809357</p>
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spelling doaj.art-336cf17870b440f0be2be37d176db2d92022-12-21T19:59:10ZengBMCTrials1745-62152009-04-011012310.1186/1745-6215-10-23The ANTOP study: focal psychodynamic psychotherapy, cognitive-behavioural therapy, and treatment-as-usual in outpatients with anorexia nervosa - a randomized controlled trialSchauenburg Henningde Zwaan MartinaGiel Katrin EHerzog WolfgangTeufel MartinGross GabyFriederich Hans-ChristophWild BeateSchade-Brittinger CarmenSchäfer HelmutZipfel Stephan<p>Abstract</p> <p>Background</p> <p>Anorexia nervosa is a serious eating disorder leading to high morbidity and mortality as a result of both malnutrition and suicide. The seriousness of the disorder requires extensive knowledge of effective treatment options. However, evidence for treatment efficacy in this area is remarkably weak. A recent Cochrane review states that there is an urgent need for large, well-designed treatment studies for patients with anorexia nervosa. The aim of this particular multi-centre study is to evaluate the efficacy of two standardized outpatient treatments for patients with anorexia nervosa: focal psychodynamic (FPT) and cognitive behavioural therapy (CBT). Each therapeutic approach is compared to a "treatment-as-usual" control group.</p> <p>Methods/Design</p> <p>237 patients meeting eligibility criteria are randomly and evenly assigned to the three groups – two intervention groups (CBT and FPT) and one control group. The treatment period for each intervention group is 10 months, consisting of 40 sessions respectively. Body weight, eating disorder related symptoms, and variables of therapeutic alliance are measured during the course of treatment. Psychotherapy sessions are audiotaped for adherence monitoring. The treatment in the control group, both the dosage and type of therapy, is not regulated in the study protocol, but rather reflects the current practice of established outpatient care. The primary outcome measure is the body mass index (BMI) at the end of the treatment (10 months after randomization).</p> <p>Discussion</p> <p>The study design surmounts the disadvantages of previous studies in that it provides a randomized controlled design, a large sample size, adequate inclusion criteria, an adequate treatment protocol, and a clear separation of the treatment conditions in order to avoid contamination. Nevertheless, the study has to deal with difficulties specific to the psychopathology of anorexia nervosa. The treatment protocol allows for dealing with the typically occurring medical complications without dropping patients from the protocol. However, because patients are difficult to recruit and often ambivalent about treatment, a drop-out rate of 30% is assumed for sample size calculation. Due to the ethical problem of denying active treatment to patients with anorexia nervosa, the control group is defined as "treatment-as-usual".</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN72809357</p>http://www.trialsjournal.com/content/10/1/23
spellingShingle Schauenburg Henning
de Zwaan Martina
Giel Katrin E
Herzog Wolfgang
Teufel Martin
Gross Gaby
Friederich Hans-Christoph
Wild Beate
Schade-Brittinger Carmen
Schäfer Helmut
Zipfel Stephan
The ANTOP study: focal psychodynamic psychotherapy, cognitive-behavioural therapy, and treatment-as-usual in outpatients with anorexia nervosa - a randomized controlled trial
Trials
title The ANTOP study: focal psychodynamic psychotherapy, cognitive-behavioural therapy, and treatment-as-usual in outpatients with anorexia nervosa - a randomized controlled trial
title_full The ANTOP study: focal psychodynamic psychotherapy, cognitive-behavioural therapy, and treatment-as-usual in outpatients with anorexia nervosa - a randomized controlled trial
title_fullStr The ANTOP study: focal psychodynamic psychotherapy, cognitive-behavioural therapy, and treatment-as-usual in outpatients with anorexia nervosa - a randomized controlled trial
title_full_unstemmed The ANTOP study: focal psychodynamic psychotherapy, cognitive-behavioural therapy, and treatment-as-usual in outpatients with anorexia nervosa - a randomized controlled trial
title_short The ANTOP study: focal psychodynamic psychotherapy, cognitive-behavioural therapy, and treatment-as-usual in outpatients with anorexia nervosa - a randomized controlled trial
title_sort antop study focal psychodynamic psychotherapy cognitive behavioural therapy and treatment as usual in outpatients with anorexia nervosa a randomized controlled trial
url http://www.trialsjournal.com/content/10/1/23
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