Trial document




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  DRKS00000590

Trial Description

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Title

Internet-based therapist-supported intervention for Binge Eating Disorder

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Trial Acronym

[---]*

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URL of the Trial

http://www.stopp-essanfall.de

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Brief Summary in Lay Language

Binge Eating Disorder is characterized by recurrent episodes of binge eating and is often associated with overweight and obesity. Cognitive-behavioural therapy has proved to be very efficient in the therapy of Binge Eating Disorder. Aim of this study is to investigate the efficacy of an Internet-based cognitive-behavioural therapy. Participants engage in 20 writing- or homework-sessions over a period of 4 months. They are provided with regular feedback and support by the therapist

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Brief Summary in Scientific Language

The study aims at evaluating the efficacy and feasibility of a therapist-supported Internet-based cognitive-behavioural intervention for adults suffering of Binge Eating Disorder within a randomized controlled trial comparing this intervention with a waiting-group condition. Patients will be assessed at baseline, mid-treatment, post-treatment, 3-, 6-, 12-, and 24-months follow-up. The treatment modules will concentrate on eating behaviour, body image, and emotion regulation. During a period of 4 months the participants engage in 20 45-minute writing or homework sessions. The therapists provide the participants with feedback about their writings and instructions on how to proceed.

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Organizational Data

  •   DRKS00000590
  •   2010/10/27
  •   [---]*
  •   yes
  •   Approved
  •   281-10-04102010, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  •   U1111-1117-5420 
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Health Condition or Problem studied

  •   F50.9 -  Eating disorder, unspecified
  •   E66 -  Obesity
  •   Binge Eating Disorder
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Interventions/Observational Groups

  •   Experimental intervention: Internet-based therapist-supported cognitive-behavioural therapy for adults with Binge Eating Disorder
  •   Control interventions: waiting list control condition
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Number of binge eating days over the previous 28 days before end of treatment (measured with the German-language version of the Eating Disorder Examination (EDE))

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Secondary Outcome

Number of binge eating days over the previous 28 days before mid-treatment (EDE); number of binge eating days over the previous 28 days before follow-up (3, 6, 12, and 18 months after end of treatment) (EDE); abstinence from binge eating (EDE); other eating disorder symptoms (EDE, DEBQ); weight loss (BMI-SDS); depression and anxiety (BDI, BAI); therapeutic work alliance (patient's and therapist's view) (WAI-S, WAI-T); quality of life (Questionnaire on Life Satisfaction); personality traits (NEO-FFI), self-efficiacy (SWS); compliance

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/04/15
  •   130
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Internet access; meeting the DSM-IV-TR criteria of Binge eating disorder; informed consent

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Exclusion Criteria

current bulimia nervosa; major psychiatric comorbidity; acute risk of suicide; history of psychotic or dissociative symptoms; any severe substance-related abuse or dependence disorder; serious medical condition which influences weight or eating (e.g. type 1 diabetes mellitus or thyroid problems); insufficient knowledge of the German language or illiteracy; currently in psychotherapy; current intake of antipsychiotic or weight-addicting drugs; pregnacy or lactation

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Addresses

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    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Lepizig
    • Ms.  Prof. Dr.   Anette  Kersting 
    • Semmelweisstr. 10
    • 04103  Leipzig
    • Germany
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    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Leipzig
    • Ms.  Dr.  Birgit  Wagner 
    • Semmelweisstr. 10
    • 04103  Leipzig
    • Germany
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    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Leipzig
    • Ms.  Dr.  Birgit  Wagner 
    • Semmelweisstr. 10
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • IFB Adipositas Erkrankungen
    • Liebigstraße 21
    • 04103  Leipzig
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.