Trial document





This trial has been registered retrospectively.
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  DRKS00006566

Trial Description

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Title

Antisaccadic Training to improve food-related impulsivity

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study examines if a training connected with food-related impulsivity is useful as an intervention for patients with Binge Eating Disorder (BED).
There is evidence that patients with BED have an increased level of food-related impulsivity.
The patients perform a computer-based training.
There are 20 study participants with BED or subsyndromal BED.
The aim of the study is to test if the intervention is makeable and if there are evidence for its efficacy.

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Brief Summary in Scientific Language

This study is a proof of concept study. It will be examined if a computer-based training is practicable to improve food-related impulsivity. An experimental group performs an antisaccadic training. These results are compared with a control group which performs a placebo-training.

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Organizational Data

  •   DRKS00006566
  •   2014/10/10
  •   [---]*
  •   yes
  •   Approved
  •   648/2013BO2, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   F50.8 -  Other eating disorders
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Interventions/Observational Groups

  •   Antisaccadic training: participants have to look in the opposite direction to the presented (high caloric food trail) trail (right or left, inbetween fixationcross), four times in 2 weeks (3 times over 4 minutes, 40 trails)
  •   no training: the task is to let the eyes wandering, everthing else is identic to the experimental group, 4 times in 2 weeks
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

food related impulsivity: binge eating is examined by Eating-Disorder-Examination_questionnaire (EDE-Q) basline and after 6 weeks (phone appointment), food Craving is examined by Food Cravings Questionnaire (FCQ) baseline and after 2 weeks, the food trails are examined by the concept of Wanting and Liking baseline and after 2 weeks

proof of concept: experience with recruting/dropouts and evaluation of the training by the participants


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Secondary Outcome

General eating pathology (EDE-Q) and
General impulsivity (Barrat Impulsiveness Scale (BIS-15) and questionnaire of Behavioural Inhibition/Activation System (BIS/BAS)) are examined at the first appointment (baseline).
The analysis of eyemovment is tested exploratory over the whole training.


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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/08/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   55   Years
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Additional Inclusion Criteria

older than 18 years
Binge Eating Disorder (BED) or subsyndromal BED

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Exclusion Criteria

Mental disorder (psychosis, bipolar disorder)
Substance abuse
Suicidality
Pregnancy and breatfeeding
Intake of psychotropic drugs (exception antidepressants: SSRI, SNRI, TZA)
Current psychotherapy to improve BED
Current program to lose weight, current diet, or other tries to reduce weight

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Addresses

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    • Psychosomatische Medizin und Psychotherapie
    • 72076  Tübingen
    • Germany
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    • Psychosomatische Medizin und Psychotherapie
    • Ms.  Dr. Dipl. Psych.  Katrin  Giel 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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    • Psychosomatische medizin und Psychotherapie
    • Ms.  Cant. Psych.  Eva  Speer 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Psychosomatische Medizin und Psychotherapie
    • 72076  Tübingen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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