Trial document




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  DRKS00007689

Trial Description

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Title

Impulsivity-focused group intervention to reduce binge eating episodes in patients with binge eating disorder

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Trial Acronym

IMPULS

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Binge Eating Disorder (BED) is characterised by recurring episodes of binge eating with a perceived loss of control. Exprimental studies hint that general as well as food-related impulsivity represent a risk factor for BED (cf. Schag, Schönleber et al., 2013; Schag, Teufel et al., 2013).
Accordingly, we propose that a behavioral intervention specifically focusing on impulsivity is able to increase the control about impulsive eating behaviour and thus, reduce binge eating episodes, impulsivity and weight in the longterm.
In this project, we investigate the efficacy of a manualised impulsivity-focused behavioural modification programme for patients with BED in a randomised controlled trial.

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Organizational Data

  •   DRKS00007689
  •   2015/01/14
  •   [---]*
  •   yes
  •   Approved
  •   471/2014BO2, 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

  •   F50.9 -  Eating disorder, unspecified
  •   DSM-5: Binge Eating Disorder
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Interventions/Observational Groups

  •   experimental group: patients with Binge Eating Disorder participating on the impulsivitry-focused behavioural modification programme. This is a group intervention with 8 weekly sessions á 90 minutes, i.e. the duration of the intervention is 8 weeks.
  •   control group: patients with Binge Eating Disorder who do not participate on the impulsivitry-focused behavioural modification programme.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The frequency of binge eating episodes within the last 4 weeks at T0 (at the beginning) and T1 (after 8 weeks (at the end of the training period)), assessed by Item 10 of the Eating Disorder Examaniation Interview (Hilbert & Tuschen-Caffier, 2004)

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Secondary Outcome

Changes between T0 and T1 as well as T1 and T2 (3 months after end of the training period) concerning a) impulsivity: eyetracking variables assessing fodd-related and general impulsivity in the free exploration and antisaccade paradigms, BIS-15 and BIS/BAS questionnaires, b) psychopathology und impulsive eating behaviour by EDE, EDE-Q, BDI II, BMI (kg/m2), DEBQ, YFAS, FCQ-S and FCQ-T, c) Ratings of the valence of the used stimuli in the eye tracking paradigms.
Further, we analyse process questionnaires concerning binge eating episodes and impulsive behaviour, weekly assessed between T0 and T1, i.e. eight times
and an evaluation questionnaire concerning the impulsivity-focused behavioral modification programme.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/03/09
  •   78
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

diagnosis of Binge Eating Disorder according to DSM-5, age about 18, written and informed consent

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Exclusion Criteria

1. current bulimia nervosa, current addictive disorders, psychotic disorders, bipolar I disorder, 2. current suicidality, 3. pregnancy, lactation, 4. somatic disorders influencing eating behaviour or weight with altered medication within the last three weeks, 5. current psychotherapeutic treatment of Binge Eating Disorder

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Addresses

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    • Universitätsklinikum Tübingen, Innere Medizin VI, Psychosomatische Medizin und Psychotherapie
    • Ms.  Dr. rer. nat.  Kathrin  Schag 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Innere Medizin VI, Psychosomatische Medizin und Psychotherapie
    • Ms.  Dr. rer. nat.  Kathrin  Schag 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Innere Medizin VI, Psychosomatische Medizin und Psychotherapie
    • Ms.  Dr. rer. nat.  Kathrin  Schag 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Tübingen, AKF-Programm (Angewandte Klinische Forschung) der Medizinischen Fakultät
    • Geissweg 3
    • 72076  Tübingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/09/30
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Trial Publications, Results and other Documents

  •   Schag, K., Leehr, E. J., Martus, P., Bethge, W., Becker, S., Zipfel, S., Giel, K.E. (2015). Impulsivity-focused group intervention to reduce binge-eating episodes in patients with binge-eating disorder: study protocol of the randomised controlled IMPULS trial. BMJOpen, 5(12), e009445.
  •   Schag, K., Leehr, E.J., Becker, S., Zipfel, S., Giel, K.E. (2016). Impulsivitätsbezogene Verhaltensmodifikation zur Reduktion von Essanfällen bei Patienten mit Binge-Eating-Störung – ein Trainingsprogramm für Gruppen. Psychotherapie, Psychosomatik, Medizinische Psychologie 66(11), 449-454.
  •   Schag, K., Rennhak, S., Leehr, E. J., Skoda, E.-M., Becker, S., Bethge, W., Martus, P., Zipfel, S., Giel, K.E. (in press). IMPULS: Impulsivity-Focused Group Interventionto Reduce Binge Eating Episodes in Patients withBinge Eating Disorder – A Randomised ControlledTrial. Psychother Psychosom.
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