Trial document




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  DRKS00000542

Trial Description

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Title

Treatment of Binge eating disorder in adolescents

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Trial Acronym

BEDA study

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URL of the Trial

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Brief Summary in Lay Language

Binge eating disorder is characterized by repeated episodes of binge eating. This disorder is the most common eating disorder, occurs in both sexes and is frequently associated with overweight and obesity. While studies have shown that binge eating disorder in adults can effectively be treated by psychotherapy, evidence for adolescents is largely lacking. For adults with binge eating disorder, cognitive-behavioral therapy is the standard psychological treatment.
In this single-center randomized-controlled trial, the efficacy of a cognitive-behavioral treatment program tailored to adolescents with binge eating disorder is evaluated. Building on evidence-based cognitive-behavioral therapy for adults with binge eating disorder, the program adapted to adolescents aims at establishing healthy eating behaviors that prevent binge eating episodes from occurring and contribute to a stabilization of body weight. Further goals are the development of a positive body image and self-acceptance. Strategies for coping with negative emotions and problem-solving in everyday life are acquired. In addition, the transfer of the learned behaviors into daily routine is supported.
After baseline diagnostics, 60 study participants will be randomized to one of two treatment conditions. Half the participants will immediately start with cognitive-behavioral therapy, the other half will start with therapy after a four-month waiting period. The treatment program includes 20 individual sessions with the adolescent over four months. Additionally, parents are involved in the treatment via coaching. For all participants of both treatment conditions, comprehensive individual diagnostics are conducted at baseline (and for the delayed treatment control condition additionally two months prior to treatment and at the beginning of treatment), mid-treatment, post-treatment, six-months, and 12-months follow-up. It is expected that cognitive-behavioral therapy will significantly reduce binge eating days when compared to the delayed treatment control condition. It is further expected that the specific eating disorder psychopathology, general psychopathology, body weight, quality of life, and self-esteem will be significantly improved.
Positive evaluation of an amendment concernig an increased number of trial participants on 04.06.2014.

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Brief Summary in Scientific Language

Recent research indicates that binge eating is a common and clinically significant condition in youth. About 20-35% adolescents in treatment for overweight suffer from binge eating, and up to 25% present with a full-syndrome binge eating disorder (BED). Binge eating is associated with increased eating disorder and general psychopathology and an increased risk for overweight and obesity.
Controlled studies of CBT generally report substantial reductions in binge eating and most associated problems like comorbid psychopathology and impaired quality of life.
By now, however, there are no treatments available for binge eating in adolescents. Therefore, the goal of this research project is to evaluate in adolescents with BED efficacy of a cognitive-behavioral treatment (CBT) manual – the gold-standard treatment for adults with BED.
In a single-center randomized-controlled efficacy trial, 60 adolescents meeting the DSM-IV-TR criteria of BED will be randomized to CBT (start of treatment after randomization) or a waiting-list (WL) (start of treatment 4 month after randomization) control condition. The individual outpatient treatment for adolescents with BED lasts 4 months and will be comprised of 20 sessions. The manual comprises the following phases: (1) Initial treatment phase for motivational enhancement; (2) Intensive treatment phase including modules on eating behavior, body image, and emotion regulation; (3) Self-management phase for relapse prevention. Patients will prospectively be assessed at baseline (additional assessments for WL: 2 months and directly before start treatment), mid-treatment, post-treatment, six-months and twelve-months follow-up after end of treatment. Results from the planned trial will contribute to the implementation of effective evidence-based treatment of adolescent binge eating in order to prevent excessive weight gain. This clinical trial is based on the hypothesis that because of CBT the number of days with BED can be reduced definitely in comparison to the waiting-list.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00000542
  •   2012/05/22
  •   [---]*
  •   yes
  •   Approved
  •   235-10-23082010, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   10004716:binge eating
  •   F50.8 -  Other eating disorders
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Interventions/Observational Groups

  •   cognitive-behavioral therapy (CBT) over a period of 4 months (20 individual sessions) (start of treatment after randomization)
  •   waiting-list (WL) control condition receive also cognitive-behavioral therapy (CBT) over a period of 4 months (20 individual sessions) (start of treatment 4 month after randomization)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Number of binge eating episodes during the last 28 days before end of treatment (i. e. 4 months after randomization for CBT and WL) using EDE interview (eating disorder examination).

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Secondary Outcome

CBT: basline/randomization=week 0; start of treatment=after randomization; midtreatment=2 months after randomization; end of treatment=4 months after randomisation; follow-up 6 months after end of treatment=10 month after randomisation; follow-up 12 months after end of treatment= 16 months after randomization

WL: baseline/randomization=week 0; additional visits (compared to CBT): 2 months after randomization and before start of treatment (4 months after randomization); start of treatmnet=4 months after randomization; midtreatment=6 months after randomization; end of treatment=8 months after randomization; follow-up 6 monhts after end of treatment=14 months after randomization; follow-up 12 months after end of treatmetn=20 months after randomization

- number of binge eating episodes during the last 28 days before midtreatment (2 months after randomization) using EDE interview
- WL: number of binge eating episodes during the last 28 days before end of treatment (4 months after start of treatment, 8 months after randomisation) using EDE interview
- maintenance in CBT and WL: number of binge eating episodes during the last 28 days before follow-up (6 and 12 months after end of treatment) using EDE interview
- abstinence from binge eating using EDE interview and EDE questionaire at baseline, once a week during treatment and follow-up (6 and 12 months after end of treatment)
- psychopathology using subscales of EDE interview and DEBQ (durtch eating behavior questionnaire) at baseline, midtreatment, end of treatment and follow-up (6 and 12 months after end of treatment)
- psychiatric comorbidity using K-DIPS (children diagnostic interview of psychological disorders) at baseline, end of treatment and follow-up (6 and 12 months after end of treatment)
- severity of depressive symptoms using BDI (Beck-Depression-Inventory) at baseline, midtreatment, end of treatment and follow-up (6 and 12 months after end of treatment)
- self-esteem using RSES (Rosenbergs self esteem scale) at baseline, midtreatment, end of treatment and follow-up (6 and 12 months after end of treatment)
- quality of life using SF-12 questionnaire at baseline, midtreatment, end of treatment and follow-up (6 and 12 months after end of treatment)
- development of BMI (BMI-SDS) at baseline, once a week during treatment and follow-up (6 and 12 months after end of treatment)
- compliance: attendance at treatment, time delay of treatment
- laboratory values - hormones (e. g. Leptin, Ghrelin), Insulin, Glucose, neuro transmitters (e. g. Serotonine)
- epigenetic analyses

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/04/27
  •   73
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   12   Years
  •   20   Years
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Additional Inclusion Criteria

• binge eating disorder according to DSM-IV-TR (with or without objectiv huge amount of food) or according to suggested research criteria of DSM-5 (with or without objectiv huge amount of food) or DSM-5 subthreshold
• informed consent
• age between 12 and 20 years

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Exclusion Criteria

• bulimia nervosa
• major psychiatric comorbidity
• physical diseases that influence weight or eating
• current use of anti-psychotic medication or medication that influence weight
• ongoing psychotherapy
• ongoing hospitalization
• ongoing consecutive weight reduction
• girls or young women during pregnancy or lactation
• non-compliance
• concomitant participation in other interventional clinical trials

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Addresses

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    • IFB AdipositasErkrankungenVerhaltensmedizinUniversitätsklinikum Leipzig AöR
    • Ms.  Prof. Dr. Dipl.-Psych.  Anja  Hilbert 
    • Stephanstr. 9c
    • 04103  Leipzig
    • Germany
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    • IFB AdipositasErkrankungenVerhaltensmedizinUniversitätsklinikum Leipzig AöR
    • Ms.  Prof. Dr. Dipl.-Psych.  Anja  Hilbert 
    • Stephanstr. 9c
    • 04103  Leipzig
    • Germany
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    • IFB AdipositasErkrankungenVerhaltensmedizinUniversitätsklinikum Leipzig AöR
    • Ms.  Prof. Dr. Dipl.-Psych.  Anja  Hilbert 
    • Stephanstr. 9c
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/12/07
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Trial Publications, Results and other Documents

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