An interventional study of Behavioral training and verum stimulation and Behavioral training and sham stimulation in Binge-Eating Disorder, sponsored by Prof. Dr. Katrin Giel. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by Prof. Dr. Katrin Giel · Not applicable, Interventional, and Treatment
There is evidence that impairment of impulse regulation is involved in the development and maintenance of eating disorders, especially in Binge Eating Disorder (BED). BED is characterized by recurrent episodes of binge eating with experienced loss of control over eating. Controlling impulsive behaviour, cognitive flexibility, planning and decision making are key abilities of impulse regulation. Some of these impaired cognitive functions are linked to decreased activity of certain brain regions. Transcranial direct current stimulation (tDCS) is a well-established method to alter brain activity. In the current project, we explore if a computer-assisted training programme for patients with BED that is combined with tDCS is feasible and able to ameliorate impulse regulation and impulsive eating behaviour. We hypothesize that the cognitive training programme with additional tDCS will result in a greater decrease of BED symptoms and a stronger increase in impulse regulation skills compared with the cognitive training programme without tDCS by using a placebo stimulation.
Patients with BED form a subgroup of obese patients with a disinhibited eating pattern that is associated with major impairments in cognitive control. The dorsolateral prefrontal cortex (dlPFC) has been identified as a brain region closely tied to cognitive control processes and crucially involved in the control of eating behaviour. This suggests the dlPFC as a target for the modulation of cognitive control processes over eating in BED. This modulation can be achieved by both, a cognitive training task and by noninvasive brain stimulation using tDCS. In studies with healthy normal-weight participants, (1) different cognitive training task enhance control over eating behaviour, (2) tDCS is an effective tool to ameliorate cognitive control processes, and (3) has beneficial effects on motivational aspects of eating behaviour, i.e. food craving. Based on this evidence, we will use a combination of a cognitive control task and tDCS to enhance cognitive control over eating in patients with BED. This is to the best of our knowledge one of the first studies to use tDCS as an intervention to enhance cognitive control over eating in patients with BED.
o Sample size: We will allocate 40 patients in the trial, i.e. 20 patients in each study arm.
o Recruitment: Patients are recruited by announcements, mails to the distributor list of the university hospital, existing databases of patients, and current patients of the university hospital. Patients are screened by a standardized checklist. In- and exclusion criteria are checked during the screening procedure and during the baseline diagnostic before randomisation.
o Standard Operating Procedures: For the recruitment, diagnostic and experimental sessions, Standard Operating Procedures are documented for the experimenter. This includes the order of clinical interviews, questionnaires and operating with the technical measurement instruments. The experimenters are regularly supervised. All adverse events will be listed and severe adverse events will be reported immediately to the PIs.
o Quality assurance plan: Randomized allocation to the stimulation condition (verum vs. sahm) and statistical analyses is done externally by the Institute of Clinical Epidemiology and Applied Biometry, University Tübingen, Germany (ICEAB). Objective technical measurement instruments are mostly used to record data.
o Data checks: Data is recorded mostly by objective technical measurement instruments, so no external monitoring is needed. We will spot check entered questionnaire data, in particular binge eating frequency in the past four weeks will be double checked as this is the primary outcome (PO).
o Source data verification: Data are spot checked by comparing the entries in the source data with the entries in the database. Each PO entry will be double checked. There are pre-defined criteria for entering data into the database.
A data dictionary that contains detailed descriptions of each variable and how to be entered is available.
o Plan for missing data: Missing data and invalid data as well as the reasons will be recorded.
o Statistical analysis plan: A mixed model approach will be used to analyze the PO and secondary outcomes (SOs).
259 studies on the registry are indexed under Binge-Eating Disorder; 54 are open to participants now.
This study's enrollment of 41 is below the median of 75 across 217 interventional studies indexed under Binge-Eating Disorder.
Browse Binge-Eating Disorder studies →This is the only study on the registry with Prof. Dr. Katrin Giel as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This arm consists of the cognitive control training (six sessions) combined with 2mA anodal tDCS over the right dlPFC (F4) during the training for 20 minutes.
Other: Behavioral training and verum stimulation
This arm consists of cognitive control training (six sessions) with sham-tDCS. 2 mA Sham-tDCS (40 seconds of tDCS) is applied to the right dlPFC (F4) before the trainings starts.
Other: Behavioral training and sham stimulation
Cognitive control training and verum tDCS
Cognitive control training and sham tDCS
Binge eating frequency
Change of the frequency of Binge eating episodes in the last 4 weeks according to the Eating Disorder Examination Interview (EDE) between baseline (T0) and diagnostic post assessment (T8). The EDE is a validated semi-structured clinical interview.
Time frame: assessed at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
Binge eating frequency follow-up
Change of the frequency of Binge eating episodes in the last 4 weeks according to EDE between baseline (T0) and 3 months follow up (T9)
Time frame: assessed at baseline (T0) and at 3 months follow-up (T9)
antisaccade task
antisaccade task error rate and latency assessed by eye tracking
Time frame: assessed at baseline (T0), the six training sessions within two weeks (T1-T6) and the post measurement of task performance within one week after the training (T7)
Go/No-Go task
Go/No-Go task task error rate and latency
Time frame: at baseline (T0) and at the post measurement of task performance within one week after the training (T7)
stimulus rating
one self-developed questionnaire including visual analogue scales (0-10 cm) concerning valence, appetite, wanting, liking of the presented stimuli
Time frame: at baseline (T0) and and the post measurement of task performance within one week after the training (T7)
Eating disorder pathology (EDE)
assessed by the Eating Disorder Examination (EDE), Range 0-6 with higer scores indication higer eating disorder pathology
Time frame: assessed at baseline (T0), at diagnostic post assessment four weeks after treatment (T8) and 3 months follow-up (T9)
eating behaviour (TFEQ)
assessed by the Three-factor Eating Questionnaire (TFEQ), Range 0-1 with higher scores indicating more pathological eating behaviour
Time frame: at baseline (T0), at the post measurement of task performance within one week after the training (T7) and at diagnostic post assessment four weeks after treatment (T8)
food craving (FCQ-S)
assessed by the Food Craving Questionnaire, State Version (FCQ-S), Range 1-5 with higher scores indicating higher food craving
Time frame: at baseline (T0), the six training sessions within two weeks (T1-T6) and the post measurement of task performance within one week after the training (T7)
impulsive behaviours per week
assessed by a self-developed process analysis questionnaire, values \> 0 (unlimited frequency) with higher scores indicating more impulsive behaviours per week
Time frame: at baseline (T0), the six training sessions within two weeks (T1-T6), the post measurement of task performance within one week after the training (T7) and at diagnostic post assessment four weeks after treatment (T8)
impulsivity (UPPS)
assessed by the "UPPS Impulsive Behavior Scale" (UPPS), Range 1-4 with higher scores indicating higher impulsivity
Time frame: at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
well-being (WHO-5)
assessed by the "WHO (Five) - Well-being Questionnaire" (WHO-5), Range 0-5 with higher scores indicating higher well-being
Time frame: at baseline (T0), the post measurement of task performance within one week after the training (T7) and at diagnostic post assessment four weeks after treatment (T8)
depressive symptoms (BDI II)
assessed by the Becks Depression Inventory, Version 2 (BDI II), Range 0-3 with higher scores indicating higher depressive symptoms
Time frame: at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
Body Mass Index (BMI)
computed by objectively assessed weight and height
Time frame: at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
acceptance and feasibility
drop-out rate throughout T0 to T9, percentage of included patients from the eligible patients at T0
Time frame: from baseline (T0) throughout all measurement points until 3 months follow-up (T9)
evaluation of the training programme
self-developed questionnaire at T7 (Range 1-5 with higher cores indicating more satisfaction with the training programme)
Time frame: assessed at the post measurement of task performance within one week after the training (T7)
Plan to share: No
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.