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Antisaccadic Training to improve food-related impulsivity

Organizational Data

DRKS-ID:
DRKS00006566
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2014-10-10
Last update in DRKS:
2014-10-10
Registration type:
Retrospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

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.

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.

Health condition or problem studied

ICD10:
F50.8 - Other eating disorders
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
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)
Arm 2:
no training: the task is to let the eyes wandering, everthing else is identic to the experimental group, 4 times in 2 weeks

Endpoints

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
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.

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Placebo
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Psychosomatische Medizin und Psychotherapie Tübingen

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2014-08-01
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
20
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
Female
Minimum Age:
18 Years
Maximum Age:
55 Years
Additional Inclusion Criteria:
older than 18 years Binge Eating Disorder (BED) or subsyndromal BED

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

Addresses

Primary Sponsor

Psychosomatische Medizin und Psychotherapie
72076 Tübingen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Psychosomatische Medizin und Psychotherapie
Dr. Dipl. Psych. Katrin Giel
Osianderstraße 5
72076 Tübingen
Germany
Telephone:
07071/ 29-86719
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Psychosomatische medizin und Psychotherapie
Cant. Psych. Eva Speer
Osianderstraße 5
72076 Tübingen
Germany
Telephone:
07071/86726
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Psychosomatische Medizin und Psychotherapie
Dr. Dipl. Psych. Katrin Giel
Osianderstraße 5
72076 Tübingen
Germany
Telephone:
07071/ 29-86719
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Psychosomatische Medizin und Psychotherapie
72076 Tübingen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2013-11-28
Ethics committee number:
648/2013BO2
Vote of the Ethics Committee:
Approved
Date of the vote:
2014-01-13

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry