Trial Description Organizational Data

DRKS-ID: DRKS00006566
Date of Registration in DRKS: 2014/10/10
Date of Registration in Partner Registry or other Primary Registry: [---]*
PLEASE NOTE: This trial has been registered retrospectively.
Trial Description
Title
Antisaccadic Training to improve food-related impulsivity
Trial Acronym
[---]*
URL of the trial
[---]*
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.
Organizational Data
DRKS-ID: DRKS00006566
Date of Registration in DRKS: 2014/10/10
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee Nr.: 648/2013BO2 , Ethik-Kommission an der Medizinischen
Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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DRKS-ID: DRKS00006566
Date of Registration in DRKS: 2014/10/10
Date of Registration in Partner Registry or other Primary Registry: [---]*
Secondary IDs
Health condition or Problem studied
ICD10: F50.8 - Other eating disorders
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
Characteristics
Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: [---]*
Who is blinded: patient/subject
Control: Placebo
Purpose: Treatment
Assignment: Parallel
Phase: N/A
Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A
Primary Outcome
food related impulsivity: binge eating is examined by Eating-DisorderExamination_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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DRKS-ID: DRKS00006566
Date of Registration in DRKS: 2014/10/10
Date of Registration in Partner Registry or other Primary Registry: [---]*
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.
Countries of recruitment
DE Germany
Locations of Recruitment
University Medical Center Psychosomatische Medizin und Psychotherapie,
Tübingen
Recruitment
Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2014/08/01
Target Sample Size: 20
Monocenter/Multicenter trial: Monocenter trial
National/International: National
Inclusion Criteria
Gender: 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
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DRKS-ID: DRKS00006566
Date of Registration in DRKS: 2014/10/10
Date of Registration in Partner Registry or other Primary Registry: [---]*
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: [---]*
Fax: [---]*
E-mail: [---]*
URL: [---]*
Contact for Scientific Queries
Psychosomatische Medizin und Psychotherapie
Ms. Dr. Dipl. Psych. Katrin Giel
Osianderstraße 5
72076 Tübingen
Germany
Telephone: 07071/ 29-86719
Fax: [---]*
E-mail: katrin.giel at med.uni-tuebingen.de
URL: [---]*
Contact for Public Queries
Psychosomatische medizin und Psychotherapie
Ms. Cant. Psych. Eva Speer
Osianderstraße 5
72076 Tübingen
Germany
Telephone: 07071/86726
Fax: [---]*
E-mail: eva.speer at med.uni-tuebingen.de
URL: [---]*
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
Psychosomatische Medizin und Psychotherapie
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DRKS-ID: DRKS00006566
Date of Registration in DRKS: 2014/10/10
Date of Registration in Partner Registry or other Primary Registry: [---]*
Institutional budget, no external funding (budget of sponsor/PI)
Psychosomatische Medizin und Psychotherapie
72076 Tübingen
Germany
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: [---]*
Status
Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*
Trial Publications, Results and other documents
* This entry means the parameter is not applicable or has not been set.
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