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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00008107 |
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Date of registration:
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29/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Neural Correlates of Overvaluation of Shape and Weight in Binge Eating Disorder
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Scientific title:
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Neural Correlates of Overvaluation of Shape and Weight in Binge Eating Disorder
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Date of first enrolment:
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22/11/2016 |
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Target sample size:
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60 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00008107 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: No treatment / Standard of care; Assignment: parallel; Study design purpose: basic science
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Stefanie
Biehl |
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Address:
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Schleichstraße 4
72076
Tübingen
Germany |
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Telephone:
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+49 (0)7071 29 77199 |
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Email:
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stefanie.biehl@uni-tuebingen.de |
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Affiliation:
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Eberhard Karls Universität Tübingen |
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Name:
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Sophia Antonia
Press |
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Address:
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Schleichstraße 4
72076
Tübingen
Germany |
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Telephone:
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+49(0) 7071 29-77188 |
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Email:
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sophia-antonia.press@uni-tuebingen.de |
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Affiliation:
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Eberhard Karls Universität Tübingen |
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Key inclusion & exclusion criteria
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Inclusion criteria: Diagnosis of BED according to DSM-V criteria as the primary diagnosis, BMI between 25 and 45, ability and willingness to provide informed consent.
Exclusion criteria: High risk of suicide; Co-occurring psychotic or bipolar disorder, alcohol/substance dependence within the past six months, and/or Borderline Personality Disorder; Medical disorder that would affect weight and/or ability to participate; Insufficient German language skills; Current participation in psychotherapeutic treatment other than that offered in the study; Current participation in a weight-control program; Taking medication that would affect weight; Pregnancy; History of metal or metal fragments in the body (e.g. through accident or traumatic injury); Irremovable medical devices (e.g. pacemaker, cochlea implant); Past head or heart surgery; History of untreated claustrophobia or panic attacks in confined spaces; Non-removable metal attached to the body (e.g. piercings); Large tattoo in the head or neck area and/or tattoo where the use of metallic ink cannot be excluded; No consent to be informed of incidental findings that may come to light as a consequence of participation in the study
Age minimum:
18 Years
Age maximum:
69 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Eating disorder, unspecified
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Binge Eating Disorder
F50.9
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F50.9
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Intervention(s)
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Group 1: Mirror confrontation training - 1 cognitive preparation, 4 mirror exposure sessions (1 session per week for 5 weeks), duration per session between 60 and 90 minutes, Intervention took place in the period from December 2016 to September 2021
Group 2: Waiting list (training after appr. 3 months waiting time)
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Primary Outcome(s)
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Activity in extrastriate and fusiform body areas as well as limbic areas during self-body exposure (assessed with fMRI pre and within two weeks post mirror exposure/waiting period)
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Secondary Outcome(s)
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Self-report data on eating behaviour, body dissatisfaction, and shape/weight concerns (assessed with questionnaires pre and post mirror exposure/waiting period)
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Source(s) of Monetary Support
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Else Kröner-Fresenius-Stiftung
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Ethics review
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Status: Approved
Approval date: 11/06/2015
Contact:
ethik.kommission@med.uni-tuebingen.de
Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
+49-7071-2977661
ethik.kommission@med.uni-tuebingen.de
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