search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Emotion processing in anorexia nervosa: what happens in the brain?


- candidate number15862
- NTR NumberNTR4351
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-dec-2013
- Secondary IDsNL45093 protocol number
- Public TitleEmotion processing in anorexia nervosa: what happens in the brain?
- Scientific TitleEmotion processing in anorexia nervosa: what happens in the brain?
- ACRONYMNA
- hypothesisPrimary Objective:
1) To examine how the brain regions and responses involved in the appraisal of ambiguous affective stimuli differ between anorexia nervosa patients and healthy control participants.

Secondary Objective(s):
To assess how anorexia nervosa patients differ from healthy control participants in terms of: 1) emotion processing, 2) the effects of processing ambiguous affective stimuli on levels of (negative) emotions, 3) the association between measures of emotion processing and emotional and neural responses to ambiguous affective stimuli.
- Healt Condition(s) or Problem(s) studiedAnorexia nervosa, Emotional processing, fMRI, Brain
- Inclusion criteriaAnorexia nervosa participants:
-Diagnosed with AN of ED-NOS-AN (DSM-IV criteria) of ANR (DSM-5 criteria)
-Right-handed
-Female
-Age between 18 and 35 years of age at the day of screening
-BMI below 17.5 kg/m2
-Having written informed consent
-Willing to comply with the study procedures
-Willing to accept use of all anonymized data, including publication, and the confidential use and storage of all data.
-Willing to receive information about chance findings of pathology and approving of the disclosure of this information to the general physician.

Healthy control participants:
-Right-handed
-Female
-Age between 18 and 35 years of age at the day of screening
-Having given written informed consent
-Willing to comply with the study procedures
-Willing to accept use of all anonymized data, including publication, and the confidential use and storage of all data -Willing to receive information about chance findings of pathology
- Exclusion criteriaAnorexia nervosa participants:
-Having a history of or current excessive alcohol consumption (> 28 units per week)
-Having a drug dependency.
-Not having a general practitioner
-Participation in any other clinical trial in the week preceding this study
-Contra-indications to MRI scanning on the basis of the MRI screening form, including:
- Claustrophobia
- Metal objects in the body incompatible with MRI scanning
-Having a history of medical or surgical events that may significantly affect the study outcome, such as brain surgery.
-Working at the group Experimental Psychopathology of the Department of Social Sciences of the Utrecht University, the Image Sciences Institute or the Radiology Department of the UMC Utrecht or Altrecht Eating Disorders Rintveld as employee or student.

Healthy control participants:
-A current or lifetime psychiatric disorder
-Having a history of or current excessive alcohol consumption (> 28 units per week)
-Having a drug dependency.
-Participation in any other clinical trial in the week preceding this study
-Contra-indications to MRI scanning on the basis of the MRI screening form, including:
- Claustrophobia
- Metal objects in the body incompatible with MRI scanning
-Having a history of medical or surgical events that may significantly affect the study outcome, such as brain surgery. -Working at the group Experimental Psychopathology of the Department of Social Sciences of the Utrecht University, the Image Sciences Institute or the Radiology Department of the UMC Utrecht or Altrecht Eating Disorders Rintveld as employee or student.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2014
- planned closingdate31-dec-2015
- Target number of participants30
- InterventionsNot applicable.
- Primary outcomeUpon ambiguous affective stimuli, different brain regions in Anorexia nervosa patients will be activated with different responses compared tot healthy controls.
- Secondary outcomeAnorexia patients differ from healthy controls in terms of (1) emotion processing (ERQ, RME task, PANAS, IUS, BDI, STAI), (2) the effects of processing ambiguous affective stimuli (WOF task), and (3) the association beteen measures of emotion processing and emotional and neuronal esponses to ambiguous affective stimuli
- Timepointsonce
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Lot Sternheim
- CONTACT for SCIENTIFIC QUERIESDr. Lot Sternheim
- Sponsor/Initiator Utrecht University (UU)
- Funding
(Source(s) of Monetary or Material Support)
Neuroscience & Cognition Utrecht
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD11-dec-2013 - 2-feb-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl