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Cognitive bias modification imagery (CBM-I)


- candidate number15958
- NTR NumberNTR4340
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-dec-2013
- Secondary IDsP13.195 
- Public TitleCognitive bias modification imagery (CBM-I)
- Scientific TitleCognitive bias modification for patients with cluster-C personality disorder (CBM-I ST) a pre-therapy
- ACRONYMCBM-I
- hypothesisPrimary Objective:
Is CBM-I successful in changing the cognitive bias in patients with cluster-C personality disorders or personality disorder NOS?

Secondary Objective(s):
Will patients following CBM-I show a significant reduction in symptoms and personality problems?
Can mental flexibility predict successfulness in changing cognitive bias in patients who have underwent the CBM-I?
- Healt Condition(s) or Problem(s) studiedCluster B/C, Personality disorder
- Inclusion criteriaCluster C personality disorders or personality disorders NOS as primary diagnosis
- Exclusion criteria1. Having no computer or Internet/ not able to work with a computer
2. Not able to read/ speak Dutch
3. IQ<80
4. Prior schema therapy for more than 3 months
5. Having ADHD, substance disorder needing detoc, lifeteime psychotic disorder, narcistic, antisocial personality disorder
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate1-jan-2017
- Target number of participants24
- InterventionsAfter a variable baseline period subjects will receive CBM-I via a computer on a daily bases during 2 weeks. The main parameter within this research is the score on the daily measurements; the VAS-MCB and the PANAS. It is to be expected that patients with personality disorder benefit by following the computer task training. The scores are expected to be significantly lower on the VAS-MCB and the PANAS - after the intervention - in comparison to the control condition (baseline condition).
- Primary outcome Is CBM-I successful in changing the cognitive bias in patients with cluster-C personality disorders or personality disorder NOS?
- Secondary outcome Will patients following CBM-I show a significant reduction in symptoms and personality problems?
Can mental flexibility predict successfulness in changing cognitive bias in patients who have underwent the CBM-I?
- TimepointsMultiple baseline design Primary outcome; daily measurements Secondary outcome; 4 timepoints
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. M. F. Vreeswijk, van
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Spinhoven
- Sponsor/Initiator Leiden University Medical Center (LUMC), University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
Investigator initiated trial ( IIT )
- PublicationsN/A
- Brief summaryRationale: The proposed study investigates whether a Cognitive Bias Modification Imagery (CBM-I) intervention will change cognitive biases of patients with cluster-C personality disorders or personality disorder NOS in a more positive way. It is hypothesized that they will end up with having a more positive perspective on who they are, on others and the world around them.
- Main changes (audit trail)
- RECORD30-dec-2013 - 2-feb-2014


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