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The effectiveness of a serious game for first episode psychotic patients with anxiety symptoms using cognitive bias modification: a randomized controlled trial.


- candidate number15417
- NTR NumberNTR4172
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-sep-2013
- Secondary IDs 
- Public TitleThe effectiveness of a serious game for first episode psychotic patients with anxiety symptoms using cognitive bias modification: a randomized controlled trial.
- Scientific TitleThe effectiveness of a serious game for first episode psychotic patients with anxiety symptoms using cognitive bias modification: a randomized controlled trial.
- ACRONYM
- hypothesisBy playing the serious game 'Bias Blaster', social anxiety and self-stigmatization in people with a first episode of psychosis will decrease.
- Healt Condition(s) or Problem(s) studiedPsychosis, Social anxiety,
- Inclusion criteria- psychotic disorder, according to the MiniSCAN
- social anxiety problems (LSAS score > 30)
- > 18 years
- receiving treatment from the Early Intervention of Psychosis (VIP) team of GGZ Friesland
- sufficient understanding of the Dutch language
- Exclusion criteria- acute suicidality
- severely psychotic
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2013
- planned closingdate30-sep-2015
- Target number of participants100
- InterventionsThe intervention consists of a serious computer game that participants will be playing for 12 weeks, once a week for 30-60 minutes. The game is called 'Bias Blaster' and contains exercizes based on cognitive bias modification-interpretation (CBM-I).
- Primary outcomeSocial anxiety, measured with the Liebowitz Social Anxiety Scale (LSAS).
- Secondary outcomeSelf-stigmatization, measured with the Internalized Stigma of Mental Illness Scale (ISMIS) Gaming experience, measured with the Gaming Experience Questionnaire (GEQ) Depressive symptoms measured with the Beck Depression Inventory (BDI)
- TimepointsIntervention condition: T0: baseline assessment, T12 (12 weeks): outcome assessment, T24: follow-up assessment

Control condition: T0: baseline assessment, T12 (12 weeks): control assessment, T24: control assessment/baseline assessment, T36: outcome assessment, T48: follow-up assessment
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Nynke Boonstra
- CONTACT for SCIENTIFIC QUERIES Nynke Boonstra
- Sponsor/Initiator GGZ Friesland
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- PublicationsN/A
- Brief summaryMany people with a psychotic disorder suffer from social anxiety and self-stigmatization. Research has shown that Cognitive Bias Modification (CBM-I) can be an effective treatment strategy for social anxiety and possibly self-stigmatization. However, only two small scale studies (n=8 and n=32) have investigated the effect of CBM-I on social anxiety in people with a psychotic disorder. Results of these two studies showed some preliminary positive effects. One of the recommendations of the authors of these two studies was to make the exercises of the CBM-I training more interactive and less boring. That is why we developed a serious game in which the CBM-I training could be integrated. The aim of this study is to investigate whether playing this game can have a positive effect on social anxiety and self-stigmatization.
- Main changes (audit trail)
- RECORD13-sep-2013 - 6-dec-2013


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