The objective of this study is to examine wheter a serious game using cognitive bias modification is effective on anxiety symptoms regarding patients with an autism spectrum disorder.
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Anxiety symptoms measured with LSAS.
Secondary outcome
Game experience measured with GEQ
Background summary
Autism Spectrum Disorders (ASD) are neuropsychiatric disorders which expressin
childhood and penetrate deeply into the development of the adulthood. Comorbid
mental disorders are widespread along ASD. Social anxiety is a common comorbid
disorder in people with ASD. There is no evidence based treatment for social
anxiety in people with ASD. Cognitive therapy appears to be effective.
Cognitive Bias Modification interpretation (CBM-I), a new but evidence-based
intervention in patients with social anxiety disorder, is for patients with an
ASD unknown. Within a recently developed serious game for people with a
psychotic disorder, these CBM-I components were used. We hypothesize that
playing this game by patients with ASD also has an effect in reducing comorbid
social anxiety in this group.
Study objective
The objective of this study is to examine wheter a serious game using cognitive
bias modification is effective on anxiety symptoms regarding patients with an
autism spectrum disorder.
Study design
A randomised controlled trial with a cross over design.
Intervention
The intervention is a serious game using cognitive bias modification designed
to reduce anxiety symptoms.
Study burden and risks
Previous studies on the effect of CBM-I on social anxiety showed no evidence
that the intervention in any way can harm the subject. Subjects receive
explanation of the procedure and the purpose of the investigatio in nadvance.
Subjects are then asked both oral and written informed consent, in accordance
with the applicable rules (Polit, Beck, 2012). Subjects receive time to decide
whether they would like to participate for one week.
Subjects in the control receive treatment as usual. The burden of the study to
the subject is low. there is one assessment of about 60 minutes requested for
the T0 measurement. Too much fora patient it can be split up in two
measurements. A development history and the DSM5 ASD interview is conducted by
default in the diagnosis phase of the developmental clinic and is therefore
already available. Follow-up measurements (after 12 and 24 weeks) takes about
15 minutes.
Benefit from participation in the study for subjects hopefully will be the
decline of social anxiety.
Sixmastraat 2
Leeuwarden 8932 PA
NL
Sixmastraat 2
Leeuwarden 8932 PA
NL
Listed location countries
Age
Inclusion criteria
- An Autism Spectrum disorder (ASS).
- Social anxiety symptoms determined with the LSAS (score > 30)
- > 18 years treated at friesland mental health care.
- sufficient understanding of the Dutch language (especially reading comprehension).
-
Exclusion criteria
- suïciderisk
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54371.042.15 |