The goal of the study is to examine whether optimal exposure is more effective than CBT as usual in youth with anxiety disorders. The secondary objective is to investigate whether decreases in harm expectancies are predictive of treatment outcome,…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is change in the severity of the anxiety disorder as
measured with the ADIS, a semi-structured clinical interview.
Secondary outcome
Secundary study parameters are decreases in harm expectancies and habituation
of fear and whether these predict treatment outcome.
Background summary
Although exposure based cognitive behaviour therapy (CBT) is effective in
reducing anxiety in youth, there is ample room for improvement. One way to
improve its effectiveness may be to incorporate findings from recent
experimental research regarding underlying mechanisms into the standardised CBT
treatments. While most CBT manuals are based on the assumption that
*habituation*, the experience that anxiety will decrease when confronted with
the feared situation, is responsible for treatment effects, findings from
experimental research are in line with the *inhibitory learning hypothesis*. In
this hypothesis, it is posited that a non-anxiety eliciting association is
formed during CBT which exists parallel to the intact remaining anxiety
eliciting association. In order for CBT to be most effective, the key is to
maximally enhance the non-anxiety association by using various techniques. This
newly adapted version of exposure-based CBT is referred to as *optimal
exposure*.
Study objective
The goal of the study is to examine whether optimal exposure is more effective
than CBT as usual in youth with anxiety disorders. The secondary objective is
to investigate whether decreases in harm expectancies are predictive of
treatment outcome, as predicted by the inhibitory learning hypothesis, and
whether changes in anxiety during exposure are predictive of treatment outcome
as predicted by the habituation hypothesis.
Study design
The study is a multiple-baseline intervention study with children being
randomly assigned to a 2-, 4-, 6- or 8-week waitlist period.
Intervention
Optimal exposure. Youth will be exposed to their fears in a step-by-step
manner. Therapists use a newly adapted CBT treatment protocol and will be
supervised bi-weekly.
Study burden and risks
Patients profit from participation in this study by receiving state-of-the-art
treatment. At pre-treatment, posttreatment and follow-up, the semi-structured
clinical interview ADIS is conducted with youth and parents. This takes 90
minutes maximally. At pre-treatment youth and parents are asked to fill in a
questionnaire which takes 20 minutes. Youth and parents are asked to fill in
questionnaires twice a week during the study (22 weeks in total). Filling in
the questionnaire takes five minutes.
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
* Age between 12-18
* Sufficient knowledge of the Dutch language
* A primary diagnosis of at least one of the following anxiety disorders: separation anxiety, generalized anxiety disorder, or social phobia according to the ADIS
Exclusion criteria
* Absence of permission of legal guardian(s)
* Different and more urgent request for help
* (Risk of) suicidality, psychosis or domestic violence
* Mental retardation
* Use of medication for psychiatric problems
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 | NL65797.091.18 |