The general aim of this project is to better understand the mechanisms involved in safety learning, specifically in adolescents with and without clinical anxiety. First, we aim to investigate differences in vicarious and non-vicarious safety…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are conditioned response (measured by means of skin
conductance response), subjective levels of distress, US expectancy ratings,
anxiety symptoms and quality of life.
Secondary outcome
Other relevant study parameters are susceptibility to peer influence, pubertal
development, perceptions of the observed learning model, and demographics,
measured with questionnaires.
Background summary
Clinical anxiety disorders are one of the most prevalent disorders in modern
society. Exposure-based cognitive behavioral therapy (CBT) has received the
most empirical support for treating anxiety disorders in children and
adolescents, however response rates are still only around 50%. A very important
mechanism for exposure-based CBT is safety learning, in which adolescents have
relatively more difficulty. Tapping into adolescent-specific ports-of-entry,
such as peer influence, might therefore help enhance treatment effectiveness.
In the current study, we will investigate whether peer influence might enhance
adequate safety learning by comparing vicarious safety learning to
non-vicarious safety learning in adolescents with and without clinical anxiety.
Golkar et al. (2013) already showed first evidence that vicarious safety
learning, as compared to non-vicarious safety learning, may be related to more
efficient down regulation of anxiety in an adult population, hence we aim to
replicate these results in two samples: typically developing and clinically
anxious adolescents.
Study objective
The general aim of this project is to better understand the mechanisms involved
in safety learning, specifically in adolescents with and without clinical
anxiety. First, we aim to investigate differences in vicarious and
non-vicarious safety learning. Second, we aim to investigate whether
adolescents with clinical anxiety show delayed safety learning, compared to
typically developing adolescents. Third, we aim to investigate vicarious and
non-vicarious safety learning in relation to CBT treatment outcomes in the
clinical anxiety group.
Study design
The current study is a within x between subjects design. Participants are
randomly assigned to the vicarious non-vicarious safety learning condition. We
will compare the effects of vicarious versus non-vicarious safety learning, as
measured physically (by means of skin conductance response) and subjectively
(self-reported level of distress and US expectancy ratings). We will compare
two groups: clinical anxiety and typically developing adolescents. Lastly, in
the clinical anxiety group, the relation between safety learning (physical and
subjective) and treatment effectiveness of CBT treatment as usual (by means of
reduction in anxiety symptoms), is investigated on within subject level.
Study burden and risks
The burden to participants is considered to be minimal, as the study consists
only of questionnaires and one behavioural task. For the typically developing
adolescents, the study consists of one session, which includes the safety
learning task and questionnaires. For the clinically anxiety group, the study
consists of six sessions. The first session is equal to the typically
developing group, consisting of the safety learning task and questionnaires.
The other five session consists of questionnaires that are conducted during and
after treatment as usual. All session will take between 20-60 minutes. Risk of
participation is also considered to be minimal, because the behavioural task is
based on validated safety learning paradigms used with children and adolescents
(Britton et al., 2013; Lau et al., 2011;), and in clinically anxious
adolescents (Lau et al., 2008; Waters, Henry & Neumann, 2009), which were shown
to be safe to use.
Sint Jorisweg 2
Delft 2612 GA
NL
Sint Jorisweg 2
Delft 2612 GA
NL
Listed location countries
Age
Inclusion criteria
Typically developing adolescents
- Sufficiency in the Dutch language
- In between age 12 to 18 years old
For the clinical anxiety group, the following additional inclusion criteria are
in place:
- Diagnosed with a clinical anxiety disorder
- Awaiting the start of CBT treatment for their anxiety disorder, or recently
started CBT treatment but not yet received exposure therapy.
- Not currently receiving other forms of treatment for anxiety
Exclusion criteria
For the clinical anxiety group, the following additional exclusion criteria are
in place:
- Current PTSD diagnosis
- Current autism spectrum disorder diagnosis
- Current use of psychotropic medications (unless they quit 24 hours before
participation). For this criterium, a consult with the general practitioner or
the psychiatrist is needed before participants can enroll.
For the typically developing group, the following additional exclusion
criterium is in place:
- Any current or past diagnosed psychiatric disorders
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL87055.058.24 |