Anxiety Disorders Clinical Trial
Official title:
An Investigation of General Predictors for Cognitive Behavioral Therapy Outcome for Anxiety Disorders in a Naturalistic Setting
The aim of this study is to investigate the predictive value of emotion regulation and attentional control for outcome of Cognitive Behavioural Therapy for adults with anxiety disorders in a naturalistic setting.
Anxiety disorders are a pervasive problem, with an estimated 12-month prevalence of 16.6 %,
and they are associated with significant impairment and high social costs. Cognitive
behavioral therapy (CBT) has shown to be effective and for treating of anxiety disorders. CBT
is furthermore cost-effectiveness.This has made CBT the first choice of treatment for anxiety
disorders in many mental health settings around the world. Despite this impressive
evidence-base, a relatively large group of individuals do not benefit from CBT, relapse, or
drop out of treatment. Thus, there is a clear and pressing need to improve the efficacy and
effectiveness of CBT for anxiety disorders. One way in which to improve is to identify
predictors of CBT outcome. In naturalistic clinical settings, identification of prognostic
factors can help allocate resources to those presumed to benefit most from CBT, while also
identifying those who may need additional CBT, adjunctive therapy, or entirely different
treatment to maximize outcomes.
Current knowledge about who is most likely to benefit from CBT is sparse and stems primarily
from well-controlled laboratory settings. These results may not generalize to patient
outcomes in mental health settings, in which patients with more severe and comorbid disorders
are often seen. Thus, naturalistic studies have the potential to significantly increase
knowledge, inform clinical strategies, and thus improve the treatment offered in mental
health settings. Furthermore, existing studies have mostly investigated socio-demographic
factors as predictors of drop-out and non-response. However, these variables have shown to be
either non-significant or inconsistent predictors of outcome. Results concerning comorbidity
as a predictor are also mixed. In sum, knowledge on who is most likely to benefit from CBT is
sparse, and to date no reliable predictors have been identified.
While prior work has primarily emphasized atheoretical predictors, it may prove more fruitful
to focus on predictor variables stemming from psychological theories. Identifying such
predictors can provide direct prognostic information for clinicians. Additionally, these
predictors could also inform the development of adjunctive components of treatment that may
optimize the treatment for those with poorer CBT outcome. Some exciting studies suggest that
such a line of inquiry could yield relevant results.
Maintaining factors is one aspect highlighted by several therapeutic approaches/theories as
crucial for the treatment of anxiety disorders, and accordingly these factors are often the
target of cognitive and behavioral treatments. Emotion regulation and attentional control are
examples of key maintaining factors in anxiety disorders. CBT, which aims to teach patients
cognitive reappraisal of maladaptive cognitions and encourages approach (rather than
avoidance) behavior via cognitive restructuring and exposure, may be more suitable for
patients with certain characteristics. Specifically, recent research and theory suggest that
it is crucial for effective treatment of anxiety disorders that clients learn to tolerate
fear while being exposed to anxiety-provoking stimuli, rather than merely habituating to the
stimuli. Learning to tolerate fear may require emotion regulation skills and the ability to
control attention and this has been supported by recent studies. However, so far only certain
areas of emotion regulation have been investigated and to date never in a naturalistic
setting. Attentional control has never been examined as a predictor of CBT outcomes.
Accordingly, this study is designed to investigate the predictive value of attentional
control and of three facets of emotion regulation skills.
Attentional control There is strong evidence that individuals with anxiety disorders have
biased attention towards threatening stimuli, but there is no consensus as to why these
biases occur. Recent research suggests that it is not the threat bias per se that is
problematic. Rather, individual differences in the ability to voluntarily control attention
may affect the impact of threatening information hence increasing or decreasing the anxiety
symptoms. A potential consequence may be that individuals with low ability to voluntarily
control their attention have difficulties participating in exposure and/or do not progress in
the exposure hierarchy, because the level of anxiety gets too high. This may subsequently
lead to failure to learn that fear is not dangerous or even drop-out of CBT. Furthermore, a
pronounced bias towards irrelevant negative information may take up so many resources that
processing of important, relevant information is hampered, making it difficult to engage in
goal-oriented behavior while experiencing anxiety.
Emotion regulation as predictor Novel theoretical frameworks emphasize that difficulties in
emotion regulation are associated with the development and maintenance of anxiety disorders.
Additionally, emotion regulation skills may be required to engage in and benefit from CBT.
Furthermore, in an attempt to increase effectiveness, several newer treatments have included
emotion regulation training in their treatments protocols.
The present study aims to examine attentional control and three facets of emotion regulation:
1. awareness and understanding of emotions,
2. acceptance of emotions, and
3. the ability to engage in goal-directed behavior, and refrain from impulsive behavior,
when experiencing negative emotions as general predictors of outcome in CBT for anxiety
disorders in a naturalistic, community-based mental health setting.
Our secondary aim is to examine a theoretical variables (i.e., socio-demographic data and
clinical characteristics, such as comorbidity) as predictors of CBT outcome, as these have
yet to be examined as predictors in real-world clinical settings in a mixed anxious sample.
Investigators expect that low ability to control attention will be associated with poorer
treatment outcome. Similarly, it is expected that high scores on emotion dysregulation will
be related to poorer treatment outcome. Given the exploratory nature of this study we will
also be interested in testing non-linear relationships.
Method In order to maximize external validity, investigators are conducting the study within
two real-world treatment clinics and employing minimal exclusion criteria recruiting a sample
with mixed principal anxiety disorders. Patients will be recruited from the two clinics.
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