An Investigation of General Predictors for CBT Outcome for Anxiety Disorders in a Naturalistic Setting
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Cognitive behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): The participants will receive 12-16 sessions of manualized group-based CBT with a maximum of 8 participants in each group. The therapists are trained psychiatrists, psychologists, or nurses under supervision. The treatment manuals are developed by mental health professionals in the Capital Region of Denmark. The treatment program includes traditional CBT components (e.g., psychoeducation, identification of thoughts and feelings, exposure, cognitive restructuring, and relapse prevention).
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with anxiety disorders from outpatient clinics.