Facing Fears by Focussing on Behaviour, Body, or Mind?
Condition: Social Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Anxiety problems are a major concern of youth mental health given that the prevalence of
      anxiety disorders in Dutch adolescents aged 12 to 18 is approximately 10 percent. In this
      group, social phobia like speech or performance anxiety are among the most common.
      Intervention programs based on the principles of exposure-based Cognitive Behavioral Therapy
      (CBT) have proven to be the most effective and most applied in therapy for social anxiety
      among adolescents. Thus far, research has mainly focused on effectiveness of "intervention
      packages" consisting of multiple CBT elements (i.e., exposure plus cognitive restructuring
      and relaxation exercises). The most common CBT element in current intervention packages for
      anxiety in youth is exposure, which is often only applied after providing the child with
      cognitive restructuring (CR) and relaxation exercises (RE) as preparation for exposure.
      However, although most empirical evidence supports the value of the use of exposure, there is
      hardly empirical evidence for the additional value of CR or RE. In addition, it is unclear
      whether the combination of these elements with exposure is counterproductive compared to the
      use of exposure only. After all, without lengthening the treatment, the addition of CR and/or
      RE will leave the therapist and child with less time to spend on exposure exercises.This
      study proposes to evaluate the effectiveness of these three different types of CBT-elements
      in the treatment of speech/performance anxiety among adolescents.
    

Detailed description: 
      Objective: The primary goal of this study is to evaluate which elements add to the
      effectiveness of current CBT programs. Second, it will be investigated whether the effect of
      exposure is reduced by the addition of cognitive restructuring and relaxation exercises. In
      addition, it will be explored how a given element is effective (i.e., mediation), by
      investigating which dimension of anxiety (approach/avoidance behavior, cognitions or bodily
      tension) is changed by which specific element, in a group of adolescents with the
      performance/public speaking subtype of social phobia.

      Study design: Randomized Controlled Trial with three parallel groups (intervention versus
      intervention versus intervention).

      Study population: Adolescents aged 12 to 15 years with subclinical or higher levels of the
      fear of performance/public speaking subtype of social phobia.

      Intervention: Adolescents will be randomly assigned to one of the three conditions based on
      their age, gender and severity of the social phobia. All adolescents will be offered a
      psycho-education session on anxiety, social phobia and exposure. Following this session
      either four exposure sessions (condition A) or two exposure session and two additional
      sessions are offered. The additional session are either two cognitive restructuring sessions
      (condition B) or two relaxation sessions (condition C). Each session will be given in groups
      consisting of five to eight participants. Every session will take up to an hour and is
      implemented by a psychologist assisted by a master student in psychology, who will receive
      training and supervision by a certified CBT therapist.

      Main study parameters/endpoints (see outcome measures paragraph): The main study parameter is
      level of fear of performance/public speaking symptoms. Secondary study parameters are
      subjective level of fear, fearful cognitions, bodily tension, avoidance, coping (possible
      mediator variables), social phobia diagnosis, speech behavior, and self-efficacy. Tertiary
      study parameters are healthcare costs and quality of life (cost-effectiveness), note:
      cost-effectiveness is assessed for another study. Other study parameters are social phobia
      severity, comorbid anxiety and depression, and demographic variables (possible moderator
      variables); and credibility and expectancy of the treatment, treatment satisfaction, and
      treatment compliance (treatment characteristics).
    

Intervention name(s): Cognitive behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): All conditions start with a psycho-education session (PE). Subsequently, participants in condition A follow four exposure sessions (EX). Participants in condition B follow two cognitive restructuring (CR) followed by two exposure sessions. Participants in condition C follow two relaxation exercises sessions (RE) followed by two exposure sessions. All sessions will take place at their school in a group of five to eight adolescents (week 9,10,11,12,13,14). The sessions will be provided by a psychologist who receives training and supervision by a certified CBT therapist. The psychologist is assisted by a master student in psychology.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment