Facing Fears in Big or Smalls Steps?
Condition: Specific Phobia
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, specific phobias are among the most common. Cognitive Behavioral Therapy (CBT) with
      exposure as its key ingredient, takes a prominent place in national guidelines for the
      treatment of anxiety disorders. These guidelines are based on empirical support that exposure
      is effective in the treatment of specific phobia. Therapists help phobic adolescents to
      overcome their fear by gradually, step by step, working their way up from less scary
      situations to situations that cause a greater deal of anxiety. Although it is clear that
      exposure is effective, the size of the steps to be taken in this process remains unclear.
      However, there are multiple reasons to assume that one or the other works best. On the one
      hand, adolescents will soon gain trust in their own abilities when taking small steps, which
      enlarges their feeling of self-control (e.g., self-efficacy). On the other hand there is the
      risk that these small steps might be experienced as safety behavior and avoidance, which is
      counterproductive to the essence of exposure (i.e., overcoming the fear) and undermines the
      potential effect. This might result in either a longer treatment or insufficient treatment
      benefits. Considering this risk, and the fact that confrontation with a feared object or
      situation in daily life is also not a step-by-step process, this study proposes to evaluate
      the optimal dosage of exposure, by studying whether exposure in big steps is more effective
      than exposure in small steps.
    

Detailed description: 
      Objective: The primary goal of this study is to evaluate whether exposure in big steps is
      more effective than a small step-by-step approach. The secondary goal is to find child,
      parent and therapist factors that possibly relate to the effectiveness of the exposure
      exercises.

      Study design: Randomized Controlled Trial (RCT) with two parallel groups (intervention versus
      intervention).

      Study population: Adolescents aged 12 to 17 years with a specific phobia of the
      animal/situational subtype.

      Intervention (if applicable): The intervention will be designed as a CBT, a therapy which has
      proven to be effective in treating specific phobia. The intervention consists of three
      individual sessions, each up to 60 minutes long. Each condition starts with a
      psycho-education session on specific phobias and exposure, during which the participants will
      create a fear hierarchy (from 1 as least fearful to 10 as most fearful). Following this
      session either two exposure-in-big-steps or two exposure-in-small-steps sessions are offered.
      In the big steps exposure condition the adolescent moves in three big steps from bottom to
      top (1-5-10) in their fear hierarchy. In the small steps exposure condition the adolescent
      moves in many small steps from bottom to top in their fear hierarchy, for example from 1 to 2
      to 3 to 4 etc. The intervention will be provided by an experienced mental health
      professional.

      Main study parameters/endpoints (see outcome measures paragraph): The main study parameter
      isseverity of the specific phobia. Secondary study parameters are out-session fear, fearful
      cognitions, bodily tension, avoidance, coping, in-session fear, in-session harm expectancy
      (possible mediator variables), approach 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 specific phobiadiagnosis, general
      comorbidity, comorbid anxiety and depression, and demographic variables (possible moderator
      variables); and credibility and expectancy of the treatment, treatment satisfaction,
      treatment integrity and therapeutic alliance (treatment characteristics).
    

Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Each intervention will contain a 60-minute psycho-education session (PE) and two 60-minute exposure sessions (EX), conducted by a mental health professional together with a master student in psychology, who are both weekly supervised by a CBT certified psychologist. In the first (PE) session, participants learn about anxiety, specific phobias and exposure. During this session they will create a fear hierarchy (1 relating to least fearful and 10 indicating most fearful situation), formulate their cognition about the feared object or situation and determine what they want to achieve during treatment (e.g. goal situation). The next two sessions consist of exposure exercises in either big or small steps.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment