Specific Phobia Clinical Trial
Official title:
Optimizing Exposure in the Treatment of Anxiety in Youth: Facing Fears In-session or Out-session?
Anxiety problems are a major concern of youth mental health given that the prevalence of anxiety disorders in Dutch children aged up to 12 is approximately 4 to 8 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. Yet, despite the empirical evidence of its efficacy, a gap between theory and practice remains, with exposure-based CBT being underused in clinical practice. For example, a recent Dutch survey found that exposure was mostly practiced outside the formal therapy sessions as homework assignment. It is questionable whether this is effective, given that it might be hard for children to do these assignments independently (e.g., without the help of a therapist or their parents). This study therefore proposes to evaluate the effectiveness of different degrees of therapist and parent involvement during exposure, comparing therapist supported exposure with self-supported exposure with and without the use of parents as co-therapists.
Objective: The primary goal of this study is to evaluate whether therapist supported
in-session exposure exercises are more effective than individual out-session exposure
exercises, or parent supported out-session exposure exercises. 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 three parallel groups (intervention
versus intervention versus intervention).
Study population: Children aged 8 to 12 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. In the following two sessions,
that differ per condition, either two therapist-guided in-session exposure exercises or two
self-guided out-session exposure sessions are offered. In the out-session exposure sessions
the child conducts the exposure exercises either with or without the help of a parent. The
intervention will be provided by an experienced mental health professional.
Main study parameters/endpoints (see outcome measures paragraph): The main study parameter is
specific phobia severity. Secondary study parameters are subjective level of fear, fearful
cognitions, bodily tension, avoidance, coping (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, parental fear, parental modelling behaviors, and demographic variables (possible
moderator variables); and credibility and expectancy of the treatment, treatment compliance,
treatment satisfaction, and therapeutic alliance (treatment characteristics).
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