Facing Fears in Big or Smalls Steps?

Specific Phobia Clinical Trial

Official title: Optimizing Exposure in the Treatment of Anxiety in Youth: Facing Fears in Big or Smalls Steps?

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Specific Phobia

• NCT number: NCT03688373
• Study type: Interventional
• Source: University of Groningen
• Status: Completed
• Phase: N/A
• Start date: October 4, 2017
• Completion date: March 4, 2021