Clinical trial NCT03688373: Facing Fears in Big or Smalls Steps?
Official title: Optimizing Exposure in the Treatment of Anxiety in Youth: Facing Fears in Big or Smalls Steps?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Specific Phobia
Lead sponsor: University of Groningen
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2018-09-28
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Aged between 12-17 years old and in secondary school
* Sufficient knowledge of the Dutch language
* Meeting the criteria of specific phobia of the situational or animal subtype

Exclusion Criteria:

* Absence of permission of legal guardian(s)
* Currently in treatment or receiving medication for anxiety
* Received CBT for anxiety in the past 12 months
* Specific phobia that do not fall under the situational or animal subtype, for example:

  * Aerophobia: fear of flying
  * Emetophobia: fear of vomiting
  * Hemophobia: fear of blood
  * Hosophobia: fear of infection
  * Astraphobia: fear of lightning
* Different and more urgent request for help
* (Risk of) suicidality, psychosis or domestic violence

Primary outcomes:
measure: Change in specific phobia severity (Interference, number of symptoms and general impression of the psychologist)
timeFrame: Time Frame: At intake (T0), four weeks later at pre-intervention assessment (T1), another four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)
Secondary outcomes:
measure: Change in level of anxiety (Subjective level of fear, Fearful cognitions, Bodily tension, Avoidance and Coping)
timeFrame: Time Frame: In the first treatment session (T2), one week later in the second treatment session (T3), one week later in the third treatment session (T4), and one week later at post-intervention (T5), and four weeks later at follow-up assessment (T6)
measure: Change in approach behaviour (Time and Distance)
timeFrame: Time Frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and four weeks later at follow-up assessment (T6)
measure: Change in self-efficacy (Academic, Social and Emotional)
timeFrame: Time Frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and four weeks later at follow-up assessment (T6)
Other outcomes:
measure: Cost-effectiveness (Healthcare costs and In quality adjusted life years)
timeFrame: Time Frame: At pre-intervention assessment (T1) and eight weeks later at follow-up assessment (T6)
measure: Change in specific phobia diagnosis (Interference, number of symptoms and general impression of the psychologist)
timeFrame: Time Frame: At intake (T0), four weeks later at pre-intervention assessment (T1), another four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)
measure: Comorbid anxiety and depression symptoms
timeFrame: Time Frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)
measure: Change in in-session fear before and after each exposure exercise
timeFrame: During the second (T3) and the third (T4) treatment session
measure: In-session harm expectancy before and after each exposure exercise
timeFrame: During the second (T3) and the third (T4) treatment session
measure: Change in treatment credibility and expectancy of the treatment
timeFrame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)
measure: Change in treatment satisfaction during and after treatment
timeFrame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)
measure: Therapeutic alliance during the treatment
timeFrame: One week after the last intervention week, at post-intervention assessment (T5)
Locations:
city: Drachten
country: Netherlands
facility: Accare Drachten
state: Friesland
city: Leeuwarden
country: Netherlands
facility: Accare Leeuwarden
state: Friesland
city: Groningen
country: Netherlands
facility: Accare Universitair Centrum voor Kinder en Jeugdpsychiatrie
Study officials:
affiliation: University of Groningen
name: Peter de Jong, Prof
role: STUDY_CHAIR
affiliation: University of Groningen
name: Maaike Nauta, Prof
role: STUDY_DIRECTOR
affiliation: University of Groningen
name: Miriam Lommen, Dr
role: STUDY_DIRECTOR
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