Clinical trial NCT03688360: Facing Fears In-session or Out-session?
Official title: Optimizing Exposure in the Treatment of Anxiety in Youth: Facing Fears In-session or Out-session?
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: 55
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
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 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Aged between 8-12 years old and in primary school
* Sufficient knowledge of the Dutch language
* Meeting the criteria of a 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: 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: During the first intervention week (T2), the second week (T3), and the third week (T4), and one week later at post-intervention assessment (T5), and four weeks later at follow-up assessment (T6)
measure: Change in approach behaviour towards phobic stimulus (Time and distance)
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 self-efficacy (Academic, Social and Emotional)
timeFrame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)
Other outcomes:
measure: Cost-effectiveness (Healthcare costs and In quality adjusted life years)
timeFrame: 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: 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: Change in comorbid anxiety and depression symptoms
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 parental fear (Phobia, Avoidance and Associated anxiety)
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 parental modelling behaviours (Modelling and Reassurance)
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 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
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 compliance to the treatment
timeFrame: During the second intervention week (T3), and the third intervention week (T4), and one week later at post-intervention assessment (T5), and four weeks later at follow-up assessment (T6)]
measure: Therapeutic alliance in the treatment
timeFrame: One week after the last intervention week, at post-intervention assessment (T5)
Locations:
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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