Clinical trial NCT03711513: Facing Fears by Focussing on Behaviour, Body, or Mind?
Official title: Core Elements of Cognitive Behavioural Therapy in Treating Speech Anxiety in Youth: Facing Fears by Focussing on Behaviour, Body, or Mind?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Lead sponsor: University of Groningen
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2018-10-18
Enrollment: 65
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
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, social phobia like speech or performance anxiety are among the most common. Intervention programs based on the principles of exposure-based Cognitive Behavioral Therapy (CBT) have proven to be the most effective and most applied in therapy for social anxiety among adolescents. Thus far, research has mainly focused on effectiveness of "intervention packages" consisting of multiple CBT elements (i.e., exposure plus cognitive restructuring and relaxation exercises). The most common CBT element in current intervention packages for anxiety in youth is exposure, which is often only applied after providing the child with cognitive restructuring (CR) and relaxation exercises (RE) as preparation for exposure. However, although most empirical evidence supports the value of the use of exposure, there is hardly empirical evidence for the additional value of CR or RE. In addition, it is unclear whether the combination of these elements with exposure is counterproductive compared to the use of exposure only. After all, without lengthening the treatment, the addition of CR and/or RE will leave the therapist and child with less time to spend on exposure exercises.This study proposes to evaluate the effectiveness of these three different types of CBT-elements in the treatment of speech/performance anxiety among adolescents.

Detailed description: Objective: The primary goal of this study is to evaluate which elements add to the effectiveness of current CBT programs. Second, it will be investigated whether the effect of exposure is reduced by the addition of cognitive restructuring and relaxation exercises. In addition, it will be explored how a given element is effective (i.e., mediation), by investigating which dimension of anxiety (approach/avoidance behavior, cognitions or bodily tension) is changed by which specific element, in a group of adolescents with the performance/public speaking subtype of social phobia.

Study design: Randomized Controlled Trial with three parallel groups (intervention versus intervention versus intervention).

Study population: Adolescents aged 12 to 15 years with subclinical or higher levels of the fear of performance/public speaking subtype of social phobia.

Intervention: Adolescents will be randomly assigned to one of the three conditions based on their age, gender and severity of the social phobia. All adolescents will be offered a psycho-education session on anxiety, social phobia and exposure. Following this session either four exposure sessions (condition A) or two exposure session and two additional sessions are offered. The additional session are either two cognitive restructuring sessions (condition B) or two relaxation sessions (condition C). Each session will be given in groups consisting of five to eight participants. Every session will take up to an hour and is implemented by a psychologist assisted by a master student in psychology, who will receive training and supervision by a certified CBT therapist.

Main study parameters/endpoints (see outcome measures paragraph): The main study parameter is level of fear of performance/public speaking symptoms. Secondary study parameters are subjective level of fear, fearful cognitions, bodily tension, avoidance, coping (possible mediator variables), social phobia diagnosis, speech 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 social phobia severity, comorbid anxiety and depression, and demographic variables (possible moderator variables); and credibility and expectancy of the treatment, treatment satisfaction, and treatment compliance (treatment characteristics).

Eligibility criteria: Inclusion Criteria:

* Adolescents are aged between 12-15 years old
* Sufficient knowledge of the Dutch language
* Subclinical or higher level of the fear of performance/public speaking subtype of social phobia (SPAI-C PPF score \>6 (MEAN + 1 SD); Beidel, 1996)

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
* Past or current diagnosis of ASS/ADHD
* Different or more urgent request for help
* (Risk of) suicidality or suicidal ideation (as evidenced by checking CDI item 9 score \>1 and confirmation in the ADIS interview)

Primary outcomes:
measure: Change in fear of performance/public speaking symptoms
timeFrame: At screening (T0), 6 weeks later at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)
Secondary outcomes:
measure: Change in level of anxiety
timeFrame: Weekly during the five intervention weeks (T2, T3, T4, T5, T6), and one week after the last intervention sessies at post-intervention assessment (T7), and then six weeks later at follow-up assessment (T8)
measure: Change in social phobia diagnosis
timeFrame: at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)
measure: Change in speech behavior
timeFrame: at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)
measure: Change in self-efficacy
timeFrame: at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)
Other outcomes:
measure: Change in cost-effectiveness
timeFrame: At pre-intervention assessment (T1) and 6 weeks after the intervention at follow-up assessment (T8)
measure: Change in severity of the social phobia
timeFrame: at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)
measure: Change in comorbid anxiety and depression
timeFrame: at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)
measure: Change in treatment credibility and expectancy
timeFrame: at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)
measure: Change in treatment satisfaction
timeFrame: at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)
measure: Change in compliance
timeFrame: Weekly during the five intervention weeks (T2, T3, T4, T5, T6), and one week after the last intervention session at post-intervention assessment (T7), and then six weeks later at follow-up assessment (T8)
Locations:
city: Leek
country: Netherlands
facility: RSG De Borgen Lindenborg
state: Groningen
city: Zwolle
country: Netherlands
facility: Greijdanus College
state: Overijssel
city: Groningen
country: Netherlands
facility: Gomarus College
city: Groningen
country: Netherlands
facility: CSG Augustinus
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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