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…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is level of fear ofperformance/public speaking
symptoms.
Secondary outcome
Secondary study parameters are subjective level of fear, fearful cognitions,
bodily tension, avoidance, coping (possible mediator variables), social phobia
diagnosis, approach behavior, and self-efficacy. Tertiary study parameters are
healthcare costs and quality of life (cost-effectiveness). 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, treatment compliance, and
treatment integrity (treatment characteristics).
Background 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 (Nederlands Jeugd Instituut, 2016). 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). 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
(Reynolds, Wilson, Austin, & Hooper, 2012). 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.
Study 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 each three parallel groups (intervention
versus intervention versus intervention).
Intervention
Adolescents will be randomly assigned to one of the three conditions. 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 bya psychologist assisted by a master
student in psychology, who will receive training and supervision by a certified
CBT therapist.
Study burden and risks
The potential value of the current study is that we gain insight in the
effectiveness of three most commonly used CBT elements in the treatment of
social anxiety among adolescents. Regarding this insight we can provide
therapists and teachers with evidence-based recommendations for optimizing
their treatment of adolescents with anxiety disorders. A possible direct
benefit of participating in this study, is that we offer adolescents with
speech or performance anxiety an effective intervention to treat their fear of
public speaking.. A burden for the participating adolescents is that they have
to attend the three assessments and five treatment sessions. However, we will
try to schedule these meetings right after school, to keep this burden
justifiable. In addition, given that five out of the eight meetings (i.e. the
treatment sessions) and a number of questionnaires in the assessments (the
RCADS and SEQ) are part of care as usual, we consider the burden of
participation to be fair. Moreover, the used intervention is less of a burden
that care as usual, given that the current intervention exists of five
sessions, whereas the care as usual intervention consists of twelve sessions.
Therefore, we only consider the additional interviews, questionnaires and
behavioral test during the assessments as a burden for participation. However,
the duration of the assessments is limited to 80 minutes, with a number of
questionnaires shortened to Visual Analogue Scales (VAS). Therefore the burden
for participating in this study is comparable to other studies in the child-
and adolescent psychiatry. In addition, the only risk of participation is
short-lived distress during the exposure exercises. This level of distress will
not exceed stress as experienced when encountering a public speaking situation
in daily life or in regular treatment. In addition, there is a common view that
the marked stigma is one of the major drawbacks in conducting intervention
studies at school. However, a recent study found that a similar program for
depression at school was not associated with marked stigma in absolute terms
(Rapee et al., 2006). We assume that the same holds for providing a program for
speech anxiety at schools. In sum, we are of opinion that this burden and risk
outweigh the potential benefits of less anxious adolescents. Moreover, we
consider the research question most relevant to children and adolescents, since
we cannot be sure whether findings in adults can be generalized to youth. This
means that for answering this question we are restricted to group relatedness.
Grote Kruisstraat 2/1
Groningen 9712 TS
NL
Grote Kruisstraat 2/1
Groningen 9712 TS
NL
Listed location countries
Age
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)
Exclusion criteria
* Absence of permission of legal guardian(s)
* Currently in treatment or receiving medication for anxiety
* Received Cognitive Behavioural Therapy for anxiety in the past 12 months
* Past or current diagnosis of autism/ADHD
* Different or more urgent request for help
* (Risk of) suicidality or suicidal ideation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL60377.042.16 |
Other | wordt aangemeld bij NTR |