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…
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 specific phobia diagnosis of the of the animal,
natural environment, medical, situational or other subtype.
Secondary outcome
Secondary:
Out-session fear
Fearful cognitions
Bodily tension
Avoidance
Coping
In-session fear
In-session harm expectancy
Approach behaviour
Self-efficacy
Other:
Healthcare costs
Quality of life
Specific phobia severity
General comorbidity
Comorbid anxiety and depression
Demographic variables
Credibility and expectancy of the treatment
Treatment satisfaction
Treatment integrity
Therapeutic alliance
Background summary
Anxiety problems are a major concern of youth mental health given that the
prevalence of anxiety disorders in Dutch children ages 8 to 12 is 4-8 percent
and in Dutch adolescents aged 12 to 18 is approximately 10 percent (Nederlands
Jeugd Instituut, 2016). 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 (Wolitzky-Taylora et al. 2008;
Craske, 1999). 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 (Olatunji, Deacon, &
Abramowitz, 2009). 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. Clinicians argue
that 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 (Hedtke, Kendall, & Tiwari, 2009). 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.
Study 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
Singe Blind Randomized Controlled Trial (RCT) with two parallel groups
(intervention versus intervention).
Intervention
Two conditions recieving each three sessions:
A. 1 Psycho-education session (PE) + 2 exposure sessions in big steps working
towards treatment goal
B. 1 PE + 2 EXP sessions in small steps working towards treatment goal
Study burden and risks
The potential value of the current study is that we gain insight in the most
optimal dosage of exposure in the treatment of anxiety in youth. Regarding this
insight we can provide therapists 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 a specific phobia an effective intervention to treat their anxiety
disorder. A possible indirect benefit of participation is that in case the
provided intervention was not sufficient in reducing the specific phobia,
participants will be invited for a re-intake and provided with additional care
at the current or another mental health care center. A burden for the
participating children and their parents is that they have to visit the mental
health care center seven times during participation in this study. However,
given that four out of the seven visits are part of care as usual, we consider
this burden justifiable. It*s the intake, treatment sessions and a number of
questionnaires in the assessments, like the RCADS, SCAS and SEQ, that are part
of care as usual. In addition, the used intervention is less of a burden than
care as usual, given that the current intervention exists of three 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 direct burden for participation. However, the
duration of the assessments is limited to 80 minutes, with a number of
questionnaires shortened to Visuals 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 the feared object or
situation in daily life or in regular treatment. Therefore, we are of opinion
that this burden and risk outweigh the potential benefits of less anxious
children. Moreover, we consider the research question most relevant to
children, and less relevant to adolescents or adults, who generally do not
involve their parents in treatment. 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
• Aged between 8-17 years old and in primary or secondary school • Sufficient
knowledge of the Dutch language • Meeting the criteria of a specific phobia of
the situational or animal subtype either one of the following subtypes: o
Animal: fear of pets, insects, spiders, small reptiles and amphibians, farm
animals, birds o Natural environment: fear of heights, darkness, thunder, fire
o Medical: fear of blood, needles, medical or dental care, injury, choking o
Situational: fear of enclosed places, elevators, escalators, using one specific
type of transportation (cars, buses, trains, ships) o Other: fear of loud
sounds, fireworks, costumed characters, amputated limbs, fruit etc
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 cannot be treated with either
in-session or out-session exposure due to absence of available phobic stimuli,
for example: o Animal: fear of zoo animals o Natural environment: fear of
water, lightning, storms, fires o Medical: fear of invasive medical procedures,
infection, vomiting o Situational: fear of using multiple types of
transportation (cars, buses, trains, ships), plane flights o Other: fear of
open spaces etc. • Different and more urgent request for help • (Risk of)
suicidality, psychosis or domestic violence
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 | NL59986.042.16 |
| Other | wordt aangemeld bij NTR |