The primary goal of this study is to evaluate the effectiveness of VR-exposure therapy (VRET) in diminishing anxiety and avoidance within adolescents with social anxiety. We expect that, compared to the within-person baseline and standard treatment…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Participants will complete daily dairies with 3 to 6 idiographic questions
throughout all phases of the treatment. These will consist of the top problems
and goals of the participant, and will be focused on the 1) anxiety
feelings/emotion, 2) cognitions or negative expectations and 3) avoidance
behavior or safety behavior. Parents will also rate the behaviors of the
adolescents in a daily dairy. As these measures are idiographic, it will depend
per participants how the questions are asked, and which questions will be
included.
Secondary outcome
To explore participants' experiences, an interview will be conducted with all
participants and parents at the end of the study to identify how they
experienced VRET, what could be improved and what was already good. This
interview will be semi-structured and conducted by the researchers.
Background summary
Social anxiety disorder (SAD) is most prevalent in adolescence, with a
prevalence rate between 2.0% and 5.7% depending on the diagnostic criteria.
Most of the socially anxious situations that adolescents endure are within the
school environment. Adolescents with higher social anxiety have higher odds of
poorer school functioning and lower aspirations of higher education, and having
SAD is related to more school refusal. First-line treatment for SAD is
cognitive behavioral therapy (CBT), typically with an exposure component, which
has been found to be effective in diminishing social anxious symptoms. Using
virtual reality exposure therapy (VRET) can help to reduce attrition and open
up possibilities for more exposure scenarios. However, there is a lack of
studies in adolescents with SAD, or with anxiety in general, where VRET is
assessed as possible treatment option. The purpose of the current study is to
see whether VRET is effective in diminishing social anxiety in adolescents.
Study objective
The primary goal of this study is to evaluate the effectiveness of VR-exposure
therapy (VRET) in diminishing anxiety and avoidance within adolescents with
social anxiety. We expect that, compared to the within-person baseline and
standard treatment phases, VRET further decreases anxiety and avoidance
behavior. Moreover, we want to explore what changes come first and what changes
will follow with regard to the following modalities that treatment can change.
The secondary objective is to explore the experiences of the clients with VRET
through an semi-structured interview.
Study design
The study is a multiple baseline (MB) single case experimental design (SCED).
The baseline length will be randomly assigned to participants.
Intervention
All participants will follow all 5 phases of the study design: Baseline,
Standard Treatment, VRET, Exposure in vivo and Follow-up. The VRET is the
intervention of interest and trends of symptoms will be compared with the other
phases of the treatment. VRET consists of making a hierarchy of anxious
situations for the participant and selecting the appropriate videos that fit
within the individual hierarchy. During the therapy session, participants will
practice exposure in VR with these videos, going from least to most
frightening.
Study burden and risks
The burden of participants is filling out a daily dairy which would take
approximately one minute to complete per day. Moreover, at the start of each
phase there will be a short questionnaire regarding social anxiety and
avoidance, which takes about 10 to 15 minutes to complete. As the VRET is
already in use in practice and has been shown effective in adult population, we
are not expecting any additional risks in participating in the study.
Warandelaan 2
Tilburg 5037 AB
NL
Warandelaan 2
Tilburg 5037 AB
NL
Listed location countries
Age
Inclusion criteria
1. Aged 12 up to and including 16 years
2. Currently in high school
3. Experiencing social anxiety in the school setting
4. Able to understand, read, write and communicate sufficiently in the Dutch
language
Exclusion criteria
1. Having epilepsy
2. The child has a severe physical impairment, such as deafness or blindness.
3. An IQ<80 as estimated by the therapist or based on information in the
clinical record.
4. The presence of symptoms in more urgent need of treatment (e.g., suicidal
intent/acts, acute psychosis).
5. Starting (new) psychotropic medication in the three months prior to the
start of the study or during the study period.
6. Having received VRET before the start of the study
7. Following other psychological treatment simultaneously to the study (except
for all treatments stated in the study design, such as CBT and systemic
therapy).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL85347.028.23 |