The objectives of the study are to see whether or not ZeroPhobia 1) minimizes symptoms of flying/spider phobias and 2) whether these effects are maintained at follow-up timepoints.The ultimate goal is to judge whether or not ZeroPhobia can be…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The most important outcome measurements are the Fear of Flying Questionnaire,
'Flight Anxiety Situations questionnaire' (FAS; van Gerwen et al., 1999), and
the Fear of Spiders Questionnaire (FSQ, Szymanski & O*Donohue, 1995). The FAS
is a 32-item self-report flight anxiety questionnaire. The anxiety subscale has
a 7-point Likert-scale ('no anxiety' to 'very severe anxiety'). The total score
can be between 0 - 115. The FSQ is a 18-item self report spider anxiety
questionnaire. .
Secondary outcome
- Aviophobia: The self-report Flight Anxiety Modality questionnaire (FAM; van
Gerwen et al., 1999) has 18 items measuring anxiety and anticipation anxiety
symptoms in flight situations. The FAM has a 5-point Likert answering scale
type, from 1 (com-pletely not) to 5 (very intense). The reliability is good
(Nousi et al., 2008).
- Questions related to aviophobia or arachnophobia: duration of the problem,
amount of flights undertaken/interactions with spiders, safety behaviours,
presence of negative flight/spider experiences (at baseline) and questions
about whether participants have taken a flight/interacted with a spider after
ZeroPhobia (post-test, follow-up)
- Arachnophobia: The Spider Phobia Questionnaire (Klorman, Hastings, Weerts,
Mela-med, & Lang, 1974), a 31-item self-report questionnaire for measuring
spider anxiety. This questionnaire is often used for research into spider fear.
The SPQ has been found to be high in internal consistency (Johnsen & Hugdahl,
1990).
-Beck Anxiety Inventory (BAI; Beck et al., 1988) is a 21-item self-report
questionnaire assessing symptoms of anxiety. Patients record how much they have
been bothered by each symptom during the past week, including the day the
questionnaire is admin-istered. Each item is rated on a 4-point Likert scale
ranging from 0 = not at all to 3 = severely: I could barely stand it. The total
score ranges from 0 to 63. The following guidelines are recommended for the
interpretation of scores: 0 * 9, normal or no anx-iety; 10 * 18, mild to
moderate anxiety; 19 * 29, moderate to severe anxiety; and 30 *63, severe
anxiety. Internal consistency is high (0.90 * 0.94) and convergent validity is
good (Brown et al., 1997).
-The nine-item mood module of the Patient Health Questionnaire (PHQ-9; Kroenke
et al, 2007) is used to screen subjects with depressive disorders. The 9 items
are each scored 0 * 3, total score range is 0 * 27. In a review of Wittkampf et
al. (Wittkampf et al., 2007), a sensitivity of 0.77 (0.71 * 0.84) and a
specificity of 0.94 (0.90 * 0.97) was found for the PHQ-9. This questionnaire
will be completed at baseline, post-test and follow-up.
-The Web Screening Questionnaire (WSQ; Donker, van Straten, Marks, and
Cuijpers, 2009) is a 15-item questionnaire aimed to screen for depressive
disorder, alcohol abuse/dependence, GAD, PTSD, social phobia, panic disorder,
agoraphobia, specific phobia, and OCD. Only three items of the WSQ will be
asked for the purposes of this study * panic disorder, agoraphobia, and OCD.
The questionnaire has been found to have both good sensitivity (0.72 * 1.00)
and specificity (0.44 * 0.77) (Donker et al., 2009).
-The Interpersonal Reactivity Index (IRI; Davis, 1980) is a self-report
questionnaire measuring different types of empathy. 7 items from the
sub-section *Fantasy* will be given to participants as baseline. This will be
used to measure general ability to fanta-sized and experience absorption or
transportation into fantasy worlds. This questionnaire has been found to be
reliable and valid (Davis, 1994).
- Demographic variables (gender, age, education level, marital status,
employment status).
- System Usability Scale (SUS; Bangor et al., 2008): 10 items about user
friendliness of the app. The SUS is composed of 10 statements that are scored
on a 5-point scale of strength of agreement. Final scores for the SUS can range
from 0 to 100, where high-er scores indicate better usability. This means that
products that are at least passable have SUS scores above 70, with better
products scoring in the high 70s to upper 80s. Truly superior products score
better than 90. Products with scores less than 70 should be considered
candidates for increased scrutiny and continued improvement and should be
judged to be marginal at best. Reliability is good (Bangor et al. 2008). This
questionnaire will be completed at post-test.
- User-friendliness of ZeroPhobia as a treatment will be in part measured with
the 6- item self-report treatment expectation scale called the
Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000). The CEQ
measures expectations of the participants before the start of the treatment.
This questionnaire will be used alongside the post-test Client Satisfaction
Questionnaire (CSQ; Attkisson & Zwick, 1982) to determine if ZeroPhobia did in
fact meet expectations.
- User-friendliness will also be measured using single item questions directly
asking about the user experience of ZeroPhobia and the realism of the VR
environments. This also includes one open question asking for any other
feedback on the app a participant would like to give.
- Igroup Presence Questionnaire (IPQ; Schubert, Friedmann and Regenbrecht
2001), a 14-item questionnaire, which assess realism and *presence* in the VR
environment. Each of the items has five response categories from fully disagree
(1) to fully agree (5). Chronbach`s alpha is good (* = .73). This
questionnaire along with some open questions about user experience of the VR
environment will be completed at post-test.
- Ecological Momentary Assessment: One question about current anxiety level
during exposure in VR
- Usage data from the ZeroPhobia app: frequency and duration of practice during
expo-sure in VR, frequency and duration of time spent in the modules.
- Flight usage questions, including when was the last time you flew on an
airplane, how many times have you flown in the past 3/12 months and how long
was each of these flights?
- Professional treatment (medication and other psychiatric treatment) will be
asked during the screening process, but also at post-test and follow up
timepoints in order to control for possible other therapeutic effects.
- Negative Effects Questionnaire (NEQ) to asses side effects of psychological
treatments (Rozenthal et al., 2014).
Background summary
Specific phobias, like intense fears of flying (aviophobia) or spiders
(arachnophobia), are the most common forms of psychological disorder world
wide. Specific phobia has a long history of clinic study, and very effective
treatments using exposure therapy exist (Wolitzky*Taylor et al., 2008).
However, because of the high costs, stigma, and long waitlists, access to
evidence based therapy is currently limited. Meta-anlyses about the
effectiveness of virtual reality exposure therapy (VRET) for people with a
specific phobia have shown that VRET is as effective as traditional forms of
exposure therapy (Marino et al, 2015;. Parsons en Rizzo 2008; Powers en
Emmelkamp 2008; Opris et al., 2012). VRET, however, has relatively high costs
and therefore low accessibility to the majority of the population. This project
uses new technology and new scientific developments in order to create an
affordable treatment modality that would be available to everyone anywhere.
ZeroPhobia is a self-help virtual reality (VR) exposure therapy for fear of
flying and fear of spiders that is delivered via a smart phone application
(app) in combination with rudimentary, cardboard VR glasses. Our hypothesis is
that ZeroPhobia will be practical and effective in minimizing symptoms of
anxiety.
Study objective
The objectives of the study are to see whether or not ZeroPhobia 1) minimizes
symptoms of flying/spider phobias and 2) whether these effects are maintained
at follow-up timepoints.The ultimate goal is to judge whether or not ZeroPhobia
can be feasibly released for commercial use. Secondary objectives are to
understand whether ZeroPhobia (3) is user-friendly, (4) if it is effective in
reducing depression and anxiety, (5) to determine whether usage intensity and
presence in the VR environment influences the effects of ZeroPhobia, (6) to
determine whether exposure or evaluating thoughts mediate anxiety outcomes, and
(7) whether ability to fantasize influences the effectiveness of VRET.
Study design
This study will be a randomized controlled trial with two arms: ZeroPhobia
experimental condition and a waitlist control condition.
Intervention
The intervention ZeroPhobia is 6-week self-help VRET for aviophobia and
arachnophobia that is delivered through a smartphone application (app) in
combination with rudimentary cardboard VR glasses. ZeroPhobia includes modules
of psychoeducation, case examples, exposure through VR, cognitive techniques,
monitoring of symptoms, and relapse prevention. Participants in the waitlist
condition will be offered the intervention directly after post-test.
Study burden and risks
Burden of participation consists of completing online baseline questionnaires
(15 minutes) and completing the intervention (6 weeks x 5-20 minutes and daily
exposure for 3 weeks, 10 minutes each). In addition, participants are asked to
complete an online post-intervention evaluation immediately after the
intervention (20 minutes) and, for those in the control condition, and, for
those who received active treatment, a follow-up after 3 and 6 months (15
minutes each). For those in the control group for arachnophobia, participants
will be asked to fill in the primary outcome measure (1-2 minutes) after the
intervention.
There is minimal risk and the burden for participants is limited. The risk of
cyber sickness has been minimized by optimizing the frame rate. In addition,
fast moving objects are not used and test subjects cannot move through the VR
environment very quickly either. The chance of falling is only present when
practicing in the VR environment (after module 3 in the app). The risk of
falling is minimized by safety instructions: they are instructed to hold on to
a solid object and to remove sharp objects in their immediate environment.
Elderly people (> 65 years) who are more vulnerable to falling are excluded
from the study.
The participants are instructed to remove their VR glasses if they experience
cyber sickness, high anxiety, or loss of balance. This will quickly reduce the
symptoms. Should an undesirable effect nevertheless occur, the test subject can
approach the research team by email or telephone for the necessary support.
Van der Boechorststraat 7 7
Amsterdam 1081 BT
NL
Van der Boechorststraat 7 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
- Aviophobia: scoring above 56 on the Flight Anxiety Situations
questionnaire (FAS; van Gerwen et al., 1999; 2018; Nousi et al., 2008)
- Arachnophobia: scoring above 80 on the Fear of Spiders Questionnaire (FSQ;
Szymanski & O*Donohue, 1995)
- between 18-64 years old
- have access to a smart phone and internet
- must live in the Netherlands and have a Dutch telephone number
- willing to participate in the research study and providing informed consent
Exclusion criteria
- have insufficient knowledge of the Dutch language
- *are under current treatment for specific phobia or psychotropic medication
(unless on stable dosage for the previous 3 months and no changes planned
during the study period)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL70238.029.19 |
| OMON | NL-OMON24641 |
| OMON | NL-OMON27993 |